tag:blogger.com,1999:blog-73765172741296495412024-03-13T13:20:17.503-07:00Prostate Cancer MedicationTony Musgrave (aka tony pcm)http://www.blogger.com/profile/11994182692767580358noreply@blogger.comBlogger7125tag:blogger.com,1999:blog-7376517274129649541.post-87940580350279148962014-05-06T01:25:00.002-07:002014-05-06T01:26:49.060-07:0005 May, 2014 - THINGS ARE MOVING A BIT - 1. Petition Signature List has been presented to the Minister - 2. PBAC to consider a PBS subsidy but it is NOT ENOUGH!<span style="font-family: Times New Roman;">
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<span style="font-size: 11pt; mso-bidi-font-family: Arial;"> <span style="font-size: 11pt; mso-bidi-font-family: Arial;">EVEN
MORE PUBLIC INPUT IS VITAL OR MANY WILL STILL BE DENIED THIS ESSENTIAL DRUG.
This updates my last post dated </span><st1:date day="7" month="4" year="2014"><span style="font-size: 11pt; mso-bidi-font-family: Arial;">7 April, 2014</span></st1:date><span style="font-size: 11pt; mso-bidi-font-family: Arial;">. In providing the
following analysis I am motivated by a greater sense of urgency than ever
before.<span style="mso-spacerun: yes;"> </span>My own cancer has spread widely
throughout my body as a result of failure of ADT therapy. I learned this bad
news only last month. I have already started treatment on chemotherapy
(Docetaxel) myself.<span style="mso-spacerun: yes;"> </span><o:p></o:p></span><br />
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<b style="mso-bidi-font-weight: normal;"><span style="font-size: 11pt; mso-bidi-font-family: Arial;"><o:p> </o:p></span></b></div>
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<span style="font-size: 11pt; mso-bidi-font-family: Arial;">There
are two new events to note and one represents a new opportunity to move our
case forward:<o:p></o:p></span></div>
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<span style="font-size: 11pt; mso-bidi-font-family: Arial;"><o:p> </o:p></span></div>
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<span style="font-size: 11pt; mso-bidi-font-family: Arial;">1.
Last </span><st1:date day="1" month="5" year="2014"><span style="font-size: 11pt; mso-bidi-font-family: Arial;">Thursday, 01 May, 2014</span></st1:date><span style="font-size: 11pt; mso-bidi-font-family: Arial;"> I submitted a copy of our
Petition with a list of 5946 signatures and all the comments to date to a
Ministerial Adviser. I have been assured the Petition will receive the
Minister's personal consideration. While I continue to urge new supporters to
add their signatures to this petition at <a href="http://chn.ge/QsuSHc"><span style="mso-bidi-font-family: "Times New Roman";"><span style="color: blue;">http://chn.ge/QsuSHc</span></span></a>
. I believe it's time to step up the tempo to obtain maximum impact. <o:p></o:p></span></div>
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<span style="font-size: 11pt; mso-bidi-font-family: Arial;"><o:p> </o:p></span></div>
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<span style="font-size: 11pt; mso-bidi-font-family: Arial;">2.
The current restrictions on abiraterone (Zytiga) are now under reconsideration.
PUBLIC SUBMISSIONS to the Pharmaceutical Benefits Advisory Committee (PBAC) for
consideration at its July, 2014 meeting have been invited by the committee. <o:p></o:p></span></div>
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<span style="font-size: 11pt; mso-bidi-font-family: Arial;">The
PBS listing request <span style="color: black;">before the PBAC for consideration
at its July, 2014 Meeting reads (see details:<span style="mso-spacerun: yes;">
</span><a href="http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/agenda/07-2014" title="http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/agenda/07-2014"><span style="mso-bidi-font-family: "Times New Roman";"><span style="color: blue;">http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/agenda/07-2014</span></span></a> ):
</span><o:p></o:p></span></div>
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<b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;"><span style="font-size: 11pt; mso-bidi-font-family: Arial;">"... To
request extension of the current Section 85 Authority required listing for
abiraterone for the treatment of metastatic castration resistant prostate
cancer (mCRPC) to include patients who have progressed following treatment with
androgen deprivation therapy (ADT), who would not have benefit from immediate
chemotherapy." <span style="color: red;"><o:p></o:p></span></span></i></b></div>
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<b style="mso-bidi-font-weight: normal;"><u><span style="color: black; font-size: 11pt; mso-bidi-font-family: Arial;">My comment:</span></u></b><span style="color: red; font-size: 11pt; mso-bidi-font-family: Arial;"> This is still
very restrictive because, at present, chemotherapy has to fail before patients
can have abiraterone via a PBS subsidy. It is axiomatic that chemotherapy is
nasty because it kills normal body cells at the same time as it kills cancer
cells - only less quickly (hopefully). Chemotherapy is supposed to kill cancer
cells before it kills you (eg, from body organ failure or infection). Organ
damage is also why chemo causes bad side-effects and why patients have to have
cortisone to reduce these. Nevertheless, although all recipients will suffer
from side-effects to a greater or lesser extent, most men do survive it and do
obtain a benefit from immediate chemotherapy. The consequence of restricting
subsidized Abiraterone to those <b style="mso-bidi-font-weight: normal;"><u>who
would not have benefit from immediate chemotherapy</u></b> means that most
mCRPC patients will still not be eligible. How are they defined? Hopefully the
number that will have access under this new, somewhat obscure proposal will
include those who cannot tolerate chemo (perhaps less than 10%). Indeed, to
give access to even a few more is good and therefore it should be supported,
but it doesn't go far enough.</span><span style="color: black; font-size: 11pt; mso-bidi-font-family: Arial;"><o:p></o:p></span></div>
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<span style="color: black; font-size: 11pt; mso-bidi-font-family: Arial;"><o:p> </o:p></span></div>
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<span style="font-size: 11pt; mso-bidi-font-family: Arial;">The
invitation by the PBAC to make public submissions is a good opportunity for all
readers, including the 5,949 supporters who have now signed the Petition to
influence the Minister's consideration of our request that <b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;">the PBS pay the cost of
abiraterone for all, repeat <u>ALL</u>, advanced prostate cancer patients whose
condition has become incurable, without the requirement of failing chemotherapy
first</i></b> <b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;"><span style="color: black;">or being among the few <u>who would not have
benefit from immediate chemotherapy</u></span></i></b><span style="color: black;">
. <o:p></o:p></span></span></div>
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<span style="color: black; font-size: 11pt; mso-bidi-font-family: Arial;">For information on how, please read on and thank you so much for
your kind support (Tony): <o:p></o:p></span></div>
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<b style="mso-bidi-font-weight: normal;"><u><span style="font-size: 14pt; mso-bidi-font-family: Arial;">NB:</span></u></b><b style="mso-bidi-font-weight: normal;"><span style="font-size: 14pt; mso-bidi-font-family: Arial;"> Your personal submission can made in, <i style="mso-bidi-font-style: normal;">"</i></span></b><b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;"><span style="color: #222222; font-family: Helvetica; font-size: 14pt; mso-bidi-font-family: "Times New Roman";">... the<a href="http://www.health.gov.au/internet/main/publishing.nsf/Content/PBAC_online_submission_form"><span style="color: #1157ad; text-decoration: none; text-underline: none;"> PBAC online submission
form</span></a> or </span></i></b><b style="mso-bidi-font-weight: normal;"><span style="color: black; font-size: 14pt; mso-bidi-font-family: Arial;"><span style="mso-spacerun: yes;"> </span><a href="http://goo.gl/z4gZpQ"><span style="mso-bidi-font-family: "Times New Roman";"><span style="color: blue;">http://goo.gl/z4gZpQ</span></span></a>
.<o:p></o:p></span></b></div>
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<b style="mso-bidi-font-weight: normal;"><span style="color: black; font-size: 14pt; mso-bidi-font-family: Arial;"><o:p> </o:p></span></b></div>
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<i style="mso-bidi-font-style: normal;"><span style="color: #222222; font-family: Helvetica; font-size: 11pt; mso-bidi-font-family: "Times New Roman";">When you have completed the form and pressed the SUBMIT button,
your form will be sent electronically to the PBAC Secretariat and you will
receive email confirmation of receipt which will include a copy of your
comments"."This form is also available in hardcopy on request from
the PBAC Secretariat on (02 )6289 7099. </span></i><span class="skypepnhmark"><span style="color: #222222; font-family: Helvetica; font-size: 11pt; mso-bidi-font-family: Arial;">(this information </span></span><span class="skypepnhfreetextspan"><span style="color: #222222; font-size: 11pt; mso-bidi-font-family: Arial;">extracted from PBAC PDF (How Tos) located at </span></span><span style="color: black; font-size: 11pt; mso-bidi-font-family: Arial;"><a href="http://goo.gl/EeqxOP" title="http://goo.gl/EeqxOP"><span style="mso-bidi-font-family: "Times New Roman";"><span style="color: blue;">http://goo.gl/EeqxOP</span></span></a>
.)</span><i style="mso-bidi-font-style: normal;"><span style="color: #222222; font-family: Helvetica; font-size: 11pt; mso-bidi-font-family: "Times New Roman";"><o:p></o:p></span></i></div>
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<span class="skypepnhmark"><i style="mso-bidi-font-style: normal;"><span style="color: #222222; font-family: Helvetica; font-size: 11pt; mso-bidi-font-family: Arial;"><span style="mso-spacerun: yes;"> </span><o:p></o:p></span></i></span></div>
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<span style="font-size: 11pt;">You could choose either, to
draft your own individual submission to the PBAC or if you prefer to use a
prepared email or letter you could avail yourself of the prepared the text
below. Please read this anyway because it contains a resumé of the latest
Therapeutic Goods Administration (TGA) approval status of Abiraterone (note
that the TGA is separate from the PBAC).<span style="mso-spacerun: yes;">
</span><o:p></o:p></span></div>
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<span style="font-size: 11pt;">New readers can make both a
public submission to the PBAC and also sign my petition on this site<span style="mso-spacerun: yes;"> </span><a href="http://chn.ge/QsuSHc"><span style="color: blue;">http://chn.ge/QsuSHc</span></a>
. Every input will help at this stage. <o:p></o:p></span></div>
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<span style="font-size: 11pt;"><o:p> </o:p></span></div>
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<b style="mso-bidi-font-weight: normal;"><span style="color: black; font-size: 11pt; mso-bidi-font-family: Arial;">Please go to <a href="http://goo.gl/z4gZpQ"><span style="mso-bidi-font-family: "Times New Roman";"><span style="color: blue;">http://goo.gl/z4gZpQ</span></span></a>
and fill out the submission form.<o:p></o:p></span></b></div>
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<b style="mso-bidi-font-weight: normal;"><span style="color: black; font-size: 11pt; mso-bidi-font-family: Arial;"><o:p> </o:p></span></b></div>
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<b style="mso-bidi-font-weight: normal;"><span style="color: black; mso-bidi-font-family: Arial; mso-bidi-font-size: 12.0pt;"><span style="font-size: small;">The
form asks for your details first. Then, here is a SUGGESTED TEXT for copy and pasting
in Q. 5 in the form in answer to the question</span></span></b><b style="mso-bidi-font-weight: normal;"><span style="color: #222222; mso-bidi-font-family: Arial; mso-bidi-font-size: 12.0pt;"><span style="font-size: small;">, "Do you have any comments on the consumer input
process?":<o:p></o:p></span></span></b></div>
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<span style="color: #222222; font-size: 11pt; mso-bidi-font-family: Arial;">"</span><span style="font-size: 11pt; mso-bidi-font-family: Arial;">Abiraterone (Zytiga manuf. Janssen-Cilag) has recently been approved by
the Therapeutic Goods Administration (TGA) after failure of androgen
deprivation therapy (ADT) for incurable metastatic castrate resistant prostate
cancer (CRPC) patients. That's it. There is no condition requiring they have
prior chemotherapy or that the chemo should fail before they qualify,<span style="color: black;"> or that they would not benefit from immediate
chemotherapy.</span><b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;"><span style="color: red;"><o:p></o:p></span></i></b></span></div>
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<span style="color: black; font-size: 11pt; mso-bidi-font-family: Arial;">Therefore, the request for consideration by the PBAC at its July
2014 meeting is too restrictive. As the existing TGA approval does not require
prior chemotherapy wealthy patients can already have it by paying $3,500 pm.
The vast majority cannot afford this cost and so are denied access to a PBS
subsidy until after they fail treatment with chemotherapy. Their only
alternative choice is a toxic chemotherapy drug. The government requires this
even though the alternative, abiraterone, is safer, kinder and effective. They
could access abiraterone if it had a PBS subsidy. Currently, the only
alternative to chemotherapy is an earlier, more painful death using the
palliative care option to ease their passing. <o:p></o:p></span></div>
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<span style="color: black; font-size: 11pt; mso-bidi-font-family: Arial;"><o:p> </o:p></span></div>
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<span style="color: black; font-size: 11pt; mso-bidi-font-family: Arial;">Chemotherapy is nasty because it kills normal body cells at the
same time as it kills cancer cells - only less quickly (hopefully). Chemo is
supposed to kill cancer cells before it kills the patient (eg, from body organ
failure or infection). Organ damage is also why chemo causes bad side-effects
and why patients have to have cortisone to reduce these. Nevertheless, although
all recipients will suffer from side-effects to a greater or lesser degree,
most men do survive and obtain a benefit from immediate chemotherapy. <o:p></o:p></span></div>
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<span style="color: black; font-size: 11pt; mso-bidi-font-family: Arial;"><o:p> </o:p></span></div>
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<span style="color: black; font-size: 11pt; mso-bidi-font-family: Arial;">The request that the PBAC will consider in July has some merit. It
will possibly help a few and therefore should be supported but it still falls
far short of the need. The consequence of restricting subsidized abiraterone to
those "<u>who would not have benefit from immediate chemotherapy"</u>
means that most mCRPC patients will still not be eligible. The condition as
worded is somewhat obscure. How is this group defined? Hopefully it includes a
number who simply cannot tolerate chemotherapy (perhaps fewer than 10%). Making
more patients eligible is good and the request will possibly help a few and so
it should be supported. It just doesn't go far enough.<o:p></o:p></span></div>
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<span style="color: black; font-size: 11pt; mso-bidi-font-family: Arial;"><o:p> </o:p></span></div>
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<span style="color: black; font-size: 11pt; mso-bidi-font-family: Arial;">The cost to the Government might be another $30 million or so.
There would be obvious offset savings because abiraterone is given as tablets
at home with no need for expensive chemotherapy, which imposes a heavy burden
on hospital in-patient resources and takes over much of the valuable time
remaining in patients' lives, lives that are already diminished by their
cancer. At present I am spending four hours every Monday (3 weeks in every 4)
in order to have monitoring blood tests and IV infusions of three or four
different drugs including Docetaxel. This has given me a refreshing insight
into how costly the chemotherapy alternative to abiraterone is. The expense
involves all the hospital infrastructure costs including the physical and
service side of maintaining, a day hospital bed, plus an oncology nurse, and
aide, a medical oncologist, the drugs, infusion fluids and equipment. I reckon
there wouldn't be much change out of $3,500 (the monthly cost of abiraterone
tablets, self-administered at home. Even if it is a bit cheaper, the other
costs, medical and humanitarian, have to have a value if we are a compassionate
society.<o:p></o:p></span></div>
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<span style="font-size: 11pt;">Effectively, the choice is
either, to live on for a while without pain and the side-effects of chemo, or
actually to die sooner. This choice is being directly affected by
recommendations to and decisions by the government and its agencies. These are
not medical decisions. In the light of the TGA approval referred to above there
is no medical reason for withholding a PBS subsidy permitting access to
abiraterone by all incurable CRPC patients. Not providing a subsidy is
discrimination between equally deserving sufferers on the basis of means. This
is unfair.<o:p></o:p></span></div>
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<span style="font-size: 11pt;"><o:p> </o:p></span></div>
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<span style="color: black; font-size: 11pt; mso-bidi-font-family: Arial;">I urge the PBAC to exercise compassion as well as scientific and
economic scrutiny in formulating its recommendation, so that:<o:p></o:p></span></div>
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<span style="color: black; font-size: 11pt; mso-bidi-font-family: Arial;"><span style="mso-spacerun: yes;"> </span><b style="mso-bidi-font-weight: normal;">All incurable CRPC ADT resistant patients (metastatic and
pre-metastatic) should qualify for a PBS subsidy of abiraterone after failure
of androgen deprivation therapy (ADT), giving all an equal chance for the best
possible outcome, irrespective of their financial means<o:p></o:p></b></span></div>
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<b style="mso-bidi-font-weight: normal;"><span style="color: black; font-size: 11pt; mso-bidi-font-family: Arial;"><o:p> </o:p></span></b></div>
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<span lang="EN" style="color: black; font-size: 11pt; mso-ansi-language: EN; mso-bidi-font-family: Arial;">This information also appears in my
Facebook post dated 04 May, 2014, see: </span><span style="color: black; font-size: 10pt; mso-bidi-font-family: Arial;"><a href="https://www.facebook.com/tony.pcm.5" title="https://www.facebook.com/tony.pcm.5"><span style="mso-bidi-font-family: "Times New Roman";"><span style="color: blue;">https://www.facebook.com/tony.pcm.5</span></span></a> </span><o:p></o:p></div>
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Tony Musgrave (aka tony pcm)http://www.blogger.com/profile/11994182692767580358noreply@blogger.com0tag:blogger.com,1999:blog-7376517274129649541.post-84704743330359294272014-04-05T21:25:00.001-07:002014-04-05T21:27:21.178-07:0005April14 IMPORTANT NEWS - IF YOU CAN AFFORD TO PAY, Zytiga (Abiraterone) is now approved for mCRP patients before chemotherapy<span style="font-family: Times New Roman;">
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<b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial; font-size: 14pt;">05April14<span style="mso-spacerun: yes;"> </span>IMPORTANT NEWS - Zytiga (Abiraterone) is now approved
by TGA for "pre-chemo" <i>metastatic castration resistant prostate
cancer (mCRP)</i></span><i><span style="font-family: Times New Roman; font-size: small;"> </span></i></b><b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial; font-size: 14pt;">patients. </span></b><span style="font-size: small;"><b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial;">Yet they still
have to pay a small fortune for this drug that has now been accepted as an
effective, low risk treatment and often preferable to chemotherapy.</span></b><span style="font-family: Arial;"> <b style="mso-bidi-font-weight: normal;">This is
because it has not yet been recommended for a PBS subsidy by the PBAC. The new
Minister for Health is urged to fix this so that several thousand Australian
men might live longer without pain or the ill-effects of chemotherapy.</b></span></span><b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial;"><o:p><span style="font-size: small;"> </span></o:p></span></b></div>
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<span style="font-family: Arial;"><span style="font-size: small;"><span style="mso-spacerun: yes;"> </span>(<b style="mso-bidi-font-weight: normal;">Please
sign my petition to the Minister</b> at </span><a href="http://chn.ge/QsuSHc"><span style="color: blue; font-size: small;">http://chn.ge/QsuSHc</span></a><span style="font-size: small;">
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<b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial; font-size: 14pt;"><o:p></o:p></span></b> </div>
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<b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial;">Here is a very brief summary of the Current TGA
Regulatory Status of Abiraterone.</span></b><b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial; font-size: 14pt;"> </span></b><span style="font-family: Arial;">(The following are key brief excerpts from the
original document¹ which has has 31 pages - see: </span><span style="color: black; font-family: Arial; font-size: 10pt;"><a href="http://www.tga.gov.au/pdf/auspar/auspar-abiraterone-acetate-140122.pdf" title="http://www.tga.gov.au/pdf/auspar/auspar-abiraterone-acetate-140122.pdf"><span style="color: blue;">http://www.tga.gov.au/pdf/auspar/auspar-abiraterone-acetate-140122.pdf</span></a>
) (There is some highlighting of significant words).<o:p></o:p></span></div>
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<span style="font-family: Arial; font-size: 11pt;">"The
product received initial Australian Register of Therapeutic Goods (ARTG)
Registration on </span><st1:date day="27" month="2" year="2012"><span style="font-family: Arial; font-size: 11pt;">27 February 2012</span></st1:date><span style="font-family: Arial; font-size: 11pt;">." <o:p></o:p></span></div>
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<span style="color: black; font-family: Arial; font-size: 11pt; mso-fareast-language: EN-AU;"><o:p> </o:p></span></div>
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<b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial; font-size: 11pt;">"Clinical findings</span></b><span style="font-family: Arial; font-size: 11pt;"> <b style="mso-bidi-font-weight: normal;">(a summary)</b> </span><b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial; font-size: 14pt;">...</span></b><span style="font-family: Arial; font-size: 11pt;"> <o:p></o:p></span></div>
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<span style="font-family: Arial; font-size: 11pt;"><o:p> </o:p></span></div>
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<span style="font-family: Arial; font-size: 11pt;">The <u>Overall Survival</u> (OS) and
<u>Radiographic Progression-Free Survival</u> (rPFS) data are supported by
convincing results on the <u>secondary endpoints</u>, particularly those
relating to the initiation of <u>cytotoxic chemotherapy</u> and <u>opiate
analgesia</u>. The other endpoints suggest that abiraterone is likely to be
also associated with maintenance of <u>functional status</u>/<u>quality of life</u>.
