NICE has announced that pembrolizumab (Keytruda) will be available on the Cancer Drugs Fund as an option for the adjuvant treatment of melanoma with lymph node involvement in adults who have undergone complete resection.
In making the decision, a NICE appraisal committee considered evidence from the ongoing randomised KEYNOTE-054 trial, which demonstrated improved recurrence-free survival (RFS) with pembrolizumab versus standard care. At the most recent data cut (October 2017), median RFS in the pembrolizumab arm had not been reached. Pembrolizumab showed a statistically significant improvement in RFS compared with placebo (HR 0.57; 95% CI 0.43-0.74; P<0.0001).
With a median follow-up of just 16 months (range: 2.5 months to 25.3 months), data on distant metastases-free survival and overall survival are immature, which created uncertainty around the cost-effectiveness of pembrolizumab in this setting.
Considering the uncertainty of the data and the fact that the treatment would represent a significant change to existing treatment pathways for melanoma, NICE concluded it could not recommend pembrolizumab for routine use.
However, given the clinical and cost-effectiveness evidence, the committee agreed that pembrolizumab has the potential to be cost-effective when compared with routine surveillance and meets criteria for inclusion in the Cancer Drugs Fund.
Pembrolizumab will be available once marketing authorisation has been received, which is expected early next month.
