THE NEUROPSYCHIATRY INNOVATION GAP IN EUROPE: APPROVAL, REIMBURSEMENT AND HTA VALUE RATINGS IN FRANCE AND GERMANY (2010-2025)
Author(s)
Andreas Reif, MD1, Concha Caudevilla, Sr., PhD2, Tetsuro Ito, BSc, MBA, MSc3, Callum Ewen, BSc, MSc4, Celso Arango, PhD, MD5.
1University Hospital Frankfurt – Goethe University; Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Frankfurt, Frankfurt am Main, Germany, 2J&J Innovative Medicine, Zug, Switzerland, 3EMEA Compound Market Access Leader - Mood Disorders, Janssen, High Wycombe, United Kingdom, 4Costello Medical, London, United Kingdom, 5Hospital General Universitario Gregorio Marañón, Madrid, Spain.
1University Hospital Frankfurt – Goethe University; Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Frankfurt, Frankfurt am Main, Germany, 2J&J Innovative Medicine, Zug, Switzerland, 3EMEA Compound Market Access Leader - Mood Disorders, Janssen, High Wycombe, United Kingdom, 4Costello Medical, London, United Kingdom, 5Hospital General Universitario Gregorio Marañón, Madrid, Spain.
OBJECTIVES: Previous research identified a quantitative innovation gap in neuropsychiatry between the US and Europe [1]; however, binary reimbursement counts may overestimate real-world access. This targeted literature review (TLR) assessed health technology assessment (HTA) value ratings in France and Germany, and whether low-value ratings contribute to attrition across the access pathway.
METHODS: Building on a TLR of FDA-approved treatments for 17 psychiatric conditions (2010-2025) [1], HTA value assessments in France and Germany were analysed. For EMA-approved treatments with completed appraisals, Amélioration du Service Médical Rendu (ASMR) ratings (France; I-V: major-no improvement) and added-benefit conclusions (Germany) were mapped to a three-stage attrition framework: regulatory approval, reimbursement decision and clinical value ratings.
RESULTS: Of 62 FDA-approved psychiatric treatments, 23 received EMA approval (63% attrition). Of these, 20 were reimbursed in ≥1 major EMA market, but only two in all five markets (France, Germany, Italy, the Netherlands, Spain). In France, 12/23 (52%) EMA-approved treatments were reimbursed. Among 15 appraisals, nine (60%) received ASMR V, five (33%) received ASMR IV, and one had insufficient SMR; none achieved ASMR I-III. In Germany, 5/23 (22%) EMA-approved treatments were reimbursed. Among eight appraisals, six (75%) found “no added benefit”, one achieved “minor added benefit” (restricted subpopulation) and one demonstrated “considerable added benefit”. Overall, three attrition points emerged: EMA approval (63% lost), low reimbursement (52% France; 22% Germany) and low-value ratings (60% in ASMR V; 75% “no added benefit” among appraised).
CONCLUSIONS: This innovation gap in neuropsychiatry extends beyond approval; most appraised treatments received low-value ratings, suggesting HTA frameworks may not adequately capture relevant results such as tolerability, quality of life and carer impact. Attrition may deter future European neuropsychiatric research investment and efforts such as reviewing the access pathway (including a more holistic value assessment) may help narrow the innovation gap in neuropsychiatry. [1]. Reif A. Presented at HTAi [ID: 718].
METHODS: Building on a TLR of FDA-approved treatments for 17 psychiatric conditions (2010-2025) [1], HTA value assessments in France and Germany were analysed. For EMA-approved treatments with completed appraisals, Amélioration du Service Médical Rendu (ASMR) ratings (France; I-V: major-no improvement) and added-benefit conclusions (Germany) were mapped to a three-stage attrition framework: regulatory approval, reimbursement decision and clinical value ratings.
RESULTS: Of 62 FDA-approved psychiatric treatments, 23 received EMA approval (63% attrition). Of these, 20 were reimbursed in ≥1 major EMA market, but only two in all five markets (France, Germany, Italy, the Netherlands, Spain). In France, 12/23 (52%) EMA-approved treatments were reimbursed. Among 15 appraisals, nine (60%) received ASMR V, five (33%) received ASMR IV, and one had insufficient SMR; none achieved ASMR I-III. In Germany, 5/23 (22%) EMA-approved treatments were reimbursed. Among eight appraisals, six (75%) found “no added benefit”, one achieved “minor added benefit” (restricted subpopulation) and one demonstrated “considerable added benefit”. Overall, three attrition points emerged: EMA approval (63% lost), low reimbursement (52% France; 22% Germany) and low-value ratings (60% in ASMR V; 75% “no added benefit” among appraised).
CONCLUSIONS: This innovation gap in neuropsychiatry extends beyond approval; most appraised treatments received low-value ratings, suggesting HTA frameworks may not adequately capture relevant results such as tolerability, quality of life and carer impact. Attrition may deter future European neuropsychiatric research investment and efforts such as reviewing the access pathway (including a more holistic value assessment) may help narrow the innovation gap in neuropsychiatry. [1]. Reif A. Presented at HTAi [ID: 718].
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HPR61
Topic
Health Policy & Regulatory
Topic Subcategory
Health Disparities & Equity, Public Spending & National Health Expenditures, Reimbursement & Access Policy
Disease
Mental Health (including addiction), No Additional Disease & Conditions/Specialized Treatment Areas