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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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Draft guidance consultation

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1 Recommendations

1.1

Encorafenib plus binimetinib should not be used to treat BRAF V600E mutation-positive advanced non-small-cell lung cancer (NSCLC) in adults.

1.2

This recommendation is not intended to affect treatment with encorafenib plus binimetinib 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 clinician consider it appropriate to stop.

What this means in practice

Encorafenib plus binimetinib is not required to be funded in the NHS in England to treat BRAF V600E mutation-positive advanced NSCLC in adults. It should not be used routinely in the NHS in England.

This is because the available evidence does not suggest that encorafenib plus binimetinib is value for money in this population.

Why the committee made these recommendations

For this evaluation, the company asked for encorafenib plus binimetinib to be considered only for untreated BRAF V600E mutation-positive advanced NSCLC. This does not include everyone who it is licensed for because the license covers all lines of treatment.

The standard treatment option for BRAF V600E mutation-positive NSCLC is dabrafenib plus trametinib. Dabrafenib plus trametinib is not well tolerated because of side effects such as fever. So, there is an unmet need for treatments for this condition.

Encorafenib plus binimetinib has not been directly compared in a clinical trial with dabrafenib plus trametinib. The results of an indirect comparison suggest encorafenib plus binimetinib may be more effective than dabrafenib plus trametinib. But this is uncertain because of limitations in how the indirect comparison was done.

Because of uncertainties in the economic model, it is not possible to determine the most likely cost-effectiveness estimate for encorafenib plus binimetinib. But it is likely to be above the range that NICE considers an acceptable use of NHS resources. So, encorafenib plus binimetinib should not be used.