Use of follow-on disease-modifying treatments for multiple sclerosis: Consensus recommendations.
Mult Scler
; 28(14): 2177-2189, 2022 12.
Article
em En
| MEDLINE
| ID: mdl-36000489
ABSTRACT
BACKGROUND:
As patents for multiple sclerosis (MS) therapies expire, follow-on disease-modifying treatments (FO-DMTs) become available at reduced cost. Concerns exist that cheaper FO-DMTs are used simply to reduce healthcare costs. However, the well-being of people with MS should take priority.OBJECTIVES:
To identify best practices for FO-DMT development and use by agreeing on principles and consensus statements through appraisal of published evidence.METHODS:
Following a systematic review, we formulated five overarching principles and 13 consensus statements. Principles and statements were voted on by a multidisciplinary panel from 17 European countries, Argentina, Canada and the United States.RESULTS:
All principles and statements were endorsed by >80% of panellists. In brief, FO-DMTs approved within highly regulated areas can be considered effective and safe as their reference products; FO-DMTs can be evaluated case by case and do not always require Phase III trials; long-term pharmacovigilance and transparency are needed; there is lack of evidence for multiple- and cross-switching among FO-DMTs; and education is needed to address remaining concerns.CONCLUSION:
Published data support the use of FO-DMTs in MS. The consensus may aid shared decision-making. While our consensus focused on Europe, the results may contribute to enhanced quality standards for FO-DMTs use elsewhere.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Esclerose Múltipla
Tipo de estudo:
Guideline
/
Systematic_reviews
Limite:
Humans
País/Região como assunto:
America do norte
/
America do sul
/
Argentina
Idioma:
En
Revista:
Mult Scler
Assunto da revista:
NEUROLOGIA
Ano de publicação:
2022
Tipo de documento:
Article
País de afiliação:
Reino Unido