New drug Apalutamide (Erlyand) not approved for the PBS in Australia

[Admin]

New drug Apalutamide (Erlyand) not approved for the PBS

 

Jim Marshall (not a doctor) said ...

The PBAC (the expert committee that recommends whether drugs go on the PBS) has said that it cannot yet recommend Apalutamide (Erlyand).

The PBAC said if evidence longer life benefit comes in the future this could change. (The evidence so far is only that it will delay further treatment.)

They also said there is no evidence yet about how successful  Abiraterone (Zytiga) or Enzalutamide (Xtandi) treatment might be after Apalutamide treatment.

The PBAC also said the price the company was asking was too high given the evidence put forward.

They said they did take into consideration evidence from consumers (many of them our members - we thank you for that) the benefits of delaying further metastasis and symptoms getting worse.

... end Jim

 

PBS: Pharmaceutical Benefits Scheme

PBAC: Pharmaceutical Benefits Advisory Committee

 

Drug: APALUTAMIDE Tablet 60 mg Erlyand® Janssen-Cilag Pty Ltd New listing (Major Submission)

 

Purpose of submission: To request an Authority Required listing for the treatment of nonmetastatic castration resistant prostate cancer in combination with androgen deprivation therapy.

 

PBAC outcome: The PBAC did not recommend the listing of apalutamide for the treatment of non-metastatic castration-resistant prostate cancer. The PBAC considered that apalutamide provided a substantial benefit to some patients in delaying metastases but the survival benefit was uncertain as the trial data were immature. The PBAC noted the consumer comments and acknowledged the potential quality of life benefits associated with delaying metastasis and symptomatic progression. The PBAC considered that the appropriate treatment pathway is unclear as there are insufficient data demonstrating the degree of efficacy of abiraterone or enzalutamide after treatment with apalutamide. The PBAC considered that it is likely that other treatments, such as enzalutamide, are likely to enter the same market space as apalutamide. The PBAC advised that the incremental cost-effectiveness ratio was underestimated due to the estimated gain in overall survival being implausibly high in the economic analysis presented.

  

Sponsor Comment: Jansen was disappointed with the PBAC’s decision not to recommend apalutamide (ERLYAND®). Janssen welcomes the PBAC’S acknowledgment of the substantial benefit in delaying metastases and maintain that apalutamide is associated with a survival advantage. Janssen will continue to work towards a listing for this important product in the treatment of prostate cancer. 

[tonymax]

Jim,

 

Did Janssen's application involve use of Apalutamide pre chemo or post chemo or both.

I presume pre chemo as PBAC indicate for non-metastatic castration resistant PC without mentioning chemo.

PBAC seem to be worried about a treatment pathway where enzalutamide or abiraterone may be used after apalutamide

No evidence yet of matching best drug to individual patients at whatever stage of the disease.

 

Is it true that Abiraterone will soon come off patent and may then become a much cheaper generic drug?

 

How long until Enzalutamide may do the same?

 

Tony

[Admin]

Tony

1. Yes. This application was pre-chemo.

Quote

 

A new drug has been developed and tested for men with castrate-resistant prostate cancer who have no metastases.

 

In the trial of Apalutamide (Erlyand®), half the men on the drug still had no sign of metastases at 40.5 months. In contrast, half the men on the placebo (dummy tablets) reached this point after 16.2 months.

 

The drug passed the first step in Australia by gaining  TGA (Therapeutic Goods Administration) approval in only 4 months. So, now it can be legally be prescribed and sold in Australia.

 

Today the company selling the drug (Janssen) took the next step by asking the Pharmaceutical Benefits Advisory Committee (PBAC) to approve the drug being put on the PBS so it is available to men who need it at an affordable price.

 

2. Abiraterone may come off patent soon. It was due to come off now, but Johnson & Johnson are fighting in the courts to extend the patent.

3. I don't know the length of the Enzalutamide patent, but we can expect a proposal that it should be used for the same type of man as Apalutamide was tested on - men with castrate-resistant prostate cancer who have no metastases.

Jim

 

 

 

[Charles (Chuck) Maack]

Sad that the PBAC failed to see the merit of this androgen receptor blocking medication that can hold off metastases for many months, while, apparently, enzalutamide will meet the same fate since the SPARTAN trial showed apalutamide had a longer range of effectiveness than that shown for enzalutamide in the PROSPER trial. It appears cost is the mitigating factor.  We can hope that Janssen can see fit to offer the availability of apalutamide at a cost that will meet PBAC approval.