UK Agency's Rejection of Eli Lilly, GlaxoSmithKline, PharmaMar S.A.'s Ovarian Cancer Drugs Stand

December 24, 2014
By Riley McDermid, BioSpace.com Breaking News Sr. Editor

The British drug cost watchdog National Institute for Clinical Excellence (NICE) said today that it will continue its longstanding rejection of three ovarian cancer drugs, Eli Lilly 's Gemzar (gemcitabine), GlaxoSmithKline 's Hycamtin (topotecan) and PharmaMar's Yondelis (trabectedin), over concerns that they are priced too high, but will continue to recommend generic chemotherapy regimen paclitaxel and Janssen's Caelyx (pegylated liposomal doxorubicin hydrochloride (PLDH).

“These recommendations have been developed according to the best available evidence from the manufacturers, an independent assessment group, health professionals and patient organisations,” said Andrew Dillon, NICE chief executive, in a statement.

“The manufacturers and other organisations who are registered stakeholders for this appraisal can appeal against any of these recommendations, but only if they believe NICE has either acted unfairly or exceeded its powers,” he said. “Otherwise, this draft guidance will proceed to publication next year.”

World health authorities estimate that ovarian cancer is the fifth most common cancer, in the U.K. with 6,356 women in England and Wales diagnosed last year. Of those, only 35 percent are likely to survive 10 years or more, found national health statistics.

As such, the agency has come under increasing fire from patient advocacy groups to review how it rejects drugs that can have life-saving benefits, but after launching an internal look at its guidance, said it was still not convinced the drugs provided enough value to justify their cost.

“[NICE] still found the three drugs provided less benefit to patients than other options when the disease recurs for the first time at least six months after first-line platinum-based chemotherapy,” said a report on the guidance.

NICE said in its statement that it will continue to recommend National Health Service providers use paclitaxel in combination with a platinum regimen or as monotherapy, which is within its approved usage for treating recurrent ovarian cancer. PLDH combined with platinum will also remain on the list as an option for treating recurrent ovarian cancer, said NICE.