AstraZeneca, Merck's Lynparza rejected by NICE in prostate cancer over pricing—again

For AstraZeneca and Merck's Lynparza in prostate cancer, a first-in-class approval isn't a guarantee for reimbursement in England.

Following a negative draft guidance, the National Institute for Heath and Care Excellence (NICE) has decided not to recommend Lynparza for NHS coverage in BRCA-positive prostate cancer. The England and Wales drug cost watchdog deemed the PARP inhibitor “not cost-effective at its current price.”  

The indication, in metastatic BRCA-positive prostate cancer following prior hormonal therapy, has already been rejected twice by NICE, both because of cost issues.

The decision was met with disappointment, with the Institute of Cancer Research saying that ‘double counting’ the costs acts “as a penalty for innovation.” NICE said that the drug could be reviewed again under a revised price.

NICE's verdict has also created a rift within the U.K. A year ago, the Scottish Medicines Consortium has recommended the use of Lynparza for Scottish men.

In 2019, the drug scored NICE recommendation with use via the Cancer Drugs Fund, with a discount for maintenance treatment of advanced BRCA mutation-positive ovarian cancer after chemotherapy, allowing patients to apply for CDF approval for the drug at its discounted price.

More recently, the companies’ efforts to prove the drug across tumor types haven’t all panned out. In July, AstraZeneca and Merck stopped a phase 3 trial testing the drug in colorectal cancer after it was found unlikely to succeed. An independent data monitoring panel found that Lynparza by itself and alongside Avastin as a first-line maintenance treatment for colorectal cancer that has not progressed following first-line induction could not improve upon Avastin combined with chemotherapy in terms of stalling death or tumor progression. That marked a second trial flop for the drug in just a few months, after a trial testing it paired with Keytruda failed it stall tumor progression or extend lives.

Earlier this year in March, the drug scored an approval in patients with high-risk early breast cancer with HER2-negative germline BRCA mutations who have received chemotherapy treatment before surgery. The green light made the drug the first PARP inhibitor, and the first targeted therapy, for the post-surgery breast cancer setting.