OBJECTIVES

This study aims to assess the costs of all-cause grade 3/4 AEs for nivolumab (Nivo) and dabrafenib + trametinib (Dab + Tram) as adjuvant therapies in stage III B/C BRAF- mutated (MT) cutaneous melanoma in Portugal.

METHODS

All-cause grade 3/4 AE rates of Nivo and Dab + Tram were obtained from the Checkmate 238 trial patient-level data (Weber et al., 2017) and the published COMBI-AD trial results (Long et al., 2017). AE unit costs (expressed in €, 2019 values) were obtained from Portaria n.º 254/2018. This analysis assumed that each grade 3/4 AE resulted in hospitalization and occurred only once per patient during the trial period. AE rates for stage IIIB/C patients in COMBI-AD were assumed to be equivalent to the rates for stage IIIA/B/C patients. In the main analysis, costs of grade 3/4 AEs with corresponding any-grade AEs reported in >10% patients receiving Nivo or Dab+Tram were assessed. A sensitivity analysis assessed the costs for other grade 3/4 AEs.

RESULTS

The all-cause grade 3/4 AE costs per patient were 314 € for Nivo and 1,291 € for Dab + Tram. The three most costly AEs were diarrhea (108 €), hypertension (106 €) and fatigue (69 €) for Nivo, and hypertension (257 €), fatigue (191 €) and pyrexia (149 €) for Dab+Tram. After adding other grade 3/4 AEs costs in sensitivity analysis, Nivo still had lower per-patient AE costs compared with Dab+Tram (1,347 € vs. 1,853 €).

CONCLUSIONS

Nivo, as an adjuvant therapy, is associated with lower average grade 3/4 AE costs vs Dab + Tram for resected stage III B/C BRAF-MT cutaneous melanoma. Future real-world studies are warranted to assess a broader range of AEs and associated costs beyond the trial period.