Cost-Utility Analysis Alongside the GORTEC 2014-01 TPExtreme trial: TPEx versus EXTREME as first-line treatment in patients with recurrent or metastatic head and neck squamous cell carcinoma.

Objectives: The randomized GORTEC 2014-01 TPExtreme trial showed no significant improvement in overall survival with TPEx chemotherapy regimen (docetaxel-platinum-cetuximab) versus EXTREME regimen (platinum-fluorouracil-cetuximab) in first line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). However, the TPEx regimen had a favorable safety profile, and could provide an alternative to standard of care with the EXTREME regimen in this setting. Our aim was to assess the cost-utility of the TPEx strategy versus EXTREME strategy in the French setting.

Methods: We used a decision-analytic semi-Markov model with four health states and one-month cycles. Resource use was prospectively collected in the GORTEC 2014-01 TPExtreme trial (NCT02268695). Transition probabilities were assessed from patient-level data from the trial (n=539). In the base-case analysis, direct medical costs from the French National Insurance Scheme and quality-adjusted life years (QALYs) were computed in both arms over an 18-month time horizon to estimate the incremental net monetary benefit (INMB). Deterministic sensitivity analysis and probabilistic sensitivity analysis were conducted.

Results: The TPEx regimen was associated with a gain in QALYs (+0.057) and a decrease in cost (-€4 485). In the base-case scenario, the TPEx strategy was dominant over the EXTREME strategy with a positive INMB amounting to €7 349. For a willingness-to-pay of €50 000 per QALY, the probability of TPEx regimen being cost-effective was 64% and varied between 58% and 67% in the scenario analyses.

Conclusion: The TPEx regimen is likely to be cost-effective compared to EXTREME in the French setting.