Introduction 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), 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.

Methods 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.

Results 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 205 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 509 days in 2024 overall, with conditional decisions taking on average 282 more days than unconditional ones in 2024. Kaplan-Meier analysis showed that by 24 months post-HTA decision, 98.2% of unconditional indications were reimbursed, compared to only 49.3% of conditional indications. Meanwhile, the backlog of unreimbursed indications increased from 48 in 2022 to 164 in 2024, and linear projections suggest it could reach 280 by 2026 under the current system.

Discussion 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.

All authors are employees of Novartis Pharma Services Romania SRL and report no other conflicts of interest.

As all authors are employees of Novartis Pharma Services Romania SRL, the work presented in this manuscript was conducted as part of their employment responsibilities, and no additional external funding was received.

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

All data produced in the present study are available from public sources.