PROJECTED IMPACT OF PERSONALIZED MRNA NEOANTIGEN CANCER VACCINES IN MEDICARE: A SCENARIO ANALYSIS USING TRIAL EFFICACY AND LINKED DATA POPULATION ESTIMATES
Author(s)
Onur Baser, MA, MS, PhD1, Precious Nchekwube, MPH2, Lixuan Wu, MS2, Nehir Yapar, BS2, Wanlin Guo, MS2, Xianxin Zhu, MS2;
1City University of New York (CUNY), Graduate School of Public Health, New York, NY, USA, 2Columbia Data Analytics, New York, NY, USA
1City University of New York (CUNY), Graduate School of Public Health, New York, NY, USA, 2Columbia Data Analytics, New York, NY, USA
OBJECTIVES: To model potential reduction in cancer recurrences if trial‑level benefits of personalized mRNA neoantigen vaccines were realized in routine practice using efficacy from published trials; population sizes approximated from Medicare-Enhanced Labs & Demographics (MELDTM) dataset, linking 100% Medicare fee‑for‑service (FFS) claims+EMR and patient‑reported outcome (PRO) measures
METHODS: Scenario analysis conducted for high‑risk resected melanoma and selected high‑risk resected non-small-cell lung cancer (NSCLC) and colorectal cancers. Melanoma: Hazard ratios (HRs), absolute recurrence‑free survival (RFS) gains from phase-II personalized mRNA vaccine+PD‑1 studies (~HR: recurrence/death≈0.56; absolute≈18-20 percentage‑point RFS improvement ~2 years vs PD‑1). Conservative hypothetical HRs:0.65-0.70 per broader mRNA/neoantigen vaccine literature and immunotherapy experience were applied. Annual resected high‑risk melanoma (~15,000), stage II-III NSCLC (~25,000), stage II-III colorectal cancer (~30,000) approximated using published incidence, stage distributions in older adults, and prior Medicare‑based studies. Baseline recurrence and modeled risks under vaccine+checkpoint therapy were combined to estimate annual recurrences “averted” if 50% beneficiaries received effective vaccine regimen.
RESULTS: Melanoma: Assuming baseline 45% 3‑year recurrence risk with PD‑1 and HR=0.56 for vaccine+PD‑1, projected 3‑year recurrence risk falls to ~27% among 7,500 vaccinated patients (50% uptake:15,000; ~1,350 recurrences averted over 3 years). Stage II-III NSCLC: Baseline 3‑year recurrence risk ~55%; hypothetical HR=0.70; 50% uptake in 25,000 beneficiaries (12,500=treated) would reduce recurrence risk to ~41%, yielding ~1,750 fewer recurrences. Stage II-III colorectal cancer: Baseline 3‑year recurrence risk ~35%; HR=0.65, 50% uptake among 30,000 (15,000 treated) would lower risk to ~24% and avert ~1,650 recurrences. Modeled impact: ~4,700-4,800 recurrences averted/incident annual cohort if half received effective regimens, achieving trial‑like benefit. Sensitivity analyses varying HRs:0.5-0.8 and uptake:30-70% showed wide but positive potential benefit (~2,000 to >7,000 recurrences averted/year across cancers).
CONCLUSIONS: Projections are hypothetical and contingent on regulatory approval, real‑world effectiveness, manufacturing logistics, and equitable access, highlighting the potential value of mRNA vaccines.
METHODS: Scenario analysis conducted for high‑risk resected melanoma and selected high‑risk resected non-small-cell lung cancer (NSCLC) and colorectal cancers. Melanoma: Hazard ratios (HRs), absolute recurrence‑free survival (RFS) gains from phase-II personalized mRNA vaccine+PD‑1 studies (~HR: recurrence/death≈0.56; absolute≈18-20 percentage‑point RFS improvement ~2 years vs PD‑1). Conservative hypothetical HRs:0.65-0.70 per broader mRNA/neoantigen vaccine literature and immunotherapy experience were applied. Annual resected high‑risk melanoma (~15,000), stage II-III NSCLC (~25,000), stage II-III colorectal cancer (~30,000) approximated using published incidence, stage distributions in older adults, and prior Medicare‑based studies. Baseline recurrence and modeled risks under vaccine+checkpoint therapy were combined to estimate annual recurrences “averted” if 50% beneficiaries received effective vaccine regimen.
RESULTS: Melanoma: Assuming baseline 45% 3‑year recurrence risk with PD‑1 and HR=0.56 for vaccine+PD‑1, projected 3‑year recurrence risk falls to ~27% among 7,500 vaccinated patients (50% uptake:15,000; ~1,350 recurrences averted over 3 years). Stage II-III NSCLC: Baseline 3‑year recurrence risk ~55%; hypothetical HR=0.70; 50% uptake in 25,000 beneficiaries (12,500=treated) would reduce recurrence risk to ~41%, yielding ~1,750 fewer recurrences. Stage II-III colorectal cancer: Baseline 3‑year recurrence risk ~35%; HR=0.65, 50% uptake among 30,000 (15,000 treated) would lower risk to ~24% and avert ~1,650 recurrences. Modeled impact: ~4,700-4,800 recurrences averted/incident annual cohort if half received effective regimens, achieving trial‑like benefit. Sensitivity analyses varying HRs:0.5-0.8 and uptake:30-70% showed wide but positive potential benefit (~2,000 to >7,000 recurrences averted/year across cancers).
CONCLUSIONS: Projections are hypothetical and contingent on regulatory approval, real‑world effectiveness, manufacturing logistics, and equitable access, highlighting the potential value of mRNA vaccines.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
EPH113
Topic
Epidemiology & Public Health
Topic Subcategory
Public Health
Disease
SDC: Oncology, STA: Genetic, Regenerative & Curative Therapies, STA: Vaccines