艾昆纬-使用生物仿制药的激励措施在法国和欧洲分析、评估和展望（英）-2023-28页_1mb

Summary of Incentives for Using Biosimilars in France and Europe

1. Introduction and Benefits

Biosimilars are cost-effective alternatives to biologics, developed through biotechnological processes, and significantly reduce healthcare spending by offering up to 15-30% lower prices than reference drugs. Biologics constitute 35% of European pharmaceutical spending, with an annual growth rate nearly double that of the general market, reaching 11.3%. Biosimilars save billions annually—e.g., €2.4 billion in France by 2022, easing budgetary pressures from economic crises, aging populations, and therapeutic innovations.

2. Incentive Mechanisms

• France: Incentives include shared savings programs like the Article 51 test (hospital setting, 30% savings sharing) and Addendum 9 (63 hospitals, 80% market penetration target achieved in 2021). Other mechanisms involve CAQES contracts and incentives for private prescribers, totaling €40 million annual savings by 2023.
• Other European Countries: Ireland uses financial rewards for switching to biosimilars, achieving high penetration (e.g., 45% etanercept). England employs prescription budget controls and value-sharing, with 72% market penetration. Germany has regional incentives tied to prescription quotas, increasing adoption to 78%. Spain focuses on hospital incentives, reaching 62% revenue share.
• Common Themes: Incentives primarily involve value-sharing between prescribers and payers, enhancing adoption but with varying mechanisms across countries due to specific health system structures.

3. Challenges and Critical Analysis

• Adoption faces barriers like complex incentive calculations, difficulty in measuring healthcare professional engagement, and variations in community versus hospital settings (e.g., 31% vs. 80% biosimilar penetration in France).
• Patient factors, such as treatment attachment and nocebo effects, slow transitions, requiring better patient education and support from healthcare teams.
• Success depends on simplicity, clarity, payer involvement, and tailoring to specific therapeutic contexts to ensure effective market penetration.

4. Future Perspectives

• Short Term: Accelerate incentives for community settings, targeting patients already on reference biologics. Improve measure adaptation to avoid complicating healthcare professional workflows.
• Medium Term: Manage competition from upcoming biosimilars, aiming for continued growth to cover up to 70% biologics with biosimilars by 2027.
• Long Term: Ensure affordability and access to newly authorized biologics in Europe, with incentives supporting sustainability and patient access to innovative treatments.
• Key factors: Anticipating patent expirations, adapting to new drug forms, and maintaining dynamic incentive strategies for market sustainability.

5. Conclusion

Biosimilars pose a cost-effectiveness challenge that incentives must address to guarantee access to biologics and fund health innovations. Continued policy focus on simplified, targeted incentives is essential for achieving 80% market penetration and ensuring long-term healthcare budget relief.