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Southampton Health Technology Assessments CentreNews

Cobimetinib in combination with vemurafenib for treating melanoma – NICE guidance now available

Published: 4 November 2016
New drugs for advanced melanoma

The National Institute for Health and Care Excellence (NICE) has issued guidance to the health service on the use the drug cobimetinib in combination with vemurafenib for treating unresectable or metastatic BRAF V600 mutation-positive melanoma, informed by a report produced by SHTAC.


Melanoma is a cancer of the skin. In its early stages, melanoma does not always show symptoms and can often be cured by surgical resection (removal of the lesion). However, at presentation in around 10% of people melanomas will have spread to nearby lymph nodes (stage III- advanced melanoma) or to other parts of the body (stage IV – metastatic melanoma). It occurs more commonly in fair-skinned people and there is strong association with ultra violet exposure. Melanoma is the fifth most common cancer in the UK with around 13,000 new cases diagnosed each year. More than one-third of people diagnosed with melanoma are aged less than 55 years.

The management of advanced melanoma is rapidly evolving, with a number of new drug treatments becoming available in recent years. One such drug is cobimetinib (brand name ‘Cotellic’, Roche), which is used in combination with the drug vemurafenib (brand name ‘Zelboraf’, Roche). This combination is specifically for use in patients with the BRAF V600 melanoma mutation. This mutation is found in about 50% of melanomas, and leads to accelerated growth of the tumour. The aim of this combination therapy is to slow the growth and spread of the cancer.

SHTAC produced a report to NICE critically appraising the evidence submitted by the company. NICE’s guidance is that cobimetinib in combination with vemurafenib for treating unresectable or metastatic BRAF V600 mutation-positive melanoma is not recommended for use in the NHS. The NICE Technology Appraisal Committee noted that cobimetinib plus vemurafenib is clinically effective compared with vemurafenib alone, with an increase in overall survival of 4.9 months based on current available data. However, in all of the analyses presented to the appraisal committee, the incremental cost-effectiveness ratios (ICERs) were over £100,000 per quality-adjusted life year (QALY) gained. This is substantially over the range usually considered a cost-effective use of NHS resources.

NICE have approved a number of other drugs for the treatment of melanoma, including ipilimumab, nivolumab, pembrolizumab, and trametinib in combination with dabrafenib, details of which can be found on the NICE website.

For more information on SHTAC’s previous research into cancer, please visit our Research page.



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