Radu Constantin, Serban Diana Elena, Chiriac Nona Delia
Novartis Pharma Services, Bucharest, Romania.
Front Public Health. 2025 May 30;13:1592419. doi: 10.3389/fpubh.2025.1592419. eCollection 2025.
Romania's reimbursement framework for innovative medicines relies on health technology assessments (HTAs) resulting in unconditional or conditional decisions. Although conditional decisions aim to manage financial uncertainty via Cost-Volume (CV) agreements, anecdotal evidence points to growing delays and a growing backlog of indications waiting to be reimbursed. This study is the first to systematically quantify these delays and assess their evolution over time.
We analyzed all publicly available full HTA reports (2015-2024) from Romania's National Drug Agency. Each indication was classified by HTA decision (unconditional, conditional, or negative) and reimbursement status. Descriptive analyses included mean and median durations for HTA and reimbursement processes. A Kaplan-Meier survival analysis compared time-to-reimbursement between conditional and unconditional indications. Finally, we fit a simple linear model (2022-2024) to project future backlog growth under current policies.
Out of 613 full HTA reports covering 666 indications, 44% were conditionally approved, 42% unconditionally, and 14% received a negative decision; oncology accounted for ~40% of all indications. The HTA process (submission to decision) improved considerably, with mean durations nearly halving from 208 days in 2020 to roughly 100 days in 2024. Despite these improvements, the mean time from HTA decision to reimbursement rose from 222 days in 2020 to 461 days in 2024 overall, with conditional decisions taking on average 274 more days than unconditional ones in 2024. Kaplan-Meier analysis showed that by 24 months post-HTA decision, 98.3% of unconditional indications were reimbursed, compared to only 60.1% of conditional indications. Meanwhile, the backlog of unreimbursed indications increased from 47 in 2022 to 146 in 2024, and linear projections suggest it could reach 247 by 2026 under the current system.
Despite some efficiency gains in the HTA evaluation stage, Romania's conditional reimbursement pathway remains hampered by tight budgets and administrative hurdles, prolonging patient inaccessibility-particularly in oncology, where timely treatment is critical. Strengthening administrative capacity, diversifying Managed Entry Agreement (MEA) models, and integrating new digital tools could help address these bottlenecks. Without substantial reforms, the backlog will continue growing, limiting patients' timely access to innovative therapies.
罗马尼亚创新药物报销框架依赖于卫生技术评估（HTA），评估结果会产生无条件或有条件的决定。尽管有条件决定旨在通过成本-数量（CV）协议来应对财务不确定性，但轶事证据表明，审批延迟不断增加，等待报销的适应症积压也在增多。本研究首次系统地量化了这些延迟，并评估了它们随时间的演变情况。
我们分析了罗马尼亚国家药品管理局所有公开的完整HTA报告（2015 - 2024年）。每个适应症根据HTA决定（无条件、有条件或否定）和报销状态进行分类。描述性分析包括HTA和报销流程的平均及中位数持续时间。卡普兰-迈耶生存分析比较了有条件和无条件适应症的报销时间。最后，我们拟合了一个简单线性模型（2022 - 2024年）来预测在当前政策下未来积压情况的增长。
在涵盖666个适应症的613份完整HTA报告中，44%获得有条件批准，42%获得无条件批准，14%获得否定决定；肿瘤学适应症占所有适应症的约40%。HTA流程（提交至做出决定）有了显著改善，平均持续时间从2020年的208天大幅减半至2024年的约100天。尽管有这些改善，但从HTA决定到报销的平均时间总体上从2020年的222天增至2024年的461天，2024年有条件决定的平均时间比无条件决定多274天。卡普兰-迈耶分析表明，在HTA决定后的24个月时，98.3%的无条件适应症获得报销，而有条件适应症只有60.1%。与此同时，未报销适应症的积压从2022年的47个增至2024年的146个，线性预测表明在当前系统下到2026年可能达到247个。
尽管在HTA评估阶段有了一些效率提升，但罗马尼亚的有条件报销途径仍因预算紧张和行政障碍而受阻，延长了患者无法获得药物的时间——尤其是在肿瘤学领域，及时治疗至关重要。加强行政能力、使管理进入协议（MEA）模式多样化以及整合新的数字工具可能有助于解决这些瓶颈问题。如果不进行实质性改革，积压情况将继续增加，限制患者及时获得创新疗法。
