NICE rebuffs Celgene's Revlimid in second-line multiple myeloma

Celgene’s multiple myeloma growth engine Revlimid has hit a roadblock in the United Kingdom as the country’s cost watchdog turned away the med for second-line use on value concerns.

Experts from the National Institute for Health and Care Excellence (NICE) said Revlimid would not be cost-effective for patients who’ve already had a first round of treatment with Johnson & Johnson’s Velcade.

Revlimid is already approved for third-line use under a deal in which Celgene covers the drug after 26 initial cycles of treatment, normally two years. The company offered the same arrangement for second-line use, but NICE experts still said Revlimid wasn't a good value for money in that group of patients.

The draft rejection follows a similar decision for Amgen’s Kyprolis last week. NICE decided Kyprolis was not cost-effective for patients who’ve had one prior therapy. Amgen had offered a simple discount to win a recommendation in patients previously treated with Velcade or thalidomide, but that price cut didn't satisfy NICE's requirements.

While NICE decisions only directly affect patients in the U.K., other countries use the agency’s assessments to shape their own coverage, giving added gravity to judgments by the U.K. agency.

Both draft rejections deal a fresh setback for the Big Biotechs looking to their multiple myeloma meds to propel growth. For Celgene, the company this summer abandoned its ambitions to win Revlimid an approval in lymphoma, a push that could have brought a $1 billion revenue boost. One month later, the company said it received a federal subpoena for info on its patient-assistance program for the drug.

Amgen’s setback comes on the heels of a third quarter in which Kyprolis sales came in $9 million short of analyst expectations. Since Amgen bought Onyx back in 2013 for $10 billion, the drug has frequently come up short of street estimates.