Tovecimig (CTX-009)

No budget impact model of tovecimig has been published and no price has been announced, so the budgetary effect of adding tovecimig to paclitaxel in second-line advanced biliary tract cancer cannot be estimated from public evidence. Because the trial comparator is generic paclitaxel, given identically in both arms, the incremental cost of the regimen is essentially the price of tovecimig. Modelled United States average sales price for paclitaxel was $0.115 per milligram with an intravenous administration cost of $140.16 for the first hour, and the modelled per-cycle United States costs of the FOLFOX components were $26.76 for oxaliplatin, $52.48 for calcium folinate and $18.57 for fluorouracil, against $11,730 per cycle for durvalumab and a reported average monthly United States price of $44,000 for futibatinib. Any price for tovecimig would therefore be additive to a low-cost chemotherapy backbone.

The population inputs a payer would need are partly available. Compass Therapeutics states that more than 26,500 patients are diagnosed with biliary tract cancer in the United States each year, that more than 24,000 receive first-line treatment, that more than 17,000 receive second-line treatment, and that more than 15,000 are potentially eligible for tovecimig because approximately 85% have no actionable mutation; it puts the addressable United States market in second-line biliary tract cancer at more than $3 billion and expects a Biologics License Application submission in the fourth quarter of 2026 with potential approval and launch in 2027. Market research reported approximately 19,000 incident United States cases in 2024 out of approximately 65,000 across the seven major markets, and placed tovecimig third by expected revenue among biliary tract cancer therapies in the seven major markets by 2034. United States claims data give lower second-line rates than the company funnel: 46% of 413 patients with advanced biliary tract cancer initiated second-line therapy in one cohort, and in a second cohort 514 of 1,298 patients (39.6%) died without receiving second-line therapy.

Real-world all-cause costs in advanced biliary tract cancer were $22,617 per patient per month during second-line therapy, up from $19,589 during first-line therapy, of which more than 80% was disease-related, so the existing second-line cost base is substantial before any new agent is added. Published analyses in this indication consistently found that the price of the added biologic was the dominant driver of the incremental cost-effectiveness ratio, with durvalumab at $381,864.39 per quality-adjusted life-year and pembrolizumab at $976,925 per quality-adjusted life-year from a United States payer perspective, both above the $150,000 per quality-adjusted life-year threshold applied, and price reductions of roughly 50% or more were required for targeted agents to approach cost-effectiveness in the jurisdictions studied. Tovecimig requires no companion diagnostic, so a budget impact model would not need the biomarker testing costs that were included for zanidatamab, for which immunohistochemistry testing costs formed part of the submission to the National Institute for Health and Care Excellence.