BMS' Opdivo Blasts Through NICE
This article was originally published in Scrip
Bristol-Myers Squibb's PD-1 inhibitor Opdivo (nivolumab) has won a recommendation from NICE, the health technology appraisal institute for England and Wales, for use on the NHS as a monotherapy for melanoma. The drug went straight to the final stages of the appraisal process and will compete against Merck & Co's own PD-1 inhibitor Keytruda (pembrolizumab). Meanwhile, research and patient organizations have expressed relief that NICE has okayed another "exciting" new immunotherapy for cancer.
On 22 January, NICE published its final appraisal determination recommending Opdivo in line with its licensed indications as a monotherapy for treating advanced (unresectable or metastatic) melanoma in adults. BMS has welcomed the news, but at the same time expressed concern that the institute was poised to say no to the drug for lung cancer.
Elsewhere, others applauded the swift adoption of an effective immunotherapy. "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," said Paul Workman, chief executive of The Institute of Cancer Research.
Gill Nuttall, founder of Melanoma UK was also pleased with today's news and highlighted the importance of immunotherapies, which she said are changing survival expectations in cancer. "We need to do more to bring patient access to these potentially life-extending cancer medicines as quickly as possible," she said.
Opdivo, like Keytruda, won approval from the UK's medicines regulator, the MHRA, to enter the Early Access to Medicines Scheme (EAMS), which aims to allow early availability of promising new unlicensed drugs for patients with a high unmet medical need. This meant Opdivo was made available in the UK, free of charge to the NHS, on May 30, less than a month before it won EU approval on June 19. Approval under EAMS also means the NHS is obliged to make funding available for the drug earlier following positive NICE guidance. Usually local authorities have 90 days to fund a product recommended by NICE, but this time line falls to 30 days for EAMS-approved drugs.
According to NICE, the decision to dispense with preliminary draft guidance had nothing to do with the Early Access to Medicines Scheme. NICE was able to recommend the drug for the full licensed indication based on the available evidence, for this reason there was no need for additional consultations, it said.
Opdivo costs £439 per 4 ml vial and £1,097 per 10 ml vial, excluding VAT and any local procurement discounts. NICE's appraisal committee decided that the incremental cost effectiveness ratio for the drug, compared with BMS' Yervoy (ipilimumab), Roche's Zelboraf (vemurafenib) and Novartis' Tafinlar (dabrafenib), would be less than £30,000 per quality adjusted life year gained. This meant the drug was cost-effective. This estimation included confidential discounts applied to the three drugs.
NICE also agreed that the drug could be evaluated under its end-of-life criteria, which gives it more scope to accept more expensive medicines.
In November 2015, NICE published guidance recommending Keytruda as an option for treating advanced melanoma that has not been previously treated with Yervoy. The recommendation depends on a confidential discount.