Distinguishing Incremental Cost-Effectiveness from Fiscal Affordability in the Appraisal of Potentially Curative Therapies

Incremental cost-effectiveness analysis and fiscal-affordability assessment address distinct decision problems in the health-technology appraisal of potentially curative, single-administration therapies. Incremental cost-effectiveness analysis estimates the additional costs and additional health effects of a technology relative to current practice over a lifetime horizon, conventionally expressed as an incremental cost-effectiveness ratio and appraised against a threshold intended to represent health opportunity cost under a constrained budget (Claxton et al., ۲۰۱۵; Lomas et al., ۲۰۱۸; Sanders et al., ۲۰۱۶). Fiscal affordability concerns the near-term net budgetary consequences of adoption for a defined population, typically over one to five years, and the feasibility of financing those consequences without unacceptable displacement of existing services or breach of exogenous expenditure constraints (Pearson, ۲۰۱۸; Sullivan et al., ۲۰۱۴). For chronically administered medicines the two assessments frequently yield concordant implications. For potentially curative therapies they systematically diverge because acquisition costs are incurred at the point of administration, whereas health gains and displaced chronic-care expenditure accrue over subsequent decades; because symmetric discounting reduces the present value of delayed effects; because budget-impact methods employ short analytic horizons; because eligible populations may be epidemiologically small yet fiscally material when incident and prevalent cohorts, or multiple products, coincide; because the duration of effect is uncertain relative to the period over which value is claimed; and because comparators may themselves be high-cost regimens whose full cost offsets, if attributed entirely to the new technology, inflate value-based prices (Drummond et al., ۲۰۱۹; Hampson et al., ۲۰۱۸; Pearson, ۲۰۲۳). This paper maintains an analytic separation between the two questions, synthesises the theoretical literature on the alleged cost-effective-but-unaffordable paradox, examines published appraisals to ۲۰۲۳, and specifies a sequential appraisal procedure: estimation of long-term value under explicit assumptions regarding duration, discounting, and the allocation of cost offsets; construction of a time-profiled budget-impact path by payer and uptake; and selection of financing or access instruments—price revision, phased implementation, outcomes-linked instalments, or risk pooling—matched to the binding constraint (Garrison et al., ۲۰۱۳; Lomas, ۲۰۱۹). Conflation of the two metrics obscures the opportunity-cost interpretation of the incremental cost-effectiveness ratio

کلیدواژه ها:

incremental cost-effectiveness ، fiscal affordability ، gene therapy ، health technology assessment ، opportunity cost.