NICE provisionally knocks back AstraZeneca's PARP inhibitor Lynparza in ovarian cancer maintenance setting

The National Institute for Health and Care Excellence (NICE) issued draft guidance Friday recommending against routine NHS funding of AstraZeneca's Lynparza (olaparib) for the maintenance treatment of relapsed, platinum-sensitive high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that is in response to platinum-based chemotherapy in adults.

In May, the European Commission approved Lynparza in this indication, with the decision based on clinical data showing that the PARP inhibitor significantly prolonged progression-free survival by 3.6 months versus placebo, whilst also improving overall survival following platinum-based chemotherapy. 

NICE noted that while Lynparza extends the time until cancer progresses compared with routine surveillance, the cost-effectiveness estimates for the drug "are substantially above the range normally considered cost effective." The agency added that Lynparza, which has a list price of 4635 pounds ($6031) per 28-day cycle, does not meet its end-of-life or Cancer Drugs Fund criteria.

In response to the news, AstraZeneca said in a statement that it "will continue to engage with NICE, NHS England and the Cancer Drugs Fund to try and enable access to Lynparza tablets for women with this type of ovarian cancer." The company added that it believes the drug "should be eligible" for end-of-life consideration, and thus subject to the 50 000 pounds ($65 089) cost threshold per Quality Adjusted Life Year (QALY) instead of 30 000 pounds ($39 050).

Commenting on the decision, Paul Workman, chief executive of The Institute of Cancer Research, said "NICE's decision today was a complicated one and cost was a major factor." Workman added "use of [Lynparza] in women without BRCA mutations would be more clearly cost-effective if we could learn more about which women benefit and had a better test to pick them out for treatment."

AstraZeneca, which markets Lynparza with Merck & Co., recently reported that sales of the drug reached $169 million in the third quarter, up from $81 million in the prior-year period.

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