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dc.contributor.authorMallya, U.G.*
dc.contributor.authorBoklage, S.H.*
dc.contributor.authorKoren, A.*
dc.date.accessioned2019-05-17T12:53:06Z
dc.date.available2019-05-17T12:53:06Z
dc.date.issued2018
dc.identifier.urihttps://www.scopus.com/inward/record.uri?eid=2-s2.0-85035098589&doi=10.1007%2fs40273-017-0590-5&partnerID=40&md5=d0203d852c74f7668071bf235bb7166f
dc.identifier.urihttp://hdl.handle.net/10713/9111
dc.description.abstractObjective: The aim of this study was to assess the budget impact of introducing the proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) alirocumab and evolocumab to market for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular (CV) disease requiring additional lowering of low-density lipoprotein cholesterol (LDL-C). Methods: A 3-year model estimated the costs of lipid-modifying therapy (LMT) and CV events to a hypothetical US health plan of 1 million members, comparing two scenarios—with and without the availability of PCSK9i as add-on therapy to statins. Proportions of patients with uncontrolled LDL-C despite receiving statins, and at risk of CV events, were estimated from real-world data. Total undiscounted annual LMT costs (2017 prices, including PCSK9i costs of $14,563.50), dispensing and healthcare costs, including the costs of CV events, were estimated for all prevalent patients in the target population, based on baseline risk factors. Maximum PCSK9i utilization of 1–5% over 3 years according to risk group (following the same pattern as current ezetimibe use), and 5–10% as a secondary scenario, were assumed. Results: Total healthcare budget impacts per target patient (and per member) per month for years 1, 2 and 3 were $3.62($0.10), $7.22($0.20) and $10.79($0.30), respectively, assuming 1–5% maximum PCSK9i utilization, and $15.81($0.44), $31.52($0.88) and $47.12($1.31), respectively, assuming 5–10% utilization. Results were sensitive to changes in model timeframe, years to maximum PCSK9i utilization and PCSK9i costs. Conclusions: The budget impact of PCSK9i as add-on therapy to statins for patients with hypercholesterolemia is relatively low compared with published estimates for other specialty biologics. Drug cost rebates and discounts are likely to further reduce budget impact. Copyright 2017, The Author(s).en_US
dc.description.sponsorshipAcknowledgements The authors would like to thank Sean Sullivan for contributing to the initial study concept and data analysis, and Emilie Duchesneau for her assistance conducting the analysis. Medical writing assistance and editorial support, under the direction of the authors, were respectively provided by Gauri Saal, MA Economics, and Elke Sims of Prime (Knutsford, UK), funded by Sanofi/Regen-eron according to Good Publication Practice guidelines (http://annals. org/aim/article/2424869). The sponsor was involved in the study design, collection, analysis and interpretation of data, as well as data checking of information provided in the article. The authors had unrestricted access to study data, were responsible for all content and editorial decisions, and received no honoraria related to the development of this publication.en_US
dc.description.urihttps://dx.doi.org/10.1007/s40273-017-0590-5en_US
dc.language.isoen_USen_US
dc.publisherSpringer International Publishingen_US
dc.relation.ispartofPharmacoEconomics
dc.subjectheterozygous familial hypercholesterolemiaen_US
dc.subjectclinical atherosclerotic cardiovascular diseaseen_US
dc.subjectproprotein convertase subtilisin/kexin type 9 inhibitorsen_US
dc.subjectbudget impacten_US
dc.titleBudget Impact Analysis of PCSK9 Inhibitors for the Management of Adult Patients with Heterozygous Familial Hypercholesterolemia or Clinical Atherosclerotic Cardiovascular Diseaseen_US
dc.typeArticleen_US
dc.identifier.doi10.1007/s40273-017-0590-5


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