Specific aspects of immunotherapy for multiple sclerosis in Switzerland: A structured commentary

Lutz Achtnichts ,Robert Hoepner ,Sven Schippling ,Tobias Derfuss ,Adam Czapliński ,Stefanie Müller ,Athina Papadopoulou ,Cp Kamm ,Renaud Du Pasquier ,Andrew Chan ,Caroline Pot ,Roland Martin ,Anke Salmen ,Patrice H Lalive ,Jens Kuhle ,Andreas Lutterotti ,Oliver Findling ,Nicole Kamber ,Claudio Gobbi ,Chiara Zecca

doi:10.1177/2514183x18822073

Abstract

More than a dozen substances are meanwhile available for the disease-modifying immunotherapy of multiple sclerosis (MS). However, for some substances, there is a clear difference between approval in Switzerland (Swissmedic) and neighboring countries (European Medicines Agency (EMA)). In addition, limitations imposed by the Swiss Federal Office of Public Health in the specialties list (SL) have significant effects on use in daily clinical practice. In the following, we present consensus recommendations, which were reviewed and agreed upon by the Scientific Advisory Board of the Swiss Multiple Sclerosis Society and the Swiss Neurological Society. We explicitly focus on practice-relevant differences in the approval of MS immunotherapies in Switzerland compared with the EMA area and discuss further limitations (SL) and their impact on the use in clinical practice. Immunotherapies with the same approval in Switzerland and the EMA area and symptomatic therapies are not discussed here.

Highlights

There is hardly any field of neurology where therapeutic progress has been so clearly tangible as the immunotherapy of multiple sclerosis (MS)
For the first time, a drug that alters the disease course is available for primary progressive MS, which could not be treated with immunotherapy until recently
Substances that have been approved in the EMA area but not yet in Switzerland or that have been withdrawn from the market but previously had partly different usage in Switzerland compared to the EMA area are included

Summary

Introduction

There is hardly any field of neurology where therapeutic progress has been so clearly tangible as the immunotherapy of multiple sclerosis (MS). The specific regulatory conditions in Switzerland lead to partly different usage in routine clinical practice that is not reflected in European or other national guidelines to date. This structured commentary aims to discuss immunotherapeutic drugs for which particular approval, safety requirements, or limitations in the SL exist in Switzerland. Substances that have been approved in the EMA area but not yet in Switzerland (cladribine, Mavenclad®) or that have been withdrawn from the market but previously had partly different usage in Switzerland compared to the EMA area (daclizumab, Zinbryta®) are included. Symptomatic treatment and acute treatment of MS relapses are not discussed here

Methods

Concluding remarks

Findings

Declaration of conflicting interests