NICE has approved enzalutamide (Xtandi) for metastatic, hormone-relapsed prostate cancer in patients for whom chemotherapy is not yet clinically indicated.
The evidence supporting the decision comes from the PREVAIL trial, which compared enzalutamide 160 mg once daily with placebo in adults (n=1715) with asymptomatic or mildly symptomatic metastatic hormone‑refractory prostate cancer after androgen deprivation therapy has failed and before chemotherapy is indicated.
In the planned final analysis (6 May 2012), 118 people (14.2%) receiving enzalutamide and 321 people (40.1%) receiving placebo experienced radiographic progression-free survival (rPFS), as determined by a central review team (HR 0.186; 95% CI 0.149-0.231; P
In an additional analysis in September 2013, rPFS was seen in 287 people (44.4%) in the enzalutamide arm and 502 people (59.4%) in the placebo arm (HR 0.307; 95% CI 0.267-0.353; P
The NICE appraisal committee recognised the survival benefit seen with enzalutamide in PREVAIL. However, the trial allowed for subsequent treatments after enzalutamide that were unlikely to be used in England at that position in the treatment pathway. The committee concluded that the results required adjustment to reflect UK practice.
The incremental cost-effectiveness ratio (ICER) for enzalutamide compared with best supportive care was estimated to be between £31,600 and £34,800 per quality‑adjusted life year (QALY) gained. NICE concluded that the ICER for enzalutamide was below £30,000 per QALY gained and could be considered a cost‑effective use of NHS resources.