AstraZeneca, Merck face NICE setback in bid for broader Lynparza use

Lynparza bottle
AstraZeneca and Merck recently rolled out data in first-line maintenance patients that set European Society for Medical Oncology meeting attendees abuzz. (AstraZeneca)

AstraZeneca and Merck & Co.’s Lynparza recently put up ovarian cancer data that blew away pharma watchers at a European Society for Medical Oncology meeting, and it’s been broadening its reach with new FDA approvals. But England’s drug gatekeepers aren’t convinced it’s worth the price in one of those new indications.

The National Institute of Health and Care Excellence turned back (PDF) Lynparza tablets as a recurrence-prevention agent for patients—regardless of whether they’ve tested positive for a BRCA mutation—after two rounds of platinum chemotherapy, the so-called second-line maintenance setting. The reason? It’s too costly for that patient group, a NICE appraisal committee said in draft guidance.

The drug in its capsule form is already approved in BRCA-positive patients who’ve had three or more rounds of platinum chemo, but as the agency noted, the number of patients without a mutation is much larger.

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The agency will take comments on the decision, and oftentimes an initial rejection later turns into an approval after negotiations with drugmakers. Still, it’s a delay in a key market that not only could boost sales directly but could influence coverage decisions in other countries.

RELATED: Mammoth Lynparza survival win puts AstraZeneca, Merck in line for $1B launch

NICE’s appraisers acknowledged that wider availability of Lynparza “to extend periods of remission and improve quality of life, would be greatly valued by patients and their families,” according to guidance documents posted on the agency’s website.

But the committee decided that, when compared with routine surveillance for a recurrence, Lynparza wasn’t cost effective. Its list price is £4,635 per 28-day pack, NICE said.

The setback at NICE comes at a time when PARP drugmakers are having some trouble persuading doctors, despite some stellar data showing they beat back cancer by large margins compared with the current standard-of-care approach.

RELATED: PARPs may be crushing it in the clinic, but half of doctors are still wary: executive

“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, said Marty Huber, M.D., chief medical officer at AstraZeneca rival PARP maker Tesaro.

Huber put that lag down to old habits dying hard. “You’re basically saying, ‘Okay you’ve finished your chemotherapy, now I want you to start on maintenance treatment.’ If you haven’t been doing that before, to change your practice to say, ‘Oh, I need to think to offer this patient maintenance’”—is a challenge, he said in an interview at ESMO.

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