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dc.contributor.authorMichelsen, Sissel
dc.contributor.authorNachi, Salma
dc.contributor.authorVan Dyck, Walter
dc.contributor.authorSimoens, Steven
dc.contributor.authorHuys, Isabelle
dc.date.accessioned2020-12-04T10:09:25Z
dc.date.available2020-12-04T10:09:25Z
dc.date.issued2020en_US
dc.identifier.doi10.3389/fphar.2020.594446
dc.identifier.urihttp://hdl.handle.net/20.500.12127/6602
dc.description.abstractBackground: The challenging market access of high-cost, one-time curative therapies has inspired the development of alternative reimbursement structures, such as outcome-based spread payments, to mitigate their unaffordability and answer remaining uncertainties. This study aimed to provide a broad overview of barriers and possible opportunities for the practical implementation of outcome-based spread payments for the reimbursement of one-shot therapies in European healthcare systems. Methods: A systematic literature review was performed investigating published literature and publicly available documents to identify barriers and implementation opportunities for both spreading payments and for implementing outcome-based agreements. Data was analyzed via qualitative content analysis by extracting data with a reporting template. Results: A total of 1503 publications were screened and 174 were included. Main identified barriers for the implementation of spread payments are reaching an agreement on financial terms while considering 12-month budget cycles and the possible violation of corresponding (inter)national accounting rules. Furthermore, outcome correction of payments is currently hindered by the need for additional data collection, the lack of clear governance structures and the resulting administrative burden and cost. The use of spread payments adjusted by population- or individual-level data collected within automated registries and overseen by a governance committee and external advisory board may alleviate several barriers and may support the reimbursement of highly innovative therapies. Conclusion: High-cost advanced therapy medicinal products pose a substantial affordability challenge on healthcare systems worldwide. Outcome-based spread payments may mitigate the initial budget impact and alleviate existing uncertainties; however, their effective implementation still faces several barriers and will be facilitated by realizing the required organizational changes.en_US
dc.description.sponsorshipThis work was supported by a PhD fellowship strategic basic research of the Research Foundation - Flanders (1S70720N).
dc.language.isoenen_US
dc.publisherFrontiers Mediaen_US
dc.subjectAdvanced Therapy Medicinal Product (ATMP)en_US
dc.subjectCurative Therapyen_US
dc.subjectSpread Paymenten_US
dc.subjectOutcome-Based Agreementen_US
dc.subjectAffordabilityen_US
dc.subjectPay-for-Performance (P4P)en_US
dc.subjectAnnuityen_US
dc.subjectManaged Entry Agreement (MEA)en_US
dc.titleBarriers and opportunities for implementation of outcome-based spread payments for high-cost, one-shot curative therapiesen_US
dc.identifier.journalFrontiers in Pharmacologyen_US
dc.source.volume11
dc.contributor.departmentDepartment of Clinical Pharmacology and Pharmacotherapy, KU Leuven, Belgiumen_US
dc.identifier.eissn1663-9812
vlerick.knowledgedomainOperations & Supply Chain Managementen_US
vlerick.knowledgedomainSpecial Industries : Healthcare Managementen_US
vlerick.typearticleJournal article with impact factoren_US
vlerick.vlerickdepartmentTOMen_US
dc.identifier.vperid252831en_US
dc.identifier.vperid31183en_US


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