</span><b style="mso-bidi-font-weight: normal;"><span style="color: black; font-family: Arial; font-size: 11pt; mso-fareast-language: EN-AU;"><o:p></o:p></span></b></div>
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<span style="font-family: Arial; font-size: 11pt;"><o:p> </o:p></span></div>
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<span style="font-family: Arial; font-size: 11pt;">Overall the
data from the pivotal study are considered to provide convincing evidence of
the <u>efficacy</u> of abiraterone in chemotherapy-naïve patients with mCRPC. </span><b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial;">...</span></b><span style="font-family: Arial; font-size: 11pt;"><o:p></o:p></span></div>
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<span style="font-family: Arial; font-size: 11pt;">The <u>safety profile</u> of the
drug appears <u>more favourable than that of taxane</u> <u>chemotherapy</u>. </span><b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial;">... </span></b><b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial; font-size: 11pt;">"</span></b><span style="color: black; font-family: Arial; font-size: 11pt; mso-fareast-language: EN-AU;"><o:p></o:p></span></div>
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<b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial; font-size: 11pt;">"</span></b><b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial;">Benefit-risk assessment - </span></b><b style="mso-bidi-font-weight: normal;"><span style="color: black; font-family: Arial; mso-fareast-language: EN-AU;"><o:p></o:p></span></b></div>
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<b><i><span style="font-family: Arial; font-size: 11pt;"><o:p> </o:p></span></i></b></div>
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<b><i><span style="font-family: Arial; font-size: 11pt;">First
round assessment of benefits </span></i></b><span style="font-family: Arial; font-size: 11pt;"><o:p></o:p></span></div>
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<span style="font-family: Arial; font-size: 11pt;">The benefits
of abiraterone in the proposed usage are: <o:p></o:p></span></div>
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<span style="font-family: Arial; font-size: 11pt;">• A decreased
<u>risk of disease progression</u> as assessed by bone scan/magnetic resonance
imaging (MRI)/computed tomography (CT); <o:p></o:p></span></div>
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<span style="font-family: Arial; font-size: 11pt;">• A delay in
the need for <u>chemotherapy</u> and opiate analgesia; <o:p></o:p></span></div>
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<span style="font-family: Arial; font-size: 11pt;">• Maintenance
of <u>functional status</u>/<u>quality of life</u>. <o:p></o:p></span></div>
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<span style="font-family: Arial; font-size: 11pt;"><o:p> </o:p></span></div>
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<b><i><span style="font-family: Arial; font-size: 11pt;">First
round assessment of benefit-risk balance </span></i></b><span style="font-family: Arial; font-size: 11pt;"><o:p></o:p></span></div>
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<span style="font-family: Arial; font-size: 11pt;"><o:p> </o:p></span></div>
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<span style="font-family: Arial; font-size: 11pt;">The <u>benefit-risk
balance</u> of abiraterone, given the proposed usage, was considered to be
favourable.<b style="mso-bidi-font-weight: normal;">"</b><o:p></o:p></span></div>
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<b><span style="font-family: Arial; font-size: 11pt;">"First
round recommendation regarding authorisation </span></b><span style="font-family: Arial; font-size: 11pt;"><o:p></o:p></span></div>
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<span style="font-family: Arial;"><o:p> </o:p></span></div>
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<span style="font-family: Arial; font-size: 11pt;">It was recommended that the <u>application
be approved</u>. </span><span style="color: black; font-family: Arial; font-size: 11pt; mso-fareast-language: EN-AU;">...</span><span style="font-family: Arial; font-size: 11pt;"><span style="mso-spacerun: yes;"> </span><u>restriction</u>
(in symptomatic patients in whom chemotherapy is not yet clinically indicated )
<u>seems unnecessary</u> since the <u>risks of chemotherapy are likely to
exceed the benefits</u> in asymptomatic or mildly symptomatic patients and therefore
<u>chemotherapy is unlikely to be clinically indicated</u>. <o:p></o:p></span></div>
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<span style="font-family: Arial; font-size: 11pt;">The <u>benefit-risk
balance</u> of abiraterone in the proposed indication was considered to be <u>positive</u>.<b>"</b><o:p></o:p></span></div>
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<b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;"><span style="font-family: Arial;">"Indications </span></i></b><b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial; font-size: 16pt;">...<span style="mso-spacerun: yes;"> </span></span></b><span style="font-family: Arial; font-size: 11pt;">the TGA Clinical Evaluator’s and TGA
Delegate's recommendations to approve abiraterone for the extended indication
(the sponsor agreed) (were): <o:p></o:p></span></div>
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<b style="mso-bidi-font-weight: normal;"><i><span style="font-family: Arial; font-size: 11pt;"><o:p> </o:p></span></i></b></div>
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<b style="mso-bidi-font-weight: normal;"><i><span style="font-family: Arial; font-size: 11pt;">“ZYTIGA is indicated with prednisone
or prednisolone for the treatment of patients with metastatic advanced prostate
cancer (castration resistant prostate cancer, mCRPC): </span></i></b><b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial; font-size: 11pt;"><o:p></o:p></span></b></div>
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<b style="mso-bidi-font-weight: normal;"><i><span style="font-family: Arial; font-size: 11pt;"><o:p> </o:p></span></i></b></div>
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<b style="mso-bidi-font-weight: normal;"><i><span style="font-family: Arial; font-size: 11pt;">• who are asymptomatic or mildly
symptomatic after failure of androgen deprivation therapy (ADT) or </span></i></b><b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial; font-size: 11pt;"><o:p></o:p></span></b></div>
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<b style="mso-bidi-font-weight: normal;"><i><span style="font-family: Arial; font-size: 11pt;"><o:p> </o:p></span></i></b></div>
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<b style="mso-bidi-font-weight: normal;"><i><span style="font-family: Arial; font-size: 11pt;">• who have received prior chemotherapy containing a taxane.”
</span></i></b><b style="mso-bidi-font-weight: normal;"><span style="color: black; font-family: Arial; font-size: 14pt; mso-fareast-language: EN-AU;">...</span></b><b style="mso-bidi-font-weight: normal;"><i><span style="font-family: Arial; font-size: 11pt;"><o:p></o:p></span></i></b></div>
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<b style="mso-bidi-font-weight: normal;"><span style="color: black; font-family: Arial; font-size: 11pt; mso-fareast-language: EN-AU;"><o:p> </o:p></span></b></div>
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<span style="color: black; font-family: Arial; font-size: 11pt; mso-fareast-language: EN-AU;">"Janssen (the manufacturer) concurred with the Clinical Evaluator’s
and Delegate’s assessment that <b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;">efficacy has been established in the
proposed indication. The <u>EU</u>, whose guidelines TGA adopts, also agreed
that efficacy had been established as evidenced by their approving of the
extension of indications. The new indication has also been approved in the </i></b></span><st1:country-region><st1:place><u><b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;"><span style="color: black; font-family: Arial; font-size: 11pt; mso-fareast-language: EN-AU;">USA</span></i></b></u></st1:place></st1:country-region><b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;"><span style="color: black; font-family: Arial; font-size: 11pt; mso-fareast-language: EN-AU;">, </span></i></b><st1:country-region><st1:place><u><b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;"><span style="color: black; font-family: Arial; font-size: 11pt; mso-fareast-language: EN-AU;">Canada</span></i></b></u></st1:place></st1:country-region><b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;"><span style="color: black; font-family: Arial; font-size: 11pt; mso-fareast-language: EN-AU;"> and </span></i></b><st1:country-region><st1:place><u><b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;"><span style="color: black; font-family: Arial; font-size: 11pt; mso-fareast-language: EN-AU;">New Zealand</span></i></b></u></st1:place></st1:country-region><b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;"><span style="color: black; font-family: Arial; font-size: 11pt; mso-fareast-language: EN-AU;">. <o:p></o:p></span></i></b></div>
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</span><span style="color: black; font-family: Arial; font-size: 11pt; mso-fareast-language: EN-AU;"><o:p> </o:p></span><br />
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<span style="color: black; font-family: Arial; font-size: 11pt; mso-fareast-language: EN-AU;">The <b style="mso-bidi-font-weight: normal;"><u>safety</u></b> profile in
Study COU–AA-302 (the definitive research study reported in </span><span class="citation"><span style="font-family: Arial;">N Engl J Med 2013; 368:138-148 /
</span></span><span style="font-family: Arial;"><a href="http://www.nejm.org/toc/nejm/368/2/"><span style="color: #006892; text-decoration: none; text-underline: none;">http://www.nejm.org/toc/nejm/368/2/ </span></a></span><span style="color: black; font-family: Arial; font-size: 11pt; mso-fareast-language: EN-AU;">) was consistent with abiraterone’s <b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;">well established favourable toxicity
profile, especially when compared to chemotherapy</i></b>. For a patient with
incurable mCRPC, <b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;">treatment with an oral medication as an outpatient, without the side
effects of cytotoxic chemotherapy, is clinically meaningful</i></b> in the
context of the limited available treatment options."<o:p></o:p></span></div>
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</span><b style="mso-bidi-font-weight: normal;"><span style="color: black; font-family: Arial; font-size: 16pt; mso-fareast-language: EN-AU;"><o:p> </o:p></span></b><br />
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<b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial; font-size: 11pt;">"</span></b><b><span style="color: black; font-family: Arial; font-size: 14pt; mso-fareast-language: EN-AU;">Outcome </span></b><span style="color: black; font-family: Arial; font-size: 14pt; mso-fareast-language: EN-AU;"><o:p></o:p></span></div>
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<span style="color: black; font-family: Arial; font-size: 11pt; mso-fareast-language: EN-AU;">Based on a review of quality, safety and efficacy, TGA approved the
registration of Zytiga/Janssen Abiraterone tablets (250 mg abiraterone acetate)
for oral administration, indicated for (additional indication): <o:p></o:p></span></div>
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<b style="mso-bidi-font-weight: normal;"><i><span style="font-family: Arial;">Zytiga
is indicated with prednisone or prednisolone for the treatment of patients with
metastatic castration resistant prostate cancer (mCRP) who are asymptomatic or
mildly symptomatic after failure of androgen deprivation therapy (ADT).</span></i></b><b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial;">10F<i>11"<o:p></o:p></i></span></b></div>
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<span style="font-family: Arial; mso-fareast-language: EN-AU;"><o:p> </o:p></span></div>
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<span style="font-family: Arial; font-size: 8pt; mso-fareast-language: EN-AU;"><o:p> </o:p></span></div>
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<span style="font-family: Arial;">¹ </span><b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial; font-size: 11pt;">EXTRACTED from SOURCE
Document (See the full text in the following):</span></b></div>
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<span style="font-family: Arial; font-size: 8pt; mso-fareast-language: EN-AU;"><o:p> </o:p></span></div>
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<b style="mso-bidi-font-weight: normal;"><span style="font-family: "Arial Narrow"; font-size: 10pt;">"AusPAR Zytiga
Abiraterone acetate Janssen-Cilag Pty Ltd PM-2012-02706-3-4 Final </span></b><st1:date day="22" month="1" year="2014"><b style="mso-bidi-font-weight: normal;"><span style="font-family: "Arial Narrow"; font-size: 10pt;">22 January 2014</span></b></st1:date><b style="mso-bidi-font-weight: normal;"><span style="font-family: "Arial Narrow"; font-size: 10pt;">"</span></b><b style="mso-bidi-font-weight: normal;"><span style="font-family: "Arial Narrow"; font-size: 10pt; mso-bidi-font-family: Arial; mso-fareast-language: EN-AU;"><o:p></o:p></span></b></div>
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</span><span style="font-family: Arial;"><o:p> </o:p></span><br />
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<span style="color: black; font-family: Arial; font-size: 10pt;">click on:<span style="mso-spacerun: yes;"> </span><a href="http://www.tga.gov.au/pdf/auspar/auspar-abiraterone-acetate-140122.pdf" title="http://www.tga.gov.au/pdf/auspar/auspar-abiraterone-acetate-140122.pdf"><span style="color: blue;">http://www.tga.gov.au/pdf/auspar/auspar-abiraterone-acetate-140122.pdf</span></a></span><span style="font-family: Arial; font-size: 10pt; mso-fareast-language: EN-AU;"><o:p></o:p></span></div>
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<b><span style="font-size: 14pt;"><span style="font-family: Times New Roman;">Therapeutic Goods Administration<o:p></o:p></span></span></b></div>
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<st1:address><st1:street><span style="font-family: Cambria; font-size: 10pt; mso-bidi-font-family: Cambria;">PO
Box</span></st1:street><span style="font-family: Cambria; font-size: 10pt; mso-bidi-font-family: Cambria;"> 100</span></st1:address><span style="font-family: Cambria; font-size: 10pt; mso-bidi-font-family: Cambria;"> Woden ACT 2606 </span><st1:country-region><st1:place><span style="font-family: Cambria; font-size: 10pt; mso-bidi-font-family: Cambria;">Australia</span></st1:place></st1:country-region><span style="font-family: Cambria; font-size: 10pt; mso-bidi-font-family: Cambria;"><o:p></o:p></span></div>
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<span style="font-family: Cambria; font-size: 10pt; mso-bidi-font-family: Cambria;">Email:
info@tga.gov.au<o:p></o:p></span></div>
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<span style="font-family: Cambria; font-size: 10pt; mso-bidi-font-family: Cambria;">Phone:
1800 020 653<o:p></o:p></span></div>
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<span style="font-family: Cambria; font-size: 10pt; mso-bidi-font-family: Cambria;">Fax:
02 6232 8605<o:p></o:p></span></div>
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<b><span style="font-family: Cambria; font-size: 10pt; mso-bidi-font-family: Cambria;">http://www.tga.gov.au</span></b><span style="font-family: Arial; font-size: 10pt;"><o:p></o:p></span></div>
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<o:p><span style="font-family: Times New Roman;"> </span></o:p></div>
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</span>Tony Musgrave (aka tony pcm)http://www.blogger.com/profile/11994182692767580358noreply@blogger.com0tag:blogger.com,1999:blog-7376517274129649541.post-56365174483334490672013-07-26T23:45:00.001-07:002013-07-26T23:45:21.086-07:0027Jul13: Prostate cancer (PC) patients still can't have Abiraterone (Zytiga) on PBS before chemo fails<span style="font-family: Times New Roman;">
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<span style="color: black; font-family: Arial;"><strong>Did you see Channel
9 News on 26July - Abiraterone ( Zytiga ) to be funded by the Pharmaceutical Benefits Scheme ( PBS ) from 01 August? Good news for some but bad for many
others.</strong> <o:p></o:p></span></div>
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<span style="color: black; font-family: Arial;"><o:p> </o:p></span></div>
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<span style="color: black; font-family: Arial;">The news report featured a healthy
looking man who stated that he now has prostate cancer in his bones. but
is overjoyed that he now has an effective and kinder drug, available from 1st
August and that it will cost pensioners only $5 instead of
$3,500 per month. In the presentation of this “good news” it required close attention not to
miss the brief comment that Zytiga would be available <strong>only</strong> for those who
had already ceased to respond to treatment with Docetaxel (chemotherapy). <o:p></o:p></span></div>
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<span style="color: black; font-family: Arial;"> <o:p></o:p></span></div>
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<span style="color: black; font-family: Arial;">The fear is that
most viewers will now believe (wrongly) that <strong><u>all</u> </strong>advanced PC patients
will have access to this drug. It is simply not so. Unlike in the </span><st1:country-region><st1:place><span style="color: black; font-family: Arial;">USA</span></st1:place></st1:country-region><span style="color: black; font-family: Arial;">, in </span><st1:country-region><st1:place><span style="color: black; font-family: Arial;">Australia</span></st1:place></st1:country-region><span style="color: black; font-family: Arial;"> the large proportion who could
benefit from Zytiga still cannot get it. They must suffer
the side-effects of chemotherapy first. Chemotherapy has to fail, meaning that these sufferers will be facing their "end-game" before the government subsidy cuts
in. Because this drug delays the appearance of secondary cancer in
the bones and extends life pain-free, withholding the subsidy until
they are on their last legs is unjust and unfair and not much more cost-saving than treatment with chemotherapy.<o:p></o:p></span></div>
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<span style="color: black; font-family: Arial;"> <o:p></o:p></span></div>
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</span><br />
If you have not yet done so, <span style="color: black; font-family: Arial;">please add your signature to the 5,500 already on my
