Tuesday 7 August 2012

Incurable prostate cancer patients denied new medication on the PBS



Chemotherapy-naïve (never had chemo) patients also deserve Zytiga “free” on the PBS

 
Prostate cancer (PC) is the most common male cancer in Australia and the third most common cause of death from cancer in males (Australian Cancer Database 2007). 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).°  Many men die from PC every year, most from advanced stages in its castrate resistant (hormone resistant) form. Metastatic prostate cancer occurs in most of these men after a period of treatment with LHRH agonists (drugs which suppress male hormone) and the cancer eventually becomes hormone-refractory (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.

 Abiraterone acetate (Zytiga, Janssen Cilag Pty., Ltd.) is one of the few effective new drugs 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, 2012.¹ ² This followed publication of the original clinical trial COU-AA-302 in the New England Journal of Medicine on May 26, 2011.¹

 On 1st March, 2012 (under Section 28 of the Therapeutic Goods Act 1989), abiraterone was approved for treatment of castrate resistant metastatic prostate cancer (mCRPC) but only after patients have already been treated with chemotherapy.³  It is not approved for “chemotherapy-naïve”patients (those who have not yet had chemotherapy) 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 Pharmaceutical Benefits Scheme (PBS).

 An application from (Janssen Australia) has recently been recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) but only on behalf of mCRPC patients whose cancer has progressed in spite of enduring the unpleasant side effects of chemotherapy with a“taxane”.³  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.

 The PBAC has already acknowledged that abiraterone has a better safety profile and is more convenient to administer (oral administration) than cabazitaxel. ³ Janssen R&D in the USA has announced it will seek a new indication for abiraterone in chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC) in the second half of 2012.²

 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.

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 abiraterone 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 Abiraterone can achieve this?

 These restrictions derive from criteria set by the PBAC designed to minimize financial cost.³  The 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.

Already, there is excellent evidence that abiraterone can delay progression of the cancer, minimize symptoms and lengthen life.¹ ²   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

 

STOP PRESS  08Feb'12: Extracts from Updated Research and Reports

 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 (see URL http://goo.gl/UhVu1 ).

It may take 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)


 Support for: Abiraterone in Metastatic Prostate Cancer without Previous Chemotherapy

from: National Cancer Institute UPDATE of December 11, 2012 Report:   "FDA Approval for Abiraterone Acetate"  (See WEB: http://www.cancer.gov/cancertopics/druginfo/fda-abirateroneacetate  )  URL abbreviated to: http://goo.gl/i3PBi

EXTRACT  " ... abiraterone acetate was approved by the FDA*  on December 10, 2012 for the treatment of mCRPC patients prior to receiving chemotherapy."
* Food and Drug Administration - USA
Reference:  ¹Charles J. Ryan, et al. (for the COU-AA-302 Investigators). "Abiraterone in Metastatic Prostate Cancer without Previous Chemotherapy." N Engl J Med. 2013; 368:138-48 doi: 10.1056/NEJMoa1209096   (report updated January 17, 2013)
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from N Engl J Med. 2013; 368:138-48 (UPDATE 17Jan13) : "Abiraterone in Metastatic Prostate Cancer without Previous Chemotherapy"  (See WEB: http://www.nejm.org/doi/full/10.1056/NEJMoa1209096 )  URL abbreviated to: http://goo.gl/39YeM

EXTRACT  "Conclusions: 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."
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from: UroToday (Urology News) published on Friday, 08 February 2013 16:19 (referring to the above): "Abiraterone in metastatic prostate cancer without previous chemotherapy (from study COU-AA-302)"

(See WEB: http://www.urotoday.com/Treatment-of-mCRPC/abiraterone-in-metastatic-prostate-cancer-without-previous-chemotherapy-from-cou-aa-302.html  )  URL abbreviated to: http://goo.gl/D2NGm

EXTRACT  " ... 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. ..."

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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.

 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:  https://www.change.org/en-GB/petitions/pbs-should-pay-for-abirterone-for-all-incurable-prostate-cancer-patients#.html

 
Footnotes and References:
 
° Australian Institute of Health and Welfare (AIHW):

Cancer in Australia 2010: in brief. ISSN 1039-3307; ISBN 978-1-74249-081-6; Cat. no. CAN 55; 28pp.


 
¹  American Society of Clinical Oncology (ASCO):
 
ASCO Daily News June 1-5, 2012 > Abstract LBA4518, Charles J Ryan,“Abiraterone Delays Progression in Patients with Chemotherapy-Naïve CRPC” Jun1-5’12 ASCO Annual Meeting >

J Clin Oncol 30, 2012 (suppl; abstr LBA4518) “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:


 
EXTRACTS of KEY POINTS:

 “ … 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. … “

 “ …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,

 “ …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.

 “ …the objectives of therapy development in this disease state have been met, … “

 “ … These data merit consideration as providing a new standard approach in this highly prevalent patient population faced with an unmet medical need.”

“… 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.

 "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. … “

 
¹ (additional reference) Original article (Clinical Trial COU-AA-302) published in:

 N Engl J Med 2011; 364:1995-2005May 26, 2011 Abiraterone and Increased Survival in Metastatic Prostate Cancer. “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)”

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 the COU-AA-301 Investigators

http://www.nejm.org/doi/full/10.1056/NEJMoa1014618#t=abstract


 
²  OncologyStat (a subscriber medical journal scanning and news service)

“Abiraterone Delays Progression in Patients with Chemotherapy-Naïve CRPC,” ASCO 2012: Conference Coverage Roundup: Abstract from: IMNG Medical Media. 2012 Jun 11, P Wendling “Abiraterone Blocks Chemo-Naïve Prostate Cancer” 


(Note: to read the full article it is necessary to sign up to this professional cancer news publication, OncologyStat; it takes only a few seconds on this URL and membership is free).

