NICE, abiraterone, and the economics of treatment

On Friday last week the National Institute for Health Care Excellence (NICE) in England came to the conclusion that abiraterone acetate (Zytiga) is not cost-effective in the treatment of men with chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC), based on the most recently proposed price to the National Health Service.

NICE has a new web site and the link to its media releases was down this morning, but you can find relatively detailed information about NICE’s reasoning on the FirstWordPharma web site and elsewhere.

The bottom line to the reasoning (as The “New” Prostate Cancer InfoLink has pointed out several times before) is that the Phase III clinical trial of abiraterone acetate in men with chemotherapy-naive mCRPC never showed an actual survival benefit because the sponsor stopped the trial based on a radiographic progression-free survival (rPFS) benefit alone. As a consequence, the sponsor is unable to clearly demonstrate a cost-effectiveness benefit to treatment that is based on overall survival data.

This was always going to be a potential problem for abiraterone acetate. The sponsor (probably) decided to stop the trial early because they wanted to be very sure that they would have time to establish the value of abiraterone acetate in chemotherapy-naive mCRPC well before availability of enzalutamide results for this indication. On the other hand, as a consequence, they lost the opportunity to demonstrate an overall survival benefit, and this has now come back to haunt the company.

While we absolutely think that abiraterone acetate should be available in the UK to treat men with chemotherapy-naive mCRPC, we also can understand and sympathize with why NICE has come to its current conclusion. We would note that the comparable enzalutamide trial data showed a 2.2-month median overall survival benefit associated with treatment with enzalutamide and a 30 percent reduction in risk of death (compared to treatment with a placebo), as well as an 81 percent reduction in risk of rPFS. Whether this will be sufficient for enzalutamide to gain approval from NICE for use in men with chemotherapy-naive mCRPC is not yet known. The developers of enzalutamide are still waiting for formal approval to market this drug in both Europe and the USA, but we expect such approval to be coming relatively soon.

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