FDAnews
www.fdanews.com/articles/167942-celegenes-multiple-myeloma-drug-imnovid-rejected-by-nice

Celegene’s Multiple Myeloma Drug Imnovid Rejected by NICE

October 20, 2014

UK’s healthcare cost watchdog has recommended against coverage of Celegene’s multiple myeloma drug Imnovid, in combination with dexamethasone, for treating MM patients who have failed on at least two previous treatments and whose disease has progressed on the last therapy.

In a draft guidance, the National Institute for Health and Care Excellence (NICE) said it was not able to judge with any confidence whether Imnovid (pomalidomide) is more effective than current options, including Celgene's Revlimid (lenalidomide) and Johnson & Johnson’s Velcade (bortezomib).

NICE said it was not persuaded the company’s estimates of life extension on the drug were robust, objective or plausible, and that Imnovid did not fulfill the criteria for being a life-extending, end-of-life treatment. But even if it had, NICE said the quality-adjusted life years (QALYs) gained would be too high for pomalidomide to be considered a cost-effective use of NHS resources.

The incremental cost-effectiveness ratio for Imnovid was roughly $80,000 per QALY gained compared with Velcade plus dexamethasone, NICE said. The price of a 21-tablet pack of Imnovid is roughly $14,170, the agency said.

Comments on the draft guidance are due Nov. 5. NICE said it will consider the drug again at its Nov. 19 appraisal meeting. — Neal Learner

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.