Nice rejects BMS’ immunotherapy Opdivo for previously treated kidney cancer on pricing
pharmafile | July 5, 2016 | News story | Manufacturing and Production, Research and Development, Sales and Marketing | Bristol-Myers Squibb, NICE, QALY, immunotherapy, opdivo, regulation
UK regulators have rejected Bristol-Myers Squibb’s (NYSE: BMY) immunotherapy Opdivo for previously treated kidney cancer on pricing and substantial uncertainty about the extent of the survival benefit of nivolumab when measured over the long term.
The National Institute for Health and Care Excellence (Nice) said the incremental cost-effectiveness ratio (ICER) was above £60,000 per quality-adjusted life year (QALY) gained. They concluded that, even when applying the maximum weighting to the QALY that is possible under the end of life considerations, the ICER for nivolumab did not fall within the range representative of a cost effective treatment.
BMS said the recommendation highlights the limitations of the current processes for accessing first in class medicines on the NHS. It also has the potential to deepen inconsistencies in access to this potentially life-extending cancer medicine in the UK. Nice has approved nivolumab for patients with advanced skin cancer, but looks set to deny it to those with advanced lung and kidney cancer, the company said in a statement.
In the UK, kidney cancer cases have risen dramatically over the last 30 years, with latest data showing around 11,900 people were diagnosed in 2013 and an average of 11 people died every day in 2012 from this disease, BMS said.
The regulator said it reviewed the data available on the clinical and cost effectiveness of nivolumab, having considered evidence on the nature of renal cell carcinoma (RCC). It also took into account the effective use of NHS resources.
The recommended dose and treatment schedule for nivolumab is 3 mg/kg given intravenously every 2 weeks. The list price for nivolumab is £439 per 40 mg vial or £1,097 per 100 mg vial.
Johanna Mercier, general manager, Bristol-Myers Squibb UK & Ireland, said: “Nivolumab is a game-changing medicine, which has been consistently recognised, in its approved indications, by the Medicines and Healthcare products Regulatory Agency (MHRA), as a Promising Innovative Medicine. Through the MHRA’s Early Access to Medicines Scheme (EAMS), Bristol-Myers Squibb has provided treatment to 388 UK patients across multiple tumour types prior to licence. It is now up to the Government to provide NHS access for the benefit of kidney cancer patients and their families.”
Anjali Shukla
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