The committee had uncertainty regarding the clinical effectiveness for overall survival and cost-effectiveness estimates.
The key trial submitted by the company was the ongoing CheckMate 238 randomised, double-blind study comparing adjuvant nivolumab with adjuvant ipilimumab in 906 adults who have had complete resection of stage IIIB, IIIC, or IV melanoma.
After patients had been followed for a minimum of 24 months, a statistically significant improvement in recurrence-free survival (RFS) was seen with nivolumab compared with ipilimumab (hazard ratio [HR] 0.66, 95% CI 0.54-0.81; P
The committee acknowledged that although median RFS had been reached (at 30.8 months in the nivolumab arm compared with 24.1 months in the ipilimumab arm), the data are still immature, with heavy censoring in the Kaplan-Meier curve. It also accepted that there are early indications of distant metastasis-free survival benefit with nivolumab compared to ipilimumab. The committee concluded that nivolumab is a more effective treatment than ipilimumab in terms of RFS.
However, it emphasised that CheckMate 238 had not provided any evidence on the relative efficacy of adjuvant nivolumab compared with routine surveillance. Uncertainty about clinical effectiveness created uncertainty around cost effectiveness.
“Therefore, nivolumab cannot be recommended for routine use in the NHS for the adjuvant treatment of completely resected melanoma with involvement of lymph nodes or metastatic disease,” the guidance states.
The draft guidance is now open for public consultation until 28 September 2018.