Chiara Whichello1, Karin Schölin Bywall2, Jonathan Mauer3, Watt Stephen4, Irina Cleemput5, Cathy Anne Pinto6, Eline van Overbeeke7, Isabelle Huys8, Esther W de Bekker-Grob9, Richard Hermann10, Jorien Veldwijk11. 1. Erasmus School of Health Policy & Management and Erasmus Choice Modelling Centre, Erasmus University Rotterdam, P.O. Box 1738, 3000DR Rotterdam, The Netherlands. Electronic address: whichello@eshpm.eur.nl. 2. Centre for Research Ethics & Bioethics, Uppsala University, Uppsala, Sweden, Husargatan 3, Box 564, 75237 Uppsala, Sweden. Electronic address: Karin.bywall@crb.uu.se. 3. Pfizer, Inc., 500 Arcola Road, 19426 Collegeville, PA, USA. Electronic address: jonathan.mauer@pfizer.com. 4. Pfizer Inc., 235 East 42ndStreet, 10017 New York, NY, USA. Electronic address: stephen.watt@pfizer.com. 5. Belgian Health Care Knowledge Centre (KCE), Doorbuilding (10th floor), Kruidtuinlaan 55, 1000 Brussels, Belgium. Electronic address: Irina.cleemput@kce.fgov.be. 6. Merck & Co., Inc., Kenilworth, NJ, USA. Electronic address: cathy.pinto@merck.com. 7. Clincial Pharmacology and Pharmacotherapy, University of Leuven, Herestraat 49 - Box 521, 3000 Leuven, Belgium. Electronic address: eline.vanoverbeeke@kuleuven.be. 8. Clincial Pharmacology and Pharmacotherapy, University of Leuven, Herestraat 49 - Box 521, 3000 Leuven, Belgium. Electronic address: Isabelle.huys@kuleuven.be. 9. Erasmus School of Health Policy & Management and Erasmus Choice Modelling Centre, Erasmus University Rotterdam, P.O. Box 1738, 3000DR Rotterdam, The Netherlands. Electronic address: Debekker-grob@eshpm.eur.nl. 10. AstraZeneca Pharmaceuticals L.P, One MedImmune Way, 20878 Gaithersburg, MD, USA. Electronic address: Richard.hermann@astrazeneca.com. 11. Erasmus School of Health Policy & Management and Erasmus Choice Modelling Centre, Erasmus University Rotterdam, P.O. Box 1738, 3000DR Rotterdam, The Netherlands. Electronic address: veldwijk@eshpm.eur.nl.
Abstract
BACKGROUND: 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. OBJECTIVES: 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. METHODS: 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. RESULTS: Six critical decision-points were identified for industry decision-making, three for regulatory decision-making, and six for reimbursement/HTA decision-making. 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. CONCLUSION: 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.
BACKGROUND: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. OBJECTIVES: 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. METHODS: 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. RESULTS: Six critical decision-points were identified for industry decision-making, three for regulatory decision-making, and six for reimbursement/HTA decision-making. 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. CONCLUSION: 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.
Authors: Max Waschbusch; Lisa Rodriguez; Andreas Brueckner; Kerry Jo Lee; Xuefeng Li; Oksana Mokliatchouk; Lothar Tremmel; Shuai S Yuan Journal: Pharmaceut Med Date: 2022-07-03
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Authors: Ian P Smith; Rachael L DiSantostefano; Esther W de Bekker-Grob; Bennett Levitan; Conny Berlin; Jorien Veldwijk; G Ardine de Wit Journal: Patient Date: 2021-03-15 Impact factor: 3.883