Regulatory approvals and reimbursement pathways for psychiatric treatments in the United States and Europe: a targeted literature review

INTRODUCTION:

Access to psychiatric treatments varies by condition and region; psychiatric conditions (e.g., schizophrenia) have higher rates of negative reimbursement decisions than physical conditions (e.g., psoriasis), and differences between the FDA and EMA’s regulatory pathways imply that the EMA is slower to approve treatments due to differing evidentiary priorities [1], [2], [3]. Although the EMA approves centralised marketing authorisation, pricing and reimbursement are determined by national HTA agencies, resulting in heterogenous outcomes across Europe [3], [4]. This results in an innovation gap between the US and Europe, and between European countries, underscoring the need to understand and address regulatory and market access barriers in psychiatry.

AIMS:

To explore the innovation gap between psychiatric treatments in the US and Europe through a targeted literature review.

METHODS:

Treatments were identified from a previously reported FDA approval search [5]. From December 2025 to February 2026, EMA-approved psychiatric treatments (2016–2025) were investigated for reimbursement status within France, Germany, Italy, Spain, Switzerland, the Netherlands and the UK. Key extracted data were reimbursement decision (reimbursed, negative reimbursement decision [not reimbursed], or in progress/not appraised [IP/NA]) and date of decision. Descriptive statistics summarised indication- and treatment-level reimbursement. All searches were evaluated by one reviewer, a second reviewer provided input where needed.

RESULTS:

The FDA approved 41 treatments in 8 psychiatric conditions from 2016–2025. Of these, 11 were approved by the EMA, 11 by the MHRA and 10 by Swissmedic [4]. Among EMA-approved treatments, the median number of treatments reimbursed, IP/NA and with a negative reimbursement decision were 5 (45.5%), 4 (36.4%), and 2 (18.2%), respectively. Reimbursement rates varied by country (Table). Across regulatory approval and reimbursement, treatment availability declined from the FDA to EMA to national reimbursement for all indications; no treatment was reimbursed in all 7 European countries. Between 2016–2025, MDD and schizophrenia had 5 and 14 FDA-approved treatments, respectively, compared with 2 and 3 EMA-approved treatments; of which 57.1% (8/14) and 38.1% (8/21) of country-level reimbursement decisions were positive. ADHD had 9 FDA‑approved treatments compared with 1 EMA-approved which was mostly IP/NA in 5/7 countries. Bipolar disorder showed the greatest attrition; 9 FDA‑approved treatments and none received EMA approval.

CONCLUSION:

A disparity exists between FDA and EMA approvals of psychiatric treatments and reimbursement across major European countries following regulatory approval. Across psychiatric indications, the EMA approved fewer treatments than the FDA, and an even smaller subset achieved reimbursement in European countries, consistent with previous analyses highlighting broader access challenges in psychiatry [2]. These findings indicate that European patient access to innovative psychiatric treatments is shaped by regulatory and market access barriers, contributing to reduced and heterogeneous availability compared with the US as well physical conditions.

TABLE. Reimbursement rates per country

	Reimbursement decision N=11
Country	Reimbursed	IP/NA	Negative reimbursement decision
France	6 (54.5)	4 (36.4)	1 (9.1)
Germany	2 (18.2)	7 (63.6)	2 (18.2)
Italy	6 (54.5)	2 (18.2)	3 (27.3)
Spain	5 (45.5)	3 (27.3)	3 (27.3)
Switzerland	1 (9.1)	10 (90.9)	0 (0.0)
The Netherlands	7 (63.6)	4 (36.4)	0 (0.0)
United Kingdom	2 (18.2)	7 (63.6)	2 (18.2)

References

1. . Lau F, Seifert R. Comparison of drug approvals of the FDA and EMA between 2013 and 2023. Naunyn-Schmiedeberg’s Arch Pharmacol 2026;399(1):279–299.
2. . Huang Y, Sam L, Dwibedi N, et al. Poster presented at ISPOR US 2025 [ID: HPR41].
3. . Mandslay D, Almeida D, Marques A, et al. Comparative analysis of post-authorization measures for advanced medicinal products authorized in the European Union and in the United States of America between 2009 and 2023. Clin Pharmacol Ther 2025;117:73–93.
4. . Allen N, Liberti L, Walker SR, et al. A comparison of reimbursement recommendations by European HTA agencies: is there opportunity for further alignment? Front Pharmacol 2017;8:384
5. . Reif A, Werner-Kiechle T, Caudevilla C, et al. Poster presented at HTAi 2026 [ID: 718].