Abiraterone (Zytiga) 3/3 The Australian position

[Admin]

Abiraterone (Zytiga) is approved for supply on the Australian PBS under the following conditions:

Authority Required

Castration resistant metastatic carcinoma of the prostate

Clinical criteria:

    •    The treatment must be in combination with prednisone or prednisolone,

AND

    •    The treatment must not be used in combination with chemotherapy,

AND

    •    Patient must have failed treatment with docetaxel due to resistance or intolerance; OR 

    •    Patient must be unsuitable for docetaxel treatment on the basis of predicted intolerance to docetaxel, 

AND

    •    Patient must have a WHO performance status of 2 or less,

AND

    •    Patient must not receive PBS-subsidised abiraterone if progressive disease develops while on abiraterone, 

AND

    •    Patient must not have received prior treatment with enzalutamide; OR

    •    Patient must have developed intolerance to enzalutamide of a severity necessitating permanent treatment withdrawal.

(Current 7 June 2017. Check pbs.gov.au for the latest version.)

 

So, for most men, only after treatment fails with the chemotherapy docetaxel.

 

We can assume that the Australian supplier of abirateone (Janssen) will present the results of the latest STAMPEDE and LATITUDE trials to the government's expert committee (the PBAC) suggesting that abiraterone be made available to men on the PBS earlier in treatment.

 

I am not a doctor, but these trial results are reported as being very strong. So it will come down to Janssen agreeing a pricing package with the government, if they can.

 

[Paul Edwards]

Jim, To complete the picture, Janssen the manufacturer of Abiraterone applied to the March 2017 meeting of the PBAC for an amendment so Abiraterone could be used with a corticosteroid other than prednisone or prednisolone 

 

The PBAC recommended that this application be approved. 

[pauldhodson]

Should we be lobbying our local members to make this available before castration resistance?

[Cam]

I'm new to all this PBS business, but having now read a number of reports about the success of early addition of Abiraterone to ADT, I see it as a no-brainer.  In my case I have the choice of chemo or paying a ridiculous amount of money for Abiraterone.

[pauldhodson]

Hey Cam, I looked into this recently also. My MO said I could pay for it myself, but she had no idea of the cost. She estimated $3,000pm. From what I understand Abiraterone is only available once you are castrate resistance and post-Docetaxel, or not suitable for Docetaxel. I'd like to know who we should put pressure on, perhaps Jim knows?

[Cam]

Hi Paul, at this early stage in my investigation, yes looks like $3-4k p/m if you don't meet the PBS conditions.  I'm very keen to find a way to get this on the PBS with a few less conditions but have no idea where to start.

[Admin]

It has come down to price.

The PBAC recommends that drugs go on the PBS if they are value for money.

They are happy for taxpayers to pay if a patient gets a year of quality life for around $75,000.

Using Zytiga (Abiraterone) or Xtandi (Enzalutamide) after chemo comes in at the right price.

The suppliers of Abiraterone have so far not given a price that meets the standards of the PBAC.

So, if we want it earlier, we have to pay.