1 Recommendations

1.1 Dabrafenib plus trametinib is recommended as an option for treating BRAF V600 mutation-positive advanced non-small-cell lung cancer (NSCLC) in adults, only if:

  • it is used as first-line treatment of advanced stage cancer, and

  • the company provides it according to the commercial arrangement.

1.2 This recommendation is not intended to affect treatment with dabrafenib plus trametinib 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.

Why the committee made these recommendations

Standard treatment options for BRAF V600 mutation-positive advanced NSCLC include pembrolizumab plus platinum chemotherapy. During the COVID‑19 pandemic, dabrafenib plus trametinib has also been available in the NHS as an interim treatment.

The results of a clinical trial of dabrafenib plus trametinib suggest that it shrinks tumours and increases how long people live and how long they live before their condition gets worse. But the results are uncertain because the number of people in the trial was small. Because dabrafenib plus trametinib was not directly compared with any other treatment, several potential sources of evidence for the comparator, pembrolizumab plus chemotherapy, were assessed. But the clinical-effectiveness results from all these sources are uncertain.

Because the clinical-effectiveness results are uncertain, the cost-effectiveness estimates are also uncertain. Also, there was no cost-effectiveness evidence provided for dabrafenib plus trametinib used after other treatments have not worked in people with advanced NSCLC.

After taking into account the available evidence and impact of the uncertainty, the cost-effectiveness estimates are likely to be within the range that NICE considers an acceptable use of NHS resources in people with untreated advanced NSCLC. So, dabrafenib plus trametinib is recommended for this group.

  • National Institute for Health and Care Excellence (NICE)