Latest guidance from UK’s NICE on Xtandi disappoints Astellas

UK drugs watchdog the National Institute of Health and Care Excellence (NICE) has issued new draft guidance recommending approval of Japanese drug major Astellas Pharma’s (TYO: 4503) Xtandi (enzalutamide) as an option for treating hormone relapsed metastatic prostate cancer in adults on the National Health Service.

Enzalutamide works in a different way to other drugs currently available for treating prostate cancer and the NICE plans to recommend it as an option for treating hormone relapsed metastatic prostate cancer in adults, only if their disease has progressed during or after a docetaxel-containing chemotherapy regimen, they have not been treated with abiraterone, and the manufacturer provides enzalutamide with the discount agreed in the patient access scheme.

Astellas expressed disappointment with the recommendation, which it says will delay access to this treatment option for some patients. This latter restriction has been added since the original ACD and comes just over three months since the original draft recommendations from the NICE were announced. Astellas is surprised by this as it significantly reduces drug choices for patients who have no other clinical options. In addition this limits the decision-making ability of appropriate drug choice by clinical experts.

Alan McDougall, medical director at Astellas Pharma in the UK, comments: “Today’s announcement from NICE represents a major setback for many prostate cancer patients who would otherwise be eligible for treatment with enzalutamide according to the original draft guidance and licensed indication.  Astellas is concerned that such an approach has not been taken with similar appraisals for other cancer agents and leaves prostate cancer patients disadvantaged.”