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Financing and Reimbursement Models for Personalised Medicine: A Systematic Review to Identify Current Models and Future Options

BACKGROUND: The number of healthcare interventions described as ‘personalised medicine’ (PM) is increasing rapidly. As healthcare systems struggle to decide whether to fund PM innovations, it is unclear what models for financing and reimbursement are appropriate to apply in this context. OBJECTIVE:...

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Autores principales: Koleva-Kolarova, Rositsa, Buchanan, James, Vellekoop, Heleen, Huygens, Simone, Versteegh, Matthijs, Mölken, Maureen Rutten-van, Szilberhorn, László, Zelei, Tamás, Nagy, Balázs, Wordsworth, Sarah, Tsiachristas, Apostolos
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9206925/
https://www.ncbi.nlm.nih.gov/pubmed/35368231
http://dx.doi.org/10.1007/s40258-021-00714-9
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author Koleva-Kolarova, Rositsa
Buchanan, James
Vellekoop, Heleen
Huygens, Simone
Versteegh, Matthijs
Mölken, Maureen Rutten-van
Szilberhorn, László
Zelei, Tamás
Nagy, Balázs
Wordsworth, Sarah
Tsiachristas, Apostolos
author_facet Koleva-Kolarova, Rositsa
Buchanan, James
Vellekoop, Heleen
Huygens, Simone
Versteegh, Matthijs
Mölken, Maureen Rutten-van
Szilberhorn, László
Zelei, Tamás
Nagy, Balázs
Wordsworth, Sarah
Tsiachristas, Apostolos
author_sort Koleva-Kolarova, Rositsa
collection PubMed
description BACKGROUND: The number of healthcare interventions described as ‘personalised medicine’ (PM) is increasing rapidly. As healthcare systems struggle to decide whether to fund PM innovations, it is unclear what models for financing and reimbursement are appropriate to apply in this context. OBJECTIVE: To review financing and reimbursement models for PM, summarise their key characteristics, and describe whether they can influence the development and uptake of PM. METHODS: A literature review was conducted in Medline, Embase, Web of Science, and Econlit to identify studies published in English between 2009 and 2021, and reviews published before 2009. Grey literature was identified through Google Scholar, Google and subject-specific webpages. Articles that described financing and reimbursement of PM, and financing of non-PM were included. Data were extracted and synthesised narratively to report on the models, as well as facilitators, incentives, barriers and disincentives that could influence PM development and uptake. RESULTS: One hundred and fifty-three papers were included. Research and development of PM was financed through both public and private sources and reimbursed largely through traditional models such as single fees, Diagnosis-Related Groups, and bundled payments. Financial-based reimbursement, including rebates and price-volume agreements, was mainly applied to targeted therapies. Performance-based reimbursement was identified mainly for gene and targeted therapies, and some companion diagnostics. Gene therapy manufacturers offered outcome-based rebates for treatment failure for interventions including Luxturna(®), Kymriah(®), Yescarta(®), Zynteglo(®,) Zolgensma(®) and Strimvelis(®), and coverage with evidence development for Kymriah(®) and Yescarta(®). Targeted testing with OncotypeDX(®) was granted value-based reimbursement through initial coverage with evidence development. The main barriers and disincentives to PM financing and reimbursement were the lack of strong links between stakeholders and the lack of demonstrable benefit and value of PM. CONCLUSIONS: Public-private financing agreements and performance-based reimbursement models could help facilitate the development and uptake of PM interventions with proven clinical benefit. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40258-021-00714-9.
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spelling pubmed-92069252022-06-21 Financing and Reimbursement Models for Personalised Medicine: A Systematic Review to Identify Current Models and Future Options Koleva-Kolarova, Rositsa Buchanan, James Vellekoop, Heleen Huygens, Simone Versteegh, Matthijs Mölken, Maureen Rutten-van Szilberhorn, László Zelei, Tamás Nagy, Balázs Wordsworth, Sarah Tsiachristas, Apostolos Appl Health Econ Health Policy Systematic Review BACKGROUND: The number of healthcare interventions described as ‘personalised medicine’ (PM) is increasing rapidly. As healthcare systems struggle to decide whether to fund PM innovations, it is unclear what models for financing and reimbursement are appropriate to apply in this context. OBJECTIVE: To review financing and reimbursement models for PM, summarise their key characteristics, and describe whether they can influence the development and uptake of PM. METHODS: A literature review was conducted in Medline, Embase, Web of Science, and Econlit to identify studies published in English between 2009 and 2021, and reviews published before 2009. Grey literature was identified through Google Scholar, Google and subject-specific webpages. Articles that described financing and reimbursement of PM, and financing of non-PM were included. Data were extracted and synthesised narratively to report on the models, as well as facilitators, incentives, barriers and disincentives that could influence PM development and uptake. RESULTS: One hundred and fifty-three papers were included. Research and development of PM was financed through both public and private sources and reimbursed largely through traditional models such as single fees, Diagnosis-Related Groups, and bundled payments. Financial-based reimbursement, including rebates and price-volume agreements, was mainly applied to targeted therapies. Performance-based reimbursement was identified mainly for gene and targeted therapies, and some companion diagnostics. Gene therapy manufacturers offered outcome-based rebates for treatment failure for interventions including Luxturna(®), Kymriah(®), Yescarta(®), Zynteglo(®,) Zolgensma(®) and Strimvelis(®), and coverage with evidence development for Kymriah(®) and Yescarta(®). Targeted testing with OncotypeDX(®) was granted value-based reimbursement through initial coverage with evidence development. The main barriers and disincentives to PM financing and reimbursement were the lack of strong links between stakeholders and the lack of demonstrable benefit and value of PM. CONCLUSIONS: Public-private financing agreements and performance-based reimbursement models could help facilitate the development and uptake of PM interventions with proven clinical benefit. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40258-021-00714-9. Springer International Publishing 2022-04-04 2022 /pmc/articles/PMC9206925/ /pubmed/35368231 http://dx.doi.org/10.1007/s40258-021-00714-9 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Systematic Review
Koleva-Kolarova, Rositsa
Buchanan, James
Vellekoop, Heleen
Huygens, Simone
Versteegh, Matthijs
Mölken, Maureen Rutten-van
Szilberhorn, László
Zelei, Tamás
Nagy, Balázs
Wordsworth, Sarah
Tsiachristas, Apostolos
Financing and Reimbursement Models for Personalised Medicine: A Systematic Review to Identify Current Models and Future Options
title Financing and Reimbursement Models for Personalised Medicine: A Systematic Review to Identify Current Models and Future Options
title_full Financing and Reimbursement Models for Personalised Medicine: A Systematic Review to Identify Current Models and Future Options
title_fullStr Financing and Reimbursement Models for Personalised Medicine: A Systematic Review to Identify Current Models and Future Options
title_full_unstemmed Financing and Reimbursement Models for Personalised Medicine: A Systematic Review to Identify Current Models and Future Options
title_short Financing and Reimbursement Models for Personalised Medicine: A Systematic Review to Identify Current Models and Future Options
title_sort financing and reimbursement models for personalised medicine: a systematic review to identify current models and future options
topic Systematic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9206925/
https://www.ncbi.nlm.nih.gov/pubmed/35368231
http://dx.doi.org/10.1007/s40258-021-00714-9
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