petition to the Minister for Health seeking to rectify this by approving a subsidy for Zytiga for the "pre-chemo" group as well - see: </span><span style="color: black; font-family: Arial; font-size: 11pt;"><a href="http://chn.ge/QsuSHc"><span style="mso-bidi-font-family: Arial;"><span style="color: blue; font-family: Times New Roman;">http://chn.ge/QsuSHc</span></span></a>
<span style="mso-spacerun: yes;"> </span><o:p></o:p></span><span style="font-family: Times New Roman;">
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<span style="font-family: Arial;"><o:p> </o:p></span></div>
<span style="font-family: Times New Roman;">
</span>Tony Musgrave (aka tony pcm)http://www.blogger.com/profile/11994182692767580358noreply@blogger.com0tag:blogger.com,1999:blog-7376517274129649541.post-51817125856240973472013-07-05T03:56:00.001-07:002013-07-10T00:55:55.265-07:0030Jun13: Minister for Health Tanya Plibersek approves Abiraterone subsidy but only for some (under PBS from August 2013)<span style="font-family: Times New Roman;">
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<span style="color: black; font-family: Arial; font-style: normal; mso-bidi-font-style: italic;"><strong>TOO MANY ARE MISSING OUT - </strong><em>see:</em></span><span style="color: black; font-family: Arial;"><em> </em><a href="http://goo.gl/5QEhe"><span style="font-style: normal;"><span style="color: blue;"><em>http://goo.gl/5QEhe</em></span></span></a></span><span style="color: black; font-family: Arial; font-style: normal; mso-bidi-font-style: italic;"> <strong>EXTRACT FROM MINISTER'S STATEMENT:</strong></span></div>
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<em><span style="color: black; font-family: Arial; font-style: normal; mso-bidi-font-style: italic;"><o:p> </o:p></span></em></div>
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<span lang="EN" style="font-family: Arial; mso-ansi-language: EN;">Ms. Plibersek, (quote), <em>“The PBS listing of abiraterone will benefit more than 1,000
Australians each year who would otherwise have to pay around $27,000 a year to
access the drug. This medicine offers an important treatment option for
patients who are not well enough to tolerate further chemotherapy.”</em> <o:p></o:p></span></div>
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<span lang="EN" style="font-family: Arial; font-size: 10pt; mso-ansi-language: EN;"><o:p> </o:p></span></div>
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<span style="color: black; font-family: Arial; font-style: normal; mso-bidi-font-style: italic;">Minister, only terminal patients having
failed chemotherapy will be eligible for a PBS subsidy for Abiraterone. The rest face the ordeal of chemo and
qualify only when it fails. This is illogical because chemotherapy requires hospital
resources and is costly itself. Abiraterone (tablets) can substantially delay
metastases, cause them to regress and is well tolerated. It extends life,
pain-free.<o:p></o:p></span></div>
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<span style="color: black; font-family: Arial; font-style: normal; mso-bidi-font-style: italic;"><o:p> </o:p></span></div>
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<span style="color: black; font-family: Arial; font-style: normal; mso-bidi-font-style: italic;">The FDA in </span><st1:country-region><st1:place><span style="color: black; font-family: Arial; font-style: normal; mso-bidi-font-style: italic;">USA</span></st1:place></st1:country-region><span style="color: black; font-family: Arial; font-style: normal; mso-bidi-font-style: italic;"> recognizes this and approves its use in the pre-chemotherapy group. The TGA
in </span><st1:country-region><st1:place><span style="color: black; font-family: Arial; font-style: normal; mso-bidi-font-style: italic;">Australia</span></st1:place></st1:country-region><span style="color: black; font-family: Arial; font-style: normal; mso-bidi-font-style: italic;"> still needs to do so and the PBAC to recommend PBS subsidy. This would
be humane and cost-effective. <o:p></o:p></span></div>
<span style="font-family: Times New Roman;">
</span><br />
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<span style="font-family: Arial;"><o:p> </o:p></span></div>
<span style="font-family: Times New Roman;">
</span><br />
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<span style="font-family: Arial;"><span style="font-family: Arial; font-size: 12pt; mso-ansi-language: EN-AU; mso-bidi-language: AR-SA; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-AU;">My petition with 5,400 signatures seeks to
achieve this and needs the signatures (urgently) of all supporters and of the
contacts of those who have already signed. Please ask everyone to sign it at <a href="http://chn.ge/QsuSHc">http://chn.ge/QsuSHc</a> .</span></span></div>
<span style="font-family: Times New Roman;">
</span>Tony Musgrave (aka tony pcm)http://www.blogger.com/profile/11994182692767580358noreply@blogger.com0tag:blogger.com,1999:blog-7376517274129649541.post-78504094825609033432013-05-16T03:45:00.000-07:002013-05-16T03:45:05.041-07:0016 May 2013 After the FEDERAL BUDGET - Will the Minister approve Abiraterone acetate (Zytiga)?<span style="font-family: Arial; font-size: 12pt; mso-ansi-language: EN-AU; mso-bidi-language: AR-SA; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-AU;"><span style="font-family: Times New Roman;">
</span></span><br />
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<span lang="EN-US" style="color: black; font-family: Arial; font-size: 10pt; mso-ansi-language: EN-US; mso-bidi-font-weight: bold;">16 May 2013</span><span lang="EN-US" style="color: black; font-family: Arial; font-size: 10pt; mso-ansi-language: EN-US;"> Abiraterone acetate (Zytiga) – The FEDERAL BUDGET and The Pharmaceutical
Benefits Advisory Committee (PBAC) 'Public Summary Document' Nov12 – </span><st1:stockticker><span lang="EN-US" style="color: black; font-family: Arial; font-size: 10pt; mso-ansi-language: EN-US;">SEE</span></st1:stockticker><span lang="EN-US" style="color: black; font-family: Arial; font-size: 10pt; mso-ansi-language: EN-US;"> URL: <a href="http://goo.gl/WdAOo"><u><span style="color: blue;">http://goo.gl/WdAOo</span></u></a> <span style="mso-spacerun: yes;"> </span>(Document as PDF: <a href="http://goo.gl/UPc8B"><u><span style="color: blue;">http://goo.gl/UPc8B</span></u></a>
).<o:p></o:p></span></div>
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<span lang="EN-US" style="color: black; font-family: Arial; font-size: 10pt; mso-ansi-language: EN-US;"><o:p> </o:p></span></div>
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<span lang="EN-US" style="color: black; font-family: Arial; font-size: 10pt; mso-ansi-language: EN-US;">Ministerial and Cabinet approval are the
remaining requirements for some desperately ill prostate cancer patients to
receive this drug under the Pharmaceutical Benefits Scheme (PBS). The
manufacturer’s restrictions and the PBAC’s rationalization of cost containment
pose significant constraints on who will be eligible.<o:p></o:p></span></div>
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<span lang="EN-US" style="color: black; font-family: Arial; font-size: 10pt; mso-ansi-language: EN-US;"><o:p> </o:p></span></div>
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<span lang="EN-US" style="color: black; font-family: Arial; font-size: 10pt; mso-ansi-language: EN-US;">These are the issues:<o:p></o:p></span></div>
<span style="font-family: Times New Roman;">
</span><span lang="EN-US" style="color: black; font-family: Arial; font-size: 10pt; mso-ansi-language: EN-US;">1. The prospect of chemotherapy is an
awful one. <o:p></o:p></span><br />
<span style="font-family: Times New Roman;">
</span><span lang="EN-US" style="color: black; font-family: Arial; font-size: 10pt; mso-ansi-language: EN-US;">2. The Government could easily approve a
PBS subsidy a lot sooner if it were not for all the bureaucratic process
involving application, assessments, changes of position and repeated revisions.<o:p></o:p></span><br />
<span style="font-family: Times New Roman;">
</span><span lang="EN-US" style="color: black; font-family: Arial; font-size: 10pt; mso-ansi-language: EN-US;"><o:p> </o:p></span><br />
<span style="font-family: Times New Roman;">
</span><br />
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<span lang="EN-US" style="color: black; font-family: Arial; font-size: 10pt; mso-ansi-language: EN-US;">On the one hand, the “Public Summary
Document” states that as a prerequisite to receiving a PBS subsidy for its own
drug, the manufacturer (Janssen-Cilag) required that, <o:p></o:p></span></div>
<span style="font-family: Times New Roman;">
</span><span lang="EN-US" style="color: black; font-family: Arial; font-size: 10pt; mso-ansi-language: EN-US;">- Abiraterone must not be used with
chemotherapy before it is subsidized <o:p></o:p></span><br />
<span style="font-family: Times New Roman;">
</span><span lang="EN-US" style="color: black; font-family: Arial; font-size: 10pt; mso-ansi-language: EN-US;">- a patient must have failed chemotherapy
with Docetaxel?<o:p></o:p></span><br />
<span style="font-family: Times New Roman;">
</span><span lang="EN-US" style="color: black; font-family: Arial; font-size: 10pt; mso-ansi-language: EN-US;">- a patient must have a WHO performance
status of 2 or less? <o:p></o:p></span><br />
<span style="font-family: Times New Roman;">
</span><span lang="EN-US" style="color: black; font-family: Arial; font-size: 10pt; mso-ansi-language: EN-US;">- a patient must not receive PBS-subsidised
abiraterone if progressive disease develops while on abiraterone? <o:p></o:p></span><br />
<span style="font-family: Times New Roman;">
</span><br />
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<span lang="EN-US" style="color: black; font-family: Arial; font-size: 10pt; mso-ansi-language: EN-US;"><o:p> </o:p></span></div>
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<span lang="EN-US" style="color: black; font-family: Arial; font-size: 10pt; mso-ansi-language: EN-US;">On the other there is the cost-saving
versus life-saving comment by the PBAC, <o:p></o:p></span></div>
<span style="font-family: Times New Roman;">
</span><br />
<div class="MsoNormal" style="margin: 0cm 0cm 0pt;">
<span lang="EN-US" style="color: black; font-family: Arial; font-size: 10pt; mso-ansi-language: EN-US;">“… The PBAC therefore reaffirmed its
decision from July 2012 that a risk share agreement would be required to
mitigate the financial risk to Government of treatment beyond progression (ie,
progression of the cancer after treatment with abiraterone) and use (of
abiraterone) in patients who had not previously been treated with docetaxel.”<o:p></o:p></span></div>
<span style="font-family: Times New Roman;">
</span><br />
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<span lang="EN-US" style="color: black; font-family: Arial; font-size: 10pt; mso-ansi-language: EN-US;">These and other caveats restrict the
options for patients who could otherwise receive a life extending benefit .<o:p></o:p></span></div>
<span style="font-family: Times New Roman;">
</span><span lang="EN-US" style="color: black; font-family: Arial; font-size: 10pt; mso-ansi-language: EN-US;"><o:p> </o:p></span><br />
<span style="font-family: Times New Roman;">
</span><br />
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<span lang="EN-US" style="color: black; font-family: Arial; font-size: 10pt; mso-ansi-language: EN-US;">These restrictions are at odds with the
recommendations of Ryan et al ( </span><span lang="EN-US" style="color: #333333; font-family: Arial; font-size: 10pt; mso-ansi-language: EN-US;">N Engl J Med 2013;
368:138-148 </span><span lang="EN-US" style="color: black; font-family: Arial; font-size: 10pt; mso-ansi-language: EN-US;"><a href="http://www.nejm.org/toc/nejm/368/2/"><u><span style="color: blue;">January 10, 2013</span></u></a></span><span lang="EN-US" style="color: #333333; font-family: Arial; font-size: 10pt; mso-ansi-language: EN-US;"> ) who recommend providing the drug for all advanced prostate cancer
sufferers without requiring that they have to have chemotherapy first. In the </span><st1:country-region><st1:place><span lang="EN-US" style="color: #333333; font-family: Arial; font-size: 10pt; mso-ansi-language: EN-US;">USA</span></st1:place></st1:country-region><span lang="EN-US" style="color: #333333; font-family: Arial; font-size: 10pt; mso-ansi-language: EN-US;"> this restriction has now been removed by the TGA. </span><span lang="EN-US" style="color: black; font-family: Arial; font-size: 10pt; mso-ansi-language: EN-US;">The baffling thing is why both the advisory committee and the
manufacturer should seek to impose such severe restrictions on the availability
of this vital drug when its use would reduce the need for other severe and
costly treatments, as well as giving lots of patients a pain-free extension of
life.<o:p></o:p></span></div>
<span style="font-family: Times New Roman;">
</span><span lang="EN" style="color: #333333; font-family: Arial; font-size: 10pt; mso-ansi-language: EN;"><o:p> </o:p></span><br />
<span style="font-family: Times New Roman;">
</span><br />
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<span lang="EN-US" style="color: black; font-family: Arial; font-size: 10pt; mso-ansi-language: EN-US;">The apparent focus of this report is its
economic analysis of the relative value of Abitaterone compared with other
damaging or “end-game” treatments. It is astounding that figures such as
$100,000 per patient or overall costs of $30 million (to budget) in a given
year should be agonized over, overlooking the fact that for a national budget these
are paltry sums of money for keeping advanced prostate cancer patients alive
pain-free for a substantially longer time (as they have a right to expect from
their government). <o:p></o:p></span></div>
<span style="font-family: Times New Roman;">
</span><span lang="EN-US" style="color: black; font-family: Arial; font-size: 10pt; mso-ansi-language: EN-US;"><o:p> </o:p></span><br />
<span style="font-family: Times New Roman;">
</span><br />
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<span lang="EN-US" style="color: black; font-family: Arial; font-size: 10pt; mso-ansi-language: EN-US;">It is time that the Health Minister and
Federal Cabinet approve a PBS subsidy without further delay (t</span><span lang="EN" style="color: #333333; font-family: Arial; font-size: 10pt; mso-ansi-language: EN;">he Federal Budget last Tuesday provided $691 million, allocated over five
years for new listings or amendments to the Pharmaceutical Benefits Scheme
(PBS)).</span><span lang="EN-US" style="color: black; font-family: Arial; font-size: 10pt; mso-ansi-language: EN-US;"> <o:p></o:p></span></div>
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</span><span lang="EN-US" style="color: black; font-family: Arial; font-size: 10pt; mso-ansi-language: EN-US;"><o:p> </o:p></span><br />
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<span style="color: black; font-family: Arial; font-size: 10pt;">To
date 4,790 interested persons, patients and their friends and families, have
signed my petition. It would be a great help if everyone could circulate this
request to their other friends and contacts seeking even more support for this
cause by asking them to sign the petition to the Minister at <a href="http://chn.ge/QsuSHc"><span style="color: blue;">http://chn.ge/QsuSHc</span></a> . <o:p></o:p></span></div>
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<u><span lang="EN-US" style="color: black; font-family: Arial; font-size: 10pt; mso-ansi-language: EN-US;">Footnote:</span></u><span lang="EN-US" style="color: black; font-family: Arial; font-size: 10pt; mso-ansi-language: EN-US;"> I have been told that Janssen-Cilag is negotiating with the TGA to have
Abiraterone registered and listed for PBS subsidy for the treatment of mCRPC
patients who have not received chemotherapy (but this process is very slow).<span style="mso-spacerun: yes;"> </span><o:p></o:p></span></div>
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</span>Tony Musgrave (aka tony pcm)http://www.blogger.com/profile/11994182692767580358noreply@blogger.com0tag:blogger.com,1999:blog-7376517274129649541.post-57282403101632582562013-04-16T00:38:00.000-07:002013-05-27T16:15:56.137-07:00Prostate Cancer: Not much hope for new drug but ...<span style="font-family: Times New Roman;">
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<b style="mso-bidi-font-weight: normal;"><span lang="EN-US" style="color: black; font-family: Arial; mso-ansi-language: EN-US;">Prostate Cancer:
Not much hope yet for new drug but …<o:p></o:p></span></b></div>
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<span lang="EN-US" style="color: black; font-family: Arial; mso-ansi-language: EN-US;">01May13: There is not much hope yet for Australian men
with incurable prostate cancer who need Abiraterone unless they are rich and
chemotherapy is not working <o:p></o:p></span></div>
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<span lang="EN-US" style="color: black; font-family: Arial; mso-ansi-language: EN-US;"><o:p> </o:p></span></div>
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<span lang="EN-US" style="color: black; font-family: Arial; mso-ansi-language: EN-US;">The approval process for the new drug, also called
Zytiga, appears to have stalled. There is no positive news, just one small ray
of hope for the future. <o:p></o:p></span></div>
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<span lang="EN-US" style="color: black; font-family: Arial; mso-ansi-language: EN-US;">I am reliably informed that the manufacturer, Janssen-Cilag
is currently working with the TGA to have Abiraterone registered for the treatment
of mCRPC patients who have not received chemotherapy (as is now the case in the
</span><st1:country-region><st1:place><span lang="EN-US" style="color: black; font-family: Arial; mso-ansi-language: EN-US;">USA</span></st1:place></st1:country-region><span lang="EN-US" style="color: black; font-family: Arial; mso-ansi-language: EN-US;">) and
intends to seek PBS subsidy for this indication</span><span lang="EN-US" style="color: #1f497d; font-family: Arial; mso-ansi-language: EN-US;">.</span><span lang="EN-US" style="color: black; font-family: Arial; mso-ansi-language: EN-US;">
Unfortunately, this process can seem interminable.<o:p></o:p></span></div>
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<span lang="EN-US" style="color: black; font-family: Arial; mso-ansi-language: EN-US;">This has to succeed to save Australian patients from a
premature painful death. <o:p></o:p></span></div>
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<span lang="EN-US" style="color: black; font-family: Arial; mso-ansi-language: EN-US;">All who have not yet signed the petition to the
Minister for Health, Tanya Plibersek, are urgently invited to do so at: </span><span style="font-family: Arial;"><a href="http://chn.ge/QsuSHc"><span style="mso-bidi-font-family: Arial;"><span style="color: blue; font-family: Times New Roman;">http://chn.ge/QsuSHc</span></span></a></span><span style="font-family: Arial; font-size: 10pt;"> </span><span lang="EN-US" style="color: black; font-family: Arial; mso-ansi-language: EN-US;">.</span><span lang="EN-US" style="font-family: Arial;"> </span><span style="font-family: Arial;">Read
