BMS criticises Scottish regulator over Opdivo skin cancer ‘no’
pharmafile | March 7, 2016 | News story | Medical Communications, Research and Development | Bristol-Myers Sqibb, NICE, SMC, melanoma, opdivo
Bristol-Myers Squibb says the Scottish Medicines Consortium’s (SMC) decision not to recommend its immunotherapy Opdivo (nivolumab) as a monotherapy for the treatment of advanced (unresectable or metastatic) melanoma will deny Scottish skin cancer patients access to a potentially life-extending medicine.
The SMC published guidance today not recommending the drug, which conversely, was recently approved by England and Wales regulator NICE.
Johanna Mercier, General Manager, Bristol-Myers Squibb UK & Ireland, comments: “Today’s decision highlights the inconsistency in processes for assessing medicines for reimbursement across the UK. Hundreds of advanced melanoma patients in England and Wales will soon be able to receive treatment with nivolumab through the NHS, while the same group of patients in Scotland has now been denied access. Bristol-Myers Squibb has heard from clinicians and patient groups that Scottish patients need another treatment option and we will continue to work in partnership with the reimbursement authorities and do everything in our power to achieve a swift solution.”
Melanoma is a growing health burden in Scotland with incidence having risen by 30% over the last decade – more than any other common cancer. Around 1,200 people in the country were diagnosed with skin cancer in 2013, and some 200 people died from the disease. Globally, melanoma causes more deaths than any other form of skin cancer.
Data from several clinical studies suggest Opdivo can improve melanoma outcomes compared to chemotherapy, in both treatment-naive and experienced patients. In the Phase III CheckMate -066 study, for example, patients without BRAF mutation, who had not received prior therapy, received Opdivo, and after one year, 72.9% of patients who did so were still alive, compared to 42.1% of those treated with the chemotherapy dacarbazine. Studies also indicate a superior safety profile, with Opdivo treatment resulting in fewer serious adverse events.
“Advanced melanoma is a serious disease, which frequently results in short survival. Prompt access to innovative treatments developed in the past few years is vital. Immunotherapies such as nivolumab have been shown to improve significantly survival in metastatic melanoma and also are generally well tolerated, so the decision to withhold funding is disappointing”, concludes Dr Marianne Nicolson, consultant medical oncologist.
Joel Levy
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