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    Has all of the relevant evidence been taken into account?

  • Question on Consultation

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

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    Are the recommendations sound and a suitable basis for guidance to the NHS?

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    Are there any aspects of the recommendations that need particular consideration to ensure we avoid unlawful discrimination against any group of people on the grounds of age, disability, gender reassignment, pregnancy and maternity, race, religion or belief, sex or sexual orientation?
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Draft guidance consultation

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1 Recommendations

1.1

Pembrolizumab is not recommended, within its marketing authorisation, for adjuvant treatment of non-small-cell lung cancer (NSCLC) that is at high risk of recurrence after complete resection and platinum-based chemotherapy in adults.

1.2

This recommendation is not intended to affect treatment with pembrolizumab 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.

Why the committee made these recommendations

The company positioned pembrolizumab for adjuvant treatment of NSCLC that is at high risk of recurrence after complete resection and platinum-based chemotherapy in adults whose tumours have the PD‑L1 biomarker expression on less than 50% of their tumour cells. This is narrower than the population it is licensed for. Usual treatment for people in this narrower population is active monitoring.

Clinical trial evidence shows that people with NSCLC who have pembrolizumab have longer before their cancer gets worse and live longer compared with people who have placebo. But how well pembrolizumab works in the narrower population, compared with the population it is licensed for, is uncertain.

Because of uncertainty in the clinical-effectiveness evidence for the narrower population, the assumptions used to estimate cost effectiveness are also uncertain. So it is not possible to reach a reliable cost-effectiveness estimate and pembrolizumab is not recommended.