more below.</span><span lang="EN-US" style="color: black; font-family: Arial; mso-ansi-language: EN-US;"><o:p></o:p></span></div>
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<b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial;">Government Inaction on New Prostate Cancer Drug Abiraterone (Zytiga) Gets
Media Attention <o:p></o:p></span></b></div>
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<span style="font-family: Arial;">In “The International News
Magazine” on </span><st1:date day="28" month="3" year="2013"><span style="font-family: Arial;">Thursday, 28 March 2013</span></st1:date><span style="font-family: Arial;"> Greg Rogers published and article,<span style="mso-spacerun: yes;"> </span>“Prostate Cancer Treatment Zytiga Needs
Listing on the Pharmaceutical Benefits Scheme” <span style="mso-spacerun: yes;"> </span>(URL for article: </span><span style="font-family: "Arial Narrow"; mso-bidi-font-family: Arial;"><a href="http://goo.gl/saNM9"><span style="color: blue;">http://goo.gl/saNM9</span></a></span><span style="font-family: Arial;"><span style="mso-spacerun: yes;"> </span>).<o:p></o:p></span></div>
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<span style="font-family: Arial;">Greg also provided the
following link to a letter from </span><span lang="EN-GB" style="color: black; font-family: Arial; mso-ansi-language: EN-GB;">The PCFA (Prostate Cancer Foundation
of Australia) to the Minister urging immediate action. <a href="http://www.prostate.org.au/articleLive/attachments/1/ProstateNews/Letter%20to%20Tanya%20Plibersek%20about%20abiraterone_Final.pdf" target="_blank"><span style="color: #153e7e; text-decoration: none; text-underline: none;">Read that letter here.</span></a><o:p></o:p></span></div>
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<span style="font-family: Arial;">This issue was also explored
by Rachael Brown on </span><st1:date day="31" month="3" year="2013"><span style="font-family: Arial;">31 March 2013</span></st1:date><span style="font-family: Arial;"> in an article in the Sydney Morning Herald, "<span style="color: black;">Prostate cancer drug tied up in red tape" (See: </span></span><span style="color: black; font-family: "Arial Narrow";"><a href="http://goo.gl/hEgFl"><span style="color: blue;">http://goo.gl/hEgFl</span></a>
).</span><span style="color: black; font-family: Arial;"><o:p></o:p></span></div>
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<span style="font-family: Arial;">You can help change the
discrimination against many incurable prostate cancer patients in Australia by
signing the petition <span style="color: black;">to the Minister for Health,
"</span></span><i style="mso-bidi-font-style: normal;"><span lang="EN-GB" style="font-family: Arial; mso-ansi-language: EN-GB;">PBS should pay for
Abiraterone for all incurable prostate cancer patients</span></i><b style="mso-bidi-font-weight: normal;"><span style="color: black; font-family: Arial; font-size: 10pt;">" </span></b><span style="color: black; font-family: Arial;">and
broadcast this request to all your contacts asking them to sign this petition (see
URL:<span style="mso-spacerun: yes;"> </span></span><span style="font-family: "Arial Narrow"; mso-bidi-font-family: Arial;"><a href="http://chn.ge/QsuSHc"><span style="color: blue;">http://chn.ge/QsuSHc</span></a></span><span style="color: black; font-family: Arial;"> ). All such help is much appreciated.<o:p></o:p></span></div>
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<span lang="EN-GB" style="font-family: Arial; mso-ansi-language: EN-GB;">Here is a bit of further clarification. Only half the story is getting
publicity. Even when the government eventually approves PBS listing there are
many more incurable mCRPC patients who are not be eligible and so they are
going to die painfully sooner than they should.</span><span style="font-family: Arial; font-size: 10pt;"><o:p></o:p></span></div>
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<span style="font-family: Arial;">This is happening in </span><st1:country-region><st1:place><span style="font-family: Arial;">Australia</span></st1:place></st1:country-region><span style="font-family: Arial;"> because the PBAC recommendation for a PBS subsidy
for this drug is only for those patients who have failed a course of
chemotherapy and are on their last legs. For this (first) group to get the drug
the Federal Minister now only needs to give approval. So far she hasn't and the
process is dragging on while patients suffer and die.<o:p></o:p></span></div>
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<span style="font-family: Arial;">In USA the FDA has now
approved Abiraterone acetate <i style="mso-bidi-font-style: normal;">(Zytiga)</i>
for a second group of men with advanced prostate cancer without demanding they first
fail a course of chemotherapy to qualify.<o:p></o:p></span></div>
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<span style="font-family: Arial;">In </span><st1:country-region><st1:place><span style="font-family: Arial;">Australia</span></st1:place></st1:country-region><span style="font-family: Arial;">, because of the huge cost of Abiraterone and a lack
of anyone seeking a PBS subsidy, those in this second group of incurables are
doomed to suffer the ongoing ravages of their cancer and the side effects of
chemotherapy until they also are "death's door". Only then, with
little time left, may they hope to join the first group. <o:p></o:p></span></div>
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<span style="font-family: Arial;">At present there is no such
recommendation even being considered for pre-chemotherapy patients – seemingly not
even from the manufacturer; not from the medical profession; not from involved
community organizations. Several thousand incurables who could have a useful
and pain free extension of life "pre-chemo" are being denied this
effective treatment and an earlier death is guaranteed by the inaction. Please <span style="color: black;">sign and get your friends to sign this petition at:<span style="mso-spacerun: yes;"> </span></span></span><span style="font-family: "Arial Narrow"; mso-bidi-font-family: Arial;"><a href="http://chn.ge/QsuSHc"><span style="color: blue;">http://chn.ge/QsuSHc</span></a></span><span style="color: black; font-family: Arial;"> , and what about an email to your local
member and the Leader of the Opposition<span style="mso-spacerun: yes;"> </span></span><span style="color: black; font-family: "Arial Narrow"; mso-bidi-font-family: Arial;"><a href="mailto:tony.abbott.mp@aph.gov.au"><span style="color: blue;">tony.abbott.mp@aph.gov.au</span></a></span><span style="color: black; font-family: Arial;"> .</span><span style="font-family: Arial;"><o:p></o:p></span></div>
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<b style="mso-bidi-font-weight: normal;"><span style="font-family: "Arial Narrow"; font-size: 14pt; mso-bidi-font-family: Arial;">References
and supporting articles:</span><span style="mso-bidi-font-weight: bold;"><o:p></o:p></span></b></div>
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<span style="font-family: "Arial Narrow"; mso-bidi-font-family: Arial;">In the New England Journal of Medicine (NEJM) on 17 January, 2013
researchers concluded that, <span style="color: black;">"Abiraterone </span>in
Metastatic Prostate Cancer without Previous Chemotherapy"<span style="color: black;"> improved radiographic progression-free survival, showed a
trend toward improved overall survival, and significantly delayed clinical
decline and initiation of chemotherapy in patients with metastatic
castration-resistant prostate cancer."<b style="mso-bidi-font-weight: normal;">
</b></span></span><b style="mso-bidi-font-weight: normal;"><span style="color: black; font-family: "Arial Narrow"; font-size: 10pt; mso-bidi-font-family: Arial;">(</span></b><span style="color: black; font-family: "Arial Narrow"; font-size: 10pt; mso-bidi-font-family: Arial;">see URL:<span style="mso-spacerun: yes;"> </span></span><u><span style="color: blue; font-family: "Arial Narrow"; font-size: 10pt; mso-bidi-font-family: Arial;">http://www.nejm.org/doi/full/10.1056/NEJMoa1209096</span></u><span style="color: black; font-family: "Arial Narrow"; font-size: 10pt; mso-bidi-font-family: Arial;"> )</span><b style="mso-bidi-font-weight: normal;"><span style="color: black; font-family: "Arial Narrow"; mso-bidi-font-family: Arial;"><o:p></o:p></span></b></div>
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<span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; mso-ansi-language: EN-GB; mso-bidi-font-family: Arial;">A review in <i style="mso-bidi-font-style: normal;">UroToday</i></span><span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; font-size: 10pt; mso-ansi-language: EN-GB; mso-bidi-font-family: Arial;"> (Urology News) </span><span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; mso-ansi-language: EN-GB; mso-bidi-font-family: Arial;">published on 08 February 2013 interprets the (NEJM)
report above as, "this shows that the patients can live longer without
disease progression, can live longer without symptoms, can live longer until
performance status deteriorates, can live longer until receiving chemotherapy,
can live longer until starting opiates for pain, and probably live longer
overall."<span style="mso-spacerun: yes;"> </span>(</span><span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; font-size: 10pt; mso-ansi-language: EN-GB; mso-bidi-font-family: Arial;">see URL</span><span style="color: black; font-family: "Arial Narrow"; font-size: 10pt; mso-bidi-font-family: Arial;">:<span style="mso-spacerun: yes;"> </span></span><u><span style="color: blue; font-family: "Arial Narrow"; font-size: 10pt; mso-bidi-font-family: Arial;">http://goo.gl/D2NGm</span></u><span style="color: blue; font-family: "Arial Narrow"; font-size: 10pt; mso-bidi-font-family: Arial;"> </span><span style="color: black; font-family: "Arial Narrow"; font-size: 10pt; mso-bidi-font-family: Arial;">)</span><u><span style="color: blue; font-family: "Arial Narrow"; font-size: 10pt; mso-bidi-font-family: Arial;"><o:p></o:p></span></u></div>
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</span>Tony Musgrave (aka tony pcm)http://www.blogger.com/profile/11994182692767580358noreply@blogger.com0tag:blogger.com,1999:blog-7376517274129649541.post-44947562746865754502012-08-07T15:56:00.000-07:002013-02-16T20:42:02.114-08:00Incurable prostate cancer patients denied new medication on the PBS<br />
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<b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial;">Chemotherapy-naïve
<em><span style="font-family: Arial;">(never had chemo) </span></em>patients<em><span style="font-family: Arial; font-style: normal; mso-bidi-font-style: italic;"> </span></em>also
deserve <i style="mso-bidi-font-style: normal;"><span style="color: black;">Zytiga </span></i><span style="color: black;">“free” on the PBS</span></span></b><span style="color: black; font-family: Arial;"> </span><br />
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<i style="mso-bidi-font-style: normal;"><span style="font-family: Arial; font-size: 11pt;"><o:p><span style="font-family: Times New Roman; font-size: small;"> </span></o:p></span></i><br />
<span style="font-family: Times New Roman;">
</span><i style="mso-bidi-font-style: normal;"><span style="font-family: Arial; font-size: 11pt;">Prostate cancer (PC)</span></i><span style="font-family: Arial; font-size: 11pt;"> is the most common male cancer in </span><st1:country -region="-region"><st1:place><span style="font-family: Arial; font-size: 11pt;">Australia</span></st1:place></st1:country><span style="font-family: Arial; font-size: 11pt;"> and the third most common cause of
death from cancer in males (</span><span lang="EN" style="font-family: Arial; font-size: 11pt; mso-ansi-language: EN;">Australian Cancer Database 2007)</span><span style="font-family: Arial; font-size: 11pt;">. </span><span lang="EN" style="font-family: Arial; font-size: 11pt; mso-ansi-language: EN;">It was the most
common type of newly diagnosed cancer among males in 2007 (19,403 cases), ahead
of breast cancer in females (12,567 cases).</span><span style="font-family: "Arial Narrow"; font-size: 14pt; mso-bidi-font-family: Arial;">°</span><span style="font-family: Arial; font-size: 11pt;"> <span style="mso-spacerun: yes;"> </span>Many men die from PC every year, most from
advanced stages in its castrate resistant (hormone resistant) form. Metastatic <i><u>prostate
cancer</u></i> occurs in most of these men after a period of treatment with
LHRH agonists (drugs which suppress male hormone) and the cancer eventually
becomes <i style="mso-bidi-font-style: normal;">hormone-refractory</i> (ie, resistant
to this treatment). These patients are incurable. Inevitably they will die from
their cancer. Currently, once metastases (secondary cancer deposits) are
present, chemotherapy and palliative measures for the relief of pain are needed
until the time of death.</span><br />
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</span><br />
<b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;"><span style="font-family: Arial; font-size: 11pt;"><o:p><span style="font-family: Times New Roman; font-size: small;"> </span></o:p></span></i></b><i style="mso-bidi-font-style: normal;"><span style="font-family: Arial; font-size: 11pt;">Abiraterone acetate<span style="mso-bidi-font-style: italic;">
</span></span></i><span style="font-family: Arial; font-size: 11pt;">(<i>Zytiga, </i><i style="mso-bidi-font-style: normal;">Janssen Cilag Pty., Ltd.</i>) is one of the
few <i style="mso-bidi-font-style: normal;">effective new drugs</i> proven to
prolong life and delay the onset of pain and the need for opiates in patients
with advanced prostate cancer. Abiraterone arrests cancer progression and
inhibits the development of distant metastases for a significant period. It
postpones the need for unpleasant chemotherapy drugs. Evidence for this was
presented at the annual meeting of the American Society of Clinical Oncology in
June, 2012.</span><span style="font-family: Arial; font-size: 14pt; mso-bidi-font-weight: bold;">¹ ²</span><b><span style="font-family: Arial; font-size: 11pt;"> </span></b><span style="font-family: Arial; font-size: 11pt; mso-bidi-font-weight: bold;">This
followed publication of the original clinical trial COU-AA-302 in the </span><span class="citation"><span style="font-family: Arial; font-size: 10pt;">New </span></span><span class="citation"><span style="font-family: Arial; font-size: 11pt;">England Journal
of Medicine on </span></span><span style="font-family: Arial; font-size: 11pt;"><a href="http://www.nejm.org/toc/nejm/364/21/"><span style="color: windowtext; text-decoration: none; text-underline: none;">May 26, 2011</span></a></span><span style="font-family: Arial; font-size: 10pt;">.</span><span style="font-family: Arial; font-size: 14pt; mso-bidi-font-weight: bold;">¹</span><o:p></o:p><br />
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 11pt;"><o:p><span style="font-family: Times New Roman; font-size: small;"> </span></o:p></span><span style="font-family: Arial; font-size: 11pt;">On 1<sup>st</sup> March,
2012 (under Section 28 of the Therapeutic Goods Act 1989), <span style="mso-bidi-font-style: italic; mso-bidi-font-weight: bold;">abiraterone</span>
was approved for treatment of <i style="mso-bidi-font-style: normal;">castrate
resistant metastatic prostate cancer (mCRPC)</i> but <span style="mso-bidi-font-weight: bold;">only</span> after patients have already been treated with chemotherapy.</span><strong><span style="font-family: Arial; font-size: 14pt; font-weight: normal; mso-bidi-font-weight: bold;">³ </span></strong><span style="font-family: Arial; font-size: 11pt;"><span style="mso-spacerun: yes;"> </span>It is <u><span style="mso-bidi-font-weight: bold;">not</span></u> approved for <i style="mso-bidi-font-style: normal;">“chemotherapy-naïve”patients
(those who have not yet had chemotherapy)</i> even though they also have
advanced cancer and are incurable. They are the “excluded ”group. It has been
recommended but not yet approved for subsidy via the <i style="mso-bidi-font-style: normal;">Pharmaceutical Benefits Scheme (PBS)</i>. <o:p></o:p></span><br />
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 11pt;"><o:p><span style="font-family: Times New Roman; font-size: small;"> </span></o:p></span><span style="font-family: Arial; font-size: 11pt;">An application from
(Janssen Australia) has recently been recommended by the <i style="mso-bidi-font-style: normal;">Pharmaceutical Benefits Advisory Committee (PBAC)</i> but only on
behalf of <i style="mso-bidi-font-style: normal;">mCRPC </i>patients whose cancer
has progressed in spite of enduring the unpleasant side effects of chemotherapy
with a“taxane”.</span><strong><span style="font-family: Arial; font-size: 14pt; font-weight: normal; mso-bidi-font-weight: bold;">³</span></strong><b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial; font-size: 14pt;"> <span style="mso-spacerun: yes;"> </span></span></b><span style="font-family: Arial; font-size: 11pt;">This means that those patients in
the “excluded” group will not be permitted the more effective treatment when it
will do the most good and without the side effects of the alternative,
chemotherapy. <o:p></o:p></span><br />
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 11pt;"><o:p><span style="font-family: Times New Roman; font-size: small;"> </span></o:p></span><span style="font-family: Arial; font-size: 11pt;">The PBAC has already
acknowledged that abiraterone has a better safety profile and is more convenient
to administer (oral administration) than cabazitaxel.</span><strong><span style="font-family: Arial; font-size: 14pt; font-weight: normal; mso-bidi-font-weight: bold;"> ³</span></strong><span style="font-family: Arial; font-size: 11pt;"> Janssen
R&D in the </span><st1:country -region="-region"><st1:place><span style="font-family: Arial; font-size: 11pt;">USA</span></st1:place></st1:country><span style="font-family: Arial; font-size: 11pt;"> has announced it will seek a new
indication for abiraterone in chemotherapy-naive, metastatic,
castration-resistant prostate cancer (mCRPC) in the second half of 2012.</span><b><span style="font-family: Arial; font-size: 14pt;">²</span></b><span style="font-size: 11pt;"><o:p></o:p></span><br />
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 11pt;"><o:p><span style="font-family: Times New Roman; font-size: small;"> </span></o:p></span><span style="font-family: Arial; font-size: 11pt;">Therefore, in order to
survive longer and postpone the ravages of secondary cancer the mCRPC “excluded”group
would to pay the full price to receive treatment with abiraterone. Information
from the supplier puts the approximate cost at $3,300 per month, thus placing
it out of reach of all but the richest Australians. </span><br />
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 11pt;">Why is this group of cancer
sufferers forced to endure the pain of advancing metastatic cancer in the
bones, brain and liver before they are allowed to receive <span style="mso-bidi-font-style: italic;">abiraterone<i> </i></span>funded by the PBS?
