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ORIGINAL RESEARCH article

Front. Pharmacol.
Sec. Drugs Outcomes Research and Policies
Volume 15 - 2024 | doi: 10.3389/fphar.2024.1397531

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

Provisionally accepted
Thomas Desmet Thomas Desmet 1,2*Sissel Michelsen Sissel Michelsen 1,2Elena Van Den Brande Elena Van Den Brande 1Walter Van Dyck Walter Van Dyck 2Steven Simoens Steven Simoens 1Isabelle Huys Isabelle Huys 1
  • 1 Department of Clinical Pharmacology and Pharmacotherapy, Faculty of Pharmaceutical Sciences, KU Leuven, Leuven, Belgium
  • 2 Healthcare Management Centre, Vlerick Business School, Ghent, East Flanders, Belgium

The final, formatted version of the article will be published soon.

    BACKGROUND: New 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. OBJECTIVES: This 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. METHODS: Semi-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. RESULTS: Interviews 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.

    Keywords: semi-structured interviews, Managed Entry Agreements (MEA), Annuity, Spread payment, outcome-based reimbursement, Advanced therapy medicinal product (ATMP), Curative therapy

    Received: 07 Mar 2024; Accepted: 19 Dec 2024.

    Copyright: © 2024 Desmet, Michelsen, Van Den Brande, Van Dyck, Simoens and Huys. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Thomas Desmet, Department of Clinical Pharmacology and Pharmacotherapy, Faculty of Pharmaceutical Sciences, KU Leuven, Leuven, 3000, Belgium

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.