英文_EFPIA_小型市场不可用和延迟的根本原因——国家分析_42页_999kb

Summary of European Access Hurdles Portal Analysis for Smaller Markets

Core Content

This document provides an analysis of the reasons for delays in filing and reimbursement of newly centrally approved medicines in smaller European markets, specifically focusing on Malta, Cyprus, and Latvia. It highlights the challenges and inefficiencies in the pricing and reimbursement (P&R) systems, the impact of local context, and the limitations of the European Access Hurdles Portal in capturing the full picture of these barriers.

Main Points

Malta

• Low Reimbursement Rate: Only 1% of innovative medicines are reimbursed.
• Low Filing Rate: 9% of products are filed for inclusion in the Government Formulary List (GFL), which does not guarantee access.
• Alternative Access: 15% of products are available through alternative schemes like the Community Chest Fund and the Exceptional Medicines Treatment Committee (EMTC).
• Key Barriers:
  • Under-resourced P&R system: Delays in decision-making and budget constraints affect filing.
  • Lack of transparency: Companies are discouraged from filing due to uncertainty about the status of their submissions.
  • Single-winner tenders: These are price-only and last 3-4 years, potentially excluding innovative medicines.
  • Small treatable population: Makes budget impact analysis difficult and less attractive for MAHs.
  • Lack of company presence: Complicates the filing process and reduces the likelihood of a viable business case.
  • External reference pricing: Influences pricing decisions and may discourage filing.
  • Budget constraints: The pharmaceutical budget has not increased in line with the overall healthcare budget.

Cyprus

• Low Reimbursement Rate: Only 1% of innovative medicines are reimbursed.
• Low Filing Rate: 20% of products are filed for inclusion in the positive reimbursement list (GESY), but few are actually reimbursed.
• Alternative Access: 27% of products are accessible through a named patient programme, which was previously managed by the Ministry of Health but is now under GESY.
• Key Barriers:
  • New P&R system: Introduced in 2019, leading to initial backlogs and uncertainty.
  • Complex and opaque P&R process: Lack of transparency discourages filing.
  • Fluctuating healthcare budget: Budget for medicines has not grown with the overall healthcare budget.
  • Lack of local data: Makes budget impact analysis challenging, especially for orphan drugs.
  • Influence of external reference pricing: Greece is heavily referenced, affecting pricing and decision-making.

Latvia

• Low Reimbursement Rate: Only 10% of innovative medicines are reimbursed.
• Low Filing Rate: 29% of products are filed for inclusion in the positive reimbursement list, but only 10% are reimbursed.
• Alternative Access: 6% of products are available through named patient programmes, though these are inefficient and underdeveloped.
• Key Barriers:
  • Constrained healthcare budget: Leads to a queue of products awaiting reimbursement.
  • Political prioritization: Decisions may favor certain therapy areas over others.
  • Limited epidemiological data: Hinders budget impact analysis and innovative contracting.
  • Lack of transparent P&R process: Companies are unsure of the status of their filings and may avoid submitting new products.

Key Findings

• Portal Limitations: The current Portal data may underrepresent certain barriers, such as reliance on other countries’ evaluations and the impact of political decisions.
• Alternative Access: These schemes provide access to some products without formal filing, but they are not fully captured in the Portal data.
• Market Dynamics: The size of the treatable population, budget constraints, and lack of local infrastructure and company presence significantly impact the feasibility and speed of filing.
• Systemic Challenges: All three countries face systemic issues in their P&R systems that make it difficult for MAHs to justify the cost of launching new medicines.

Conclusion

The analysis underscores the complexity of P&R systems in smaller markets and highlights the need for more transparent and efficient processes. The Portal data, while informative, may not fully reflect the nuanced challenges faced by MAHs, suggesting the potential need for additional categories or more detailed reporting to capture the true landscape of access hurdles.