Healthcare Systems across Europe and the US: The Managed Entry Agreements Experience

Abstract

This systematic study aims at analyzing the differences between the approach of the European healthcare systems to the pharmaceutical market and the American one. This paper highlights the opportunities and the limitations given by the application of managed entry agreements (MEAs) in European countries as opposed to the American market, which does not regulate pharmaceutical prices. Data were collected from the Organisation for Economic Co-operation and Development (OECD), the European Medicines Agency, and the national healthcare agencies of US and European countries. A literature review was undertaken in PubMed, Scopus, MEDLINE, and Google for a period ten years (2010-2019). The period 2020-2021 was considered to compare health expenditure before and after the SARS-CoV-2 pandemic. Scarce information from national agencies has been given in terms of MEAs related to the COVID-19 pandemic. The comparison between the United States approach and the European one shows the importance of a market access regulation to reduce the cost of therapies, increasing the efficiency of national healthcare systems and the advantages in terms of quality and accessibility to the final users: patients. Nevertheless, it seems that the golden age of MEAs for Europe was during the examined period. Except for Italy, countries will move to other forms of reimbursements to obtain higher benefits, reducing the costs of an inefficient implementation and outcomes in the medium term.

Keywords: drug pricing; health policies; managed entry agreements; pharmaceutical market; pharmaceutical risk sharing.

Figure 1

Health Expenditure as % of GDP and Pharmaceutical Expenditure per capita (in USD) of 29 OECD countries in 2015 [2].

Figure 2

Pharmaceutical Spending as % of total Health Expenditure in 2019 (pharmaceuticals in hospitals are not considered) [2].

Figure 3

Pharmaceutical Spending as % of total Health Expenditure (pharmaceuticals in hospitals are not considered) and Pharmaceutical Spending as % of total Health Expenditure in the period of 2010–2019 [2].

Figure 4

Regulatory flux for the approval of pharmaceutical products (abbreviations: NDA, new drug application; FDA, Food and Drug Administration; HHS, Department of Health and Human Services; CMS, Centers for Medicare & Medicaid Services; HMO, health maintenance organization; PBM, pharmacy benefit manager) [12].

Figure 5

Comparison between four different drug prices, before and after an estimated discount applied in the US market, compared with the price set in four European countries [19].

Figure 6

The taxonomy of Managed Entry Agreements (MEAs) is divided into two main forms: Financial schemes and performance-based agreements.

Figure 7

Bars chart: Percentage of arrangements developed in different therapeutic areas. Pie chart: Percentage of performance-based arrangements in 2013. CED: coverage with evidence development; CTC: conditional treatment continuation; PLR: performance-linked reimbursement.

Figure 8

The Italian price and reimbursement process and the panel of different managed agreements that are available.