1 Recommendations

1.1 Vismodegib is not recommended within its marketing authorisation for treating symptomatic metastatic basal cell carcinoma, or locally advanced basal cell carcinoma that is inappropriate for surgery or radiotherapy, in adults.

1.2 This recommendation is not intended to affect treatment with vismodegib that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

Current treatment for metastatic basal cell carcinoma, or locally advanced basal cell carcinoma that is inappropriate for surgery or radiotherapy, is best supportive care.

Clinical trial evidence shows that overall survival data in people with locally advanced basal cell carcinoma are limited. Only a small number of people with metastatic basal cell carcinoma were included in trials. There are also no trials directly comparing vismodegib with best supportive care. The results of an analysis comparing the treatments suggests that vismodegib may provide some benefit, but the methods used are not good enough for decision-making.

The most likely estimate of cost effectiveness for vismodegib compared with best supportive care is much higher than £30,000 per quality-adjusted life year (QALY) gained. The economic assessment may not have fully captured the quality-of-life benefits of vismodegib, but taking this into account would not lower the estimate of cost effectiveness to an acceptable level.

Vismodegib cannot be recommended because of the uncertainty in the evidence and because it is not cost effective.