NICE opts not to recommend Opdivo for head and neck cancer
- Draft guidance from the National Institute for Health and Care Excellence (NICE), which advises the English and Welsh sectors of the U.K.'s National Health service (NHS), recommends against the routine use of Bristol-Myers Squibb's Opdivo (nivolumab) in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck (SCCHN).
- While the analysis showed significant improvements in survival rates over the short term in patients with SCCHN taking Opdivo, NICE describes the data on the long term survival and quality of life for patients as "uncertain," and so the additional cost was considered too high.
- This is not the final recommendation. The guidance is out for public consultation until May 4, 2017.
Almost 10,000 people are diagnosed with squamous cell carcinoma of the head and neck (SCCHN) each year in the U.K., and of these, around 600 would be eligible for Opdivo (nivolumab) treatment if it was recommended by NICE at the end of the consultation period.
"The draft guidance is now out for consultation, and I think it’s important that consultees, including the company, healthcare professionals and the public submit their comments on this draft recommendation so that they can be considered by the committee," said Carole Longson, director of the health technology evaluation centre at NICE.
Not everyone was in agreement with the decision by NICE, which is known for being firm on high priced drugs. But the pricing watchdog isn't being blamed; critics are calling on the industry to lower prices and better show the value of its drugs.
"This decision denies patients a genuine breakthrough treatment that makes a real difference for people with relapsed metastatic head and neck cancer. It is another example, and a particularly stark one, of an innovative cancer therapy not being made available on the NHS because of cost," said Professor Paul Workman, CEO of The Institute of Cancer Research, London.
"We need to recognize that the price of cancer drugs is much too high, and that’s particularly the case with the exciting new wave of immunotherapies. We need pharmaceutical companies to bring down the cost of drug development through smaller, more targeted trials, and to do much more to pass on the savings to patients," added Workman.
Bristol-Myers called the decision "deeply concerning" and said it failed to see the value that Opdivo can bring to patients.
One of the challenges that Bristol-Myers Squibb has had to face throughout its rollout of Opdivo is the push back over costs. In May 2016, NICE said that Opdivo was clinically effective but not cost-effective in non-small cell lung cancer (NSCLC) in a draft recommendation which was confirmed in October 2016.
The NICE committee is meeting again on April 12. According to Bristol-Myers Squibb, this "marks the final chance for NICE to make nivolumab available on the NHS for advanced lung cancer patients, after a lengthy 18-month process of negotiations. If the negative decision is not overturned, there will be no access to nivolumab for lung cancer patients in England and Wales."
However, the push back hasn't been universal — in June 2016, Opdivo got the go-ahead from NICE for advanced melanoma, alone or in combination with Yervoy (ipilimumab). And in October 2016, after a consultation that originally turned down its recommendation, NICE stated that Opdivo should be made available for advanced renal cell cancer (RCC) based on Bristol-Myers Squibb's provision of additional data and a simple discount patient access scheme.
Follow Suzanne Elvidge on Twitter