Encorafenib plus binimetinib can be used as an option to treat BRAF V600E mutation-positive advanced non-small-cell lung cancer (NSCLC) in adults, only if:
it is used at first line, and
the company provides them according to the commercial arrangements.
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 healthcare professional consider it appropriate to stop.
What this means in practice
Encorafenib plus binimetinib must be funded in the NHS in England for the condition and population in the recommendations, if it is considered the most suitable treatment option. It should be funded in England within 90 days of final publication of this guidance.
There is enough evidence to show that encorafenib plus binimetinib provides benefits and value for money, so it can be used routinely across the NHS in this population.
NICE has produced tools and resources to support the implementation of this guidance.
For this evaluation, the company asked for encorafenib plus binimetinib to be considered only for untreated (that is, at first line) BRAF V600E mutation-positive advanced NSCLC. This does not include everyone who it is licensed for because the licence 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 that encorafenib plus binimetinib may be more effective than dabrafenib plus trametinib.
After taking into account the clinical evidence and impact of its uncertainty, the cost-effectiveness estimates are within the range that NICE considers an acceptable use of NHS resources. So, encorafenib plus binimetinib can be used.