A Proposal for Value-Based Managed Entry Agreements in an Environment of Technological Change and Economic Challenge for Publicly Funded Healthcare Systems
- Xoxi, Entela
- Rumi, Filippo
- Kanavos, Panos
- Dauben, Hans-Peter
- Gutierrez-Ibarluzea, Iñaki
- Wong, Olivier
- Rasi, Guido
- Cicchetti, Americo
ISSN: 2673-3129
Year of publication: 2022
Volume: 4
Type: Article
More publications in: Frontiers in Medical Technology
Abstract
Managed entry agreements (MEA) represent one of the main topics of discussion between the European National Payers Authorities. Several initiatives on the subject have been organized over the past few years and the scientific literature is full of publications on the subject. There is currently little international sharing of information between payers, mainly as a result of the confidentiality issues. There are potential benefits from the mutual sharing of information, both about the existence of MEAs and on the outcomes and results. The importance of involving all the players in the decision-making process on market access for a medicinal product (MP) is that it may help to make new therapies available to patients in a shorter time. The aim of this project is to propose a new pathway of value-based MEA (VBMEA), based on the analysis of the current Italian pricing and reimbursement framework. This requires elaboration of a transparent appraisal and MEA details with at least a 24-month contract. The price of the MP is therefore valued based on the analysis of the VBMEA registries of the Italian Medicines Agency. Although the proposal focuses on the Italian context, a similar approach could also be adapted in other nations, considering the particularities of the single health technology assessment (HTA)/payer system.
Bibliographic References
- Eichler, (2011), Nat Rev Drug Discov, 10, pp. 495, 10.1038/nrd3501
- Wenzl, (2019), Performance-Based Managed Entry Agreements For New Medicines in OECD Countries and EU Member States: How They Work and Possible Improvements Going Forward.
- Kanavos, (2017), Glob Pol., 8, pp. 84, 10.1111/1758-5899.12386
- Facey, (2021), Pharmacoeconomics., 7, pp. 1, 10.1007/s40273-021-01050-5
- Godman, (2021), J Comp Eff Res., 10, pp. 1019, 10.2217/cer-2020-0273
- Efthymiadou, (2021), Int J Technol Assess Health Care, 37, pp. e31, 10.1017/S0266462321000039
- Russo, (2021), Health Policy
- Facey, (2020), Int J Technol Assess Health Care, 3, pp. 1, 10.1017/S026646232000063X
- Faulkner, (2016), Clin Pharmacol Ther 100., 10.1002/cpt.508
- Xoxi, (2021), Front Pharmacol, 12, pp. 699466, 10.3389/fphar.2021.699466
- 2017
- Fortinguerra, (2020), Br J Clin Pharmacol 86., 10.1111/bcp.14138
- Law August 7,. n. 135 website2012
- Law August 6,. n. 125 website2015
- Law December 11,. n. 232 website2016
- Law December 27,. n. 205 website2017
- 2019
- 2019
- 2021
- 2020
- 2021
- 2021
- 2020
- 2021
- 2021
- 2021
- 2021
- Montilla, (2015), Int J Technol Assess Health Care 31., 10.1017/S0266462315000446
- Italy Post-Marketing Successful Strategies to Manage Pharmaceutical Innovation. In: Braithwaite J, Russell M, Matsuyama Y, editors1927 CicchettiA CorettiS IacopinoV MontillaS XoxiE LucaP Health Systems Improvement across the Globe. Success Stories from 60 Countries2017
- 2021
- Decreto Ministero della Salute 2 agosto2019
- 2020
- 2020
- Jommi, (2018), Equitable Access to High-Cost Pharmaceuticals. vol. 4., 10.1016/B978-0-12-811945-7.00004-X
- Flume, (2016), J Market Access Health Pol., 4, pp. 30970, 10.3402/jmahp.v4.30970
- Jommi, (2020), Clin Ther, 42, pp. 15, 10.1016/j.clinthera.2019.11.006
- Trotta, (2019), BMJ Open, 9, pp. e033728, 10.1136/bmjopen-2019-033728
- Villa, (2019), Health Policy
- Russo, (2021), Value Health, 24, pp. 1273, 10.1016/j.jval.2021.04.1278
- 2021
- 2016
- (2020), Draft Guideline On Registry-Based Studies EMA/.
- EUnetHTA, (2019), Vision Paper on the Sustainable Availability of the Proposed Registry Evaluation and Quality Standards Tool (REQueST) Report produced as part of EUnetHTA Joint Action 3 Work Package 5B (Post-Launch Evidence Generation and Registries).
- Hatswell, (2016), BMJ Open., 6, pp. e011666, 10.1136/bmjopen-2016-011666
- Patel, (2021), 24, pp. 1118, 10.1016/j.jval.2021.01.015
- Najafzadeh, (2017), Clin Pharmacol Ther, 102, pp. 914, 10.1002/cpt.873
- Coorevits, (2013), J Intern Med, 274, pp. 547, 10.1111/joim.12119
- CHMP/EWP/83561/2005. LondonEMA2006
- Gray, (2020), Drug Saf., 43, pp. 623, 10.1007/s40264-020-00944-1
- 2012
- 2019
- 2018
- Garattini, (2015), Eur J Health Econ, 16, pp. 1, 10.1007/s10198-014-0585-5
- Onder, (2021), Eur J Prev Cardiol., 21, pp. zwab096, 10.1093/eurjpc/zwab096
- Russo, (2020), Eur Rev Med Pharmacol Sci., 24, pp. 5758, 10.26355/eurrev_202005_21368
- Breccia, (2020), Cancer Med., 9, pp. 4160, 10.1002/cam4.3071
- 2015
- 2021
- 2021
- 2020
- (2021), HTA WP 10 -HTA Outcomes-Based Managed Entry Agreements (OBMEA): Tools to Support Use and Implementation With a Rare Disease
- 2019
- Khosla, (2021), Ther Innov Regul Sci, 55, pp. 889, 10.1007/s43441-021-00288-7
- 2018
- (2019), Driving the digital transformation of Germany's healthcare system for the good of patients The Act to Improve Healthcare Provision through Digitalisation and Innovation.