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. 2022 Jun 16:4:888404.
doi: 10.3389/fmedt.2022.888404. eCollection 2022.

A Proposal for Value-Based Managed Entry Agreements in an Environment of Technological Change and Economic Challenge for Publicly Funded Healthcare Systems

Entela Xoxi  1 , Filippo Rumi  1 , Panos Kanavos  2 , Hans-Peter Dauben  3 , Iñaki Gutierrez-Ibarluzea  4 , Olivier Wong  5 , Guido Rasi  6 , Americo Cicchetti  1
Affiliations

A Proposal for Value-Based Managed Entry Agreements in an Environment of Technological Change and Economic Challenge for Publicly Funded Healthcare Systems

Entela Xoxi et al. Front Med Technol. .

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.

Keywords: innovativeness; managed entry agreement (MEA); pharmaceutical pricing and reimbursement; real-world data (RWD); registries; value-based agreements; value-based framework.

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Conflict of interest statement

OW was employed by Medi-Qualité Omega. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
The flow of AIFA decision on individual-level registry with or without MEA.
Figure 2
Figure 2
Distribution (%) of the types of MEA (*) patient-level for 2020 within AIFA registries.
Figure 3
Figure 3
Current AIFA MEA registry pathway.
Figure 4
Figure 4
New pathway based on VBMEA AIFA registry.
See this image and copyright information in PMC

References

    1. Eichler HG, Abadie E, Breckenridge A, Flamion B, Gustafsson LL, Leufkens H, et al. . Bridging the efficacy-effectiveness gap: a regulator's perspective on addressing variability of drug response. Nat Rev Drug Discov. (2011) 10:495–506. 10.1038/nrd3501 - DOI - PubMed
    1. Wenzl M, Chapman S. Performance-Based Managed Entry Agreements For New Medicines in OECD Countries and EU Member States: How They Work and Possible Improvements Going Forward. OECD Health Working Papers, No. 115, Paris: OECD Publishing; (2019).
    1. Kanavos P, Ferrario A, Tafuri G, Siviero P. Managing risk and uncertainty in health technology introduction: the role of managed entry agreements. Glob Pol. (2017) 8:84–92. 10.1111/1758-5899.12386 - DOI
    1. Facey KM, Espin J, Kent E, Link A, Nicod E, O'Leary A, et al. . Implementing outcomes-based managed entry agreements for rare disease treatments: nusinersen and tisagenlecleucel. Pharmacoeconomics. (2021) 7:1–24. 10.1007/s40273-021-01050-5 - DOI - PMC - PubMed
    1. Godman B, Fadare J, Kwon HY, Dias CZ, Kurdi A, Dias Godói IP, et al. . Evidence-based public policy making for medicines across countries: findings and implications for the future. J Comp Eff Res. (2021) 10:1019–52. 10.2217/cer-2020-0273 - DOI - PubMed

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