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Tovecimig

Second-line advanced biliary tract cancer

Also known as CTX-009, ABL001
89 sources

Section 5 of 6

Economic information and modeling report

33 evidence topics · 20 sources

Modeling overview

Summary

No budget impact model, cost-effectiveness analysis, or health technology assessment of tovecimig was identified, and no price for tovecimig has been announced. Compass Therapeutics guides to a Biologics License Application submission in the fourth quarter of 2026 and to potential approval and launch in 2027, and states that launch preparation for a focused United States biliary tract cancer market is under way. The company puts the addressable United States market in second-line biliary tract cancer at more than $3 billion. It reported $180 million in cash, cash equivalents and marketable securities at June 30, 2026, expected to fund operations into 2028, and $209 million at December 31, 2025, and states that it would incur significant commercialization expenses if tovecimig were approved. Under the license agreement covering tovecimig, ABL Bio has received a $5 million upfront payment and a $6 million milestone payment and is eligible for up to $96 million in development and regulatory milestones, up to $303 million in commercial milestones, and tiered single-digit royalties on net sales in oncology, with a further $75 million in development and regulatory milestones and $110 million in commercial milestones in ophthalmology. South Korean rights are held by Handok and China rights were sublicensed to Elpiscience, with a 15% sublicense royalty due to ABL Bio.

The modeling context for the indication comes from published economic evaluations of other systemic therapies in advanced biliary tract cancer and from one health technology assessment of a second-line therapy. A systematic review of 20 economic studies published between January 2010 and March 2025 found that conventional chemotherapy regimens generally produced more favorable economic results than newer systemic therapies, that first-line immunotherapy combinations and biomarker-directed targeted therapies frequently produced incremental cost-effectiveness ratios above jurisdiction-specific willingness-to-pay thresholds, and that no dedicated peer-reviewed cost-effectiveness analysis of FOLFOX versus active symptom control in biliary tract cancer was identified. From a United States payer perspective, durvalumab added to gemcitabine and cisplatin produced an incremental cost-effectiveness ratio of $381,864.39 per quality-adjusted life-year for a gain of 0.42 quality-adjusted life-years, and pembrolizumab added to chemotherapy produced $976,925 per quality-adjusted life-year for a gain of 0.144 quality-adjusted life-years, both above the $150,000 per quality-adjusted life-year threshold applied. The National Institute for Health and Care Excellence recommended zanidatamab for HER2-positive advanced biliary tract cancer after at least one line of systemic treatment in May 2026, with FOLFOX plus active symptom control and active symptom control alone as the comparators and with an acceptable incremental cost-effectiveness ratio set towards the upper end of the £25,000 to £35,000 per quality-adjusted life-year range; the list price and the size of the commercial discount are confidential.

Economic model, cost-effectiveness analysis, or health technology assessment of tovecimig

No evidence found.

Company plans for commercialization and commercialization expenditure

Budget impact model

Approach and framework

Budget impact model of tovecimig: approach and framework

No evidence found.

Perspective and time frame

Budget impact model of tovecimig: perspective and time frame

No evidence found.

Epidemiology and eligible population inputs

Budget impact model of tovecimig: eligible population inputs

No evidence found.

Cost assumptions

Budget impact model of tovecimig: cost assumptions

No evidence found.

United States drug cost inputs per treatment cycle for regimens used in advanced biliary tract cancer
DrugBaseline cost in the United States, USD per cycle
Gemcitabine“15.06”
Cisplatin“8.72”
Durvalumab“11,730”
Oxaliplatin“26.76”
Calcium folinate“52.48”
Fluorouracil“18.57”
Irinotecan“35.88”
Capecitabine“180.6”
Regorafenib“21,546”
Companion diagnostic or biomarker testing cost for tovecimig

No evidence found.

United States cost of liposomal irinotecan with fluorouracil and leucovorin in second-line biliary tract cancer

No evidence found.

Model outcomes

Budget impact model of tovecimig: model outcomes

No evidence found.

Results

Base case
Budget impact model of tovecimig: base-case results

No evidence found.

Scenario analyses
Budget impact model of tovecimig: scenario analyses

No evidence found.

Budget impact model discussion

Summary

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.