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Draft guidance consultation

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1 Recommendations

1.1

Durvalumab is not recommended, within its marketing authorisation, as neoadjuvant treatment with platinum-based chemotherapy, then alone as adjuvant treatment, for treating non-small-cell lung cancer (NSCLC) in adults whose cancer:

  • is resectable (tumours 4 cm or over, or node positive) and

  • has no epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.

1.2

This recommendation is not intended to affect treatment with durvalumab 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

Usual treatment for resectable NSCLC in adults is nivolumab with chemotherapy then surgery. A resectable tumour is one that can be removed surgically.

Clinical trial evidence shows that, compared with placebo, durvalumab decreases the likelihood of:

  • an event that would stop people having surgery (for example, the cancer getting worse), and

  • their cancer coming back after surgery.

Durvalumab has not been directly compared in a clinical trial with usual treatment. The method used to compare durvalumab indirectly may not give a reliable estimate of how well it works compared with usual care.

The uncertainty in the clinical evidence means that the economic model is too uncertain to give reliable cost-effectiveness estimates. So durvalumab is not recommended.