The economic and health consequences of shared clinical decision-making for hepatitis B birth dose vaccination.

内容摘要

In December 2025, the Advisory Committee on Immunization Practices recommended individual-based decision-making-termed shared clinical decision-making (SCDM) on CDC schedules-for hepatitis B (HepB) birth-dose vaccination in infants of mothers documented as HBsAg-negative at delivery. We evaluated projected economic, health, and distributional consequences for the 2026 US birth cohort. A hybrid decision tree-Markov cohort model took the societal perspective over a lifetime horizon for 3.6 million 2026 US births, under three coverage-decline scenarios (10-, 20-, and 30-percentage-point). Costs (2026 US dollars) and outcomes were discounted 3% annually. Outcomes included costs, infections, deaths, quality-adjusted life years (QALYs), and equity impacts by insurance, race/ethnicity, hospital type, and geography. Probabilistic sensitivity analysis used 10,000 iterations; reporting followed CHEERS 2022. Under the base-case 20-percentage-point decline, SCDM was projected to produce approximately 44 additional acute infections, 8 additional chronic HBV cases, 2 additional HBV-related deaths (incomplete-linkage scenario), and 56 discounted QALYs lost per cohort. Assuming incremental counseling time for all policy-sensitive births, SCDM generated approximately $301 million in net societal cost-driven principally by provider counseling opportunity cost, not disease treatment-and was dominated by universal vaccination. With counseling time assigned zero cost, SCDM remained less effective but less costly, implying approximately $0.7 million per QALY to retain universal vaccination. Modeled burdens concentrated among Medicaid/CHIP and safety-net populations. This early assessment used scenario-based coverage-decline, counseling-time, mortality, and completion assumptions as post-policy data were unavailable; results are projections, not observations. Moving from universal birth-dose vaccination to SCDM was projected to reduce timely vaccination and increase preventable infections across all scenarios. The societal-cost conclusion hinged on whether SCDM imposed counseling-time burden at scale, whereas the unfavorable health-effect direction was robust. Postimplementation evidence on coverage, counseling, completion, and linkage to care is needed before treating SCDM as low-cost or low-risk. In the United States, newborn babies are usually given the first dose of the hepatitis B vaccine in the hospital, within a day of birth. This “birth dose” protects infants from a virus that can cause serious, lifelong liver disease.In December 2025, a US vaccine advisory committee changed this recommendation for babies whose mothers had tested negative for hepatitisB. Instead of recommending the birth dose for every newborn, it suggested that parents and their doctor decide case by case. This study used a computer model to estimate what that change could mean for the roughly 3.6 million babies born in the United States in 2026.The model projected that if fewer newborns receive the dose on time, there would be more hepatitis B infections, more long-term (chronic) infections, and a small number of additional deaths over these children’s lifetimes. The change was also estimated to cost society about $301 million—mainly because of the extra time doctors and nurses would spend discussing the decision with families, not because of treating illness. Even when that counseling time was assumed to cost nothing, the policy still led to more infections and worse health.The projected harms fell most heavily on babies from lower-income families and under-resourced hospitals, which could widen existing health gaps.Because the policy is new, these results are projections based on assumptions, not real-world measurements. Tracking what actually happens, including vaccination rates and infections, is needed before treating this change as low-cost or low-risk.