The Ministry of Health Commission recommended including only 8 INNs out of 23 reviewed in the list of vital and essential drugs

In the context of the specified rare nosologies, the possibility of classifying two more drugs as VED was also considered: danicopan and iptacopan. Representatives of the National Medical Research Center of Hematology emphasized at the meeting that these two options and ravulizumab are recorded in the draft clinical guidelines with narrowly prescribed indications. The experts also emphasized that ravulizumab demonstrates effectiveness where eculizumab, the comparison drug, does not provide positive dynamics. Representatives of the Federal Antimonopoly Service (FAS), however, pointed out the risks of expanding the prescriptions of the drug in question and, accordingly, an increase in budget costs. The Ministry of Industry and Trade drew attention to the long-term patent protection of ravulizumab - until 2038.

The manufacturer of eculizumab (TN Atsveris), the domestic Biocad, sent a letter to the Ministry of Health, according to the department itself, about plans to reduce the price. AstraZeneca, which produces ravulizumab (TN Ultomiris), also twice proposed to reduce the price to 142 thousand rubles. During the discussion, Generium reported an even greater reduction in the price of its eculizumab (TN Elizariya) than in the case of Biocad.

Kirill Kulyaev, Chairman of the organization for helping patients with diseases associated with uncontrolled activation of complement, "Another Life", emphasized at the meeting the incorrectness of identifying eculizumab and ravulizumab, as reported by clinicians. Kulyaev noted that in patients with PNH who were prescribed ravulizumab, the use of increased doses of eculizumab does not lead to effective treatment and is associated with irrational costs. Nevertheless, the application for ravulizumab was rejected by the specialized commission. Similar decisions followed for danicopan and iptacopan.

In August 2024, experts approved ravulizumab for inclusion in the list of vital and essential drugs during a meeting of the Ministry of Health commission. The decision was also enshrined in the draft government resolution with adjustments to the list submitted by the department in September of the same year, but ravulizumab was not included in the version of the document adopted in January 2025.

On the eve of the current meeting of the commission in "Another Life", Vademecum reported that a letter had been sent to the Deputy Head of the Ministry of Health of the Russian Federation Sergey Glagolev with a request to take into account, when considering the possibility of classifying ravulizumab, danicopan and iptacopan as VED, the difficulties of patients in several regions of the country in obtaining these therapies even after their appointment by a medical commission. According to the organization, problems arise in Moscow, the Republic of Buryatia, Kaliningrad, Tomsk and Lipetsk regions: in responses to patients' requests, some departments refer to the absence of prescribed drugs in the list of VED and offer alternative treatment.

In general, most of the approvals were made on the first day of the commission meeting: on August 6, the experts approved 7 out of 15 INNs. Thus, they recommended including in the VED the long-term enzyme replacement therapy for patients with Fabry disease from the Italian Chiesi - pegunigalsidase alfa (TN Elfabrio), a drug for the treatment of anemia from the American Bristol Myers Squibb - luspatercept (TN Reblozil), blood coagulation factor VIII from the American CSL Behring - lonoctocog alfa (TN Afstila). Similar decisions were made for two antitumor drugs - capivasertib (TN Akdayna from AstraZeneca) and camrelizumab (TN Areima from Petrovax). The department accepted the application for consideration of Kapivasertib for the possibility of inclusion in the list of vital and essential drugs back in January 2025, but in April the commission for the formation of lists issued a negative decision on this position.

The specialized commission also considered it possible to add enfortumab vedotin (TN Padcev Onco from Japanese Astellas Pharma), which is used to treat bladder cancer, to the list of vital and essential drugs. A similar decision was made on August 6 regarding pretomanid (TN Raxtemi from American Viatris), which is used in combination with bedaquiline and linezolid to treat pulmonary tuberculosis in adult patients with extensive drug resistance.

On the second day of the meeting, August 7, the experts approved only two drugs out of eight considered. Thus, the antitumor drug darolutamide (TN Nubeka from the German Bayer) may appear on the list. Its inclusion in the list was already considered and approved in 2022, but the regulator's decision was not implemented in government regulations. The Ministry of Health commission also made a positive decision on the drug for reducing the duration of neutropenia during intensive myelosuppressive cytotoxic chemotherapy for malignant diseases pegfilgrastim (TN Poexo from PSK Pharma).

Among the drugs that the Ministry of Health commission refused to include in the VED on August 7, in addition to ravulizumab, danicopan and iptacopan, there is the immunosuppressant belumosudil (TN Reztireg, supplied to Russia by the French Sanofi), which is currently being purchased for the needs of the wards of the state fund "Circle of Good". The drug was one of the first to be purchased under the mechanism approved in 2023, which allows for the formation of a reserve of drugs for immediate assistance to patients.

At the end of the meeting, Petrovax managed to challenge the commission's decision regarding pegunigalsidase alfa from Chiesi, which had been approved on the first day. The Russian pharmaceutical manufacturer believed that the Center for Expertise and Quality Control of Medical Care (CEQMC) had incorrectly calculated the cost of the Chiesi drug and had come to the false conclusion that its price was lower than that of the comparison drug, agalsidase beta from Petrovax. The manufacturer also doubted that the drug approved by the commission was more effective and safer than Petrovax's products. The chief freelance specialist in medical genetics at the Ministry of Health, Sergei Kutsev, did not support Petrovax's objections, but the chairman of the commission, Sergei Glagolev, announced a decision to reconsider the inclusion of pegunigalsidase alfa in the list of vital and essential drugs during the next meeting of the body in November 2025.