NICE rejects Celgene's Abraxane for pancreatic cancer over limited benefits, cost

The National Institute for Health and Care Excellence published draft guidance Tuesday recommending against NHS reimbursement of Celgene's Abraxane (nab-paclitaxel), in combination with Eli Lilly's Gemzar (gemcitabine), for previously untreated metastatic pancreatic cancer as the drug's "limited benefits compared to current treatments do not justify its cost." The agency issued similar draft guidance on Abraxane in September.

NICE noted that patients with newly diagnosed pancreatic cancer are usually offered the chemotherapy regimen FOLFIRINOX, although this can be associated with serious side effects, in which case other treatment options include Gemzar alone or in combination with Roche's Xeloda (capecitabine). The agency indicated that information submitted by Celgene showed that FOLFIRINOX is likely to be more effective than Abraxane plus Gemzar. Further, although the combination was more effective than Gemzar alone, it resulted in more serious side effects. NICE added that Abraxane plus Gemzar also resulted in more side effects than Gemzar in combination with Xeloda, but was shown to have similar effectiveness.

"Although [Abraxane] is more effective than one of the treatment options currently available, [it] is associated with more side effects and is also more expensive," NICE chief executive Andrew Dillon remarked. "Unfortunately the development of new treatments for pancreatic cancer has been very limited in recent years," Dillon added.

Commenting on the NICE ruling, Adrian Kilcoyne, medical director at Celgene UK & Ireland, said "this decision is a serious setback for both clinicians and patients." Abraxane gained expanded approval from the European Commission in combination with Gemzar to include the first-line treatment of adults with metastatic pancreatic cancer in January 2014. According to the company, the average cost of a 28-day course of Abraxane is 1481 pounds ($2300).

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