OBJECTIVES: In this study, we present cost-effectiveness (CE) outcomes of pembrolizumab + chemotherapy (P+CT) for patients with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) and a combined positive score (CPS) of 1-19, compared with cetuximab-containing regimens (CCRs: ‘EXTREME’, cetuximab/5-FU/cis-, or carboplatin and ‘TPEx’, cetuximab/docetaxel/cis-, or carboplatin). The CE analysis was developed from an Italian National Health Service perspective.

METHODS: A three-state partitioned-survival model was developed to estimate the CE of P+CT versus EXTREME and TPEx. We incorporated previously published comparative efficacy results for the CPS 1-19 subgroup for the CCRs from four trials (EXTREME [NCT00122460], TPEXTREME [NCT02268695], GORTEC [NCT01289522], and CheckMate-651 [NCT02741570]), while the CPS 1-19 subgroup data of KEYNOTE-048 (NCT02358031) were used for P+CT. Survival models were applied according to their statistical goodness-of-fit. Costs were identified from Italian reference sources. Outcomes were expressed as costs, quality-adjusted life years (QALYs), and the incremental cost-effectiveness ratio (ICER).

RESULTS: The CE analysis based on within-KEYNOTE-048 data, thus a direct treatment comparison, generated an ICER of €163,134/QALY for P+CT versus EXTREME (above the standard willingness-to-pay threshold of €60,000/QALY for Italy). Across the four alternative data sources for CCR, i.e. indirect treatment comparisons, results ranged from an ICER of €66,113/QALY, to P+CT being dominated by EXTREME and TPEx: both CCRs provided more QALYs at lower costs.

CONCLUSIONS: For R/M SCCHN patients with CPS 1-19, our analyses demonstrate that CCRs can represent more effective treatment options, which are likely cost-effective in Italy as opposed to P+CT. Across all scenarios, CCRs were cost saving, and in some scenarios CCRs yielded more QALYs. Further research could establish a more accurate estimate of the relative effectiveness of the aforementioned treatment regimens for R/M SCCHN CPS 1-19, while the robustness of the current analyses does not indicate that the overall CE results would change.