Thursday, 16 May 2013

16 May 2013 After the FEDERAL BUDGET - Will the Minister approve Abiraterone acetate (Zytiga)?

16 May 2013 Abiraterone acetate (Zytiga) – The FEDERAL BUDGET and The Pharmaceutical Benefits Advisory Committee (PBAC) 'Public Summary Document' Nov12 – SEE URL:  (Document as PDF: ).

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.

These are the issues:
1. The prospect of chemotherapy is an awful one.
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.

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,
- Abiraterone must not be used with chemotherapy before it is subsidized
- a patient must have failed chemotherapy with Docetaxel?
- a patient must have a WHO performance status of 2 or less?
- a patient must not receive PBS-subsidised abiraterone if progressive disease develops while on abiraterone?

On the other there is the cost-saving versus life-saving comment by the PBAC,

“… 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.”

These and other caveats restrict the options for patients who could otherwise receive a life extending benefit .

These restrictions are at odds with the recommendations of Ryan et al ( N Engl J Med 2013; 368:138-148 January 10, 2013 ) who recommend providing the drug for all advanced prostate cancer sufferers without requiring that they have to have chemotherapy first. In the USA this restriction has now been removed by the TGA. 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.

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).

It is time that the Health Minister and Federal Cabinet approve a PBS subsidy without further delay (the Federal Budget last Tuesday provided $691 million, allocated over five years for new listings or amendments to the Pharmaceutical Benefits Scheme (PBS)).

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 .

Footnote: 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).  


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