The U.K.’s National Institute of Health and Care Excellence (NICE) has decided not to recommend Lynparza (olaparib) tablets as maintenance treatment for women with relapsed ovarian cancer who respond to platinum-based chemotherapy due to unsatisfactory cost-effectiveness.
However, this is not the advisory committee’s final guidance on the therapy, and its decision could be reversed following the ongoing consultation period.
AstraZeneca and Merck (known as MSD outside the U.S. and Canada) were looking for NICE’s recommendation for Lynparza use (two 150 mg tablets a day) on the U.K.’s National Health System (NHS) for women with high-grade epithelial ovarian, fallopian tube, or primary cancer of the peritoneum, regardless of BRCA mutations.
Although clinical experts explained to the committee that Lynparza extends the time until cancer progression compared with routine surveillance and that the U.K. has worse survival rates and outcomes than other developed countries, NICE considered that “cost-effectiveness estimates are substantially above the range normally considered cost effective,” as written in its draft guidance.
“Olaparib does not meet NICE’s end-of-life or Cancer Drugs Fund criteria. Therefore, it is not recommended,” the committee wrote.
Presented clinical trial data included two double-blind placebo-controlled trials — the Phase 2 Study 19 trial on Lynparza capsules (NCT00753545) and the SOLO-2 Phase 3 study on the tablet formulation (NCT01874353).
According to the experts, earlier treatment with Lynparza would be beneficial, as there is progressive loss of sensitivity to platinum-based chemotherapy with repeated courses.
Overall, the presented evidence led the committee to conclude that wider availability of Lynparza, “to extend periods of remission and improve quality of life, would be greatly valued by patients and their families.”
However, because of the tablets’ list price (as of October 2018) of £2,317.50 ($2,970.71) per 14-day pack and £4,635 ($5,941.42) per 28-day cycle, excluding value-added tax (VAT), NICE decided the therapy is not cost-effective enough to warrant including it on the NHS.
NICE is taking comments on its decision until Nov. 30. The appraisal committee will meet again on Jan. 8, 2019, to issue a final decision.
Lynparza capsules are approved in the U.K. for patients with BRCA1 or BRCA2 mutated ovarian cancer after response to second-line or subsequent platinum-based chemotherapy. However, this capsule formulation will be phased out when no longer needed by patients.
The U.K. setback for Lynparza, a PARP enzyme inhibitor, adds to difficulties that other PARP makers are having in broadening patient use for the therapies. “What we’re seeing is, 40%, 50% of women who are eligible for a PARP as maintenance treatment for ovarian cancer are still not receiving it,” Marty Huber, MD, Tesaro’s chief medical officer, said in a news story by Fierce Pharma.
Lynparza acts by preventing cells from repairing their DNA errors. The faster division of these cells leads to faster accumulation of errors than in healthy cells, causing their death. The medication is particularly effective in cancers with mutations in DNA-repairing genes, such as BRCA1 and BRCA2.
In May, the European Medicines Agency approved Lynparza tablets for the same indication that NICE is recommending against. Last week, the U.S. Food and Drug Administration granted priority review to this formulation as a maintenance treatment for women newly diagnosed with advanced ovarian cancer.