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For the first time in Ukraine patients will have free access to medicines against spinal muscular atrophy

9 December 2022

Today at a government meeting the proposal of the Ministry of health of Ukraine to purchase 9 medicines under managed access agreement was supported, 8 of them were purchased centrally earlier, and 1 will be purchased for the first time.

A managed access agreement is a mechanism for purchasing original (innovative) medicines based on the results of direct and confidential negotiations between the customer and the pharmaceutical manufacturer. Negotiations are based on the results of reviewing materials for evaluating medical technologies, which contain data on indicators of clinical and economic effectiveness of medicines.

Due to the fact that original (innovative) medicines are produced only by one manufacturer, the competitive procurement tool for them cannot be fully effectively used.

For the first time in Ukraine, due to the use of a tool (managed access agreement) that allows keeping the price confidential, it was possible to centrally purchase the drug “Eurisdi” (“Risdiplam”) for the treatment of children with spinal muscular atrophy (SMA). Medicines will be provided to patients free of charge.

SMA is a rare neuromuscular disease that leads to limb atrophy and death. “Risdiplam” is the only medicine against spinal muscular atrophy that can be treated independently at home, because it should be taken orally.

“By approving the list of medicines purchased under managed access agreements today, the Cabinet of Ministers has finalized the huge work carried out by the Ministry of Health and Medical Procurement of Ukraine. Positive negotiations with Roche on the purchase of Risdiplam for the treatment of patients with spinal muscular atrophy are a real breakthrough for a free and independent Ukraine, which cares about its citizens! I thank to the Armed Forces of Ukraine for allowing us to implement our plans even during the war,” Viktor Liashko stressed.

The drug will be available for patients with type 1 spinal muscular atrophy in 2023. This medication will be given to patients with SMA who meet the criteria for inclusion in the program (age, type of disease, etc.), including those who will be diagnosed based on the results of the extended neonatal screening program. Detailed conditions for patients to receive this medicine will be announced later.

Also, according to the results of the conclusion of managed access agreements with the companies “Sanofi”, “BioMarin”, “Takeda” on medicines that were previously purchased centrally, it will be possible to save only in 2022 about 10 million US dollars (for conversion to currency price of 2021) and about 100 million UAH (for the use of hryvnia prices in 2021). Drugs purchased under managed access agreements are used to treat rare (orphan) diseases, such as Gaucher’s disease, mucopolysaccharidosis, hemophilia, etc.

This mechanism is used in many countries of the world, in particular in Italy, France, Netherlands, Belgium, Sweden, Denmark, Finland, Australia, Lithuania and others.