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    Has all of the relevant evidence been taken into account?
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The content on this page is not current guidance and is only for the purposes of the consultation process.

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 advanced NSCLC when RET fusion status is unknown is pembrolizumab plus pemetrexed and chemotherapy. Untreated advanced NSCLC when RET fusion status is known is usually treated with chemotherapy alone. Usual treatment for those who have already had treatment is docetaxel with or without nintedanib (whether RET fusion status is known or not).

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 indirect comparisons of pralsetinib compared with some usual treatments are highly uncertain, while comparisons with other usual treatments were not provided.

The above limitations in the clinical evidence mean the results from the economic model are very uncertain. Because of this it is not possible to determine a cost-effectiveness estimate for pralsetinib. So, it cannot be recommended for routine use.

Because of the issues with the economic model, pralsetinib's potential for use in the Cancer Drugs Fund could not be assessed. So pralsetinib cannot be recommended for use in the Cancer Drugs Fund.