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      Navigating the Reimbursement Conundrum in Drug Repurposing: Balancing Access, Pricing, and Innovation

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        1 , 2 , , 1 , 2 , 1 , 2 , 1 , 2
      RExPO24 Conference
      REPO4EU
      RExPO24
      3-5 July 2024
      Health Technology Assessment, Reimbursement, Drug Repurposing, Pharmaceutical Regulation
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            Abstract

            Drug repurposing holds enormous potential but suffers from many well-documented challenges that span issues with data access, collaboration, R&D, business case, legal and regulatory 1. Within the regulatory challenge, there has been a lot of talk about difficulties with navigating regulatory routes with a repurposed drug as a non marketing authorization holder, and indeed that remains challenging in the case of shelved drugs and where becoming a marketing authorization holder is not an option 2. But what comes after marketing authorization is not commonly considered. We know examples of repurposed drugs that had steep price increases and became unaffordable for patients and health systems (e.g. colchicine 3, mexiletine 4). On the other hand, we know that there may not always be a viable business case for repurposing a drug because the drug would not pass the reimbursement stage at a profitable price. The fragmentation of reimbursement processes, with each jurisdiction having their own set of rules and reimbursement criteria, adds an additional challenge. This talk is about the tension between preventing evergreening and incentivizing innovative drug repurposing, how this affects pricing and reimbursement policies in major markets, and what policy changes could be made in the context of drug repurposing. It will start with an overview of the regulatory and reimbursement ecosystem drug repurposers operate in, including the proposed EU pharmaceutical legislation, and EU regulation on Health Technology Assessment with the requirement for joint clinical assessments. Incentives for innovating and main regulatory and reimbursement challenges are discussed. The societal impact of different pricing mechanisms is presented and illustrated in an example HTA process with value-based pricing as the guiding principle. Finally, ideas will be put forward to address the reimbursement conundrum.

            Content

            Author and article information

            Conference
            RExPO24 Conference
            REPO4EU
            19 April 2024
            Affiliations
            [1 ] Department of Clinical Epidemiology and Health Technology Assessment (KEMTA), Maastricht University Medical Center, Maastricht, the Netherlands ( https://ror.org/02d9ce178)
            [2 ] Care and Public Health Research Institute (CAPHRI), Maastricht University, the Netherlands ( https://ror.org/02jz4aj89)
            Author notes
            Author information
            https://orcid.org/0000-0002-2175-7999
            https://orcid.org/0000-0003-3102-6011
            https://orcid.org/0000-0002-1090-1721
            https://orcid.org/0000-0002-5649-6768
            Article
            10.58647/REXPO.24000038.v1
            fc6aff55-6418-4805-9c8c-0e315fe5bb95

            This work has been published open access under Creative Commons Attribution License CC BY 4.0 , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Conditions, terms of use and publishing policy can be found at www.scienceopen.com .

            RExPO24
            3
            Munich, Germany
            3-5 July 2024
            History
            : 19 April 2024
            Product

            REPO4EU

            Funding
            Funded by: funder-id , European Union;
            Award ID: 101057619
            Categories

            Data sharing not applicable to this article as no datasets were generated or analysed during the current study.
            Economics of health & social care
            Health Technology Assessment,Reimbursement,Drug Repurposing,Pharmaceutical Regulation

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