Event

Explore pharmaceutical pricing and reimbursement systems across Europe

Pharmaceutical reimbursement systems in Europe vary widely, shaped by national policies and healthcare priorities. This course explores decision-making processes, focusing on public health insurers, HTA, and value-based pricing and the expected impact of EU-HTA Regulation. Participants will gain insights into reimbursement frameworks, market access strategies, and regulatory trends.

Key topics covered:

Market Access Fundamentals:

• The role of public health insurers as monopoly buyers.

• How payer priorities and health technology assessments (HTA) influence reimbursement decisions.

• The increasing shift towards value-based pricing and managed entry agreements.

Payer Perspectives and Value Assessment:

• Emphasis on outcomes-based contracts and the strategic use of real-world evidence.

• Diverse interpretations of “value” and how it shapes access and innovation.

Country-Specific Reimbursement Pathways and New EU Regulation:

• France: SMR/ASMR ratings, CEPS negotiations, health economics vs. pricing committee tensions.

• Germany: AMNOG early benefit assessments, rigid technical criteria, post-assessment price negotiations.

• Italy: Regional decision-making, Grade model for innovation, value-based contracts.

• Spain: Regional variation, therapeutic positioning, increasing reliance on post-launch RWE.

• UK: QALY thresholds, multiple access routes, and flexible patient access schemes.

• Netherlands: Centralized HTA with cost-effectiveness emphasis, fragmented private insurer implementation.

• Poland: Tiered HTA processes, Ministry of Health negotiations, innovation-driven access pathways.

Overview of EU HTA Regulation:

• Impact on Member States’ access timelines, regulatory alignment, and opportunities for harmonization.

Comparative Analysis of EU Market Access:

• Similarities: Formal HTA processes, value assessment frameworks, price negotiations.

• Differences: Cost-effectiveness thresholds, clinical evidence standards, timelines, and decision-making levels.

Value-Based Pricing and Market Dynamics:

• How “value” is defined and measured across systems.

• The implications of pricing approaches for patient access and innovation sustainability.

After completing this course, you should be able to:

• Have a clear understanding of the reimbursement frameworks in major European countries.

• Be equipped to compare and contrast the key characteristics of each system, appreciating the diversity and rationale behind national approaches.

• Gain insights into the latest regulatory developments and market access strategies.

• Be able to apply this knowledge to real-world scenarios in pharmaceutical policy, access planning, and health economics.

• Understand the EU-HTA Regulation with its limit and opportunities.

Participants will leave with the tools and knowledge needed to navigate the European reimbursement landscape with confidence, applying real-world insights to drive strategic decision-making in global market access.

This course is designed for individuals with intermediate experience within a single healthcare system wishing to broaden their appreciation of other reimbursement systems.

This short course is offered in-person at the ISPOR Europe 2024 conference.

Buxton, Derbyshire, UK

Schedule:

LENGTH: 8 Hours | Course runs 1 day

Sunday, 9 November 2025 | Course runs 1 Day
08:00-17:00 Central European Time (CET)