Is an Orphan Drug’s Cost-Effectiveness Associated with US Health Plan Coverage Restrictiveness?

James D. Chambers (), Nikoletta M. Margaretos (), Daniel E. Enright (), Rosa Wang () and Xin Ye ()
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James D. Chambers: Tufts Medical Center
Nikoletta M. Margaretos: Tufts Medical Center
Daniel E. Enright: Tufts Medical Center
Rosa Wang: Daiichi Sankyo, Inc.
Xin Ye: Daiichi Sankyo, Inc.

PharmacoEconomics, 2022, vol. 40, issue 2, No 7, 225-232

Abstract: Abstract Background and Objectives Orphan drugs’ high prices raise questions about whether their costs are worth their benefits. We examined the association between an orphan drug’s cost-effectiveness and health plan coverage restrictiveness. Methods We analyzed a dataset of US commercial health plan coverage decisions (information current as of 2019) for orphan drugs (n = 3298). We used multi-level random-effect logistic regression to examine the association between orphan drug cost-effectiveness and coverage restrictiveness. We identified cost-effectiveness estimates from the Tufts Medical Center Cost-Effectiveness Analysis Registry, and from the Institute for Clinical and Economic Review’s value assessments. We included only cost-effectiveness studies not funded by product manufacturers. We included the following independent variables: cancer indication, availability of alternatives, pediatric population, number of years since US Food and Drug Administration (FDA) approval, disease prevalence, annual cost, additional non-orphan indication, safety, and inclusion in a FDA expedited review program. Results Plans restricted drug coverage in 29.7% (n = 981) of decisions. Plans were more likely to restrict drugs with incremental cost-effectiveness ratios of $50,000–$175,000 per quality-adjusted life-year [QALY] (odds ratio = 1.855, p $500,000 per QALY/dominated (odds ratio = 2.032, p

Date: 2022
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DOI: 10.1007/s40273-021-01096-5

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