PBAC July Meeting Minutes and Enzalutamide before Docetaxel

[Nev Black]

The recommendations from the July PBAC Meeting became available Friday night.

Not the result we were hoping for from this meeting.

Enzalutamide (Xtandi)®  Capsule 40 mg 

Astellas Pharma Australia Pty Ltd 

Change to listing  (Minor Submission)   

Prostate cancer Resubmission to request an Authority Required listing for the treatment of asymptomatic metastatic castration resistant prostate cancer in chemotherapy-naïve patients

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 that the proposal to achieve a cost-effective listing was unacceptable. The PBAC advised that further negotiations between the sponsor and the Department regarding the proposed price of enzalutamide, the proposed financial caps and the size of the patient population are required, to ensure that an acceptable incremental cost effectiveness ration (ICER) is achieved. In its consideration of the major resubmission in March 2017, the PBAC requested that the sponsor adjust the assumption of the duration of post-docetaxel treatment with enzalutamide in the active surveillance arm of the economic model, and stated that the ICER should remain at $45,000 - $75,000/QALY. In the minor resubmission, the sponsor made requested adjustments to the model but also proposed various other strategies to deliver an acceptable ICER. The probability that these strategies actually delivered the requested ICER could not be accurately determined.   The PBAC was concerned that the size of the proposed patient population is uncertain, and that the proposed subsidisation caps may not be reached, resulting in a higher average DPMQ and a higher ICER than those proposed in the minor resubmission.  

Sponsor comment Astellas will consider the issues raised by the PBAC and continue to investigate options to improve access to enzalutamide for metastatic castration resistant prostate cancer, chemotherapy-naïve patients.

 

JULY 2017 PBAC OUTCOMES – DEFERRALS

 

Full list of recommendations from the meeting.

http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/pbac-outcomes/recommendations-pbac-july-2017

 

[JimmyToowong]

Posted for Chuck Maack:

 

Sorry to learn this my Australian friends.

Chuck

[tonymax]

Can we please set up a meeting with Gail Wiseman of Astellas ASAP to try to find a way forward on this.

Some patients like me are getting huge benefits on clinical trial with pre chemo Enzalutamide.

Denying this benefit to those in our wider community who could also benefit is criminal in my view.

If we can do it with Xofigo we can do it with pre chemo Enzalutamide.

 

Regards             Tony