1.1 Pembrolizumab is recommended for use within the Cancer Drugs Fund as an option for the adjuvant treatment of stage III melanoma with lymph node involvement in adults who have had complete resection. It is recommended only if the conditions in the managed access agreement for pembrolizumab are followed.
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 clinician consider it appropriate to stop.
Why the committee made these recommendations
There are currently no adjuvant immunotherapies recommended by NICE for people who have stage III melanoma with lymph node involvement who have had complete resection.
Clinical evidence comes from KEYNOTE‑054, an ongoing randomised trial. It is likely to improve recurrence-free survival but the size of the benefit is unclear in the long term, because the trial is ongoing. Also, data about overall survival and how long people might live without developing distant metastases are limited. This means that the estimates of cost effectiveness are also very uncertain.
Pembrolizumab has the potential to be cost effective, but more evidence is needed to address the clinical uncertainties. Longer follow‑up data from KEYNOTE‑054 on how many people develop distant metastases and overall survival would help to address some of the uncertainties. Therefore, pembrolizumab is recommended for use in the Cancer Drugs Fund for people who have stage III melanoma with lymph node involvement who have had complete resection.