1 Recommendations

1.1 Selpercatinib is recommended with managed access as an option for treating RET fusion-positive advanced non-small-cell lung cancer (NSCLC) in adults, only if:

1.2 This recommendation is not intended to affect treatment with selpercatinib 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

The scope for this appraisal was selpercatinib for untreated RET fusion-positive advanced NSCLC, which is narrower than its marketing authorisation. Selpercatinib is already recommended with managed access for previously treated RET fusion-positive advanced NSCLC (see NICE's technology appraisal guidance 760).

Standard treatment for untreated RET fusion-positive advanced NSCLC is pemetrexed plus platinum-based chemotherapy and pembrolizumab plus pemetrexed and platinum-based chemotherapy. Selpercatinib is another option.

Clinical trial evidence suggests that selpercatinib could be effective for untreated RET fusion-positive advanced NSCLC. But the results are uncertain because it was not compared directly with anything and the trial is continuing to collect results. Indirect comparisons with standard treatments suggest selpercatinib could increase how long people live and how long they have before their cancer gets worse. But the results from these are uncertain too.

Because the clinical-effectiveness evidence is uncertain, the cost-effectiveness estimates are also uncertain. The most likely estimates are higher than what NICE considers to be a cost-effective use of NHS resources, even when considering the condition's severity and its effect on quality and length of life. So, selpercatinib cannot be recommended for routine use.

Selpercatinib could be cost effective if more evidence confirms that people live longer with treatment. Direct comparisons from the ongoing trial could help address the uncertainty about how long people live. So, selpercatinib is recommended for use with managed access.