Enzalutamide - Try again

[Admin]

The Pharmaceutical Benefits Advisory Committee (PBAC) considered Enzalutamide before Docetaxel chemotherapy once again.

Once again the PBAC didn't endorse the submission.

Once again told the company (Astellas) what more evidence they need before they could put it on the PBS.

 

So, once again, over to Astellas to meet the new conditions.

Once again, for us, a waiting game!

 

The actual wording today was:

 

The PBAC deferred recommending an extended PBS listing for enzalutamide for the treatment of metastatic castrate-resistant prostate cancer (mCRPC) prior to docetaxel, on the basis of requiring: a further price reduction to maintain an acceptable ICER, after including in the economic model a more appropriate assumption of the duration of post- docetaxel treatments in the active surveillance arm of the model; a broadening of the proposed restriction to include symptomatic patients, given that restriction to asymptomatic patients was unworkable and inappropriate; and a review of the financial estimates to provide a basis for a meaningful risk share arrangement to manage uncertainties regarding utilisation in the pre- and post-docetaxel settings.
The clinical trial evidence presented in the submission does not specifically provide a comparison of the current treatment (i.e., enzalutamide after docetaxel) versus proposed treatment (enzalutamide before docetaxel) for the management of patients, which was of interest to the PBAC. However, on the basis of direct evidence presented by the resubmission the comparison of enzalutamide and active surveillance, (or ‘placebo’ in the trial), in the PREVAIL trial in asymptomatic or mildly symptomatic, chemotherapy naïve mCRPC patients over a maximum treatment duration of 31 months resulted in significant increases in the time:
• before a patient was given cytotoxic chemotherapy (median of approximately 17.2 months)
• before onset of cancer pain (median of approximately 5.5 months)
• on treatment (either enzalutamide or placebo), which may be related to time to ‘disease progression’ (median of approximately 13.1 months).
The PBAC considered that a claim of superior comparative efficacy with respect to quality of life outcomes compared to watchful waiting was reasonable, but that the effect size was modest. The PBAC accepted the claim that enzalutamide has a manageable safety profile.

[Paul Edwards]

Quite a few of the applications made to the PBAC were "REJECTED ".

 

The good news for us is that the application regarding Enzalutamide was "DEFERRED ", rather than "REJECTED ".

 

As  Jim says, it's now up to Astellas, the manufacturer of Enzalutamide, to provide the PBAC with the further evidence  that the PBAC requires.

 

Thank you to all of you who made submissions to the PBAC. It is clear that the PBAC took notice of what we said about the Quality of Life  benefits provided by Enzalutamide.