The Ministry of Health recommended the orphan drug gilteritinib for inclusion in the VED

09 November 2022


Astellas’ gilteritinib (TN Xospata) is planned for inclusion in the VED list in 2024. The decision was made by the commission of the Ministry of Health on the formation of drug lists, FV reports .

Gilteritinib is an orphan drug for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia with a FLT3 mutation, which is associated with a particularly aggressive form of the disease and a higher risk of relapse. According to the representative of the NMRC of Hematology, there are only 50 such patients per year.

According to the public procurement portal, in 2022 the drug was purchased at an average price of 1.9 million rubles per package. Astellas’ application first featured the price of 710,000 rubles. As Timofey Nizhegorodtsev, deputy head of the FAS, noted, the service staff checked and found out that today “this is the lowest price for the drug in the world, given the current exchange rates.” But the commission vote was equally divided. Ilya Wesker, the company’s representative, offered the drug at 650,000 rubles per package. As a result, the commission recommended the drug to be included in the VED list.

At the meeting of the commission, it was decided not to recommend for the inclusion in the VED list a new dosage form of GSK’s belimumab, a drug for the treatment of systemic lupus erythematosus, in the form of solution for subcutaneous administration. Now the VED list features the drug in the form of a concentrate for the preparation of a solution for infusions, and its administration requires medical control. As Kamil Saitkulov, the manufacturer’s representative, noted, the solution for infusions can be replaced with a solution for subcutaneous administration.

The meeting turned down the application for the exclusion of potassium and magnesium asparaginate, a therapy to compensate for the deficiency of potassium and magnesium. The item of including the antitumor drug ruxolitinib in the program of the 14 Cost-Intensive Nosologies program (VZN) was withdrawn from the vote. The statement was withdrawn by the manufacturer, Novartis, because the inclusion of the drug would have a significant impact on the budget of the program.




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