Importance of aligning the implementation of new payment models for innovative pharmaceuticals in European countries

ABSTRACT

Introduction

The uptake of complex technologies and platforms has resulted in several challenges in the pricing and reimbursement of innovative pharmaceuticals. To address these challenges, plenty of concepts have already been described in the scientific literature about innovative value judgment or payment models, which are either (1) remaining theoretical; or (2) applied only in pilots with limited impact on patient access; or (3) applied so heterogeneously in many different countries that it prevents the health care industry from meeting expectations of HTA bodies and health care payers in the evidence requirements or offerings in different jurisdictions.

Areas covered

This paper provides perspectives on how to reduce the heterogeneity of pharmaceutical payment models across European countries in five areas, including 1) extended evaluation frameworks, 2) performance-based risk-sharing agreements, 3) pooled procurement for low volume or urgent technologies, 4) alternative access schemes, and 5) delayed payment models for technologies with high upfront costs.

Expert opinion

Whilst pricing and reimbursement decisions will remain a competence of EU member states, there is a need for alignment of European pharmaceutical payment model components in critical areas with the ultimate objective of improving the equitable access of European patients to increasingly complex pharmaceutical technologies.

KEYWORDS:

• Affordability
• alternative access schemes
• complex technologies
• evaluation framework
• innovative pharmaceuticals
• payment model
• value judgment
• uncertainty

Article highlights

• The uptake of complex technologies and platforms has resulted in several challenges in the pricing and reimbursement of innovative pharmaceuticals.

• To address these challenges, several new payment models for special innovative pharmaceutical technologies have been described in the scientific literature.

• Apart from financial managed entry agreements, novel payment model components are applied only in pilots with limited impact on patient access or applied heterogeneously in different countries.

• If changes in payment model components and related value judgment methods go into different directions in EU member states, multinational pharmaceutical companies may not be able to generate a truly global value proposition and supportive evidence package, which is uniformly acceptable in the majority of countries.

• The highest need is not the design of additional novel payment models, but the uptake and more aligned use of previously piloted payment model components in EU member states. The paper outlines the vision of the authors on the five most important areas for harmonized actions in the European Union.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Acknowledgments

The authors gratefully acknowledge the contribution of all other members of the PRO-CURA consortium. Special thanks to Dalia Dawoud and Jamie Elvidge for their professional input.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.