NICE Refuses AZ’s Lynparza

The high cost of AstraZeneca’s ovarian cancer treatment Lynparza doesn’t match the uncertainty of its survival benefits, the UK’s healthcare cost agency says.

In preliminary draft guidance released last week, the National Institute for Health and Care Excellence declined to recommend the drug for patients with relapsed, platinum-sensitive ovarian, fallopian tube or peritoneal cancer caused by BRCA1 or BRCA2 mutations.

NICE based its opinion on an appraisal committee’s estimate that  the drug would cost the National Health Service $74,732 per patient per year — a figure far higher than the institute’s $30,412 to $45,618 threshold for determining cost-effectiveness.

That low-ball estimate doesn’t take into account the cost of testing for BRCA mutations, especially noninherited ones, NICE says. Many families have known histories of BRCA-caused breast and ovarian cancers, but others don’t.

Committee members also were concerned that too many predictors from AZ’s primary Phase II trial comparing Lynparza with placebo were identified after the trial was completed. While AZ stated that progression-free survival was the trial’s primary objective, time to giving up on the drug and time to starting first and second subsequent therapies were figured out only after the study was completed, the draft guidance says.

Small subgroups of only 136 patients with BRCA mutations were identified and their data analyzed afterward, as well, NICE says.

Comments on the preliminary draft are due June 22, after which the committee will issue final draft guidance for another round of comments before releasing final, binding guidance.

AstraZeneca did not respond to a request for comment by press time.

Read the draft guidance at www.fdanews.com/06-01-15-NICEolaparib.pdf. — Lena Freund