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

Celgene

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.

Free Daily Newsletter

Like this story? Subscribe to FiercePharma!

Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them. Sign up today to get pharma news and updates delivered to your inbox and read on the go.

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.

Suggested Articles

Wall Street analysts are worried that generics price erosion in the U.S. is taking more of a toll on Sandoz than it is on its competitors.

Takeda sells €1.5 billion European drugs; top Indian drugmakers expand in China; Eisai moves closer to a quick Alzheimer’s blood test.

For just the second time, the DOJ indicted an opioid distributor for its role in illegally pushing pills at the height of the addiction epidemic.