Barriers and Potential Solutions for Implementation of Outcome-Based Spread Payments for High-Cost, One-SHOT Curative Therapies
Author(s)
Michelsen S*1;Nachi S2;Van Dyck W3;Simoens S2, Huys I2
1University of Leuven, Leuven, VBR, Belgium, 2University of Leuven, Leuven, Belgium, 3Vlerick Business School, Brussels, Belgium
OBJECTIVES: 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 solutions for the practical implementation of outcome-based spread payments for the reimbursement of one-shot therapies in European healthcare systems.
METHODS: Barriers for the implementation of outcome-based spread payments may arise through either the notion of spreading payments or the required outcome correction of payments. 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 extracted via 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-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.
CONCLUSIONS: 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 realising the required organisational changes.
METHODS: Barriers for the implementation of outcome-based spread payments may arise through either the notion of spreading payments or the required outcome correction of payments. 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 extracted via 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-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.
CONCLUSIONS: 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 realising the required organisational changes.
Conference/Value in Health Info
2020-11, ISPOR Europe 2020, Milan, Italy
Value in Health, Volume 23, Issue S2 (December 2020)
Code
RO1
Topic
Health Policy & Regulatory, Study Approaches
Topic Subcategory
Literature Review & Synthesis, Reimbursement & Access Policy, Risk-sharing Approaches
Disease
Genetic, Regenerative and Curative Therapies, Rare