There are 2.8 million people living with MS but many people do not have access to disease modifying therapies (DMTs). The DMTs may simply not be available or too expensive for the person with MS. In 7 out of 10 countries people face barriers in accessing treatment.
‘Off-label’ DMTs are treatments that have regulatory approval for another disease but are used to treat MS, often when MS-specific (‘on-label’) treatment options are limited. The Atlas of MS found that 87% of countries use off-label DMTs to treat MS.
The evidence base for off-label DMTs is often limited, as there are no financial incentives for pharmaceutical companies to run large clinical trials for MS. This can make it difficult for people with MS and clinicians to consider whether off-label treatment options are appropriate for the specific person and clinical circumstances.
To support this decision-making, MSIF decided to collaborate with the McMaster GRADE Center in association with Cochrane Canada, and the Cochrane MS group to develop the methodology and systematically review all available evidence for two commonly used DMTs: azathioprine and rituximab. In addition, MSIF put together an independent global and multi-disciplinary panel to assess the evidence and make recommendations for the use of these two DMTs in relapsing and progressive forms of MS (MSIF Off-Label Treatments panel [MOLT panel]). The recommendations are specifically aimed at low-resource settings where a range of DMTs are not available and affordable. Low-resource settings include low- and middle-income countries and disadvantaged populations in high-income settings, e.g. uninsured, refugees.
The recommendations were open for public comment until 25 April 2022: read the recommendations here.
A summary of comments received, as well as responses to these comments, is now available.
In addition, we have prepared:
- A scope document explaining the purpose of the recommendations.
- A Frequently Asked Questions (FAQs) document to give more context to the recommendations.