Chemotherapy-naïve (never had chemo) patients also deserve Zytiga “free” on the PBS
Prostate cancer (PC) is the most common male cancer in
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
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
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 ).
Support for: Abiraterone in Metastatic Prostate Cancer without Previous Chemotherapy
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
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
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):
ASCO Daily News
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. … “
(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.…”
³ Pharmaceutical Benefits Advisory Committee (PBAC)
EXTRACTS of KEY MILESTONES:
Nov, 2011 Pharmaceutical Benefits Advisory Committee (PBAC) Public Summary Document
“… 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.
“ … 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
March 2012 PBAC Outcomes - 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”
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
July 2012 Agenda for the July 2012 PBAC Meeting
“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.)
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).)
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.
Blog updated 17Feb13