Jim wrong again! Zytiga (abiraterone) not rejected, but not clear

[Admin]

Clarification

Jim Marshall (not a doctor) said ...

The PBAC is a committee that recommends which drugs go on the PBS (Pharmaceutical Benefits Scheme) to be free, or nearly free, to people in Australia who need them.

The PBAC at its November 2012 meeting considered whether Zytiga (abiraterone) should be put on the PBS to be free, or nearly free, to men who have failed chemotherapy with docetaxel (Taxotere).

The PBAC has approved this happening, subject to certain conditions.

That is sometimes NOT the end of the process. Companies can withdraw their request for listing if the conditions set are not acceptable to them.

In the past, Zytiga (abiraterone) has been approved by the PBAC under certain conditions more than once, but the company has withdrawn its application on each occasion because it found the conditions unacceptable.

So, we must wait to hear if the company (Janssen-Cilag Pty Ltd) is satisfied with the conditions before we celebrate the listing of Zytiga on the PBS.

... end Jim

Obfuscation

Jim Marshall (who apparently can't distinguish between 2011 and 2012, and is not a doctor) said ...

My apologies to all for mis-informing you about Zytiga (abiraterone).

Thanks to Euan for pointing out my error.

Here is the actual text:

November 2012 PBAC Outcomes - Positive Recommendations

DRUG AND FORM

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

July 2012 PBAC Outcomes - Positive RecommendationsJanssen-Cilag Pty Ltd

Major submission

DRUG USE AND TYPE

Prostate cancer

LISTING REQUESTED BY SPONSOR

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.

Link (November 2012)

and from July:

July 2012 PBAC Outcomes - Positive Recommendations

DRUG AND FORM

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

Janssen-Cilag Pty Ltd

Minor Submission

DRUG USE AND TYPE

Metastatic prostate cancer

LISTING REQUESTED BY SPONSOR

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.

PBAC RECOMMENDATION

The PBAC recommended listing abiraterone tablets as an Authority Required listing for the treatment, in combination with prednisone or prednisolone, of castration resistant metastatic carcinoma of the prostate in a patient who has failed treatment with docetaxel on a cost-minimisation basis with cabazitaxel and cost-effectiveness basis when compared with best supportive care.

Link (July 2012)

The November decision changes "metastatic advanced prostate cancer (castration resistant prostate cancer) in whom disease progression has occurred following treatment with docetaxel"

to

"castration resistant metastatic carcinoma of the prostate in a patient who meets certain criteria"

which leaves me none the wiser.

If the criteria do not preclude use of Zytiga (abiraterone) pre-chemotherapy this would seem to be a great step forward. [jm: On further reading of the history of this drug approval I think it most likely that use pre-chemotherapy is specifically ruled out in the "certain criteria". You can read this history here (not simple).]

I'm sorry I can't help members with a clear indication of how and when a positive recommendation leads to PBS listing.

[jm; The first stumbling block is that the conditions set by the PBAC may not be acceptable to the company, and it may withdraw the request to list, as it has on more than one occasion in the past.]

But I imagine that expensive decisions like this go to cabinet.

Can anyone clarify the position?

... end Jim

[tonymax]

Jim,

My reading of the PBAC recommendation is the words are designed to ease cabinet's cost concerns and get their approval for Zytiga.

There may even be a pre chemo opportunity here.

Cost minimisation with cabazitaxel is a bit obscure given each patient may respond to neither of them, only one of them or both of them.

Cost effectiveness basis when compared to best supportive care is also obscure - how do you compare cost effectiveness if Zytiga keeps you alive and best supportive care does not.

I think oncologists should be able to use a broad interpretation here and we might do OK from it

Regards Tony M

[Admin]

The following sentence in the original post was incorrect. It has been removed:

In the meantime, I have had a report of a man in need getting access to Zytiga (abiraterone) post chemo on a PBS script.

Reason: I am informed by the man that this was NOT a PBS script. The drug, he says, was possibly supplied under the Special Access Scheme, that allows access to unapproved drugs in certain circumstances.