A comprehensive analysis by public health experts at Novartis Romania has revealed that patients in Romania face an average wait of 460 days to access innovative medicines after they have been approved for reimbursement by the National Agency for Medicines and Medical Devices (ANMDM). This finding is part of a study titled ‘Delayed Access to Innovative Medicines in Romania: A Comprehensive Analysis of the Reimbursement Processes’, published in the international journal Frontiers in Public Health.
The study analyzed 613 Health Technology Assessment (HTA) reports from 2015 to 2024, covering over 660 therapeutic indications approved by the European Medicines Agency (EMA). The results showed that while the evaluation timeline from submission to HTA decision improved from 208 days in 2020 to approximately 100 days in 2024, the subsequent administrative process has slowed down. The average duration from HTA decision to medicine availability doubled during the same period, reaching 461 days in 2024.
Key Findings
- Conditionally approved indications required 274 more days on average to reach reimbursement compared to unconditional approvals.
- Within 24 months of the HTA decision, 98.3% of unconditionally reimbursed indications were listed for funding, compared to only 60.1% of conditional ones.
- The number of new medicines and indications with positive HTA evaluation but incomplete reimbursement process more than tripled from 47 in 2022 to 146 in 2024.
- Researchers predict this number could reach 247 by 2026 without structural reforms.
Impact on Patients
These delays particularly affect critical areas like oncology, which accounts for about 40% of all indications analyzed. The postponement of access to potentially life-saving treatments is significant for patients where every day counts.
Expert Commentary
“Ensuring timely access to innovative medicines is a fundamental goal of modern healthcare systems,” said Nona Chiriac, lead researcher and Value, Access, and Public Affairs Director at Novartis Romania. “While delays in reimbursement are not unique to Romania, our country remains among those with the longest gaps between EMA approval and actual patient access.” Chiriac emphasized the need for substantial reforms to create a more sustainable and equitable reimbursement system.
Romania’s Reimbursement Framework
The process for accessing reimbursed medicines in Romania involves multiple steps after EMA approval:
- Health Technology Assessment (HTA) by ANMDMR
- Reimbursement decision
- For conditional approvals, negotiation of Cost-Volume or Cost-Volume-Result agreements
- Inclusion in the list of free and reimbursed medicines through a government decision
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The Romanian healthcare system faces chronic underfunding, with per capita healthcare expenditure being one of the lowest in the EU at €1,663 in 2021, compared to the European average of €4,030. The system is heavily oriented towards hospital care, and only 45% of pharmaceutical costs are covered by public funds, compared to 59% across the EU.
The study’s findings highlight the urgent need for reforms to improve patient access to innovative medicines in Romania.
