NICE green light for Merck's Keytruda in advanced skin cancer

The National Institute for Health and Care Excellence (NICE), the medicines watchdog for England and Wales, has in final guidance issued today said “yes” to pembrolizumab for treating advanced skin cancer after treatment with ipilimumab.

NICE recommends that US pharma giant Merck & Co’s (NYSE: MRK) Keytruda (pembrolizumab) is made available on the National Health Service as a treatment for some patients with advanced melanoma which is either unresectable (when the full tumor cannot be removed) or metastatic. Pembrolizumab has a marketing authorization in the UK as monotherapy ‘for the treatment of advanced (unresectable or metastatic) melanoma in adults’. This is broader than the indication covered by this appraisal which looked at using pembrolizumab in people who had already had ipilimumab.

Keytruda is recommended for the indication covered by the company evidence submission, that is:
•        after the disease has progressed with ipilimumab and, for BRAF V600 mutation-positive disease, a BRAF or MEK inhibitor (such as dabrafenib or vemurafenib [BRAF inhibitors] or trametinib or cobimetinib [MEK inhibitors]); and
•        when the company provides pembrolizumab with the discount agreed in the patient access scheme.