When chemotherapy fails (and this is inevitable) they will be much closer to
death and only then might the PBS pay for the medication. Why should they be
denied a significant extension of life pain-free when this new drug <span style="mso-bidi-font-style: italic;">Abiraterone<i> </i></span>can achieve this?</span><br />
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 11pt;"><o:p><span style="font-family: Times New Roman; font-size: small;"> </span></o:p></span><span style="font-family: Arial; font-size: 11pt;">These restrictions derive
from criteria set by the PBAC designed to minimize financial cost.</span><span style="font-family: Arial; font-size: 14pt; mso-bidi-font-weight: bold;">³</span><b><span style="font-family: Arial; font-size: 11pt;"> </span></b><span style="font-family: Arial; font-size: 11pt; mso-bidi-font-weight: bold;"><span style="mso-spacerun: yes;"> </span>The</span><span style="font-family: Arial; font-size: 11pt;"> rules are oppressive. Cost savings are to be achieved at
the expense of the pain and suffering and the faster track to death determined
by government edict for mCRPC sufferers. </span><br />
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 11pt;">Already, there is excellent
evidence that <span style="mso-bidi-font-style: italic; mso-bidi-font-weight: bold;">abiraterone</span>
can delay progression of the cancer, minimize symptoms and lengthen life.</span><span style="font-family: Arial; font-size: 14pt; mso-bidi-font-weight: bold;">¹ ²</span><b><span style="font-family: Arial; font-size: 11pt;"> <span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span></span></b><span style="font-family: Arial; font-size: 11pt;">Surely, Australian men with
incurable prostate cancer are just as worthy of receiving costly treatment as others,
eg, HIV aids, renal dialysis, organ transplants, etc.. The cost of chemotherapy
and “best supportive care” treatment, alternatives to abiraterone that are
already approved for subsidy for PC patients, can themselves be very expensive.
Therefore the current restrictions on the availability of abiraterone are
unreasonable and oppressive. Budgetary restrictions need to be lifted,
otherwise many more men will die before they can get this new drug</span><br />
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</span><br />
<o:p><span style="font-family: Times New Roman;">
</span></o:p><span style="font-family: Times New Roman;"></span><br />
<span style="font-family: Times New Roman;"></span><br />
<span style="font-family: Times New Roman;"><div class="MsoNormal" style="margin: 0cm 0cm 0pt;">
<b style="mso-bidi-font-weight: normal;"><u><span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; font-size: 14pt; mso-ansi-language: EN-GB; mso-bidi-font-family: Arial;">STOP PRESS 08Feb'12: Extracts from Updated Research and Reports
<o:p></o:p></span></u></b></div>
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<span style="font-family: "Arial Narrow"; mso-bidi-font-family: Arial;"><o:p> </o:p></span><span style="font-family: "Arial Narrow";">In November 2012 the
Pharmaceutical Benefits Advisory Committee (PBAC) recommended listing Abiraterone
on a cost-minimisation basis with cabazitaxel and cost‑effectiveness basis when
compared with best supportive care </span><b><span style="color: black; font-family: "Arial Narrow"; font-size: 10pt;">(</span></b><span style="color: black; font-family: "Arial Narrow"; font-size: 10pt; mso-bidi-font-weight: bold;">see</span><span style="color: blue; font-family: "Arial Narrow"; font-size: 10pt; mso-bidi-font-weight: bold;"> </span><span style="color: black; font-family: "Arial Narrow"; font-size: 10pt; mso-bidi-font-weight: bold;">URL</span><span style="font-family: "Arial Narrow";">
</span><u><span style="color: blue; font-family: "Arial Narrow"; font-size: 10pt;">http://goo.gl/UhVu1</span></u><span style="color: black; font-family: "Arial Narrow"; font-size: 10pt;"> <b style="mso-bidi-font-weight: normal;">)</b></span><span style="color: black; font-family: "Arial Narrow";">. <o:p></o:p></span></div>
<br />
<span style="color: black; font-family: "Arial Narrow";"><o:p><div class="MsoNormal" style="margin: 0cm 0cm 0pt;">
<span style="color: black; font-family: "Arial Narrow";"><span style="font-size: small;">It may take</span></span><b style="mso-bidi-font-weight: normal;"><span style="color: black; font-family: "Arial Narrow"; font-size: 10pt;"> </span></b><span style="color: black; font-family: "Arial Narrow";"><span style="font-size: small;">several months to receive Ministerial and Cabinet approval, which could still be denied. Even if a PBS subsidy is approved, it will benefit only those patients with incurable prostate cancer who have failed treatment with chemotherapy. Those who have not had chemo first will not be eligible. Unlike the FDA in the USA, The Therapeutics Goods Administration (TGA) in Australia has not given approval for these patients. Without such approval no application for PBAC consideration is possible under the "rules". As a consequence about 2,000 Australian men will inevitably develop painful secondaries forcing them onto chemotherapy. They are being left without access to this effective treatment that offers a pain-free extension of life. If the Government so decided, this process could and should be expedited)<u><o:p></o:p></u></span></span></div>
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</o:p></span>
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<span style="font-family: "Arial Narrow";"><o:p> <strong><span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; font-size: 14pt; mso-ansi-language: EN-GB; mso-bidi-font-family: Helvetica; mso-bidi-language: AR-SA; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-US;">Support for: Abiraterone
in Metastatic Prostate Cancer without Previous Chemotherapy</span></strong></o:p></span></div>
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<span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; font-size: 10pt; mso-ansi-language: EN-GB; mso-bidi-font-family: Arial;">from: National
Cancer Institute UPDATE of </span><st1:date day="11" month="12" year="2012"><span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; font-size: 10pt; mso-ansi-language: EN-GB; mso-bidi-font-family: Arial;">December 11, 2012</span></st1:date><span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; font-size: 10pt; mso-ansi-language: EN-GB; mso-bidi-font-family: Arial;"> Report:<span style="mso-spacerun: yes;"> </span></span><span style="font-family: "Arial Narrow";">"FDA
Approval for Abiraterone</span> <span style="font-family: "Arial Narrow";">Acetate"<span style="mso-spacerun: yes;"> </span></span><span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; font-size: 10pt; mso-ansi-language: EN-GB; mso-bidi-font-family: Arial;">(See WEB:</span><span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; mso-ansi-language: EN-GB; mso-bidi-font-family: Arial;">
</span><u><span style="color: blue; font-family: "Arial Narrow"; font-size: 10pt; mso-bidi-font-weight: bold;">http://www.cancer.gov/cancertopics/druginfo/fda-abirateroneacetate</span></u><span style="color: black; font-family: "Arial Narrow"; font-size: 10pt; mso-bidi-font-weight: bold;"><span style="mso-spacerun: yes;"> </span>)<span style="mso-spacerun: yes;">
</span>URL abbreviated to: </span><u><span style="color: blue; font-family: "Arial Narrow"; font-size: 10pt; mso-bidi-font-weight: bold;">http://goo.gl/i3PBi </span></u><span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; mso-ansi-language: EN-GB; mso-bidi-font-family: Arial;"><o:p></o:p></span></div>
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<b style="mso-bidi-font-weight: normal;"><u><span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; mso-ansi-language: EN-GB; mso-bidi-font-family: Arial;">EXTRACT</span></u></b><span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; font-size: 10pt; mso-ansi-language: EN-GB; mso-bidi-font-family: Arial;"><span style="mso-spacerun: yes;"> </span></span><span lang="EN-GB" style="color: black; font-family: Arial; mso-ansi-language: EN-GB;">"
... abiraterone acetate was approved by the FDA<b style="mso-bidi-font-weight: normal;">*</b><span style="mso-spacerun: yes;"> </span>on </span><st1:date day="10" month="12" year="2012"><span lang="EN-GB" style="color: black; font-family: Arial; mso-ansi-language: EN-GB;">December 10, 2012</span></st1:date><span lang="EN-GB" style="color: black; font-family: Arial; mso-ansi-language: EN-GB;"> for
the treatment of mCRPC patients prior to receiving chemotherapy."<o:p></o:p></span></div>
<b style="mso-bidi-font-weight: normal;"><span lang="EN-GB" style="color: black; font-family: Arial; font-size: 14pt; mso-ansi-language: EN-GB;">*</span></b><span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; font-size: 8pt; mso-ansi-language: EN-GB; mso-bidi-font-family: Arial;"> Food and Drug Administration - </span><st1:country-region><st1:place><span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; font-size: 8pt; mso-ansi-language: EN-GB; mso-bidi-font-family: Arial;">USA</span></st1:place></st1:country-region><span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; font-size: 8pt; mso-ansi-language: EN-GB; mso-bidi-font-family: Arial;"><o:p></o:p></span><br />
<b style="mso-bidi-font-weight: normal;"><span style="font-family: "Arial Narrow"; font-size: 10pt; mso-bidi-font-family: Arial;">Reference:</span></b><b style="mso-bidi-font-weight: normal;"><span style="font-family: "Arial Narrow"; font-size: 14pt; mso-bidi-font-family: Arial;"><span style="mso-spacerun: yes;">
</span>¹</span></b><span lang="EN-GB" style="font-family: "Arial Narrow"; font-size: 8pt; mso-ansi-language: EN-GB;">Charles J. Ryan, </span><em><span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; font-size: 8pt; mso-ansi-language: EN-GB; mso-bidi-font-family: Helvetica;">et al.</span></em><span lang="EN-GB" style="font-family: "Arial Narrow"; font-size: 8pt; mso-ansi-language: EN-GB;">
(for the COU-AA-302 Investigators). "Abiraterone in Metastatic Prostate
Cancer without Previous Chemotherapy." </span><em><span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; font-size: 8pt; mso-ansi-language: EN-GB; mso-bidi-font-family: Helvetica;">N Engl J Med.</span></em><span lang="EN-GB" style="font-family: "Arial Narrow"; font-size: 8pt; mso-ansi-language: EN-GB;">
2013; 368:138-48 doi: 10.1056/NEJMoa1209096<span style="mso-spacerun: yes;">
</span>(report updated </span><st1:date day="17" month="1" year="2013"><span lang="EN-GB" style="font-family: "Arial Narrow"; font-size: 8pt; mso-ansi-language: EN-GB;">January 17, 2013</span></st1:date><span lang="EN-GB" style="font-family: "Arial Narrow"; font-size: 8pt; mso-ansi-language: EN-GB;">)<o:p></o:p></span><br />
<b style="mso-bidi-font-weight: normal;"><span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; mso-ansi-language: EN-GB; mso-bidi-font-family: Arial;">________________________________________________________________________________<o:p></o:p></span></b><br />
<br />
<span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; font-size: 8pt; mso-ansi-language: EN-GB; mso-bidi-font-family: Arial;">from </span><i style="mso-bidi-font-style: normal;"><span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; font-size: 8pt; mso-ansi-language: EN-GB; mso-bidi-font-family: Helvetica;">N <em><span style="font-family: "Arial Narrow"; mso-bidi-font-family: Helvetica;">Engl J Med.</span></em></span></i><span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; font-size: 8pt; mso-ansi-language: EN-GB; mso-bidi-font-family: Helvetica;"> 2013; 368:138-48 (UPDATE
17Jan13) </span><span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; font-size: 8pt; mso-ansi-language: EN-GB; mso-bidi-font-family: Arial;">:</span><span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; font-size: 10pt; mso-ansi-language: EN-GB; mso-bidi-font-family: Arial;"> </span><span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; mso-ansi-language: EN-GB; mso-bidi-font-family: Helvetica;">"Abiraterone</span><span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; font-size: 8pt; mso-ansi-language: EN-GB; mso-bidi-font-family: Helvetica;"> </span><span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; mso-ansi-language: EN-GB; mso-bidi-font-family: Helvetica;">in Metastatic Prostate Cancer without Previous Chemotherapy" </span><span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; font-size: 8pt; mso-ansi-language: EN-GB; mso-bidi-font-family: Helvetica;"><span style="mso-spacerun: yes;"> </span></span><span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; font-size: 10pt; mso-ansi-language: EN-GB; mso-bidi-font-family: Helvetica;">(See WEB: </span><u><span lang="EN-GB" style="color: blue; font-family: "Arial Narrow"; font-size: 8pt; mso-ansi-language: EN-GB; mso-bidi-font-family: Helvetica;">http://www.nejm.org/doi/full/10.1056/NEJMoa1209096</span></u><span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; font-size: 10pt; mso-ansi-language: EN-GB; mso-bidi-font-family: Helvetica;"> )<span style="mso-spacerun: yes;"> </span>URL abbreviated to: </span><u><span style="color: blue; font-family: "Arial Narrow"; font-size: 10pt;">http://goo.gl/39YeM<o:p></o:p></span></u><br />
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<b style="mso-bidi-font-weight: normal;"><u><span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; mso-ansi-language: EN-GB; mso-bidi-font-family: Arial;">EXTRACT</span></u></b><span lang="EN-GB" style="font-family: Arial;"> <span style="mso-spacerun: yes;"> </span></span><span style="font-family: Arial;">"Conclusions: <span style="color: #333333;">Abiraterone
improved radiographic progression-free survival, showed a trend toward improved
overall survival, and significantly delayed clinical decline and initiation of
chemotherapy in patients with metastatic castration-resistant prostate
cancer."</span></span><span style="color: #333333; font-family: "Arial Narrow"; mso-bidi-font-family: Arial;"><o:p></o:p></span></div>
<span style="color: #333333; font-family: "Arial Narrow"; mso-bidi-font-family: Arial;">_______________________________________________________________________________</span><b style="mso-bidi-font-weight: normal;"><u><span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; font-size: 10pt; mso-ansi-language: EN-GB; mso-bidi-font-family: Arial;"><o:p></o:p></span></u></b><br />
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<span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; font-size: 10pt; mso-ansi-language: EN-GB; mso-bidi-font-family: Arial;">from: UroToday (Urology
News) published on </span><st1:date day="8" month="2" year="2013"><span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; font-size: 10pt; mso-ansi-language: EN-GB; mso-bidi-font-family: Arial;">Friday, 08 February 2013</span></st1:date><span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; font-size: 10pt; mso-ansi-language: EN-GB; mso-bidi-font-family: Arial;"> </span><st1:time hour="16" minute="19"><span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; font-size: 10pt; mso-ansi-language: EN-GB; mso-bidi-font-family: Arial;">16:19</span></st1:time><span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; font-size: 10pt; mso-ansi-language: EN-GB; mso-bidi-font-family: Arial;"> (referring to the above): </span><span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; mso-ansi-language: EN-GB; mso-bidi-font-family: Arial;">"Abiraterone in metastatic prostate
cancer without previous chemotherapy (from study COU-AA-302)"</span><b style="mso-bidi-font-weight: normal;"><span lang="EN-GB" style="font-family: "Arial Narrow"; font-size: 14pt; mso-bidi-font-family: Arial;"> </span></b><span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; font-size: 10pt; mso-ansi-language: EN-GB; mso-bidi-font-family: Helvetica;"><o:p></o:p></span></div>
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<span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; font-size: 10pt; mso-ansi-language: EN-GB; mso-bidi-font-family: Helvetica;">(See WEB: </span><u><span style="color: blue; font-family: "Arial Narrow"; font-size: 8pt; mso-bidi-font-family: Arial;">http://www.urotoday.com/Treatment-of-mCRPC/abiraterone-in-metastatic-prostate-cancer-without-previous-chemotherapy-from-cou-aa-302.html
</span></u><span style="color: black; font-family: "Arial Narrow"; font-size: 8pt; mso-bidi-font-family: Arial;"><span style="mso-spacerun: yes;"> </span></span><span style="color: black; font-family: "Arial Narrow"; font-size: 10pt; mso-bidi-font-family: Arial;">)<span style="mso-spacerun: yes;"> </span>URL abbreviated to: </span><u><span style="color: blue; font-family: "Arial Narrow"; font-size: 10pt; mso-bidi-font-family: Arial;">http://goo.gl/D2NGm <o:p></o:p></span></u></div>
<br />
<div class="MsoNormal" style="margin: 0cm 0cm 0pt;">
<b style="mso-bidi-font-weight: normal;"><u><span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; mso-ansi-language: EN-GB; mso-bidi-font-family: Arial;">EXTRACT</span></u></b><span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; mso-ansi-language: EN-GB; mso-bidi-font-family: Arial;"> <span style="mso-spacerun: yes;"> </span></span><span lang="EN-GB" style="color: black; font-family: Arial; mso-ansi-language: EN-GB;">"
... In summary, this shows that the patients can live longer without disease
progression, can live longer without symptoms, can live longer until
performance status deteriorates, can live longer until receiving chemotherapy,
can live longer until starting opiates for pain, and probably live longer
overall. ..." <o:p></o:p></span></div>
</span><br />
<h4>
<span lang="EN-GB" style="color: black; font-family: "Arial Narrow"; font-size: 12pt; mso-ansi-language: EN-GB; mso-bidi-font-family: Helvetica; mso-bidi-language: AR-SA; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-US;">_____________________________________________________________________________</span><br />
My Goal: Make Abiraterone acetate (Zytiga)
available immediately via the Pharmaceutical Benefits Scheme for ALL patients
