The Astellas drug, which was launched in the UK in July, is recommended for adults in whom first-line hormonal therapy has failed and whose cancer has progressed during or after docetaxel chemotherapy.
The approval is conditional on a discount agreed in a confidential patient access scheme agreed between Astellas and the Department of Health.
Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, said: “There are few treatments available for patients at this stage in their cancer so we are very pleased that we are able to produce draft guidance recommending enzalutamide. It is an effective treatment and it also allows patients to be treated at home as it can be taken orally.”
The NICE decision, if confirmed, would take Xtandi out of the clinical and commercial ‘twilight zone’ of therapies available to NHS patients only via the Cancer Drugs Fund, which will cease to be available at the end of this year.
Xtandi has a unique mechanism of action: it takes effect at three distinct steps in the androgen receptor signalling pathway within cancer cells, reducing their growth and potentially killing them.
Metastatic prostate cancer is incurable, and 72% of patients die within three years of diagnosis. Xtandi has been shown to improve overall survival by 4.8 months relative to placebo, and to be less toxic than the standard treatment (abiraterone).
NICE accepted that the cost per QALY for enzalutamide compared with abiraterone was “associated with some degree of uncertainty” – but it was “satisfied” that the cost per QALY was below the £30,000 threshold.