Health care in Spain in 2023, particularly regarding drug approvals and restrictions, was meticulously documented in the Annual Report by Farmaindustria, the association representing the pharmaceutical industry. The report provides detailed data on how often new drugs and indications were subject to prescribing or reimbursement restrictions, highlighting the outcomes of submissions to the Interministerial Commission on Drug Prices (CIPM).
A total of 195 new medicines and indications were submitted to the CIPM in 2023. Of these submissions, 72% received favorable outcomes. The success rates varied across different categories: new active substances, 75%; new indications, 69%; new formulations, 77%; combinations, 83%; oncology drugs, 68%; and non-oncology drugs, 71%.
Health Care Challenges: 47% of Approved Drugs in Spain Face Prescribing or Reimbursement Restrictions
Despite the relatively high approval rates, 47% of the approved drugs or indications faced prescribing or reimbursement restrictions. These restrictions were categorized as follows: by indication only, 36%; by reimbursement conditions only (e.g., expenditure ceilings, maximum cost per patient), 6%; and by both indication and reimbursement conditions, 5%.
The report indicates that non-oncology drugs were more frequently subject to these restrictions, with 59% facing limitations compared to 33% of oncology therapies.
The report also sheds light on the average times from obtaining a national code for medications to their listing as approved products. These times varied significantly depending on the type of drug: non-orphan and non-oncology drugs took 442 days, non-oncology orphan drugs took 705 days, orphan oncology drugs took 719 days, and non-orphan oncology drugs took 779 days.
This data suggests that oncology drugs, whether orphan or non-orphan, face longer delays before reaching the market compared to non-oncology drugs.
Health Care Update: Price Reductions for Certain Drug Classes in Spain During 2023
Farmaindustria’s report also notes that some drug classes experienced price reductions in 2023. In the outpatient setting, medications such as anti-diabetics, anti-epileptics, and asthma/COPD treatments saw price cuts. In the hospital setting, cancer therapies and migraine treatments were subject to price reductions.
The data presented by Farmaindustria reflects the complex and multifaceted nature of drug approval and reimbursement processes in Spain. The relatively high approval rates for new drugs and indications demonstrate the efficiency of the CIPM in processing applications. However, the significant proportion of drugs facing prescribing or reimbursement restrictions highlights the ongoing challenges in balancing drug accessibility with cost containment.
The longer approval times for oncology drugs, especially orphan drugs, point to potential areas for improvement in the regulatory process. These delays can impact patient access to crucial therapies, underlining the need for streamlined procedures that can expedite the availability of life-saving medications.
The findings of the report have important implications for both the pharmaceutical industry and healthcare policymakers. For pharmaceutical companies, understanding the likelihood and nature of restrictions can inform their strategic planning and market entry strategies. For policymakers, the data provides valuable insights into the current state of drug approval processes and highlights areas where policy adjustments could enhance efficiency and patient access.
Farmaindustria’s 2023 Annual Report offers a comprehensive overview of the prescribing and reimbursement landscape for new drugs and indications in Spain. By providing detailed data on approval rates, restrictions, and time to market, the report underscores the achievements and challenges within the Spanish healthcare system. Moving forward, addressing the identified bottlenecks and fostering a more efficient regulatory environment will be crucial for ensuring that patients have timely access to innovative therapies while maintaining the sustainability of the healthcare system.
Resource: This report is inspired by the article written by Neil Grubert, dated June 11, 2024.
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