Committee recommends Abiraterone and Cabazitaxel be placed on PBS

[Admin]

Jim Marshall (not a doctor) said ...

Thanks for this to Euan Perry who is always on the ball with drug news.

An advisory committee has recommended that Zytiga (abiraterone acetate) be placed on the PBS for use after chemotherapy with docetaxel. It also recommended that Jevtana (Cabazitaxel) be placed on the PBS for the same use.

Both drugs have been shown in trials to extend life.

This is a recommendation by an advisory board, not an approval. On average minor submissions from the PBAC took 16 weeks from recommendation to listing on the PBS (in 2009, the last year I can find figures for). If the PBS approves and lists these products, they will be available at the normal low PBS pharmacy prices.

If your need is more urgent than this, perhaps your doctor will be able to contact Janssen-Cilag Pty Ltd to see if any urgent arrangements can be made.

Member Tony Maxwell from Sydney gave a presentation to Janssen-Cilag Pty Ltd last Christmas and may have a contact or two for you to start with.

... end Jim

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

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

Recommended on a cost-minimisation basis with cabazitaxel. The PBAC noted that abiraterone has a better safety profile and is more convenient to administer (oral administration) than cabazitaxel.

Drug and Form

Cabazitaxel, solution concentrate for I.V. infusion,

60 mg in 1.5 mL, Jevtana®

Sanofi-Aventis Australia Pty Ltd

Minor submission

Drug use and type

Metastatic prostate cancer

Listing requested by sponsor

Authority Required listing for treatment of hormone refractory metastatic carcinoma of the prostate in patients previously treated with a docetaxel containing regimen.

PBAC Recommendation

The PBAC recommended a Section 100 (Efficient Funding of Chemotherapy) listing as an Authority Required (Private Hospital/Clinic) and an Authority Requried (STREAMLINED) (Public Hospital) listing on the basis of acceptable cost-effectiveness compared with mitozantrone.

[tonymax]

This is great news for post chemo guys and hopefully full PBS approval for Zytiga will follow quite soon.

If MDV3100 approval for post chemo guys follows in the not too distant future then they will have two powerful new drugs to fight their cancers.

Does anybody have any info on status any application for PBS approval for MDV3100 in the post chemo setting?

My understanding is that any approval for these drugs in the pre chemo setting would be a minimum 1-2 years away and possibly up to 4 years. This is the setting where they are likely to give the greatest benefit so we need to lobby for that at appropriate times. The possibility of using the two drugs together is even more exciting.