- A U.K. cost agency plans to reject Bristol-Myers Squibb's immuno-oncology drug Opdivo for treatment of a common form of lung cancer, the company said on Thursday. The draft recommendation said covering Opdivo would not be cost-effective, despite finding the drug to be clinically effective.
- Some patients in the U.K. had been able to access Opdivo through an early-access scheme, but that program has now closed. While the drug is approved in the European Union for advanced melanoma and non-small cell lung cancer, the decision from the National Institute for Health and Care Excellence (NICE) would restrict access to the drug in the U.K.
- The recommendation will be open for comment until June 3, and a second appraisal committee will meet June 15 to finalize the decision.
In a statement on the decision, Bristol Myers said it had offered "a number of pricing proposals" to NICE in hopes of winning the agency's recommendation.
Opdivo costs nearly £32,000 pounds for a course of treatment, according to NICE. Bristol Myers had agreed to a patient access scheme where it would fund the cost of the drug for patients continuing treatment beyond 26 dosing cycles, after the National Health Service paid for the first 26 cycles.
But this was apparently insufficient to win NICE's recommendation, however, handing the company a setback in its race to win global market share for Opdivo.
Opdivo and Merck's Keytruda are two of the first imunno-oncology drugs to hit markets. So far, Opdivo has racked up higher global sales but Merck continues to seek broader indications for Keytruda. Other large pharma companies are seeking to win approval for their own checkpoint inhibitor drugs.
“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 Bristol-Myers Squibb UK & Ireland.