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PBAC does not recommend Zytiga (abiraterone) before chemo, except for a few men


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Jim Marshall (not a doctor) said ...

The Pharmaceutical Benefits Advisory Committee (PBAC) has recommended that, except for a small number of men, Zytiga (abiraterone) should not be on the PBS for use before chemotherapy with docetaxel. Zytiga still stays on the PBS for use after chemotherapy with docetaxel.


The small number of men are those who are:

“unsuitable for docetaxel treatment on the basis of demonstrated or predicted intolerance to docetaxel”. For these men the PBAC suggested an amendment to the current restriction would be acceptable. I am not clear on how the timing of that will work.


So a small step forward for a few men.

No gain for the majority, as yet.

Let's hope the company's future submissions have more luck.


... end Jim



ABIRATERONE, tablet, 250 mg,  Zytiga®

 Janssen-Cilag Pty Ltd

Change to listing

(Major submission)
Prostate Cancer
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.
The PBAC rejected the submission for the following reasons:

 “watchful waiting” was not considered an appropriate comparator for establishing cost-effectiveness in this setting;

the post-hoc subgroup analysis for defining the PBS eligible population was inadequately justified; 

the ICERs for both the post-hoc sub group and particularly the more appropriate ITT population were unacceptably high; and

the total PBS cost of treatment with abiraterone shifting from post-docetaxel to post-ADT was uncertain. 


The PBAC also noted comments from clinicians that for a small number of patients the current abiraterone restriction, requiring failure of, or intolerance to, docetaxel is a hurdle in gaining access to treatment where a single administration of docetaxel would inevitably demonstrate the patient was intolerant to docetaxel. PBAC considered a solution may be to amend the current restriction to allow PBS subsidised abiraterone where a patient is considered “unsuitable for docetaxel treatment on the basis of demonstrated or predicted intolerance to docetaxel”. PBAC considered this to be a minor change that may provide access to a small number of patients who are currently disadvantaged by the requirement to demonstrate intolerance. The proposed amendment of the restriction would not expand the market and would be adequately dealt with under existing risk share arrangements.


On the basis of direct evidence presented by the submission, the comparison of abiraterone + prednisolone/prednisone and placebo + prednisolone/prednisone resulted in an improvement of approximately 5 months overall survival and 8 months progression free survival for the intention to treat (ITT) population. While this did not meet statistical significance based on the strict pre-specified significance criteria, this result may have been affected by the early termination and crossover observed in the trial.  For every 100 patients treated with abiraterone, in comparison with placebo, approximately 7 additional patients experienced hepatotoxicity.

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The Committee has not recommended the PBS listing of abiraterone for patients with metastatic castrate resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy.  


The Committee rejected the submission mainly on cost grounds.


The drug company is seeking to better understand the decision of the PBAC and will meet with the Committee at the earliest opportunity.


It is not unusual for submissions to be rejected on the first time that they are presented to the PBAC.  Only 30% of submissions are successful on the first time that they are presented to the PBAC


The submission also did not meet the Committee’s criteria on overall survival benefit.  It is possible that the Committee may waive this requirement.  The abiraterone clinical trial on which the submission was based was so successful that the Independent Monitoring Committee stopped the trial early so that all the men in the study could receive the drug.  However, this early termination of the study precluded final data collection on overall survival benefit

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