The Ministry of Health of the Russian Federation has updated the 2022 version of clinical guidelines for multiple sclerosis, adding two drugs produced by Russian companies: a therapy to improve walking function, and a new pegylated interferon. The updated guidelines, published in the clinical rubricator, are subject to revision no later than 2027.
In the new guidelines, the abbreviated name of the EDSS (Expanded Disability Status Scale) for assessing the degree of disability has been replaced with the abbreviation made from the Russian words.
Sampeginterferon beta-1a, an original development of the Russian company Biocad, which was included in the list of vital and essential drugs (VED) in 2024, was added to the list of recommended drugs. Fampridine, manufactured by the Russian company Valenta Pharm, is now recommended for adult patients with the EDSS of 4 to 7 points to improve walking function
Interferon beta-1a, glatiramer acetate, teriflunomide, and dimethyl fumarate are allowed for children and adolescents over 10 years old with relapsing-remitting multiple sclerosis when their EDSS score is below or equal to 6.5 and they do not have aggressive disease. The decision on the prescription of these drugs should be made by a medical commission, since the evidence base on their efficacy and safety in children is limited.
The updated guidelines also indicate the intervals for the administration of live attenuated vaccines before and after starting disease-modifying therapies (DMTs), and there is a list of drugs contraindicated with live vaccines.
The term “rapidly progressive multiple sclerosis” has been replaced by “aggressive multiple sclerosis”. This describes a severe form of multiple sclerosis in individuals not yet on disease-modifying therapies (DMTs), where relapses lead to a high risk of accumulating disability. The new guidelines clearly state how to diagnose this condition and specify the criteria for the diagnosis. While the previous version contained only one ICD-10 code (G35.0, Multiple sclerosis), the updated guidelines also feature codes G36.9 (Acute disseminated demyelination, unspecified) and G37.9 (Demyelinating disease of central nervous system, unspecified).
Earlier it was reported that the government has adjusted the rules of drug procurement for patients with rare and severe diseases included in the 14 Cost-Intensive Nosologies program. Now, if any unused balances of federal funding remain after the implementation of federal procurement contracts, Russian regions will be allowed to purchase additional drugs with these funds without using other sources.