Stakeholder Insights into Czech Performance-Based Managed Entry Agreements: Potential for Transformative Change in...

Area of Science:

• Health Economics
• Pharmaceutical Policy
• Value-Based Healthcare

Background:

• Managed Entry Agreements (MEAs) address rising costs of innovative medical technologies, particularly in oncology, immunology, and rare diseases.
• Performance-Based MEAs (PB MEAs) and Outcome-Based MEAs (OB MEAs) represent innovative strategies within MEAs.
• Escalating healthcare costs necessitate novel reimbursement strategies for advanced therapies.

Purpose of the Study:

• To examine the adoption and stakeholder perceptions of Performance-Based MEAs (PB MEAs) in the Czech Republic following a 2022 legislative update.
• To identify key challenges and facilitators for successful PB MEA implementation.
• To explore the role of patient involvement and stakeholder readiness in the Czech context.

Main Methods:

• Qualitative study employing semi-structured interviews with key stakeholders.
• Stakeholder groups included the Ministry of Health, pharmaceutical companies, insurers, and patient organizations.
• Analysis focused on perceptions of legislation, data quality, transparency, methodology, and implementation barriers.

Main Results:

• Stakeholders expressed concerns regarding legislative completeness, data quality, transparency, and methodology for PB MEAs.
• Pharmaceutical companies showed less concern for transparency and methodology, potentially due to international experience.
• Despite legislative advancements, significant challenges remain in data infrastructure, risk-sharing perception, and stakeholder preparedness.

Conclusions:

• Successful PB MEA implementation requires a holistic approach beyond legislation, focusing on trust, technical infrastructure, and data availability.
• Collaboration between pharmaceutical firms and payers is essential for overcoming implementation hurdles.
• Enhancing patient involvement and aligning with value-based healthcare principles are critical for future pharmaceutical reimbursement models.