Barriers and opportunities for implementation of outcome-based spread payments for high-cost, one-shot curative therapies
Michelsen, Sissel Nachi, Salma Van Dyck, Walter Simoens, Steven Huys, Isabelle
Michelsen, Sissel
Nachi, Salma
Van Dyck, Walter
Simoens, Steven
Huys, Isabelle
Citations
Altmetric:
Publication Type
Journal article with impact factor
Editor
Supervisor
Publication Year
2020
Journal
Frontiers in Pharmacology
Book
Publication Volume
11
Publication Issue
Publication Begin page
Publication End page
Publication NUmber of pages
Collections
Abstract
Background: 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.
Research Projects
Organizational Units
Journal Issue
Keywords
Advanced Therapy Medicinal Product (ATMP), Curative Therapy, Spread Payment, Outcome-Based Agreement, Affordability, Pay-for-Performance (P4P), Annuity, Managed Entry Agreement (MEA)