Monday, February 10, 2025

Managed Entry Agreements Open Doors for Expensive New Drugs in Major Markets

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High-priced medications targeting severe and previously untreatable conditions are gaining approval across South Korea, England, Australia, and Canada. These approvals come despite limited initial evidence and substantial costs, thanks largely to strategic managed entry agreements (MEAs) that facilitate their introduction to the market.

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Approval Strategies Across Countries

In England, MEAs have played a pivotal role, enabling nearly all evaluated drugs to receive positive recommendations. Similarly, South Korea has granted cost-effectiveness analysis (CEA) waivers for these medications, acknowledging the significant unmet medical needs they address. Australia and Canada have adopted a balanced approach, utilizing both indirect comparisons and head-to-head trial data to assess the effectiveness of these drugs. Notably, single-arm trials are predominantly used in South Korea and England, reflecting different methodological preferences in these regions.

Challenges with Cost-Effective Analysis

While MEAs facilitate market entry, the requirement for CEA data remains stringent in all countries except South Korea. England stands out by mandating data collection for coverage with evidence development in over half of the cases, a step less frequently observed in Australia and Canada. This emphasis on ongoing data acquisition underscores the complexities in balancing immediate patient access with long-term cost-effectiveness evaluations.

  • Managed Entry Agreements are essential for introducing high-cost drugs with limited initial evidence.
  • England relies heavily on indirect comparisons, aligning with its established HTA practices.
  • South Korea’s willingness to waive CEA requirements highlights varying international approaches to drug reimbursement.
  • Data collection requirements differ significantly, affecting how countries manage evidence gaps.

The increasing acceptance of uncertainties surrounding high-priced drugs through managed entry agreements signifies a pragmatic shift in health technology assessments. This approach not only expedites access to crucial medications for patients but also emphasizes the necessity of robust value assessments and effective uncertainty management. Furthermore, enhancing national and international collaborations for data collection can bridge evidence gaps, ensuring that these costly treatments provide genuine value for money. Stakeholders must prioritize comprehensive evaluation frameworks and foster cooperative efforts to sustain the delicate balance between innovation, accessibility, and economic viability in healthcare.

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