Budget impact of Emiltatug ledadotin
1 evidence topic · 19 sources
Summary
No price, budget impact model, cost-effectiveness analysis, or health technology assessment of emiltatug ledadotin was identified. Because no systemic therapy is approved for recurrent or metastatic ACC, there is no approved comparator whose price could anchor a budget impact estimate, a point also noted by a market research publisher. The displaced therapies would be off-label oral VEGFR tyrosine kinase inhibitors, whose reported treatment durations were a median of 5.9 months in a real-world lenvatinib cohort of 51 participants, 9.1 months in a 28-participant lenvatinib phase II trial, and 11.8 months with sorafenib, and whose administered dose is frequently below the labeled dose: dose reductions were required in 32 of 51 participants (63.6%) in the real-world lenvatinib cohort, in 24 of the 28 participants in that lenvatinib trial, and in 74% of participants receiving sorafenib, and only 16 of 51 participants (31.37%) in the real-world cohort started lenvatinib at the full 24 mg dose. No cost of these regimens in ACC was identified.
Population size is described only at the level of ACC overall. Company documents state an annual United States incidence of approximately 1,300 patients, including both frontline and relapsed ACC, and state that up to 40% of patients have the aggressive form; a genomic study describes approximately 1,200 cases per year. Servier states that more than 200,000 people have ACC worldwide. No source reports the number of people in the United States with locally advanced, recurrent, or metastatic ACC with solid histology or high-grade transformation who would be eligible for treatment.
The only product-level revenue projections are company forecasts. Mersana management forecasts prepared for the tender offer, risk-adjusted and limited to ACC-1 with direct United States sales and licensing outside the United States, projected no revenue through 2027, revenue of $145 million in 2028 rising to $230 million in 2042, and $115 million in 2043 and $57 million in 2044. A discounted cash flow analysis of these forecasts implied an equity value of $8 to $11 per share, compared with the upfront consideration of $25 per share. Contingent value right payments are tied to annual net sales of Emi-Le of at least $100 million by 2032, $200 million by 2035, and $300 million by 2037. Day One described a combined revenue opportunity of more than $1 billion across 3 indications without a separate figure for Emi-Le. Market research publishers estimated the ACC market at USD 178.2 million in the seven major markets in 2025, USD 164.0 million in the seven major markets in 2023, and USD 182.30 million globally in 2025.
Pricing analogues are indirect. In a study of injectable cancer drug prices, the median monthly price was US$14,950 in 2023, and launch prices were 120% higher for orphan than for non-orphan drugs (p = 0.051), with no consistent association between price and clinical benefit. Of 11 ADCs approved by the FDA since 2011, most had incremental cost-effectiveness ratios above a willingness-to-pay threshold of $150,000 per QALY. Disease-level cost evidence is limited to combined oral cavity, oropharyngeal, and salivary gland cancers ($79,151 in total healthcare spending in the year after diagnosis in the commercially insured population) and to a German radiotherapy evaluation in ACC (26,863 euros per life-year gained). For diagnostic testing, a reference Medicare payment for comprehensive genomic profiling (FoundationOne CDx) was $3,500.00 during its initial advanced diagnostic laboratory test period. Budget impact cannot be estimated from public data as of September 2026.