The State Enterprise “Medical Procurement of Ukraine” (MZU) signed the first managed access contract (MCA) for the purchase of orphan drugs in 2024.
As reported in the Telegram channel of the Ministry of Health, the contract was concluded for the purchase of the drug “Agalsidase beta” in two dosages of 5 mg and 35 mg for enzyme replacement therapy in Fabry disease.
The MOU is concluded for a period of two years and will be valid until December 31, 2025.
According to international practice, important innovative and expensive medicines are procured using the DCD mechanism. The essence of DCD is that through direct negotiations with drug manufacturers, the government enters into exclusive contracts that provide for confidentiality, including information on the cost and volume of purchases, while the manufacturers guarantee prices that are significantly lower than market prices.
In Ukraine, DCDs are concluded through direct negotiation procedures between the state customer (MoH, SE “MZU”) and the manufacturer. They provide for the confidentiality of certain conditions, in particular, the final price of the subject of purchase.
Fabry disease is a hereditary metabolic disorder caused by a deficiency of an enzyme (α-galactosidase A), which leads to life-threatening disorders due to renal, cardiac and cerebrovascular complications. Treatment of the disease involves symptomatic support and enzyme replacement therapy, which allows to stop organ damage.
