AUTHOR=Gozzo Lucia , Romano Giovanni Luca , Brancati Serena , Longo Laura , Vitale Daniela Cristina , Drago Filippo 

TITLE=The therapeutic value of treatment for multiple sclerosis: analysis of health technology assessments of three European countries

JOURNAL=Frontiers in Pharmacology

VOLUME=Volume 14 - 2023

YEAR=2023

URL=https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2023.1169400

DOI=10.3389/fphar.2023.1169400

ISSN=1663-9812

ABSTRACT=In accordance with European regulation, medicines containing a new active substance to treat neurodegenerative diseases as well as auto-immune and other immune dysfunctions need to be approved by the European Medicines Agency (EMA) through the centralised procedure to be marketed. However, after EMA approval, each country is responsible for national market access, following the assessment performed Health Technology Assessment (HTA) bodies as regard to the therapeutic value. 
This study aims to provide a comparative analysis of HTA recommendations issued by 3 EU countries (France, Germany and Italy) for new drugs for Multiple sclerosis (MS) following EMA approval.
In the reference period we identified 11 medicines authorized in Europe for MS, including relapsing forms of MS (RMS; n = 4), relapsing–remitting MS (RRMS; n = 6), secondary progressive MS (SPMS; n = 1), and primary progressive form (PPMS; n = 1).
We found no agreement on the therapeutic value (in particular the ‘added value’ compared to the standard of care) of the selected drugs. The majority of the evaluations resulted into the lowest score (additional benefit not proven/no clinical improvement), underlining the need for new molecules with better efficacy and safety profile for MS, especially for some forms and clinical settings.