NICE fails to back Zelboraf

NICE has failed to recommend Roche’s cancer drug Zelboraf (vemurafenib) for the treatment of unresectable locally advanced or metastatic BRAF V600 mutation-positive melanoma in draft guidance.

Its independent Appraisal Committee had uncertainties over the evidence supplied by NICE and deemed the treatment too expensive.

Sir Andrew Dillon, Chief Executive of NICE, said Zelboraf is an “expensive drug” and that its “long term benefits are difficult to quantify”.

Roche’s data came from the BRIM3 trial which compared Zelboraf with a current treatment, dacarbazine. Results showed how Zelboraf was effective for patients with skin cancer with the BRAF 600 mutation.

But its long-term effectiveness was “uncertain”, NICE said, due to patients receiving dacarbazine taking other treatments after their disease had progressed.

Roche had agreed a Patient Access Scheme for the use of Zelboraf on the NHS. However, the discount failed to convince NICE the treatment offers value for money.

It’s estimated that less than 1,000 people in England and Wales each year would be eligible for treatment with Zelboraf.