NICE recommends enzalutamide; consults on abiraterone

The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending Astellas’ Xtandi (enzalutamide) for prostate cancer which has spread in people whose first treatment has failed, who have no or mild symptoms, and for whom chemotherapy is not yet clinically indicated.

The Appraisal Committee concluded that enzalutamide is a well-tolerated treatment that delays chemotherapy (which it recognised as being valuable to patients) and improves survival. It was also found to be cost-effective.

The final draft guidance for enzalutamide is now with consultees, who have the opportunity to appeal against it. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments.

Commenting on the draft guidance, Sir Andrew Dillon, NICE chief executive, said, “In this final draft guidance we recommend enzalutamide as a treatment for patients whose prostate cancer has relapsed, but for whom chemotherapy is not yet clinically indicated. There are very few treatments available for patients at this stage of prostate cancer, so this is very good news.”

Professor Paul Workman, Chief Executive of The Institute of Cancer Research, London, said: “It is very welcome that NICE has decided that men with prostate cancer can access the drug enzalutamide without having to go through chemotherapy first.  The drug, which the ICR and The Royal Marsden helped to develop for patients, has proven benefits for extending life and improving quality of life, and the decision will mean that men can benefit earlier in the course of treatment.”

NICE consulting on draft recommendations that do not support abiraterone

NICE is also consulting on preliminary recommendations that do not support the use of Janssen’s Zytiga (abiraterone) for prostate cancer which has spread in people whose first treatment has failed, who have no or mild symptoms, and for whom chemotherapy is not yet clinically indicated. The Appraisal Committee recognised that abiraterone is a well-tolerated treatment which delayed chemotherapy but it was not convinced that the uncertain evidence for the long-term benefit of abiraterone justified accepting estimates of cost-effectiveness that were significantly above what it would normally consider acceptable.

Sir Dillon commented, “The evidence submitted for abiraterone was uncertain in terms of the extent of the quality of life and survival benefit. In addition, its current cost does not appear to justify its advantages, to patients, over current standard treatment. It is obviously disappointing not to be able to recommend abiraterone at this point.”

Commenting on the announcements about abiraterone, Professor Workman said: “It is a real blow that NICE has again decided to deny men the innovative prostate cancer drug abiraterone before chemotherapy. Abiraterone was discovered here at the ICR in England, so it is very disappointing that men in England and Wales will not be able to access the treatment – even though in Scotland it has been made available on the NHS. We need to challenge these kinds of inequalities in drug access across the UK.”