NICE 'yes' for Opdivo offers patients with advanced skin cancer new treatment option

The National Institute for Health and Care Excellence (NICE), the medicines cost watchdog for England and Wales, has today issued a Final Appraisal Determination (FAD) which recommends US pharma major Bristol-Myers’ (NYSE: BMY) Opdivo(nivolumab), as monotherapy, for the treatment of advanced (unresectable or metastatic) melanoma in adult patients.

This guidance means that National Health Service patients in England and Wales will be able to access an innovative treatment option that offers a potentially rapid and durable response in patients with previously untreated advanced melanoma, compared with chemotherapy.In 2012 around 13,500 people were diagnosed in the UK and approximately 2,100 people died from the disease. Melanoma is the most dangerous form of skin cancer.

Decision overturns former guidance

This is a reversal of a draft guidance late last year, when the NICE said the evidence provided by the company, together with its cost to the NHS – about £100,000 (~$143,000) per year per patient – has not allowed it to recommend nivolumab for routine use, over the current standard treatment docetaxel, which was first approved for use 17 years ago (the Pharma Letter December 16, 2015).