NICE has given a provisional thumbs down to a new drug for late stage skin cancer caused by a genetic mutation.
In provisional guidance, issued yesterday, the healthcare guidance body says that it is not minded to recommend use of vemurafenib (Zelboraf) for the treatment of inoperable, locally advanced or metastatic melanoma in patients with the BRAF V600 genetic mutation.
The US drugs regulator, the Food and Drugs Administration, approved vemurafenib last summer.
The data submitted by manufacturer Roche came primarily from the BRIM3 trial, which compared vemurafenib with a current treatment, dacarbazine. The results showed the drug worked in skin cancer patients with the BRAF V600 mutation, extending their life by an average of three months.
But the longer-tem effect on survival was unclear, because many of the patients taking dacarbazine were moved on to other treatments, such as vemurafenib or ipilimumab when their disease progressed, making comparison difficult.
Treatment with vemurafenib costs around £1750 per week, although Roche has agreed a discount in the form of a patient access scheme, although how much that is remains confidential.
The appraisal committee agreed that the most plausible cost per QALY (quality adjusted life year) for vemurafenib was highly uncertain due to the limitations of the available evidence, but was likely to be considerably higher than £50,000, even after taking the patient access scheme into account.
NICE appraisal committees normally recommend treatments that cost around £30,000 per QALY or less. There is no set threshold cost per QALY for end-of-life drugs, but the highest cost per QALY of such a drug recommended by NICE is £50,000.
Sir Andrew Dillon, Chief Executive of NICE said: "We need to be sure that new treatments provide sufficient benefits to patients to justify the significant cost the NHS is being asked to pay. Vemurafenib is an expensive drug and its long-term benefits are difficult to quantify.”
However, the guidance has now been put out to consultation, so no final decision has yet been made.