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 1,503 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-months budget cycles and the possible violation of corresponding international 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.
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 1,503 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-months budget cycles and the possible violation of corresponding international 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.
Authors: Rositsa Koleva-Kolarova; James Buchanan; Heleen Vellekoop; Simone Huygens; Matthijs Versteegh; Maureen Rutten-van Mölken; László Szilberhorn; Tamás Zelei; Balázs Nagy; Sarah Wordsworth; Apostolos Tsiachristas Journal: Appl Health Econ Health Policy Date: 2022-04-04 Impact factor: 3.686
Authors: Natalie Bohm; Sarah Bermingham; Frank Grimsey Jones; Daniela C Gonçalves-Bradley; Alex Diamantopoulos; Jessica R Burton; Hamish Laing Journal: Pharmacoeconomics Date: 2021-09-04 Impact factor: 4.981
Authors: Ildikó Ádám; Marcelien Callenbach; Bertalan Németh; Rick A Vreman; Johan Pontén; Tea Strbad; Dalia Dawoud; Alexander Kostyuk; Ahmed Seyam; László Nagy; Wim G Goettsch; Zoltán Kaló Journal: Front Med (Lausanne) Date: 2022-08-12
Authors: Ildikó Ádám; Marcelien Callenbach; Bertalan Németh; Rick A Vreman; Cecilia Tollin; Johan Pontén; Dalia Dawoud; Jamie Elvidge; Nick Crabb; Sahar Barjesteh van Waalwijk van Doorn-Khosrovani; Anke Pisters-van Roy; Áron Vincziczki; Emad Almomani; Maja Vajagic; Z Gulsen Oner; Mirna Matni; Jurij Fürst; Rabia Kahveci; Wim G Goettsch; Zoltán Kaló Journal: Front Med (Lausanne) Date: 2022-09-23