BUDGET IMPACT ANALYSIS OF PERIOPERATIVE PEMBROLIZUMAB PLUS STANDARD OF CARE AS TREATMENT FOR RESECTABLE LOCALLY ADVANCED HEAD AND NECK SQUAMOUS CELL CARCINOMA IN THE UNITED STATES

Author(s)

Feng (Johnson) Qian, PhD, MBA, MSc, MBBS1, Chris Yates, PharmD2, Shrishti Jain, MSc3, Debosmita Bhadra, MA4, Alok Kesarwani, BS4.
1Associate Director, Merck, Rahway, NJ, NY, USA, 2Merck & Co. Inc, Rahway, NJ, NJ, USA, 3Peritia, Gurgaon, India, 4Peritia, Gurugram, India.
OBJECTIVES: Head and neck squamous cell carcinoma (HNSCC) represents a substantial clinical and economic burden in the United States (U.S.). Early-stage disease is managed with surgery/radiotherapy, while locoregionally advanced (LA) disease requires multimodal approaches. This analysis evaluated the budget impact of formulary inclusion of perioperative pembrolizumab (intravenous [IV] and subcutaneous [SC] formulations) plus standard of care (SoC) in resectable LA HNSCC patients with programmed death‑ligand 1 (PD-L1) combined positive score (CPS) ≥ 1, from a U.S. payer perspective.
METHODS: A budget impact model with 3‑year time horizon was developed in MS Excel using MSD’s proprietary “THEOREM” platform. Model inputs included epidemiologic data, treatment-mix, trial data from the pembrolizumab and SOC arms, with a 3-year average pembrolizumab breakdown of IV versus SC formulations (IV:79%; SC:21%), and direct medical costs (2025 inflated). The model compared the reference scenario (without intervention) versus the new scenario (with intervention; market share increasing from 40% in Year 1 to 56% in Year 3) and the associated budget impact. A scenario analysis of the upper-bound uptake of the pembrolizumab SC formulation was performed.
RESULTS: For a typical 1,000,000-member U.S. health plan, the annual budget impact ranged from $459,965 to $1,508,112 over 3 years, averaging $1,074,342, with a 3-year average increase of $0.09 per member per month. In Year 1, 24 patients were treatment-eligible. One-way sensitivity analysis identified pembrolizumab market share and target population size as key drivers. Scenario analysis with 100% SC uptake resulted in a 68.7% reduction in administration costs and 1.2% net reduction in overall budget (averaging over 3 years).
CONCLUSIONS: Although formulary inclusion of pembrolizumab increases drug‑related expenditures, the SC formulation will partially offset these costs by reducing administration costs. Overall, perioperative pembrolizumab plus SoC as treatment for resectable LA HNSCC patients may offer clinical benefit without substantially increasing the budget impact for a typical U.S. health plan.

Conference/Value in Health Info

2026-11, ISPOR Europe 2026, Vienna, Austria

Value in Health, Volume 29, Issue 12S

Code

EE217

Topic

Economic Evaluation, Health Technology Assessment, Medical Technologies

Topic Subcategory

Budget Impact Analysis

Disease

Oncology

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