The National Institute for Health and Care Excellence issued a final appraisal document on Friday recommending use of Bristol-Myers Squibb's Opdivo (nivolumab) within the Cancer Drugs Fund (CDF) as an option for the adjuvant treatment of completely resected melanoma in adults with lymph node involvement or metastatic disease. The agency, which rejected NHS use of the anti-PD-1 therapy in this indication in August, noted that there are currently no adjuvant immunotherapies recommended in this indication.

NICE said that Opdivo was not backed for routine NHS use as the clinical effectiveness of the drug is "very uncertain," partly due to the lack of mature overall survival data. The agency noted that this makes the cost-effectiveness estimates also "very uncertain." NICE indicated that further data should be collected from Opdivo, including recurrence-free survival and overall survival results from the ongoing CheckMate 238 study.  

In the CheckMate 238 study, results from which were unveiled last year, seven of 10 patients in the Opdivo arm were free of cancer after 12 months, versus six of 10 given Bristol-Myers Squibb's Yervoy (ipilimumab). Meanwhile, the duration of cancer-free survival was 30.8 months in the Opdivo arm, compared to 24.1 months for patients treated with Yervoy. In addition, three in 20 patients taking Opdivo experienced severe side effects versus nine in 20 patients taking Yervoy.

NICE further noted that no studies have directly compared Opdivo with routine surveillance, which is the current standard of care for patients with completely resected stage III and IV melanoma. However, the committee concluded that the therapy is likely to be beneficial compared to routine surveillance based on the results of the two treatment options in separate studies. The agency noted that Opdivo costs 439 pounds ($561) per 4 mL vial and 1097 pounds ($1401) per 10 mL vial, although Bristol-Myers Squibb has agreed to supply the product to the NHS with an undisclosed discount.

The news comes shortly after NICE backed CDF coverage of Merck & Co.'s anti-PD-1 therapy Keytruda (pembrolizumab) in combination with Eli Lilly's Alimta (pemetrexed) and platinum chemotherapy for use in patients with untreated non-small-cell lung cancer. Similar to Opdivo, the agency determined that as further evidence is needed on the benefits of Keytruda, it could not be considered for routine NHS use in this indication.

Commenting on the news, Rose Gray, policy manager at Cancer Research UK, remarked "together, these decisions are great news for patients, who previously would have had to watch and wait for any signs of relapse," adding "they also show the value of the [CDF] as a way to make promising new treatments available to patients quickly, while more evidence is collected about their effectiveness."