Opportunities and Challenges of Cross-Country Collaborations in Market Access of Medicines: Stakeholder Perspectives on the BeNeLuxA Initiative

Author(s)

Claessens Z1, Lammens M2, Huys I2, Barbier L3
1Department of Clinical Pharmacology and Pharmacotherapy, KU Leuven, Leuven, VAN, Belgium, 2Department of Clinical Pharmacology and Pharmacotherapy, KU Leuven, Leuven, VBR, Belgium, 3Department of Clinical Pharmacology and Pharmacotherapy, KU Leuven, Leuven, Belgium

BACKGROUND: The increasing complexity and budgetary and clinical uncertainties of medicines drive countries to join forces. Cross-Country Collaborations (CCC) for market access of medicines are increasingly established with the aim of tackling these challenges by pooling expertise and building capacity. The BeNeLuxA initiative is an example of such collaboration that aims to jointly guarantee sustainable and affordable access to medicines in multiple European Member States. However, little is known about the functioning of this initiative.

OBJECTIVES: This study aims to gain insights from both policy makers and pharmaceutical industry representatives into the functioning of the BeNeLuxA initiative, identifying opportunities and challenges for BeNeLuxA and transferable learnings for CCC generally.

METHODS: Fifteen semi-structured interviews were conducted with policy and industry stakeholders knowledgeable about the BeNeluxA initiative. The interview transcripts were analyzed according to the thematic framework approach.

RESULTS: Results show that the perspective on the functioning of BeNeLuxA differs between policy and industry stakeholders. Industry stakeholders argue that this misunderstanding stems from limited communication and transparency on BeNeLuxA procedures, which is reflected in the notion that procedures are complex and unclear. Yet, they acknowledge the opportunities enabled by CCC and emphasize their support. Some of those opportunities have been translated to practice, referring to successful joint efforts for market access of two medicines, while some argue that this is only a fraction of what is possible. Recommendations to improve CCC include (I) improving communication and stakeholder dialogue, (II) creating a rooted legislative framework, (III) and adjusting the internal organisation of companies to a CCC environment.

CONCLUSIONS: Increased CCC can be an efficient way of addressing emerging accessibility and affordability challenges in the current market access framework. However, the changing European framework calls for a reevaluation of the value and position of CCCs taking into account the identified opportunities.

Conference/Value in Health Info

2022-11, ISPOR Europe 2022, Vienna, Austria

Value in Health, Volume 25, Issue 12S (December 2022)

Code

HTA121

Topic

Health Policy & Regulatory, Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes, Public Spending & National Health Expenditures, Reimbursement & Access Policy

Disease

STA: Biologics & Biosimilars, STA: Genetic, Regenerative & Curative Therapies, STA: Personalized & Precision Medicine

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