who have metastatic castration-resistant prostate cancer, without the current
requirement for prior treatment with chemotherapy.<o:p></o:p></h4>
<span style="font-family: Times New Roman;">
</span><em><span style="font-family: Arial; font-size: 11pt; font-style: normal; mso-bidi-font-style: italic;"><o:p><span style="font-family: Times New Roman; font-size: small;"> </span></o:p></span></em><em><span style="font-family: Arial; font-size: 11pt;">Your support for this
proposal would be much appreciated. How? simply click on the following URL (or
paste it into the address pane in your web browser). Then "sign" the
prepared email petitioning the federal minister for health to cover the cost
for the excluded patients under the PBS:<span style="mso-spacerun: yes;">
</span></span></em><span style="font-family: Arial; font-size: 11pt;"><a href="https://www.change.org/en-GB/petitions/pbs-should-pay-for-abirterone-for-all-incurable-prostate-cancer-patients#.html"><span style="color: blue;">https://www.change.org/en-GB/petitions/pbs-should-pay-for-abirterone-for-all-incurable-prostate-cancer-patients#.html</span></a>
<o:p></o:p></span><br />
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 11pt;"><o:p><span style="font-family: Times New Roman; font-size: small;"> </span></o:p></span><span style="font-family: Arial; font-size: 11pt;">
</span><br />
<b><u><span style="font-family: Arial; font-size: 14pt;">Footnotes and
References:</span></u></b><br />
<span style="font-family: Times New Roman;">
</span><b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial; font-size: 10pt;"><o:p><span style="font-family: Times New Roman; font-size: small;"> </span></o:p></span></b><br />
<span style="font-family: Times New Roman;">
</span><b style="mso-bidi-font-weight: normal;"><span style="font-family: "Arial Narrow"; font-size: 14pt; mso-bidi-font-family: Arial;">°</span></b><b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial; font-size: 10pt;"> </span></b><span style="font-family: Arial; font-size: 11pt;">Australian
Institute of Health and Welfare (AIHW):</span><span style="font-family: Arial; font-size: 10pt;"><o:p></o:p></span><br />
<span style="font-family: Times New Roman;">
</span><br />
<div style="tab-stops: 243.0pt;">
<b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial; font-size: 10pt;">Cancer in Australia 2010: in brief. </span></b><b style="mso-bidi-font-weight: normal;"><span lang="EN" style="font-family: Arial; font-size: 10pt; mso-ansi-language: EN;">ISSN 1039-3307; ISBN 978-1-74249-081-6;
Cat. no. CAN 55; 28pp.</span></b><span lang="EN" style="font-family: Arial; font-size: 10pt; mso-ansi-language: EN;"> </span></div>
<span style="font-family: Times New Roman;">
</span><br />
<div style="tab-stops: 243.0pt;">
<span style="font-family: Arial; font-size: 10pt;"><a href="http://www.aihw.gov.au/publication-detail/?id=6442472454"><span style="color: blue;">http://www.aihw.gov.au/publication-detail/?id=6442472454</span></a></span><o:p></o:p></div>
<span style="font-family: Times New Roman;">
</span><br />
<div style="tab-stops: 180.0pt;">
<span style="font-family: Arial; font-size: 10pt;"><o:p><span style="font-family: Times New Roman; font-size: small;"> </span></o:p></span></div>
<div style="tab-stops: 243.0pt;">
<b><span style="font-family: Arial; font-size: 14pt;">¹</span></b><b><span style="font-family: Arial; font-size: 11pt;"><span style="mso-spacerun: yes;">
</span></span></b><span style="font-family: Arial;">American Society of Clinical
Oncology (ASCO):</span><span style="font-family: Arial; font-size: 10pt;"><o:p></o:p></span></div>
<span style="font-family: Times New Roman;">
</span><span style="font-family: Arial; font-size: 10pt;"><o:p><span style="font-family: Times New Roman; font-size: small;"> </span></o:p></span><br />
<span style="font-family: Times New Roman;">
</span><b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial; font-size: 10pt;">ASCO Daily News </span></b><st1:date day="1" month="6" year="2012"><b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial; font-size: 10pt;">June 1-5, 2012</span></b></st1:date><b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial; font-size: 10pt;"> > Abstract LBA4518, Charles J Ryan,“Abiraterone Delays Progression
in Patients with Chemotherapy-Naïve CRPC”<span style="mso-bidi-font-weight: bold;"> </span>Jun1-5’12 ASCO Annual Meeting > <o:p></o:p></span></b><br />
<span style="font-family: Times New Roman;">
</span><br />
<div style="tab-stops: 243.0pt;">
<b><i><span style="font-family: Arial; font-size: 10pt;">J Clin Oncol 30, 2012 (suppl; abstr LBA4518)</span></i></b><b><span style="font-family: Arial; font-size: 10pt;"> “Interim analysis (IA) results of
COU-AA-302, a randomized, phase III study of abiraterone acetate (AA) in
chemotherapy-naive patients (pts) with metastatic castration-resistant prostate
cancer (mCRPC)” URL: <o:p></o:p></span></b></div>
<span style="font-family: Times New Roman;">
</span><br />
<div style="tab-stops: 243.0pt;">
<span style="font-family: Arial; font-size: 9pt;"><a href="http://chicago2012.asco.org/ASCODailyNews/LBA4518.aspx?et_cid=29383386&et_rid=463667997&linkid=http%3a%2f%2fchicago2012.asco.org%2fASCODailyNews%2fLBA4518.aspx"><span style="color: blue;">http://chicago2012.asco.org/ASCODailyNews/LBA4518.aspx?et_cid=29383386&et_rid=463667997&linkid=http%3a%2f%2fchicago2012.asco.org%2fASCODailyNews%2fLBA4518.aspx</span></a></span><span style="font-size: 9pt;"><o:p></o:p></span></div>
<span style="font-family: Times New Roman;">
</span><br />
<b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial; font-size: 10pt;"><o:p><span style="font-family: Times New Roman; font-size: small;"> </span></o:p></span></b><br />
<b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial; font-size: 10pt;">EXTRACTS of KEY POINTS:<o:p></o:p></span></b><br />
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 10pt;"><span style="mso-spacerun: yes;"> </span>“ … In patients with asymptomatic or mildly
symptomatic chemotherapy-naïve metastatic castration-resistant prostate cancer
(mCRPC), abiraterone acetate (AA) plus prednisone produced a statistically
significant benefit in radiographic progression-free survival (rPFS) over
placebo plus prednisone, according to a planned interim analysis of a phase III
study. … “ </span><br />
<span style="font-family: Times New Roman;">
</span><br />
<div class="MsoNormal" style="margin: 0cm 0cm 0pt; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;">
<span style="font-family: Arial; font-size: 10pt;"><span style="mso-spacerun: yes;"> </span>“ …AA plus prednisone delayed disease progression,
increased survival, and extended time with minimal or no symptoms, said Charles
J. Ryan, MD, of the Helen Diller Family Comprehensive Cancer Center at the
University of California, San Francisco. In addition, no important new safety
signals were seen in the randomized, multicenter COU-AA- 302 study, added Dr.
Ryan,<b style="mso-bidi-font-weight: normal;"><o:p></o:p></b></span></div>
<span style="font-family: Times New Roman;">
</span><br />
<div class="MsoNormal" style="margin: 0cm 0cm 0pt; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;">
<span style="font-family: Arial; font-size: 10pt;"><span style="mso-spacerun: yes;"> </span>“ …the co-primary endpoints of overall
survival (OS) and rPFS and secondary endpoints all favored the AA arm and
unanimously recommended unblinding the study and crossing patients over from
placebo to AA treatment, Dr. Ryan said.<b style="mso-bidi-font-weight: normal;"><o:p></o:p></b></span></div>
<span style="font-family: Times New Roman;">
</span><br />
<div class="MsoNormal" style="margin: 0cm 0cm 0pt; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;">
<span style="font-family: Arial; font-size: 10pt;"><span style="mso-spacerun: yes;"> </span>“ …the objectives of therapy development in
this disease state have been met, … “<b style="mso-bidi-font-weight: normal;"><o:p></o:p></b></span></div>
<span style="font-family: Times New Roman;">
</span><br />
<div class="MsoNormal" style="margin: 0cm 0cm 0pt; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;">
<span style="font-family: Arial; font-size: 10pt;"><span style="mso-spacerun: yes;"> </span>“ … These data merit consideration as
providing a new standard approach in this highly prevalent patient population
faced with an unmet medical need.”</span><span style="font-family: Arial; font-size: 9pt;"><o:p></o:p></span></div>
<span style="font-family: Times New Roman;">
</span><br />
<div style="tab-stops: 243.0pt;">
<span style="font-family: Arial; font-size: 10pt;">“…
However, a reality is that much of the life of a patient with mCRPC is lived
before chemotherapy, and in fact a large proportion of patients never receive
it,” he said.<o:p></o:p></span></div>
<span style="font-family: Times New Roman;">
</span><br />
<div style="tab-stops: 243.0pt;">
<span style="font-family: Arial; font-size: 10pt;"><span style="mso-spacerun: yes;"> </span>"The natural history of progressive mCRPC
can be prolonged, and can appear over a period of years. Therefore, several
hallmarks of disease progression (time to opiate use as a surrogate for
cancer-related pain, time to initiation of chemotherapy, time to Eastern
Cooperative Oncology Group performance status deterioration, time to PSA
progression) were used as secondary endpoints, to provide “a comprehensive
assessment of the magnitude of the clinical benefit conferred by AA,” Dr. Ryan
said. “Therapy with AA delayed, to a clinically significant degree, the onset of
these meaningful events,” he said. … “<b> </b></span></div>
<span style="font-family: Times New Roman;">
</span><br />
<div style="mso-outline-level: 2; tab-stops: 243.0pt;">
<b><span style="font-family: Arial; font-size: 10pt;"><o:p><span style="font-family: Times New Roman; font-size: small;"> </span></o:p></span></b></div>
<b><span style="font-family: Arial; font-size: 14pt;">¹</span></b><b><span style="font-family: Arial; font-size: 11pt;"> </span></b><span style="font-family: Arial; font-size: 10pt; mso-bidi-font-weight: bold;">(additional reference) </span><span style="font-family: Arial; font-size: 10pt;">Original article (Clinical Trial <span style="mso-bidi-font-weight: bold;">COU-AA-302) </span>published in: <b style="mso-bidi-font-weight: normal;"><o:p></o:p></b></span><br />
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 10pt;"><o:p><span style="font-family: Times New Roman; font-size: small;"> </span></o:p></span><st1:place><span class="citation"><span style="font-family: Arial; font-size: 10pt; font-weight: normal; mso-bidi-font-weight: bold;">N Engl</span></span></st1:place><span class="citation"><span style="font-family: Arial; font-size: 10pt; font-weight: normal; mso-bidi-font-weight: bold;"> J Med 2011; 364:1995-2005</span></span><span style="font-family: Arial; font-size: 10pt; font-weight: normal; mso-bidi-font-weight: bold;"><a href="http://www.nejm.org/toc/nejm/364/21/"><span style="color: black; text-decoration: none; text-underline: none;">May 26, 2011</span></a></span><strong><span style="font-family: Arial; font-size: 10pt;"> Abiraterone and Increased Survival
in Metastatic Prostate Cancer. </span><span style="font-family: Arial; font-size: 10pt; mso-bidi-font-weight: normal;">“Interim analysis (IA) results of
COU-AA-302, a randomized, phase III study of abiraterone acetate (AA) in
chemotherapy-naive patients (pts) with metastatic castration-resistant prostate
cancer (mCRPC)”</span></strong><span style="font-family: Arial; font-size: 10pt; font-weight: normal;"> <o:p></o:p></span><br />
<span style="font-family: Times New Roman;">
</span><br />
<div class="authors4" style="margin: 0cm 0cm 0pt;">
<span style="color: black; font-family: Arial; font-size: 8pt;">Johann
S. de Bono, M.B., Ch.B., Ph.D., Christopher J. Logothetis, M.D., Arturo Molina,
M.D., Karim Fizazi, M.D., Ph.D., Scott North, M.D., Luis Chu, M.D., Kim N. Chi,
M.D., Robert J. Jones, M.D., Oscar B. Goodman, Jr., M.D., Ph.D., Fred Saad,
M.D., John N. Staffurth, M.D., Paul Mainwaring, M.D., M.B., B.S., Stephen
Harland, M.D., Thomas W. Flaig, M.D., Thomas E. Hutson, D.O., Pharm.D., Tina
Cheng, M.D., Helen Patterson, M.D., John D. Hainsworth, M.D., Charles J. Ryan,
M.D., Cora N. Sternberg, M.D., Susan L. Ellard, M.D., Aude Fléchon, M.D.,
Ph.D., Mansoor Saleh, M.D., Mark Scholz, M.D., Eleni Efstathiou, M.D., Ph.D.,
Andrea Zivi, M.D., Diletta Bianchini, M.D., Yohann Loriot, M.D., Nicole
Chieffo, M.B.A., Thian Kheoh, Ph.D., Christopher M. Haqq, M.D., Ph.D., and
Howard I. Scher, M.D. for <span class="nlmon-behalf-of">the COU-AA-301
Investigators</span></span><span style="color: #333333; font-family: Arial;"><span style="font-size: x-small;"> <o:p></o:p></span></span></div>
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 9pt;"><a href="http://www.nejm.org/doi/full/10.1056/NEJMoa1014618#t=abstract"><span style="color: blue;">http://www.nejm.org/doi/full/10.1056/NEJMoa1014618#t=abstract</span></a>
</span><span style="font-family: Arial; font-size: 10pt;"><o:p></o:p></span><br />
<span style="font-family: Times New Roman;">
</span><br />
<div class="MsoNormal" style="margin: 0cm 0cm 0pt; mso-layout-grid-align: none;">
<span class="MsoHyperlink"><span style="font-family: Arial; font-size: 9pt;"><a href="http://www.nejm.org/doi/full/10.1056/NEJMoa1014618"><span style="color: blue;">http://www.nejm.org/doi/full/10.1056/NEJMoa1014618</span></a></span></span><span style="font-family: Arial; font-size: 14pt; mso-bidi-font-weight: bold;"><o:p></o:p></span></div>
<span style="font-family: Times New Roman;">
</span><br />
<div class="MsoNormal" style="margin: 0cm 0cm 0pt; mso-layout-grid-align: none;">
<b><span style="font-family: Arial; font-size: 14pt;"><o:p><span style="font-family: Times New Roman; font-size: small;"></span></o:p></span></b> </div>
<div class="MsoNormal" style="margin: 0cm 0cm 0pt; mso-layout-grid-align: none;">
<b><span style="font-family: Arial; font-size: 14pt;">² </span></b><span style="font-family: Arial;"><span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">OncologyStat </i>(a subscriber medical journal scanning and news
service)<o:p></o:p></span></div>
<span style="font-family: Times New Roman;">
</span><br />
<div style="tab-stops: 180.0pt;">
<b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial; font-size: 10pt;">“Abiraterone Delays Progression in
Patients with Chemotherapy-Naïve</span></b><b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial;"> CRPC,” </span></b><b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial; font-size: 10pt;">ASCO 2012: Conference
Coverage Roundup: Abstract from: IMNG Medical Media. 2012 Jun 11, P Wendling
“Abiraterone Blocks Chemo-Naïve Prostate Cancer”<span style="mso-spacerun: yes;"> </span><o:p></o:p></span></b></div>
<span style="font-family: Times New Roman;">
</span><br />
<div style="tab-stops: 180.0pt;">
<span style="font-family: Arial; font-size: 10pt; mso-bidi-font-weight: bold;"><a href="http://www.oncologystat.com/news/Abiraterone_Blocks_Chemo-Naive_Prostate_Cancer_US.html"><span style="color: blue;">http://www.oncologystat.com/news/Abiraterone_Blocks_Chemo-Naive_Prostate_Cancer_US.html</span></a><o:p></o:p></span></div>
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 10pt;">(Note: to read the full
article it is necessary to sign up to this professional cancer news
publication, <i style="mso-bidi-font-style: normal;">OncologyStat</i>; it takes
only a few seconds on this URL and membership is free). <o:p></o:p></span><br />
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 10pt;"><o:p><span style="font-family: Times New Roman; font-size: small;"> </span></o:p></span><br />
<b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial; font-size: 10pt;">EXTRACTS of KEY POINTS:</span></b><span style="font-family: Arial; font-size: 10pt;"> <o:p></o:p></span><br />
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 10pt;">“CHICAGO (EGMN) -
Abiraterone acetate plus prednisone significantly delays progression and
initiation of chemotherapy in asymptomatic or mildly symptomatic,
chemotherapy-naive, metastatic, castration-resistant prostate cancer, according
to much-anticipated data from a pivotal clinical trial. ></span><br />
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 10pt;">The second preplanned
interim analysis of the COU-AA-302 trial also revealed a strong overall
survival trend favoring abiraterone (Zytiga) over prednisone and placebo,
leading to unblinding of the phase III trial in March 2012 and crossover
treatment for the control arm. … “</span><br />
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 10pt;"><span style="mso-spacerun: yes;"> </span>“… This is the first trial to show progression
and overall survival benefits in this setting. Janssen Research &
Development announced it will seek a new indication for abiraterone in
chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC) in
the second half of 2012. > </span><span style="font-family: "Arial Narrow";"><o:p></o:p></span><br />
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 10pt;">The combination of
abiraterone plus prednisone has already demonstrated an overall survival
benefit in patients with prior chemotherapy, leading to its approval in April
2011 for mCRPC that had previously been treated with docetaxel (Taxotere)
chemotherapy.…” <o:p></o:p></span><br />
<span style="font-family: Times New Roman;">
</span><br />
<div class="MsoNormal" style="margin: 0cm 0cm 0pt;">
<span style="font-family: Arial; font-size: 10pt;">(author’s
note: From the expert commentaries extracted above two compelling reasons
emerge as to why a PBS subsidy should apply without further delay for chemo-naïve
mCRPC patients. One derives from the evidence that abiraterone is effective and
“safer …” and this has been acknowledged by the PBAC (plus Janssen-Cilag is
seeking FDA approval in the </span><st1:country -region="-region"><st1:place><span style="font-family: Arial; font-size: 10pt;">USA</span></st1:place></st1:country><span style="font-family: Arial; font-size: 10pt;"> for this group on the same basis).
