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

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1 Recommendations

1.1

Cemiplimab with platinum-based chemotherapy should not be used for untreated non-small-cell lung cancer (NSCLC) in adults when the cancer:

  • is locally advanced and not suitable for definitive chemoradiation, or metastatic

  • has PD-L1 in 1% or more of the tumour cells and

  • has no EGFR, ALK or ROS-1 aberrations.

1.2

This recommendation is not intended to affect treatment with cemiplimab with platinum-based chemotherapy 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

Cemiplimab with platinum-based chemotherapy is not required to be funded in the NHS in England for untreated NSCLC in adults when the cancer:

  • is locally advanced (and definitive chemoradiation is unsuitable) or metastatic

  • has PD-L1 in 1% or more of the tumour cells and

  • has no EGFR, ALK or ROS-1 aberrations.

It should not be used routinely in the NHS in England.

This is because there is not enough evidence to determine whether cemiplimab with platinum-based chemotherapy is value for money.

Why the committee made these recommendations

Usual treatment for advanced NSCLC includes chemotherapy alone, immunotherapy alone, or immunotherapy plus chemotherapy. Cemiplimab is a type of immunotherapy.

For this evaluation, the company asked for cemiplimab plus chemotherapy to be considered only for people who would otherwise be offered pembrolizumab plus chemotherapy. This does not include everyone who it is licensed for.

Clinical trial evidence shows that cemiplimab plus chemotherapy increases how long people have before their cancer gets worse and how long they live compared with placebo plus chemotherapy. Cemiplimab plus chemotherapy has not been directly compared in a clinical trial with pembrolizumab plus chemotherapy. The results of an indirect comparison are uncertain.

There are concerns with the economic model. This is because of:

  • the way the company structured its model

  • uncertainty about how long people stay on treatment

  • uncertainty about how long any benefits of cemiplimab last after treatment is stopped.

Because of the uncertainties in the economic model, it is not possible to determine the most likely cost-effectiveness estimates for cemiplimab plus chemotherapy. And the cost-effectiveness estimates preferred by the company and the external assessment group are above the range normally considered an acceptable use of NHS resources. So it should not be used.

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