NICE rejects AZ’s Lynparza for metastatic prostate cancer

by | 9th Mar 2021 | News

Appraisal committee highlighted uncertainties in the clinical evidence for PARP inhibitor

The UK’s National Institute for Health and Care Excellence’s (NICE) appraisal committee has chosen not to recommend AstraZeneca’s (AZ) PARP inhibitor Lynparza for BRCA-positive metastatic prostate cancer.

Lynparza (olaparib) is intended for the treatment of hormone-relapsed metastatic prostate cancer with BRCA1/2 mutations that has progressed after abiraterone or enzalutamide treatment in adults.

The current treatment for these patients includes docetaxel, cabazitaxel, or radium-223. In its draft guidance, NICE said that there is no direct cimparision of Lynparza to this current standard of care.

It added that although clinical trial evidence shows people receiving Lynparza treatment experienced improved progression-free survival and overall survival compared to people having re-treatment with abiraterone or enzalutamide, the evidence is uncertain.

This is because re-treatment with abiraterone or enzalutamide is not considered effective and is not the standard of care in the NHS.

NICE also said that it is uncertain how effective Lynparza is compared to docetaxel, cabazitaxel, or radium-223 as there is no direct comparison.

An indirect comparison suggests that Lynparza increases overall survival compared to cabazitaxel, but NICE reiterated that this is uncertain.

In addition, the cost-effectiveness estimates for Lynparza are uncertain because of the above ‘limitations’ in the clinical evidence and economic model.

This means that the estimates are higher than what NICE would usually consider an acceptable use of NHS resources.

The draft guidance is open to consultation until 26 March 2021, after which NICE will make its final recommendations for Lynparza in this indication.

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