The other is that the strength of this evidence led the <span style="mso-bidi-font-weight: bold;">COU-AA-302 clinical trial to be unblinded early so as to permit the
control group to receive the obvious benefits of the drug. Their lives would
otherwise have been sacrificed, arguably unjustifiably in order to keep the trial
“pure”. This is the moral and ethical dilemma that can sometimes arise and it
serves as a timely reminder that real people are affected for better or worse
by decisions made in the name of scientific purity. Other trials are also
ongoing in the </span></span><st1:country -region="-region"><st1:place><span style="font-family: Arial; font-size: 10pt; mso-bidi-font-weight: bold;">USA</span></st1:place></st1:country><span style="font-family: Arial; font-size: 10pt; mso-bidi-font-weight: bold;"> to confirm
the safety of abiraterone. The outcomes will be very important. Nevertheless,
there is already sufficient evidence in its favour to permit eligible patients
to make an informed decision on the balance of risks to benefits of receiving
this drug now instead of chemotherapy. It should be their choice.) </span><span style="font-family: Arial; font-size: 10pt;"><o:p></o:p></span></div>
<span style="font-family: Times New Roman;">
</span><b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial; font-size: 10pt;"><o:p><span style="font-family: Times New Roman; font-size: small;"> </span></o:p></span></b><br />
<b><span style="font-family: Arial; font-size: 14pt;">³ </span></b><b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial; font-size: 10pt;"><span style="mso-spacerun: yes;"> </span></span></b><span style="font-family: Arial; font-size: 10pt;">Pharmaceutical Benefits Advisory
Committee (PBAC) <o:p></o:p></span><br />
<span style="font-family: Times New Roman;">
</span><br />
<b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial; font-size: 10pt;">EXTRACTS of KEY MILESTONES:<o:p></o:p></span></b><br />
<span style="font-family: Times New Roman;">
</span><br />
<b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial; font-size: 10pt;">Nov, 2011 <span style="mso-spacerun: yes;"> </span>Pharmaceutical
Benefits Advisory Committee (PBAC) Public Summary Document</span></b><br />
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 10pt;"><a href="http://www.health.gov.au/internet/main/publishing.nsf/Content/pbac-psd-abirateronee-nov11"><span style="color: blue;">http://www.health.gov.au/internet/main/publishing.nsf/Content/pbac-psd-abirateronee-nov11</span></a></span><br />
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 10pt; font-weight: normal; mso-bidi-font-weight: bold;">“… 2. Background</span><span style="font-family: Arial; font-size: 10pt;"><br />
</span><br />
<span style="font-family: Times New Roman; font-size: medium;">
</span><em><span style="font-family: Arial; font-size: 10pt; font-weight: normal; mso-bidi-font-weight: bold;">The Rule of Rescue:</span></em><br />
<span style="font-family: Times New Roman; font-size: medium;">
</span><span style="font-family: Arial; font-size: 10pt; font-weight: normal; mso-bidi-font-weight: bold;">There are four factors which when applied concurrently in exceptional
circumstances, are called the ‘rule of rescue’ as follows.</span><span style="font-size: medium;"><span style="font-family: Times New Roman;"> </span></span><br />
<ul type="disc"><span style="font-family: Times New Roman;">
</span>
<li class="MsoNormal" style="margin: 0cm 0cm 0pt; mso-list: l0 level1 lfo1; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><i style="mso-bidi-font-style: normal;"><span style="font-family: Arial; font-size: 10pt;">No alternative
exists in Australia</span></i><span style="font-family: Arial; font-size: 10pt;"> to treat patients with the specific circumstances of the medical
condition meeting the criteria of the restriction. This means that there
are no nonpharmacological or pharmacological interventions for these
patients. <o:p></o:p></span></li>
<span style="font-family: Times New Roman;">
</span>
<li class="MsoNormal" style="margin: 0cm 0cm 0pt; mso-list: l0 level1 lfo1; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><span style="font-family: Arial; font-size: 10pt;">The medical condition defined by the requested
restriction is severe, progressive and expected to lead to premature
death. The more severe the condition, or the younger the age at which a
person with the condition might die, or <i style="mso-bidi-font-style: normal;">the closer a person with the condition is to death</i>, the more
influential the rule of rescue might be in the consideration by PBAC. <o:p></o:p></span></li>
<span style="font-family: Times New Roman;">
</span>
<li class="MsoNormal" style="margin: 0cm 0cm 0pt; mso-list: l0 level1 lfo1; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><span style="font-family: Arial; font-size: 10pt;">The medical condition defined by the requested
restriction <i style="mso-bidi-font-style: normal;">applies to only a very
small number of patients</i>. Again, the fewer the patients, the more
influential the rule of rescue might be in the consideration by PBAC.
However, <i style="mso-bidi-font-style: normal;">PBAC is also mindful that
the PBS is a community-based scheme and cannot cater for individual
circumstances</i>. <o:p></o:p></span></li>
<span style="font-family: Times New Roman;">
</span>
<li class="MsoNormal" style="margin: 0cm 0cm 0pt; mso-list: l0 level1 lfo1; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><span style="font-family: Arial; font-size: 10pt;">The proposed drug provides a worthwhile clinical
improvement sufficient to qualify as a rescue from the medical condition.
The greater the rescue, the more influential the rule of rescue might be
in the consideration by PBAC. <o:p></o:p></span></li>
<span style="font-family: Times New Roman;">
</span></ul>
<span style="font-family: Times New Roman;">
</span><br />
<div class="MsoNormal" style="margin: 0cm 0cm 0pt; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;">
<span style="font-family: Arial; font-size: 10pt;">(author’s note: the <i style="mso-bidi-font-style: normal;">italics</i> are mine)<o:p></o:p></span></div>
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 10pt; font-weight: normal; mso-bidi-font-weight: bold;">“ … 11. Estimated PBS Usage and Financial
Implications<o:p></o:p></span><br />
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 10pt;">The net financial cost to
the PBS was estimated by the submission to be between $30 – $60 million in Year
5 of listing. The estimate was considered uncertain because of the potential of
extended use beyond disease progression given the safety profile and ease of
administration of abiraterone.” <o:p></o:p></span><br />
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 10pt;"><o:p><span style="font-family: Times New Roman; font-size: small;"></span></o:p></span><br />
<span style="font-family: Arial; font-size: 10pt;">“ … 12.<span style="mso-spacerun: yes;"> </span>Recommendations and Reasons … ”<o:p></o:p></span><br />
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 10pt;">“ … Whilst the PBAC
considered that there are uncertainties inherent from indirect comparisons, it
accepted the submission’s clinical claims:<span style="mso-spacerun: yes;">
</span>… 3) abiraterone plus prednisone/prednisolone is non-inferior in terms
of comparative effectiveness and superior in terms of comparative safety over
cabazitaxel plus prednisone/prednisolone alone. … ”<o:p></o:p></span><br />
<span style="font-family: Times New Roman;">
</span><span style="font-family: Arial; font-size: 10pt;"><o:p><span style="font-family: Times New Roman; font-size: small;"> </span></o:p></span><br />
<span style="font-family: Arial; font-size: 10pt;">(author’s note: this
assertion stands in contradistinction to those in the key points in reference</span><b><span style="font-family: Arial; font-size: 14pt;">¹</span></b><span style="font-family: Arial; font-size: 10pt; mso-bidi-font-weight: bold;"> above, in particular, </span><span style="font-family: Arial; font-size: 10pt;">“ … AA plus prednisone delayed
disease progression, increased survival, and extended time with minimal or no
symptoms” … and “…“Therapy with AA delayed, to a clinically significant degree,
the onset of these meaningful events, … ” ie, Abiraterone is better than
non-inferior. It is acknowledged by the PBAC as safer.)<o:p></o:p></span><br />
<span style="font-family: Times New Roman;">
</span><span style="font-family: Arial; font-size: 10pt;"><o:p><span style="font-family: Times New Roman; font-size: small;"> </span></o:p></span><br />
<span style="font-family: Arial; font-size: 10pt;">“ … The PBAC therefore
rejected the submission on the basis of an unacceptably high incremental
cost-effectiveness ratio and due to uncertainty regarding the clinical place in
therapy.”</span><span style="font-family: Arial; font-size: 9pt;"><o:p></o:p></span><br />
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 10pt;">“ … 14. Sponsor’s Comment<o:p></o:p></span><br />
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 10pt;">The sponsor has no comment.“<o:p></o:p></span><br />
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 10pt;">(author’s note: in
reference </span><b><span style="font-family: Arial; font-size: 14pt;">²</span></b><span style="font-family: Arial; font-size: 10pt; mso-bidi-font-weight: bold;"> above,
third key point, see: “ … </span><span style="font-family: Arial; font-size: 10pt;">Janssen Research & Development (USA) <span style="mso-spacerun: yes;"> </span>announced it will seek a new indication (ie,
FDA approval) for abiraterone in chemotherapy-naive, metastatic,
castration-resistant prostate cancer (mCRPC) in the second half of 2012. …
“<span style="mso-spacerun: yes;"> </span>In view of this more recent
announcement by the sponsor’s </span><st1:country -region="-region"><st1:place><span style="font-family: Arial; font-size: 10pt;">USA</span></st1:place></st1:country><span style="font-family: Arial; font-size: 10pt;"> parent one hopes that this
situation has changed since November, 2011. I am seeking more information on
Janssen </span><st1:country -region="-region"><st1:place><span style="font-family: Arial; font-size: 10pt;">Australia</span></st1:place></st1:country><span style="font-family: Arial; font-size: 10pt;">’s intentions. )</span><br />
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 10pt;"><o:p><span style="font-family: Times New Roman; font-size: small;"> </span></o:p></span><br />
<b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial; font-size: 10pt;">March 2012 <span style="mso-spacerun: yes;"> </span>PBAC
Outcomes - Positive Recommendations:</span></b><br />
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 10pt;"><a href="http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/pbac-outcomes/2012-03/positive-recommendations"><span style="color: blue;">http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/pbac-outcomes/2012-03/positive-recommendations</span></a></span><br />
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 10pt;">“PBS Listing requested by
the sponsor (Janssen-Cilag Pty Ltd): <b style="mso-bidi-font-weight: normal;"><o:p></o:p></b></span><br />
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 10pt;">Authority Required listing
for the initial and continuing treatment, in combination with prednisone or
prednisolone, of patients with metastatic advanced prostate cancer (castration
resistant prostate cancer) in whom disease progression has occurred following
treatment with docetaxel”<b style="mso-bidi-font-weight: normal;"><o:p></o:p></b></span><br />
<span style="font-family: Times New Roman;">
</span><span style="font-family: Arial; font-size: 10pt;"><o:p><span style="font-family: Times New Roman; font-size: small;"> </span></o:p></span><br />
<span style="font-family: Arial; font-size: 10pt;">“PBAC Recommendation:<o:p></o:p></span><br />
<span style="font-family: Times New Roman;">
</span><br />
<div class="MsoNormal" style="margin: 0cm 0cm 0pt; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;">
<span style="font-family: Arial; font-size: 10pt;">Recommended on a cost-minimisation
basis with cabazitaxel. The PBAC noted that abiraterone has a better safety
profile and is more convenient to administer (oral administration) than
cabazitaxel.”<o:p></o:p></span></div>
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 10pt;">(author’s notes:<span style="mso-tab-count: 1;"> </span><o:p></o:p></span><br />
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 10pt;">a) “cost-minimization” !<o:p></o:p></span><br />
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 10pt;">b) in reference </span><b><span style="font-family: Arial; font-size: 14pt;">²</span></b><span style="font-family: Arial; font-size: 10pt; mso-bidi-font-weight: bold;"> above, third key point,
see: “ … </span><span style="font-family: Arial; font-size: 10pt;">Janssen
Research & Development announced it will seek a new indication for
abiraterone in chemotherapy-naive, metastatic, castration-resistant prostate
cancer (mCRPC) in the second half of 2012. … “ but this is in the </span><st1:country -region="-region"><st1:place><span style="font-family: Arial; font-size: 10pt;">USA</span></st1:place></st1:country><span style="font-family: Arial; font-size: 10pt;">, not in </span><st1:country -region="-region"><st1:place><span style="font-family: Arial; font-size: 10pt;">Australia</span></st1:place></st1:country><span style="font-family: Arial; font-size: 10pt;">. <o:p></o:p></span><br />
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 10pt;">Janssen </span><st1:country -region="-region"><st1:place><span style="font-family: Arial; font-size: 10pt;">Australia</span></st1:place></st1:country><span style="font-family: Arial; font-size: 10pt;"> would need to obtain a similar
approval from the Therapeutics Goods Administration (TGA) in </span><st1:country -region="-region"><st1:place><span style="font-family: Arial; font-size: 10pt;">Australia</span></st1:place></st1:country><span style="font-family: Arial; font-size: 10pt;"> as well as succeed with a further
request to the PBAC to include chemotherapy-naive mCRPC patients in a listing
for PBS subsidy before this “excluded” group could get any access to
abiraterone. All this regulatory process eats up precious time, time that these
patients don’t have)</span><br />
<span style="font-family: Times New Roman;">
</span><br />
<b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial; font-size: 10pt;"><o:p><span style="font-family: Times New Roman; font-size: small;"> </span></o:p></span></b><br />
<b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial; font-size: 10pt;">July 2012<span style="mso-spacerun: yes;"> </span>Agenda
for the July 2012 PBAC Meeting<o:p></o:p></span></b><br />
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 10pt;"><a href="http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/pbac-agenda"><span style="mso-bidi-font-size: 12.0pt;"><span style="color: blue;">http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/pbac-agenda</span></span></a></span><br />
<span style="font-family: Times New Roman;">
</span><br />
<div style="tab-stops: 374.5pt;">
<span style="font-family: Arial; font-size: 8pt;"><span style="mso-tab-count: 1;"> </span></span></div>
<span style="font-family: Arial; font-size: 10pt; mso-bidi-font-weight: bold;">Listing
requested by Sponsor (</span><span style="font-family: Arial; font-size: 10pt;">Janssen-Cilag
Pty Ltd<span style="mso-bidi-font-weight: bold;"> ) / <span style="mso-spacerun: yes;"> </span>Purpose of Submission:<span style="mso-spacerun: yes;"> </span><o:p></o:p></span></span><br />
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 10pt;">“Re-submission to request a
review of the March 2012 PBAC recommendation for an Authority Required listing
for the initial and continuing treatment, in combination with prednisone or
prednisolone, of patients with metastatic advanced prostate cancer (castration
resistant prostate cancer) in whom disease progression has occurred following
treatment with docetaxel.”<o:p></o:p></span><br />
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 10pt;">(author’s note:</span><span style="font-family: Arial; font-size: 8pt;"> </span><span style="font-family: Arial; font-size: 10pt;"><span style="mso-spacerun: yes;"> </span>It is still <span style="mso-bidi-font-weight: bold;">not</span> being considered for <i style="mso-bidi-font-style: normal;">“chemotherapy-naïve”patients (those who have
not yet had chemotherapy)</i> even though they also have advanced cancer and
are incurable. The “excluded ” group<span style="mso-spacerun: yes;"> </span>are
still being left to get worse and condemned to chemotherapy.) </span><span style="font-family: Arial; font-size: 8pt;"><o:p></o:p></span><br />
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Times New Roman;"></span><br />
<div class="MsoNormal" style="margin: 0cm 0cm 0pt;">
<b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial; font-size: 10pt;">26 Sep12<span style="mso-spacerun: yes;"> </span>Agenda for the November 2012 PBAC Meeting<o:p></o:p></span></b></div>
<span style="font-family: Times New Roman;">
</span><br />
<div class="MsoNormal" style="margin: 0cm 0cm 0pt;">
<span style="font-family: Arial; font-size: 10pt;"><a href="http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/pbac-agenda"><span style="color: blue;">http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/pbac-agenda</span></a><o:p></o:p></span></div>
<span style="font-family: Times New Roman;">
</span><br />
<div class="MsoNormal" style="margin: 0cm 0cm 0pt;">
<span style="font-family: Arial; font-size: 10pt;">“Resubmission<o:p></o:p></span></div>
<span style="font-family: Times New Roman;">
</span><br />
<div class="MsoNormal" style="margin: 0cm 0cm 0pt;">
<span style="font-family: Arial; font-size: 10pt;">ABIRATERONE,
tablet, 250 mg (as acetate), Zytiga<sup>®</sup></span><sup><span style="font-family: Arial; font-size: 11pt;"><o:p></o:p></span></sup></div>
<span style="font-family: Times New Roman;">
</span><br />
<div class="MsoNormal" style="margin: 0cm 0cm 0pt;">
<span style="font-family: Arial; font-size: 10pt;">Prostate
cancer</span><span style="font-family: Arial; font-size: 11pt;"><o:p></o:p></span></div>
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 10pt;">Requests a review of the
PBAC’s March 2012 recommendation to list abiraterone on a cost‑minimisation
basis to cabazitaxel as an Authority Required benefit for the treatment, in
combination with prednisone or prednisolone, of castration resistant metastatic
carcinoma of the prostate in a patient who meets certain criteria.”</span><span style="font-family: Arial; font-size: 11pt;"><o:p></o:p></span><br />
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 10pt;">(author’s note:</span><span style="font-family: Arial; font-size: 8pt;"> </span><span style="font-family: Arial; font-size: 10pt;"><span style="mso-spacerun: yes;"> </span><span style="color: black;">The request by Janssen to the PBAC for consideration at it
November, 2012 meeting (see extract above), basically reverting to the wording
used in March, including a rider, viz., “ … of castration resistant metastatic
carcinoma of the prostate in a patient who meets certain criteria.” construed
to mean those who have failed chemotherapy and to still exclude the</span> <i style="mso-bidi-font-style: normal;">chemotherapy-naive</i><span style="color: black;"> <span style="mso-spacerun: yes;"> </span>“excluded” group
that I have identified (see above).) <o:p></o:p></span></span><br />
<span style="font-family: Times New Roman;">
</span><br />
<span style="color: black; font-family: Arial; font-size: 9pt;"><o:p><span style="font-family: Times New Roman; font-size: small;">______________________________________________________________________________</span></o:p></span><br />
<span style="color: black; font-family: Arial; font-size: 9pt;"><o:p></o:p></span><br />
<span style="color: black; font-family: Arial; font-size: 9pt;"><o:p> </o:p></span>On <st1:date day="8" month="10" year="2012">08 October, 2012</st1:date> I submitted the following comment to the PBAC
for consideration at its November, 2012 meeting:<o:p></o:p><br />
<span style="font-family: Times New Roman;">
</span><b style="mso-bidi-font-weight: normal;"><span style="color: black; font-family: Arial; font-size: 9pt;">Copy:</span></b><br />
<div class="MsoNormal" style="margin: 0cm 9pt 0pt 0cm;">
<b style="mso-bidi-font-weight: normal;"><span style="color: black; font-family: Arial; font-size: 9pt;"></span></b> </div>
<div class="MsoNormal" style="margin: 0cm 9pt 0pt 0cm;">
<b style="mso-bidi-font-weight: normal;"><span style="color: black; font-family: Arial; font-size: 9pt;">"My
Consumer Comment</span></b><span style="color: black; font-family: Arial; font-size: 9pt;"> (also my clinical comment as a retired medical practitioner and
medical administrator in community and public health) <o:p></o:p></span></div>
<span style="font-family: Times New Roman;">
</span><br />
<div class="MsoNormal" style="margin: 0cm 9pt 0pt 0cm;">
<span style="color: black; font-family: Arial; font-size: 9pt;">Following radical prostatectomy and radiotherapy
I have been treated with IM Lucrin depot which kept my </span><st1:stockticker><span style="color: black; font-family: Arial; font-size: 9pt;">PSA</span></st1:stockticker><span style="color: black; font-family: Arial; font-size: 9pt;"> down for three years but
I am now “hormone refractory”<o:p></o:p></span></div>
<span style="font-family: Times New Roman;">
</span><span style="color: black; font-family: Arial; font-size: 9pt;"><o:p><span style="font-family: Times New Roman; font-size: small;"> </span></o:p></span><br />
<div class="MsoNormal" style="margin: 0cm 9pt 0pt 0cm;">
<span style="color: black; font-family: Arial; font-size: 9pt;">The real new hope for
"post-chemotherapy" mCRPC and "chemotherapy-naïve" mCRPC
patients (like me) resides in two seminal events:<o:p></o:p></span></div>
<span style="font-family: Times New Roman;">
</span><br />
<div class="MsoNormal" style="margin: 0cm 0cm 0pt;">
<span style="color: black; font-family: Arial; font-size: 9pt;">1.
