BUDGET IMPACT OF SEVABERTINIB FOR HER2-MUTATED LOCALLY ADVANCED OR METASTATIC NON-SQUAMOUS NSCLC WITH PRIOR SYSTEMIC THERAPY FROM A UNITED STATES PAYER PERSPECTIVE
Author(s)
Victoria W. Dayer, PharmD, PhD1, David Campbell, PharmD, MS1, Scott Ramsey, MD, PhD1, Bashir Kalayeh, PharmD2, Jamie Grossman, PhD2, Jean Lee, PharmD, MS2, Sreevalsa Appukkuttan, MPH2;
1Curta Inc., Seattle, WA, USA, 2Bayer Healthcare Pharmaceuticals Inc., Whippany, NJ, USA
1Curta Inc., Seattle, WA, USA, 2Bayer Healthcare Pharmaceuticals Inc., Whippany, NJ, USA
OBJECTIVES: The SOHO-01 trial established efficacy and safety of sevabertinib for HER2 (ERBB2) mutated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). This analysis estimated the budget impact of adding sevabertinib as a treatment option for adult patients with locally advanced or metastatic non-squamous NSCLC whose tumors have activating HER2 mutations, and who have received prior systemic therapy (2L) from a US payer perspective.
METHODS: Considering a 1-million-member US plan with commercial and Medicare enrollees over a 1-year time horizon, we developed an Excel-based budget impact model (BIM) to evaluate the costs for scenarios with and without sevabertinib. Treatment comparators included zongertinib and fam-trastuzumab deruxtecan-nxki. Utilization of tyrosine kinase inhibitors (TKIs) increased from 16.1% to 73.3% in the scenario with sevabertinib, accounting for 24% of TKI use. The BIM incorporated drug acquisition, administration, monitoring, and management of treatment-related adverse events (AEs) costs. Dosing, duration, and AE rates for all therapies were obtained from clinical trial publications and product prescribing information. Costs are reported in 2025 USD. Model outputs included annual budget impact and per-member per-month cost (PMPM) differences over a one-year time horizon. Sensitivity analyses assessed the impact of input parameter uncertainty on outcomes.
RESULTS: An estimated 3 patients per year within a 1-million-member plan were eligible to receive a HER2-targeted treatment in 2L NSCLC following systemic therapy. Over one year, the incremental cost of sevabertinib and overall increased utilization of the TKI class was estimated to be $34,870 ($0.003 PMPM). Higher treatment costs were partially offset by reduced administration and AE-related costs. The model results were consistent and most sensitive to changes in treatment costs and duration.
CONCLUSIONS: Sevabertinib as a treatment option for HER2-mutant NSCLC is associated with minimal budget impact for US payers, due to lower administration and AE costs as cost offsets, which supports its inclusion on formularies.
METHODS: Considering a 1-million-member US plan with commercial and Medicare enrollees over a 1-year time horizon, we developed an Excel-based budget impact model (BIM) to evaluate the costs for scenarios with and without sevabertinib. Treatment comparators included zongertinib and fam-trastuzumab deruxtecan-nxki. Utilization of tyrosine kinase inhibitors (TKIs) increased from 16.1% to 73.3% in the scenario with sevabertinib, accounting for 24% of TKI use. The BIM incorporated drug acquisition, administration, monitoring, and management of treatment-related adverse events (AEs) costs. Dosing, duration, and AE rates for all therapies were obtained from clinical trial publications and product prescribing information. Costs are reported in 2025 USD. Model outputs included annual budget impact and per-member per-month cost (PMPM) differences over a one-year time horizon. Sensitivity analyses assessed the impact of input parameter uncertainty on outcomes.
RESULTS: An estimated 3 patients per year within a 1-million-member plan were eligible to receive a HER2-targeted treatment in 2L NSCLC following systemic therapy. Over one year, the incremental cost of sevabertinib and overall increased utilization of the TKI class was estimated to be $34,870 ($0.003 PMPM). Higher treatment costs were partially offset by reduced administration and AE-related costs. The model results were consistent and most sensitive to changes in treatment costs and duration.
CONCLUSIONS: Sevabertinib as a treatment option for HER2-mutant NSCLC is associated with minimal budget impact for US payers, due to lower administration and AE costs as cost offsets, which supports its inclusion on formularies.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
EE42
Topic
Economic Evaluation
Topic Subcategory
Budget Impact Analysis
Disease
SDC: Oncology