Towards implementing new payment models for the reimbursement of high-cost, curative therapies in Europe: insights from semi-structured interviews

BackgroundNew ways of reimbursement for high-cost, one-shot curative therapies such as advanced therapy medicinal products (ATMPs) are a growing area of interest to stakeholders in market access such as industry representatives, legislative and accounting experts, physicians, hospital managers, hosp...

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Main Authors: Thomas Desmet, Sissel Michelsen, Elena Van den Brande, Walter Van Dyck, Steven Simoens, Isabelle Huys
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-01-01
Series:Frontiers in Pharmacology
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Online Access:https://www.frontiersin.org/articles/10.3389/fphar.2024.1397531/full
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author Thomas Desmet
Thomas Desmet
Sissel Michelsen
Sissel Michelsen
Elena Van den Brande
Walter Van Dyck
Steven Simoens
Isabelle Huys
author_facet Thomas Desmet
Thomas Desmet
Sissel Michelsen
Sissel Michelsen
Elena Van den Brande
Walter Van Dyck
Steven Simoens
Isabelle Huys
author_sort Thomas Desmet
collection DOAJ
description BackgroundNew ways of reimbursement for high-cost, one-shot curative therapies such as advanced therapy medicinal products (ATMPs) are a growing area of interest to stakeholders in market access such as industry representatives, legislative and accounting experts, physicians, hospital managers, hospital pharmacists, patient representatives, policymakers, and sickness funds. Due to the complex nature of ATMPs, new payment models and reimbursement modalities are proposed yet not widely applied across Europe.ObjectivesThis study aimed to elicit opinions on and insights into the governance aspect of implementing outcome-based spread payments (OBSP) in Belgium for the reimbursement of innovative therapies. Stakeholders’ responsibilities and roles were analysed and proposed solutions or general beliefs were assessed to identify necessary or sufficient conditions to establish outcome-based spread payments.MethodsSemi-structured interviews (n = 33) were conducted with physicians (n = 2), hospital pharmacists (n = 4), hospital managers (n = 2), Belgian policymakers (n = 6), legislative experts (n = 2), accounting experts (n = 5), representatives of patients (n = 3), of industry (n = 5), and sickness funds (n = 4). The interviews took place between July 2020 and October 2020. The framework method analysis was performed using Nvivo software (version 20.4.1.851). Statements were allocated into six main topics: payment structure, spread payments, outcome-based agreements, governance, transparency, and regulation.ResultsInterviews revealed the necessary conditions that, fulfilled together, are seen to be sufficient for the successful implementation of OBSP, including consensus on pricing, payment logistics, robust data infrastructure and financing, clear agreement terms (duration, outcome parameters, payment triggers), long-term patient follow-up solutions, an external multi-stakeholder governance body, and transparency regarding agreement types.ConclusionDespite the interest, the effective implementation of OBSP falls behind due to a lack of consensus on how this new reimbursement method can be a sustainable solution. By stating the necessary conditions that, when fulfilled together, are deemed sufficient for successful OBSP implementation, this study provides a framework towards overcoming implementation barriers and realizing the potential of OBSP in transforming healthcare reimbursement practices.
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spelling doaj-art-d98006e4cf164dd08abc31aebc68fc4c2025-01-20T05:23:47ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122025-01-011510.3389/fphar.2024.13975311397531Towards implementing new payment models for the reimbursement of high-cost, curative therapies in Europe: insights from semi-structured interviewsThomas Desmet0Thomas Desmet1Sissel Michelsen2Sissel Michelsen3Elena Van den Brande4Walter Van Dyck5Steven Simoens6Isabelle Huys7Clinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, BelgiumHealthcare Management Centre, Vlerick Business School, Ghent, BelgiumClinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, BelgiumHealthcare Management Centre, Vlerick Business School, Ghent, BelgiumClinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, BelgiumHealthcare Management Centre, Vlerick Business School, Ghent, BelgiumClinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, BelgiumClinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, BelgiumBackgroundNew ways of reimbursement for high-cost, one-shot curative therapies such as advanced therapy medicinal products (ATMPs) are a growing area of interest to stakeholders in market access such as industry representatives, legislative and accounting experts, physicians, hospital managers, hospital pharmacists, patient representatives, policymakers, and sickness funds. Due to the complex nature of ATMPs, new payment models and reimbursement modalities are proposed yet not widely applied across Europe.ObjectivesThis study aimed to elicit opinions on and insights into the governance aspect of implementing outcome-based spread payments (OBSP) in Belgium for the reimbursement of innovative therapies. Stakeholders’ responsibilities and roles were analysed and proposed solutions or general beliefs were assessed to identify necessary or sufficient conditions to establish outcome-based spread payments.MethodsSemi-structured interviews (n = 33) were conducted with physicians (n = 2), hospital pharmacists (n = 4), hospital managers (n = 2), Belgian policymakers (n = 6), legislative experts (n = 2), accounting experts (n = 5), representatives of patients (n = 3), of industry (n = 5), and sickness funds (n = 4). The interviews took place between July 2020 and October 2020. The framework method analysis was performed using Nvivo software (version 20.4.1.851). Statements were allocated into six main topics: payment structure, spread payments, outcome-based agreements, governance, transparency, and regulation.ResultsInterviews revealed the necessary conditions that, fulfilled together, are seen to be sufficient for the successful implementation of OBSP, including consensus on pricing, payment logistics, robust data infrastructure and financing, clear agreement terms (duration, outcome parameters, payment triggers), long-term patient follow-up solutions, an external multi-stakeholder governance body, and transparency regarding agreement types.ConclusionDespite the interest, the effective implementation of OBSP falls behind due to a lack of consensus on how this new reimbursement method can be a sustainable solution. By stating the necessary conditions that, when fulfilled together, are deemed sufficient for successful OBSP implementation, this study provides a framework towards overcoming implementation barriers and realizing the potential of OBSP in transforming healthcare reimbursement practices.https://www.frontiersin.org/articles/10.3389/fphar.2024.1397531/fullsemi-structured interviewsmanaged entry agreements (MEA)annuityspread paymentoutcome-based reimbursementadvanced therapy medicinal product (ATMP)
spellingShingle Thomas Desmet
Thomas Desmet
Sissel Michelsen
Sissel Michelsen
Elena Van den Brande
Walter Van Dyck
Steven Simoens
Isabelle Huys
Towards implementing new payment models for the reimbursement of high-cost, curative therapies in Europe: insights from semi-structured interviews
Frontiers in Pharmacology
semi-structured interviews
managed entry agreements (MEA)
annuity
spread payment
outcome-based reimbursement
advanced therapy medicinal product (ATMP)
title Towards implementing new payment models for the reimbursement of high-cost, curative therapies in Europe: insights from semi-structured interviews
title_full Towards implementing new payment models for the reimbursement of high-cost, curative therapies in Europe: insights from semi-structured interviews
title_fullStr Towards implementing new payment models for the reimbursement of high-cost, curative therapies in Europe: insights from semi-structured interviews
title_full_unstemmed Towards implementing new payment models for the reimbursement of high-cost, curative therapies in Europe: insights from semi-structured interviews
title_short Towards implementing new payment models for the reimbursement of high-cost, curative therapies in Europe: insights from semi-structured interviews
title_sort towards implementing new payment models for the reimbursement of high cost curative therapies in europe insights from semi structured interviews
topic semi-structured interviews
managed entry agreements (MEA)
annuity
spread payment
outcome-based reimbursement
advanced therapy medicinal product (ATMP)
url https://www.frontiersin.org/articles/10.3389/fphar.2024.1397531/full
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