In September 2012 the final analysis of the COU-AA-301 study was published
online in Lancet Oncology confirming that abiraterone significantly prolongs
overall survival in patients with metastatic castrate resistant prostate cancer
(mCRPC) who have progressed after docetaxel treatment. No new safety signals
were identified with increased follow-up, and <o:p></o:p></span></div>
<span style="font-family: Times New Roman;">
</span><span style="color: black; font-family: Arial; font-size: 9pt;"><o:p><span style="font-family: Times New Roman; font-size: small;"> </span></o:p></span><br />
<div class="MsoNormal" style="margin: 0cm 0cm 0pt;">
<span style="color: black; font-family: Arial; font-size: 9pt;">2.
The highly significant comments made in June, 2012 at the ASCO Conference in </span><st1:city><st1:place><span style="color: black; font-family: Arial; font-size: 9pt;">Chicago</span></st1:place></st1:city><span style="color: black; font-family: Arial; font-size: 9pt;">, viz., <o:p></o:p></span></div>
<span style="font-family: Times New Roman;">
</span><br />
<div class="MsoNormal" style="margin: 0cm 0cm 0pt;">
<span style="font-family: Arial; font-size: 9pt;">"Abiraterone
Delays Progression in Patients with Chemotherapy-Naïve CRPC: In patients with
asymptomatic or mildly symptomatic chemotherapy-naïve metastatic
castration-resistant prostate cancer (mCRPC), abiraterone acetate (AA) plus
prednisone produced a statistically significant benefit in radiographic
progression-free survival (rPFS) over placebo plus prednisone, according to a
planned interim analysis of a phase </span><st1:stockticker><span style="font-family: Arial; font-size: 9pt;">III</span></st1:stockticker><span style="font-family: Arial; font-size: 9pt;"> study" <span style="color: black;"><o:p></o:p></span></span></div>
<span style="font-family: Times New Roman;">
</span><span style="color: black; font-family: Arial; font-size: 9pt;"><o:p><span style="font-family: Times New Roman; font-size: small;"> </span></o:p></span><br />
<div style="margin-right: 9pt;">
<span style="color: black; font-family: Arial; font-size: 9pt;">More than a year ago the EU, </span><st1:country -region="-region"><st1:place><span style="color: black; font-family: Arial; font-size: 9pt;">UK</span></st1:place></st1:country><span style="color: black; font-family: Arial; font-size: 9pt;"> and </span><st1:country -region="-region"><st1:place><span style="color: black; font-family: Arial; font-size: 9pt;">USA</span></st1:place></st1:country><span style="color: black; font-family: Arial; font-size: 9pt;"> approved the subsidy of
abiraterone basically on the same terms as the Australian Sponsor’s request for
listing in March 2012. Meanwhile it is still not listed on the PBS despite
repeated consideration by the PBAC since November 2011.<o:p></o:p></span></div>
<span style="font-family: Times New Roman;">
</span><br />
<div style="margin-right: 9pt;">
<span style="color: black; font-family: Arial; font-size: 9pt;">The obvious remaining factor denying access to abiraterone for the
<i style="mso-bidi-font-style: normal;">“post-chemotherapy”</i> <span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span>patients is “cost-minimization”. Compared with
the evident benefit in regard to significant extension of life and amelioration
of symptoms cost should not be a consideration. It isn’t in other diseases such
as HIV aids where lives are also at stake.<o:p></o:p></span></div>
<span style="font-family: Times New Roman;">
</span><span style="color: black; font-family: Arial; font-size: 9pt;"><o:p><span style="font-family: Times New Roman; font-size: small;"> </span></o:p></span><br />
<div style="margin-right: 9pt;">
<span style="color: black; font-family: Arial; font-size: 9pt;">A second group excluded from receiving the obvious benefits of abiraterone
comprises<i style="mso-bidi-font-style: normal;">“chemotherapy-naïve” </i>mCRPC
patients (excluded ones including myself). Just like <i style="mso-bidi-font-style: normal;">“post-chemotherapy”</i> <span style="mso-spacerun: yes;"> </span>patients
these<i style="mso-bidi-font-style: normal;"> </i>men also have advanced cancer.
They too are incurable and the outcome for them is invariably fatal.<span style="mso-spacerun: yes;"> </span>The TGA approval of March 2012 did not include
them but they also are on death row like those who have had docetaxel,
mitoxantrone and cabazitaxel. It’s just they are at an earlier stage. They will
have to get worse even though there is an effective and less harmful remedy
available, abiraterone, all because of “cost-minimization”. <o:p></o:p></span></div>
<span style="font-family: Times New Roman;">
</span><span style="color: black; font-family: Arial; font-size: 9pt;"><o:p><span style="font-family: Times New Roman; font-size: small;"> </span></o:p></span><br />
<div style="margin-right: 9pt;">
<span style="color: black; font-family: Arial; font-size: 9pt;">The TGA has already approved abiraterone for patients in the <i style="mso-bidi-font-style: normal;">“post-chemotherapy”</i><span style="mso-spacerun: yes;"> </span>group. There is an urgent need for the TGA to
approve the drug for the<i style="mso-bidi-font-style: normal;">“chemotherapy-naïve”
</i>mCRPC group as well. The benefits and safety for the latter group were
declared at the ASCO Conference in </span><st1:city><st1:place><span style="color: black; font-family: Arial; font-size: 9pt;">Chicago</span></st1:place></st1:city><span style="color: black; font-family: Arial; font-size: 9pt;"> in June 2012. These
patients urgently need a reprieve before their condition worsens. TGA approval
would clear the way for the PBAC to recommend a PBS subsidy for this group as
well. </span></div>
<div style="margin-right: 9pt;">
<span style="font-family: Times New Roman;"></span> </div>
<div style="margin-right: 9pt;">
<span style="color: black; font-family: Arial; font-size: 9pt;">As for cost-effectiveness, the base price of abiraterone seems to
compare favourably with published costs of taxane chemotherapeutic drugs and
“best supportive care” (</span><st1:stockticker><span style="color: black; font-family: Arial; font-size: 9pt;">BSC</span></st1:stockticker><span style="color: black; font-family: Arial; font-size: 9pt;">) both of which have
known costly components. Oral administration gives abiraterone a cost
advantage. </span><st1:stockticker><span style="color: black; font-family: Arial; font-size: 9pt;">BSC</span></st1:stockticker><span style="color: black; font-family: Arial; font-size: 9pt;"> and chemotherapy attract additional costs
including IV administration, use of hospital beds and staff, treatment of side
effects, analgesia and palliative care radiotherapy. In any case, to weigh some
residual cost-saving against a patient’s best interests goes against a
fundamental principle of justice in our society. <o:p></o:p></span></div>
<span style="font-family: Times New Roman;">
</span><span style="color: black; font-family: Arial; font-size: 9pt;"><o:p><span style="font-family: Times New Roman; font-size: small;"> </span></o:p></span><br />
<div class="MsoNormal" style="margin: 0cm 9pt 0pt 0cm;">
<span style="color: black; font-family: Arial; font-size: 9pt;">Neither should cost-saving become a lottery
where some diseases are permitted high-cost treatments while others are not.
Just as Burroughs Wellcome was induced (by popular protest) to offer a 36%
lower price for AZT in 1989, price negotiation remains a further tool in the
process of cost-minimization. Agreement on price by sponsor and government must
be achieved. It should not be allowed to roll over for further reconsideration
at future PBAC meetings which would mean more delay while lives are literally
at stake.<o:p></o:p></span></div>
<span style="font-family: Times New Roman;">
</span><span style="color: black; font-family: Arial; font-size: 9pt;"><o:p><span style="font-family: Times New Roman; font-size: small;"> </span></o:p></span><br />
<span style="color: black; font-family: Arial; font-size: 9pt;">Until TGA
approval is given for inclusion of the<i style="mso-bidi-font-style: normal;">“chemotherapy-naïve”<span style="mso-spacerun: yes;"> </span></i>mCRPC group, saving money will continue
to have greater weight than delaying the development of overt metastases and painful
complications like spontaneous fractures of vertibrae and spinal nerve
compression. Who could look even one patient in the eye and say, you can have
chemotherapy with all of its downside but no, you may not have the drug abiraterone
that could delay all this suffering and extend your life, all because it costs
too much. <o:p></o:p></span><br />
<span style="font-family: Times New Roman;">
</span><span style="color: black; font-family: Arial; font-size: 9pt;"><o:p><span style="font-family: Times New Roman; font-size: small;"> </span></o:p></span><br />
<div style="margin-right: 9pt; tab-stops: 45.0pt;">
<span style="font-family: Arial; font-size: 9pt;">I therefore ask the PBAC at its November 2012 meeting to
recommend an immediate subsidy for abiraterone on the PBS for the <i style="mso-bidi-font-style: normal;">“post-chemotherapy”</i><span style="mso-spacerun: yes;"> </span>group and do what is necessary to press the
TGA to broaden its current approval to include<i style="mso-bidi-font-style: normal;">“chemotherapy-naïve” </i>mCRPC patients, this to be followed by an immediate
subsidy for them also. For those of us with the disease this is a matter of
life or death.<o:p></o:p></span></div>
<span style="font-family: Times New Roman;">
</span><span style="color: black; font-family: Arial; font-size: 9pt;"><o:p><span style="font-family: Times New Roman; font-size: small;"> </span></o:p></span><br />
<div class="MsoNormal" style="margin: 0cm 0cm 0pt;">
<span style="color: black; font-family: Arial; font-size: 9pt;">Yours
sincerely, </span><b style="mso-bidi-font-weight: normal;"><span style="color: black; font-family: Arial; font-size: 9pt;">”<o:p></o:p></span></b></div>
<span style="font-family: Arial; font-size: 11pt;"><o:p><span style="font-family: Times New Roman; font-size: small;">
</span></o:p><span style="font-family: Times New Roman; font-size: small;"></span></span><br />
<span style="font-family: Arial; font-size: 11pt;"><span style="font-family: Times New Roman; font-size: small;"></span></span><br />
<span style="font-family: Arial; font-size: 11pt;"><span style="font-family: Times New Roman; font-size: small;"><div class="MsoNormal" style="margin: 0cm 0cm 0pt; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;">
<b style="mso-bidi-font-weight: normal;"><span style="font-family: "Arial Narrow"; mso-bidi-font-family: Arial;">November 2012 PBAC Outcomes - Positive Recommendations<span style="color: black; mso-bidi-font-weight: bold;"> <o:p></o:p></span></span></b></div>
<br />
<div class="MsoNormal" style="margin: 0cm 0cm 0pt; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;">
<b><span style="color: black; font-family: "Arial Narrow"; font-size: 10pt;">LISTING
REQUESTED BY SPONSOR</span></b><span style="color: black; font-family: "Arial Narrow"; font-size: 10pt;"><o:p></o:p></span></div>
<br />
<div class="MsoNormal" style="margin: 0cm 0cm 0pt; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;">
<u><span lang="EN-US" style="color: blue; font-family: "Arial Narrow"; font-size: 10pt; mso-ansi-language: EN-US; mso-bidi-font-family: Arial;">http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/pbac-outcomes/2012-11/positive-recommendations</span></u><b><span style="color: black; font-family: "Arial Narrow"; font-size: 10pt;"><o:p></o:p></span></b></div>
<br />
<div class="MsoNormal" style="margin: 0cm 0cm 0pt; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;">
<span style="color: black; font-family: "Arial Narrow"; font-size: 10pt; mso-fareast-language: EN-AU;"><span style="mso-spacerun: yes;"> </span>Requests a review of the PBAC’s
March 2012 recommendation to list abiraterone on a cost minimisation basis to
cabazitaxel as an Authority Required benefit for the treatment, in combination
with prednisone or prednisolone, of castration resistant metastatic carcinoma
of the prostate in a patient who meets certain criteria. <o:p></o:p></span></div>
<br />
<div class="MsoNormal" style="margin: 0cm 0cm 0pt; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;">
<b><span style="color: black; font-family: "Arial Narrow"; font-size: 10pt;">PBAC
RECOMMENDATION</span></b><span style="color: black; font-family: "Arial Narrow"; font-size: 10pt;"><o:p></o:p></span></div>
<br />
<div class="MsoNormal" style="margin: 0cm 0cm 0pt; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;">
<span style="color: black; font-family: "Arial Narrow"; font-size: 10pt; mso-fareast-language: EN-AU;"><span style="mso-spacerun: yes;"> </span>The PBAC recommended listing on a
cost-minimisation basis with cabazitaxel and cost‑effectiveness basis when
compared with best supportive care<o:p></o:p></span></div>
<br />
<div class="MsoNormal" style="margin: 0cm 0cm 0pt;">
<span style="font-family: "Arial Narrow"; font-size: 10pt;"><o:p> (<span style="font-family: Times New Roman; font-size: small;"><span style="font-size: x-small;"><span style="font-family: Arial;">author’s notes:<span style="mso-tab-count: 1;"> </span></span></span>
</span></o:p></span></div>
<div class="MsoNormal" style="margin: 0cm 0cm 0pt;">
<span style="color: black; font-family: "Arial Narrow";"><span style="font-size: small;"></span></span> </div>
<div class="MsoNormal" style="margin: 0cm 0cm 0pt;">
<span style="color: black; font-family: "Arial Narrow";"><span style="font-size: small;">It may
take</span></span><b style="mso-bidi-font-weight: normal;"><span style="color: black; font-family: "Arial Narrow"; font-size: 10pt;"> </span></b><span style="color: black; font-family: "Arial Narrow";"><span style="font-size: small;">several months to receive Ministerial and Cabinet
approval, which could still be denied. Even if a PBS subsidy is approved, it
will benefit only those patients with incurable prostate cancer who have failed
treatment with chemotherapy. Those who have not had chemo first will not be
eligible. Unlike the FDA in the USA, The Therapeutics Goods Administration (TGA) in Australia has not given approval
for these patients. Without such approval no application for PBAC consideration
is possible under the "rules". As a consequence about 2,000
Australian men will inevitably develop painful secondaries forcing them onto
chemotherapy. They are being left without access to this effective treatment
that offers a pain-free extension of life. If the Government so decided, this process could and should be expedited)<u><o:p></o:p></u></span></span></div>
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</span></div>
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</span><br />
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<span style="font-family: Arial; font-size: 11pt;"><o:p><span style="font-family: Times New Roman; font-size: small;">________________________________________________________________________________ </span></o:p></span></div>
<span style="font-family: Times New Roman;">
</span><br />
<span style="font-family: Arial; font-size: 8pt;">Blog updated 17Feb13</span><br />
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<o:p><span style="font-family: Times New Roman;"> </span></o:p></div>
<span style="font-family: Times New Roman;">
</span>Tony Musgrave (aka tony pcm)http://www.blogger.com/profile/11994182692767580358noreply@blogger.com0Queen Street, Brisbane Qld 4000 Australia-29.075375179558346 152.05078125-83.218232679558341 71.19140625 25.067482320441652 -127.08984375