NICE nixes Opdivo as postsurgery melanoma therapy but leaves door open

NICE rejected Bristol-Myers Squibb's Opdivo in adjuvant melanoma over lack of overall survival data. (Bristol-Myers Squibb)

Bristol-Myers Squibb’s bid to win U.K. coverage for Opdivo as an adjuvant melanoma therapy has been nixed for now. 

The National Institute for Health and Care Excellence (NICE) has rejected the PD-1’s application for inclusion on NHS England as a postsurgery recurrence prevention treatment of resected stage III and IV melanoma. In its preliminary guidance (PDF), the cost watchdog expressed doubts about the clinical effectiveness of Opdivo because there are no trials comparing it with routine surveillance.

Besides, its overall survival benefit over BMS’ own Yervoy is still being studied in an ongoing clinical trial, even though improved recurrence-free survival has already been shown. Therefore, the institute feels “it is not possible to assess whether [Opdivo] has plausible potential to be cost effective.”

Not only was it denied a recommendation for routine use in the NHS system, but it was also deemed ineligible for coverage by the agency’s Cancer Drugs Fund, which is an extra means for patients to access drugs before clinical or cost-effectiveness data are clear enough to win full NICE backing.

However, NICE is open to more comments until Sept. 28 and will meet again to discuss any new evidence on Oct. 16. The agency often reverses its own decisions as new data, or price cuts, are offered.

BMS first won its adjuvant melanoma nod from the FDA last December after showing a recurrence improvement of more than a third over Yervoy and followed up with an EU approval late July. Analysts have predicted the additional indication could add around $1 billion in potential sales for Opdivo. But now, realization of that ambition could be delayed.

RELATED: Merck's Keytruda builds its melanoma case against Opdivo with postsurgery trial win

Opdivo is currently the only drug approved in the setting, but its archrival Keytruda is quickly catching up. The Merck & Co. drug has recently demonstrated it could cut disease recurrence by 43% compared with placebo and is also being followed up for overall survival results.

Based on the strengths both drugs have shown, Cowen & Co. analysts had previously projected the two companies will split the market equally by 2021.

After a series of clinical wins, especially in the lucrative non-small cell lung cancer arena, Keytruda overtook Opdivo as the PD-1/L1 king in the second quarter. While the $1.67 billion in sales topped its rival's $1.63 billion by only a hair’s breadth, analysts expect Keytruda can build on the victory moving forward.

Keytruda has also had its ups and downs with the U.K. cost gatekeeper, having recently won a full recommendation in first-line lung cancer, but was just rejected in relapsed or refractory Hodgkin lymphoma—an indication for which Opdivo is approved.