 
EXTRACTS of KEY POINTS:

“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. >

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. … “

 “… 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. >

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.…”

(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 USA for this group on the same basis). The other is that the strength of this evidence led the 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 USA 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.)
 
³  Pharmaceutical Benefits Advisory Committee (PBAC)

EXTRACTS of KEY MILESTONES:

Nov, 2011     Pharmaceutical Benefits Advisory Committee (PBAC) Public Summary Document

http://www.health.gov.au/internet/main/publishing.nsf/Content/pbac-psd-abirateronee-nov11

“… 2. Background

The Rule of Rescue:
There are four factors which when applied concurrently in exceptional circumstances, are called the ‘rule of rescue’ as follows.
  • No alternative exists in Australia 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.
  • 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 the closer a person with the condition is to death, the more influential the rule of rescue might be in the consideration by PBAC.
  • The medical condition defined by the requested restriction applies to only a very small number of patients. Again, the fewer the patients, the more influential the rule of rescue might be in the consideration by PBAC. However, PBAC is also mindful that the PBS is a community-based scheme and cannot cater for individual circumstances.
  • 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.

(author’s note: the italics are mine)

“ … 11. Estimated PBS Usage and Financial Implications

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.”


“ … 12.  Recommendations and Reasons … ”

“ … Whilst the PBAC considered that there are uncertainties inherent from indirect comparisons, it accepted the submission’s clinical claims:  … 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. … ”
 
(author’s note: this assertion stands in contradistinction to those in the key points in reference¹ above, in particular, “ … 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.)
 
“ … 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.”

“ … 14. Sponsor’s Comment

The sponsor has no comment.“

(author’s note: in reference ² above, third key point, see: “ … Janssen Research & Development (USA)  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. … “  In view of this more recent announcement by the sponsor’s USA parent one hopes that this situation has changed since November, 2011. I am seeking more information on Janssen Australia’s intentions. )

 
March 2012     PBAC Outcomes - Positive Recommendations:

http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/pbac-outcomes/2012-03/positive-recommendations

“PBS Listing requested by the sponsor (Janssen-Cilag Pty Ltd):

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”
 
“PBAC Recommendation:

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.”

(author’s notes: 

a) “cost-minimization” !

b) in reference ² above, third key point, see: “ … 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 USA, not in Australia.

Janssen Australia would need to obtain a similar approval from the Therapeutics Goods Administration (TGA) in Australia 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)

 
July 2012     Agenda for the July 2012 PBAC Meeting

http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/pbac-agenda

                                                                                                                                                                     
Listing requested by Sponsor (Janssen-Cilag Pty Ltd ) /  Purpose of Submission: 

“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.”

(author’s note:  It is still not being considered for “chemotherapy-naïve”patients (those who have not yet had chemotherapy) even though they also have advanced cancer and are incurable. The “excluded ” group  are still being left to get worse and condemned to chemotherapy.)


26 Sep12  Agenda for the November 2012 PBAC Meeting


“Resubmission

ABIRATERONE, tablet, 250 mg (as acetate), Zytiga®

Prostate cancer

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.”

(author’s note:  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 chemotherapy-naive  “excluded” group that I have identified (see above).)

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 On 08 October, 2012 I submitted the following comment to the PBAC for consideration at its November, 2012 meeting:
Copy:
 
"My Consumer Comment (also my clinical comment as a retired medical practitioner and medical administrator in community and public health)

Following radical prostatectomy and radiotherapy I have been treated with IM Lucrin depot which kept my PSA down for three years but I am now “hormone refractory”
 
The real new hope for "post-chemotherapy" mCRPC and "chemotherapy-naïve" mCRPC patients (like me) resides in two seminal events:

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
 
2. The highly significant comments made in June, 2012 at the ASCO Conference in Chicago, viz.,

"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 III study"
 
More than a year ago the EU, UK and USA 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.

The obvious remaining factor denying access to abiraterone for the “post-chemotherapy”   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.
 
A second group excluded from receiving the obvious benefits of abiraterone comprises“chemotherapy-naïve” mCRPC patients (excluded ones including myself). Just like “post-chemotherapy”  patients these men also have advanced cancer. They too are incurable and the outcome for them is invariably fatal.  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”.
 
The TGA has already approved abiraterone for patients in the “post-chemotherapy”  group. There is an urgent need for the TGA to approve the drug for the“chemotherapy-naïve” mCRPC group as well. The benefits and safety for the latter group were declared at the ASCO Conference in Chicago 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.
 
As for cost-effectiveness, the base price of abiraterone seems to compare favourably with published costs of taxane chemotherapeutic drugs and “best supportive care” (BSC) both of which have known costly components. Oral administration gives abiraterone a cost advantage. BSC 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.
 
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.
 
Until TGA approval is given for inclusion of the“chemotherapy-naïve”  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.
 
I therefore ask the PBAC at its November 2012 meeting to recommend an immediate subsidy for abiraterone on the PBS for the “post-chemotherapy”  group and do what is necessary to press the TGA to broaden its current approval to include“chemotherapy-naïve” 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.
 
Yours sincerely, 


November 2012    PBAC Outcomes - Positive Recommendations

LISTING REQUESTED BY SPONSOR

http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/pbac-outcomes/2012-11/positive-recommendations

 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.

PBAC RECOMMENDATION

 The PBAC recommended listing on a cost-minimisation basis with cabazitaxel and cost‑effectiveness basis when compared with best supportive care

 (author’s notes: 
 
It may take 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)


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Blog updated 17Feb13