NICE fails to recommend pembrolizumab in final draft guidance

The UK National Institute for Health and Care Excellence (NICE) has published final draft guidance that recommends against the routine use of pembrolizumab for treating locally advanced or metastatic urothelial carcinoma in adults who have had platinum-containing chemotherapy.

The decision comes after a review of new evidence collected while pembrolizumab was available via the Cancer Drugs Fund. NICE says that uncertainty remains regarding the long-term benefit of this second-line immunotherapy treatment in comparison with other options, meaning it is not a cost-effective use of National Health Service (NHS) resources at its current price.

The list price for pembrolizumab is £2,630 per 100mg vial and the typical dosage is 200mg intravenously every three weeks. Even when pembrolizumab is offered with its agreed discount, the most plausible cost-effectiveness estimate remains above what NICE normally considers acceptable, even for end-of-life treatments.

Pembrolizumab will be withdrawn from the Cancer Drugs Fund once final guidance has been published. This means that no new patients will be offered the drug, although it will not affect those whose treatment was started before the final guidance was published.

For people with advanced or metastatic bladder cancer, chemotherapy is the first-line treatment. NICE has already recommended atezolizumab, which is also an immunotherapy, for use as a second-line treatment.