Medicines Adaptive Pathways to Patients: Why, When, and How to Engage?

Autor: Eichler HG; European Medines Agency (EMA), London, UK., Bedlington N; European Patients Forum, Brussels, Belgium., Boudes M; EURORDIS-Rare Diseases Europe, Paris, France., Bouvy JC; National Institute for Health and Care Excellence (NICE), London, UK., Broekmans AW; Lygature, Utrecht, The Netherlands., Cerreta F; European Medines Agency (EMA), London, UK., Faulkner SD; Centre for the Advancement of Sustainable Medical Innovation (CASMI), Headington Oxford, UK., Forda SR; Eli Lilly and Company, London, UK., Joos A; MSD (Europe) Inc, Brussels, Belgium., Le Cam Y; EURORDIS-Rare Diseases Europe, Paris, France., Mayer MH; Eli Lilly and Company, Indianapolis, Indiana, USA., Pirard V; Sanofi-Genzyme, Brussels, Belgium., Corriol-Rohou S; Astra Zeneca, Paris, France.
Jazyk: angličtina
Zdroj: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2019 May; Vol. 105 (5), pp. 1148-1155. Date of Electronic Publication: 2018 Sep 11.
DOI: 10.1002/cpt.1121
Abstrakt: Medicines Adaptive Pathways to Patients (MAPPs) seeks to foster access to novel beneficial treatments for the right patient groups at the earliest appropriate time in the product life-span, in a sustainable fashion. We summarize the MAPPs engagement process and critical questions to be asked at each milestone of the product life-span. These considerations are of relevance for regulatory and access pathways that strive to address the "evidence vs. access" conundrum.
(© 2018 The Authors Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.)
Databáze: MEDLINE
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