NICE Wants Cost Analysis of Gilead’s Zydelig
Concerned about high treatment costs, the UK’s healthcare cost watchdog wants Gilead Sciences to provide more information on its blockbuster leukemia drug Zydelig before it will consider recommending its use.
In a preliminary draft guidance, the National Institute for Health and Care Excellence says it won’t recommend Zydelig (idelalisib) in combination with Genentech’s Rituxan (rituximab) for the treatment of chronic lymphocytic leukemia in adults with a specific mutation or in adults where the disease has relapsed following treatment and isn’t appropriate to treat again with previous therapies.
NICE has given Gilead until July 15 to present additional evidence, including a revised cost-effectiveness analysis reducing the length of treatment benefit for the two drugs to five years and a sensitivity analysis exploring the length of the combination’s benefit from end of treatment to five years.
The cost for a year’s treatment with Zydelig is about $60,000, according to NICE. Gilead has agreed to sell the drug at a discount in the UK, but the size of the discount wasn’t disclosed.
The FDA approved Zydelig in July 2014 under its breakthrough therapy designation pathway for use with Rituxan to treat patients whose CLL has returned. The drug also received accelerated approval to treat patients with relapsed follicular B-cell non-Hodgkin lymphoma and relapsed small lymphocytic lymphoma.
Gilead Sciences did not return a request for comment by press time. Read the draft guidance at http://www.fdanews.com/06-19-15-leukemia-drug.pdf. — John Bechtel