UK's NICE denies NHS access to Roche melanoma drug Zelboraf

UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has issued draft guidance which does not recommend the use of Swiss drug major Roche’s (ROG: SIX) Zelboraf (vemurafenib) for the treatment of unresectable locally advanced or metastatic BRAF V600 mutation-positive melanoma on the National Health Service.

The data submitted by the manufacturer came primarily from the BRIM3 clinical trial, which compared vemurafenib with a current treatment, dacarbazine. The results showed the drug was effective for patients with melanoma with the BRAF V600 mutation. However, the longer-tem effect on survival was uncertain because many of the patients taking dacarbazine were moved onto other treatments such as vemurafenib or ipilimumab when their disease progressed, making comparison difficult.

Treatment with vemurafenib costs around £1,750 ($2,698) per week. Roche has agreed a patient access scheme with the Department of Health, in which vemurafenib is offered at a lower price (the price reduction is confidential). The Committee agreed that the most plausible cost per QALY for vemurafenib was highly uncertain due to the limitations of the available evidence, but was likely to be considerably higher than £50,000 per QALY gained taking the patient access scheme into account. Roche itself estimated that it would be £56,400 per QALY.