Exploring the opportunities for alignment of regulatory postauthorization requirements and data required for performance-based managed entry agreements
| Autor: | Jonathan Lind Martinsson, Peter Arlett, Rick A. Vreman, Martin Wenzl, Inneke van de Vijver, Roisin Adams, Anna Nachtnebel, Lonneke Timmers, Hans-Georg Eichler, Einar Andreassen, Suzannah Chapman, Elias Pean, Tove Ragna Reksten, Guido Rasi, Wim G. Goettsch, Marc Van de Casteele, Jordi Llinares-Garcia |
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| Přispěvatelé: | Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology |
| Rok vydání: | 2021 |
| Předmět: |
Process management
Drug Industry Pricing and reimbursement Health Policy Time horizon Drug regulation Real-world data Settore MED/07 Data sharing Product (business) Intervention (law) Managed entry agreement Transparency (graphic) Data quality Agency (sociology) Costs and Cost Analysis Humans Business Reimbursement |
| Zdroj: | International Journal of Technology Assessment in Health Care, 37(1), 1. Cambridge University Press |
| ISSN: | 0266-4623 |
| Popis: | Performance-based managed entry agreements (PB-MEAs) might allow patient access to new medicines, but practical hurdles make competent authorities for pricing and reimbursement (CAPR) reluctant to implement PB-MEAs. We explored if the feasibility of PB-MEAs might improve by better aligning regulatory postauthorization requirements with the data generation of PB-MEAs and by active collaboration and data sharing. Reviewers from seven CAPRs provided structured assessments of the information available at the European Medicines Agency (EMA) Web site on regulatory postauthorization requirements for fifteen recently authorized products. The reviewers judged to what extent regulatory postauthorization studies could help implement PB-MEAs by addressing uncertainty gaps. Study domains assessed were: patient population, intervention, comparators, outcomes, time horizon, anticipated data quality, and anticipated robustness of analysis. Reviewers shared general comments about PB-MEAs for each product and on cooperation with other CAPRs. Reviewers rated regulatory postauthorization requirements at least partly helpful for most products and across domains except the comparator domain. One quarter of responses indicated that public information provided by the EMA was insufficient to support the implementation of PB-MEAs. Few PB-MEAs were in place for these products, but the potential for implementation of PB-MEAs or collaboration across CAPRs was seen as more favorable. Responses helped delineate a set of conditions where PB-MEAs may help reduce uncertainty. In conclusion, PB-MEAs are not a preferred option for CAPRs, but we identified conditions where PB-MEAs might be worth considering. The complexities of implementing PB-MEAs remain a hurdle, but collaboration across silos and more transparency on postauthorization studies could help overcome some barriers. ispartof: International Journal Of Technology Assessment In Health Care vol:37 issue:e83 pages:1-11 ispartof: location:England status: Published online |
| Databáze: | OpenAIRE |
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