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Sotorasib for previously treated KRAS G12C mutation-positive advanced non-small-cell lung cancer

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1 Recommendations

1.1

Sotorasib should not be used for treating KRAS G12C mutation-positive locally advanced or metastatic non-small-cell lung cancer (NSCLC) in adults:

  • when the cancer has progressed on platinum-based chemotherapy or anti-PD-1/PD-L1 immunotherapy, or

  • when these treatments are not tolerated.

1.2

This recommendation is not intended to affect treatment with sotorasib that was funded with managed access before final guidance was published. If this applies, NHS England and the company have an arrangement to make sure people who started treatment during the managed access period will continue to have sotorasib until they and their NHS healthcare professional consider it appropriate to stop.

What this means in practice

Sotorasib is not required to be funded and should not be used routinely in the NHS in England for the condition and population in the recommendations.

This is because there is not enough evidence to determine whether sotorasib is value for money in this population.

Why the committee made these recommendations

This evaluation reviews the evidence for sotorasib for previously treated KRAS G12C mutation-positive advanced NSCLC (NICE technology appraisal guidance 781). It also reviews new evidence collected during the managed access period, which includes evidence from clinical trials and from people having treatment in the NHS in England.

Usual treatment for KRAS G12C mutation-positive locally advanced or metastatic NSCLC in adults when the cancer has progressed on platinum-based chemotherapy or anti-PD-1/PD-L1 immunotherapy, or these treatments are not tolerated, is docetaxel.

Clinical trial evidence shows that sotorasib increases how long people have before their condition gets worse compared with docetaxel. Clinical trial and real-world evidence suggests that sotorasib may increase how long people live compared with docetaxel. But this is uncertain because of the limitations in the evidence and how the data was analysed.

There are uncertainties with the economic model, including:

  • which clinical evidence should be used in the model

  • how the long-term benefits of sotorasib are modelled

  • sotorasib's quality-of-life benefits.

Because of the uncertainties in the clinical evidence and economic model, it is not possible to determine the most likely cost-effectiveness estimates for sotorasib. Further analyses are needed. So, sotorasib should not be used.