EVEN MORE PUBLIC INPUT IS VITAL OR MANY WILL STILL BE DENIED THIS ESSENTIAL DRUG. This updates my last post dated
There
are two new events to note and one represents a new opportunity to move our
case forward:
1.
Last Thursday, 01 May, 2014 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 http://chn.ge/QsuSHc
. I believe it's time to step up the tempo to obtain maximum impact.
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.
The
PBS listing request before the PBAC for consideration
at its July, 2014 Meeting reads (see details:
http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/agenda/07-2014 ):
"... 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."
My comment: 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 who
would not have benefit from immediate chemotherapy 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.
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 the PBS pay the cost of
abiraterone for all, repeat ALL, advanced prostate cancer patients whose
condition has become incurable, without the requirement of failing chemotherapy
first or being among the few who would not have
benefit from immediate chemotherapy
.
For information on how, please read on and thank you so much for
your kind support (Tony):
NB: Your personal submission can made in, "... the PBAC online submission
form or http://goo.gl/z4gZpQ
.
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. (this information extracted from PBAC PDF (How Tos) located at http://goo.gl/EeqxOP
.)
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).
New readers can make both a
public submission to the PBAC and also sign my petition on this site http://chn.ge/QsuSHc
. Every input will help at this stage.
Please go to http://goo.gl/z4gZpQ
and fill out the submission form.
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, "Do you have any comments on the consumer input
process?":
"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, or that they would not benefit from immediate
chemotherapy.
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.
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.
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 "who would not have benefit from immediate chemotherapy"
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.
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.
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.
I urge the PBAC to exercise compassion as well as scientific and
economic scrutiny in formulating its recommendation, so that:
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
This information also appears in my
Facebook post dated 04 May, 2014, see: https://www.facebook.com/tony.pcm.5
