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    Has all of the relevant evidence been taken into account?

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    Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?

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ID3863 lifileucel - To PM for consultation (online commenting) [noCON].docx

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1 Recommendations

1.1

Lifileucel should not be used for previously treated unresectable or metastatic melanoma (Stage IIIc to Stage IV) in adults who have had:

  • a PD‑1 blocking antibody, and

  • a BRAF inhibitor with or without a MEK inhibitor, if the cancer is BRAF V600 mutation positive.

1.2

This recommendation is not intended to affect treatment with lifileucel 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 healthcare professional consider it appropriate to stop.

What this means in practice

Lifileucel 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 lifileucel is value for money in this population.

Why the committee made these recommendations

Usual treatment for previously treated unresectable or metastatic melanoma is ipilimumab, chemotherapy or best supportive care.

Lifileucel has not been directly compared in a clinical trial with usual treatment. The results of indirect comparisons with these treatments suggest that lifileucel increases how long people have before their condition gets worse and how long they live. But the results are very uncertain because of the methods used. There are also questions about how generalisable they are to NHS clinical practice.

There are also uncertainties in the economic model, including:

  • the methods used for estimating long-term outcomes

  • the costs used for setting up the service to provide lifileucel treatment, staff training and administration.

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