NICE rejects AstraZeneca and MSD’s Lynparza as NHS prostate cancer treatment

The National Institute for Health and Care Excellence (NICE) has rejected AstraZeneca (AZ) and MSD’s – known as Merck & Co in the US and Canada – Lynparza (olaparib), following an unsuccessful discussion on a price agreement with AZ.

NICE has said it is unable to recommend NHS use of AstraZeneca’s Lynparza for some patients with prostate cancer, after failing to reach an agreement on price.

Lynparza – a poly ADP ribose polymerase (PARP) inhibitor – has been deemed by NICE as “not cost-effective at its current price” as a treatment option for BRCA-positive prostate cancer that has spread to other parts of the body and relapsed following prior hormonal therapy.

In 2021, NICE rejected Lynparza for this indication and then again earlier this year, in a decision that was underpinned by issues around cost, since the regulator had stated the clinical evidence supported the overall efficacy of the drug in relapsed, BRCA-positive prostate cancer.

Its latest decision has been criticised by the Institute of Cancer Research (ICR), London, which aired concerns about criteria employed by NICE for the approval of Lynparza, stating that ‘tests for BRCA1 and BRCA2 are already included on the NHS testing directory – and the ICR believes that ‘double counting’ the costs is acting as a penalty for innovation’.

While the drug will not be available as a treatment option for men with prostate cancer in England and Wales, it was approved last year for use in Scotland by the Scottish Medical Consortium.

Speaking on behalf of the ICR, its chief executive Professor Kristian Helin, said: “I would urge NICE and the drug’s manufacturer to immediately return to the negotiating table and work towards an agreement that can make olaparib available on the NHS at an acceptable price.”

NICE did say that there is an opportunity to “look again at the drug through its rapid review process, whereby olaparib could be reviewed again under a revised price”.

In 2020, Lynparza was approved for relapsed BRCA-positive prostate cancer following the phase 3 PROfound trial, which demonstrated a reduction in the risk of disease progression or death by 78%, while it also improved overall survival compared to a new round of hormonal therapy.