NICE ‘yes’ for BMS skin cancer drug Opdivo

pharmafile | January 22, 2016 | News story | Medical Communications, Sales and Marketing BMS, Bristol-Myers Squibb, NICE, melanoma, nivolumab, opdivo, skin cancer 

NICE has approved Bristol-Myers Squibb’s skin cancer immunotherapy Opdivo (nivolumab) in final draft guidance as monotherapy for NHS patients in England and Wales.

The guidance recommends that the drug is made available with NHS funding for people with advanced melanoma – the most dangerous form of skin cancer. In 2012, some 13,500 people were diagnosed in the UK and approximately 2,100 people died from the disease. The condition can often be fatal if it advances to a stage where it cannot be surgically removed because it has spread to other parts of the body (unresectable or metastatic melanoma). 

The NICE committee decided that a consultation on the draft recommendations was not needed for this appraisal, so the recommendations could go straight to a final appraisal determination. 

Professor Paul Workman, chief executive of The Institute of Cancer Research, London, says: “It’s great to see NICE approve nivolumab, which is an effective and innovative new immunotherapy for melanoma, for use on the NHS. Patients with advanced melanoma currently have few treatment options, so it’s positive that NICE has approved this at the first time of asking. It’s vital that we get novel and exciting cancer treatments to patients as quickly as possible, and avoid the tortuous back and forths we have seen with other recent appraisals.” 

Commenting on NICE’s decision, Professor John Wagstaff, consultant oncologist at the South West Wales Cancer Institute and Swansea College of Medicine, adds: “Nivolumab has an innovative mode of action which will be a vital addition to our treatment armamentarium. Today’s decision is very welcome news for patients with advanced melanoma, as there are limited treatment options that have been shown to extend survival in this devastating disease.” 

“Melanoma can progress very quickly and many patients simply can’t afford to wait for treatment”, says Gill Nuttall, founder of the charity Melanoma UK. “We are therefore really pleased that NICE has now committed to making this medicine available to NHS patients. Immunotherapies are changing survival expectations in cancer and we need to do more to bring patient access to these potentially life-extending cancer medicines as quickly as possible.” 

Opdivo – a PD-1 (programmed death-1) immune checkpoint inhibitor – works by enhancing the ability of the immune system to find and fight cancer. Bristol-Myers Squibb is studying Opdivo across multiple tumour types, in a development programme consisting of more than 50 trials, as a monotherapy or in combination with other therapies. 

Johanna Mercier, general manager of, Bristol-Myers Squibb UK & Ireland, welcomed the regulator’s decision as “positive news for melanoma patients in the UK”, but noted that lung cancer patients continue to wait on a decision for the drug in that indication. NICE rejected Opdivo in advanced lung cancer in draft guidance last year, and a final decision is due in May 2016. 

Mercier says: “We hope that this can be revisited and are committed to continued collaboration with the reimbursement authorities to ensure that UK lung cancer patients gain rapid access to our innovative medicines in the same way that melanoma patients now will.” 

Joel Levy

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