1 Recommendations

1.1 Pralsetinib is not recommended, within its marketing authorisation, for treating RET fusion-positive advanced non-small-cell lung cancer (NSCLC) in adults who have not had a RET inhibitor before.

1.2 This recommendation is not intended to affect treatment with pralsetinib that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

Usual treatment for untreated RET fusion-positive advanced NSCLC is pembrolizumab with pemetrexed and chemotherapy, or platinum-based chemotherapy with or without pemetrexed. Usual treatment for previously treated RET fusion-positive advanced NSCLC is docetaxel chemotherapy or docetaxel with nintedanib.

The clinical evidence for pralsetinib suggests it could be clinically effective, but its benefit is uncertain because it was not compared directly with any usual NHS treatments. The results from indirectly comparing pralsetinib with some usual treatments suggest that pralsetinib could increase the time before the NSCLC gets worse and how long people live.

Pralsetinib meets NICE's criteria to be a life-extending treatment at the end of life for people with previously treated NSCLC, but not for untreated NSCLC. Because of the uncertainty in the clinical evidence, the estimates of cost effectiveness are uncertain and too high to be considered a cost-effective use of NHS resources. So pralsetinib cannot be recommended for routine use.

Pralsetinib is a new treatment and more data on its clinical effectiveness is being collected from 1 ongoing trial and 1 new trial. Collecting more data from these trials through a managed access agreement in the Cancer Drugs Fund may resolve some uncertainty in the clinical evidence. But NICE was advised that it was not possible to put a managed access agreement in place, meaning pralsetinib cannot be recommended for use in the Cancer Drugs Fund.