COMPARATIVE ANALYSIS OF NATIONAL HTA DECISIONS IN ANTINEOPLASTIC, IMMUNOMODULATORY, AND NERVOUS SYSTEM THERAPIES ACROSS FOUR EUROPEAN COUNTRIES
Author(s)
Emmanuel Lo, MSc, Sonja Nakasian, MSc, Kasem S. Akhras, PharmD;
VantEdge Access, LLC, Oak Brook, IL, USA
VantEdge Access, LLC, Oak Brook, IL, USA
OBJECTIVES: The new Joint Clinical Assessment (JCA) framework in the European Union (EU) started in January 2025 to support member states’ national HTA process to create a single EU-clinical value assessment for innovative therapies. Antineoplastics & immunomodulating agents (AIA) and treatments focusing on nervous systems (NS) make up majority of the investigational therapies under development. The objective of this research is to get insights from national HTA decisions in AIA and NS from four EU countries.
METHODS: We used our proprietary AI platform (OMNIA) to analyze publicly available final HTA outcomes for innovative therapies in France (FR), Germany (DE), Italy (IT) and Spain (ES) from January 1, 2020, to December 31, 2024. We separated the HTA reports by therapeutic area using Anatomic Therapeutic Chemical (ATC). This analysis focuses on HTA process and outcomes considering ATC, study design, comparator used in the assessment, and final outcomes decision.
RESULTS: Of the 2,326 HTA reports available on all therapeutic areas, a total of1,296 (55.7%) report were focused on AIA and NS products coming from FR (40.4%), DE (28.5 %), IT (11.0%), and ES (20.2%). Variations observed across countries in the type of studies submitted: single arm vs randomized controlled trials (23.7%, 17.6%, 25.4%, 25.6% vs. 59.8%, 60.4%, 72.5%, 63.7% for FR, DE, IT, ES, respectively), and active comparators (35.2%, 41.7%, 37.3%, 40.4%, in FR, DE, IT, ES, respectively). Positive HTA outcomes (full, partial, or conditional reimbursement, innovative designation) granted in 48.8%, 45.5%, 55.6%, 48.1%, in FR, DE, IT, ES, respectively.
CONCLUSIONS: Significant variations in key factors impacting HTA evaluations was observed across four EU countries. Findings have significant implications on pharmaceutical companies preparing for JCA submissions, and on AI tools designed to predict positive outcomes decisions.
METHODS: We used our proprietary AI platform (OMNIA) to analyze publicly available final HTA outcomes for innovative therapies in France (FR), Germany (DE), Italy (IT) and Spain (ES) from January 1, 2020, to December 31, 2024. We separated the HTA reports by therapeutic area using Anatomic Therapeutic Chemical (ATC). This analysis focuses on HTA process and outcomes considering ATC, study design, comparator used in the assessment, and final outcomes decision.
RESULTS: Of the 2,326 HTA reports available on all therapeutic areas, a total of1,296 (55.7%) report were focused on AIA and NS products coming from FR (40.4%), DE (28.5 %), IT (11.0%), and ES (20.2%). Variations observed across countries in the type of studies submitted: single arm vs randomized controlled trials (23.7%, 17.6%, 25.4%, 25.6% vs. 59.8%, 60.4%, 72.5%, 63.7% for FR, DE, IT, ES, respectively), and active comparators (35.2%, 41.7%, 37.3%, 40.4%, in FR, DE, IT, ES, respectively). Positive HTA outcomes (full, partial, or conditional reimbursement, innovative designation) granted in 48.8%, 45.5%, 55.6%, 48.1%, in FR, DE, IT, ES, respectively.
CONCLUSIONS: Significant variations in key factors impacting HTA evaluations was observed across four EU countries. Findings have significant implications on pharmaceutical companies preparing for JCA submissions, and on AI tools designed to predict positive outcomes decisions.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
HTA80
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
SDC: Neurological Disorders, SDC: Oncology, SDC: Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)