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NICE 'no' for Opdivo in kidney cancer

BMS oncology drug knocked-back in draft guidance

Bristol-Myers SquibbBristol-Myers Squibb has been dealt a blow by NICE after the English pricing watchdog refused to recommend Opdivo as a treatment for kidney cancer in patients whose disease has progressed following previous treatment.

Opdivo (nivolumab) is already indicated as a first-in-class treatment for skin cancer and BMS says the 'no' decision for the first immunotherapy in kidney cancer will “intensify [the] cancer survival lottery in the UK”.

But NICE's draft guidance suggests there is “substantial uncertainty about the extent of the survival benefit of nivolumab when measured over the long term” in renal cell carcinoma in adults.

NICE's appraisal committee found that the incremental cost-effectiveness ratio (ICER) was above £60,000 per quality-adjusted life year (QALY) gained - which meant the ICER for nivolumab “did not fall within the range representative of a cost-effective treatment”.

BMS is frustrated that NICE recognises that its PD-1 immune checkpoint inhibitor extends overall survival but will not recommend an extension to the existing indication.

It points out that this means NHS patients with advanced skin cancer can use the brand, but it will not be available to those with advanced lung and kidney cancer.

The manufacturer says that 27% of kidney cancers are diagnosed at an advanced stage, when the prognosis is poor and the goal of treatment is largely to extend survival.

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. It has always been our aim to ensure that it provides value to the NHS and for all of the cancer types where it could benefit patients.

“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.”

Studies have shown that patients treated with nivolumab had an extra 5.6 months of survival compared to those treated with Novartis' mTOR inhibitor Afinitor (everolimus) (25 months versus 19.6 months).

Rose Woodward, from the Kidney Cancer Support Network, said: “Not only is today's news deeply distressing for kidney cancer patients and their families, it demonstrates the current frustrating and fragmented approach to reviewing cancer medicines in the UK.”

Those who oppose the draft guidance now have four weeks to respond, after which the committee will make a final decision.

Article by
Adam Hill

5th July 2016

From: Regulatory



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