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NICE rejects Opdivo for lung cancer once again

Says PD-1 inhibitor is too expensive to be used routinely

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Bristol-Myers Squibb's PD-1 inhibitor Opdivo is too expensive to be used routinely in patients with non-small cell lung cancer (NSCLC), according to NICE.

The UK's cost-effectiveness watchdog has backed the use of the drug in melanoma, but has concluded that the list price of around £32,000 for an average course of Opdivo (nivolumab) in NSCLC is too high to justify its benefits.

NICE initially said it intended to deny the use of Opdivo for NSCLC in draft guidance issued last December, but BMS had hoped to convince the agency to think again during the initial comment period. 

The latest guidance is also up for a four-week consultation period before being finalised, due to conclude on 3 June, and it appears NICE is holding firm in the hope of securing a discount deal with the pharma company.

"While today's decision is disappointing for lung cancer patients, it is also a setback for British cancer care because it shows that the system which is intended to provide UK patients with new medicines has denied them yet again," said Johanna Mercier, general manager of BMS UK & Ireland.

"BMS has offered a number of pricing proposals to NICE and the Department of Health, which we are confident provide value to the NHS in lung and for nivolumab uses in other cancers," she added.  

"Unfortunately, NHS lung cancer patients are still not able to access this potentially life-extending medicine."
In trials, Opdivo extended the lives of patients compared to second line chemotherapy such as docetaxel. All told, 39% of Opdivo-treated patients were still alive at 18 months compared with 23% of those treated with docetaxel. 

Opdivo was launched in the UK last August and is already being made available to some patients via the Early Access to Medicines Scheme (EAMS). NICE says that second-line patients should now be offered docetaxel or Boehringer Ingelheim's Vargatef (nintedanib).

According to data from 2012 around 45,000 people in the UK are diagnosed with lung cancer each year, and UK survival rates lag behind those of some other European countries. Around 80% of those diagnosed with advanced disease die within a year.

Commenting on the draft recommendation, Prof Dean Fennell - chair of thoracic medical oncology at the University of Leicester - said: "Lung cancer is the UK's biggest cause of cancer deaths and making new medicines available to NHS patients is a vital part of raising standards of cancer care and survival rates in Britain to the levels seen in other European countries."

"Nivolumab has the potential to provide increased long-term survival compared with chemotherapy and with far less side effects. I hope that NICE will reconsider the value of this treatment and reverse its decision."

Article by
Phil Taylor

12th May 2016

From: Research, Regulatory



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