Based on the results of the state HTA conducted, the Center recommends including the medicinal product human normal immunoglobulin for intravenous administration in the National List of Essential Medicines and the lists of medicinal products procured with state budget funds, for the treatment of adults and children with Guillain-Barré syndrome (GBS).
Based on the results of the analysis of the clinical efficacy of the medicinal product compared with plasmapheresis in adults and children with GBS, it was established:
- equivalent effectiveness of treatment methods as assessed by the change in the degree of disability 4 weeks after randomization; the number of patients who had an improvement in disability of 1 point or more after 4 weeks, in terms of mortality, as well as death or disability after 12 months, the incidence of relapse or treatment-related disorders
- a 86% reduction in the risk of treatment discontinuation and a 69% reduction in the risk of multiple complications when using human normal immunoglobulin for intravenous administration.
This opens up the possibility of providing Ukrainian patients with rare diseases with alternative treatment.
Guillain-Barré syndrome is an orphan immune-mediated disease of the peripheral nervous system characterized by inflammation of the nerves, muscle weakness, and a risk of paralysis. In about 20% of patients, respiratory disorders develop that require mechanical ventilation, and the mortality rate is 3-10%. That is why it is important to ensure patients’ access to the necessary treatments.
Detailed information on the HTA conclusion can be found on the Center’s website at the link https://surl.li/ssevqh
