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An overview of critical decision-points in the medical product lifecycle: Where to include patient preference information in the decision-making process?
Erasmus School of Health Policy & Management and Erasmus Choice Modelling Centre, Erasmus University Rotterdam, P.O. Box 1738, 3000DR Rotterdam,The Netherlands.
Uppsala universitet, Centrum för forsknings- och bioetik, Sweden.ORCID iD: 0000-0002-5865-5590
Pfizer, Inc., 500 Arcola Road, 19426 Collegeville, PA, USA.
Pfizer Inc., 235 East 42ndStreet, 10017 New York, NY, USA.
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2020 (English)In: Health Policy, ISSN 0168-8510, E-ISSN 1872-6054, Vol. 124, no 12, p. 1325-1332Article in journal (Refereed) Published
Abstract [en]

<h1>Background</h1><p>Patient preference (PP) information is not effectively integrated in decision-making throughout the medical product lifecycle (MPLC), despite having the potential to improve patients’ healthcare options. A first step requires an understanding of existing processes and decision-points to know how to incorporate PP information in order to improve patient-centric decision-making.</p><h1>Objectives</h1><p>The aims were to: 1) identify the decision-making processes and decision-points throughout the MPLC for industry, regulatory authorities, and reimbursement/HTA, and 2) determine which decision-points can potentially include PP information.</p><h1>Methods</h1><p>A scoping literature review was conducted using five scientific databases. Semi-structured interviews were conducted with representatives from seven European countries and the US, including industry (n = 24), regulatory authorities (n = 23), reimbursement/HTA (n = 23). Finally, validation meetings with key stakeholders (n = 11) were conducted.</p><h1>Results</h1><p>Six critical decision-points were identified for <em>industry decision-making,</em> three for <em>regulatory decision-making</em>, and six for <em>reimbursement/HTA decision-making.</em> Stakeholder groups agreed that PP information is not systematically integrated, either as obligatory information or pre-set criteria, but would benefit all the listed decision-points in the future.</p><h1>Conclusion</h1><p>Currently, PP information is not considered as obligatory information to submit for any of the MPLC decision-points. However, PP information is considered an important component by most stakeholders to inform future decision-making across the MPLC. The integration of PP information into 15 identified decision-points needs continued discussion and collaboration between stakeholders.</p>

Place, publisher, year, edition, pages
2020. Vol. 124, no 12, p. 1325-1332
Keywords [en]
Patient preferences, Patient preference information, Decision-Making, HTA decision-making, Regulatory decision-making, Industry decision-making
National Category
Social and Clinical Pharmacy Medical Ethics
Identifiers
URN: urn:nbn:se:mdh:diva-62347DOI: 10.1016/j.healthpol.2020.07.007ISI: 000594538300006PubMedID: 32839011Scopus ID: 2-s2.0-85089748209OAI: oai:DiVA.org:mdh-62347DiVA, id: diva2:1753462
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IMI-PREFERAvailable from: 2023-04-27 Created: 2023-04-27 Last updated: 2023-10-23Bibliographically approved

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Schölin Bywall, Karin

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