Managed Entry Agreements for Pharmaceutical Products in Middle East and North African Countries: Payer and Manufacturer Experience and Outlook

Abstract

Objectives: The first objective is to describe current managed entry agreement (MEA) activity in the Middle East and North African (MENA) region and the pharmaceutical decision makers' perception and use of these agreements; The second objective is to describe the challenges as well as to reflect on the uncertainty related to MEAs implementation and the future outlook for MEAs activities in the region.

Study design: A prospective cross-sectional survey.

Methods: A questionnaire was sent to several pharmaceutical manufacturers and public officials involved in pricing and reimbursement of pharmaceuticals in the region.

Results: Of the 62% of total respondents, 25% were from the public sector, with the remainder from the pharmaceutical (pharma) industry. Only 42% of participants reported having MEAs running in their institutions, the majority representing Lebanon. All respondents reported the use of financial-based agreements, most referring to "discounted treatment" and, to a lesser extent, a "price volume agreement." Financial-based agreements were reported as either the only type of MEA (71.4%) being used or as being used with outcomes-based agreements (28.6%). The majority of participants ranked challenges in identifying and measuring relevant data as well as the lack of expertise in assessing health economics data. The majority of respondents projected an increase in the use of MEAs to address budget impact while improving access to innovative care.

Conclusions: Few MENA countries are implementing MEAs, which could be due to lack of data infrastructure as well as a shortage of experts in health economics. Health care stakeholders continue to be optimistic regarding the potential of MEA implementation.

Keywords: MENA; financial-based agreements; health economics; managed entry agreement; outcome-based agreements; performance-based risk-sharing arrangements.