FDAnews
www.fdanews.com/articles/167170-article-headline

NICE Recommends Against Coverage of Celgene’s Cancer Drug Abraxane

September 15, 2014

The UK’s cost-effectiveness watchdog is recommending against coverage of Celgene’s cancer drug Ambraxane with gemcitabine for patients with previously untreated metastatic pancreatic cancer, citing its expensive price and limited benefits compared with current treatments.

In its decision last Tuesday, the National Institute for Health and Care Excellence (NICE) cited information provided by Celgene that showed the current chemotherapy combination of fluorouracil, leucovorin, irinotecan and oxaliplatin was more clinically effective than Ambraxane (nab-paclitaxel) with gemcitabine.

The information also showed that although nab-paclitaxel with gemcitabine was more effective than gemcitabine alone, it resulted in more serious side effects, NICE said. Nab-paclitaxel with gemcitabine was similar in effectiveness to gemcitabine with alternative treatment capecitabine but may have more side effects, according to NICE.

Furthermore, the company estimates the average cost of a 28-day course of treatment to be nearly $2,400, a figure more expensive than current therapy, according to NICE.

The company has urged the agency to reconsider its recommendation. A Celgene spokeswoman said the company is disappointed with NICE’s preliminary draft guidance, as there are fundamental aspects of the evaluation which it believes are not reflective of the value and dataset for Abraxane.

“More importantly, we are disappointed for the patients with metastatic pancreatic cancer, because if this decision is upheld it would mean that NICE has not recommended any new treatments for pancreatic cancer in over a decade,” she said. — Jonathon Shacat

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