UK's NICE gives early no to expanded use of AstraZeneca's Lynparza
- While AstraZeneca and Merck & Co. have fresh trial data to tout for their cancer drug Lynparza, a review committee for the U.K.'s cost-effectiveness agency has recommended against expanding coverage of the industry's leading PARP inhibitor as an ovarian cancer treatment in a draft decision released Friday.
- The National Institute for Health and Care Excellence, known as NICE, found the clinical profile and pricing of the drug to exceed its cost effectiveness range when considering the drug as a maintenance treatment in recurrent, platinum-sensitive ovarian, fallopian tube and peritoneal cancer regardless of BRCA mutations.
- With a list price of £4,635 (about $6,050) for a 28-day cycle, the tablet form was too expensive to warrant National Health Service coverage, the draft concluded, and also failed to meet criteria for the Cancer Drugs Fund. The committee will accept public comments until Nov. 30 and meet again on Jan. 8, 2019.
NICE described ovarian cancer treatment options as "pitifully few" in a presentation. Despite that, the committee has initially recommended against covering broader use of AstraZeneca and Merck's Lynparza (olaparib), once again clashing with the pharmaceutical industry over concerns on pricing.
"Clinical trials show that olaparib extends the time until cancer progresses compared with routine surveillance," the draft stated. "However, the cost-effectiveness estimates are substantially above the range normally considered cost effective. Olaparib does not meet NICE's end-of-life or Cancer Drugs Fund criteria. Therefore, it is not recommended."
In a written statement provided to BioPharma Dive, AstraZeneca called it a "disappointing decision" for U.K. patients.
"AstraZeneca will continue to engage with NICE, NHS England and the Cancer Drugs Fund with the aim of enabling access to this treatment for women with ovarian cancer," the company stated.
Specifically, the British pharma stated it believes Lynparza should be eligible for end-of-life consideration, which would raise the upper limit of cost effectiveness by about 66% to £50,000 pounds, or about $65,000, per quality adjusted life year.
The reviewers focused on data from Study 19 and SOLO-2, two placebo-controlled studies testing Lynparza.
While Study 19 enrolled patients regardless of BRCA mutation, both studies showed patients who were positive for the genetic defect saw a greater benefit. Roughly 15% of people with epithelial ovarian cancer have such mutations.
In Study 19, a Phase 2 trial, those without a BRCA mutation showed an average of two additional months in progression free survival compared to placebo, while patients with such a mutation showed an improvement of seven months against placebo.
But, the NICE committee still concluded that for the entire ovarian cancer population the PARP inhibitor was "substantially above" the cost-effectiveness range.
Lynparza was originally approved in 2014 in the EU for relapsed ovarian cancer patients who are BRCA-positive and whose disease has responded to platinum-based chemotherapy. NICE recommended coverage for that approval in December 2015.
NICE's more recent decision is a reality check for Lynparza, which was recently buoyed by Phase 3 data that showed Lynparza reduced the risk of disease progression or death by 70% in BRCA mutation-positive patients after first-line chemotherapy treatment.
While AstraZeneca found itself on the wrong side of a NICE draft decision Friday, Zejula (niraparib), a rival PARP inhibitor from Tesaro, was recommended by NICE in July for the Cancer Drugs Fund for maintenance treatment of ovarian fallopian tube or peritoneal cancer for patients that responded to platinum-based chemotherapy.
NICE noted in its report Zejula is the only other approved maintenance treatment for ovarian cancer approved in Europe, with chemotherapy the sole alternative.
In 2016, there were 6,430 ovarian cancer diagnoses in England, according to NHS. Considering about 90% of such cancer cases come from epithelial cells and roughly 15% of those have BRCA mutations, roughly 900 diagnoses that year would have been in BRCA mutation-positive patients.
As part of its third quarter readout, AstraZeneca shared an ambitious timeline for Lynparza, including filing as a first-line maintenance ovarian cancer treatment in the U.S. by the end of 2018 and receiving a regulatory decision as a first-line treatment in Japan, Europe and Canada by the second half of 2019.
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