The state order of the most important and expensive drugs remained almost without new products

The need to save budget funds may affect the expansion of the list of drugs purchased under federal programs. Since the end of 2022, the Ministry of Health has recommended that the list of vital and essential drugs (VED) be supplemented with only one item, and not a single new drug has been included in the list of high-cost nosologies (VZN). Pharmaceutical companies counting on the state order warn of a threat to production plans and an increase in the risk of defects due to uncertainty.

Since the end of 2022, the commission of the Ministry of Health, which considers applications from drug manufacturers, has approved only one drug for inclusion in the Vital and Essential Drugs list and not a single drug in the VZN list, Kommersant calculated based on the minutes of the meetings published on the ministry’s website. The commission should meet once a quarter, but the last two meetings have been postponed. The last time the meeting was postponed on July 26 for an indefinite period “for technical reasons.”

Inclusion in the Vital and Essential Drugs list provides access to budgetary purchases for preferential categories of patients, the state guarantee program, and in the VZN list – to federal purchases of the most expensive therapy. Traditionally, new positions on the lists were approved by the government at the end of the year.

Legislatively, there are no clear deadlines for this, and theoretically this can be done at any time, says Alexei Fedorov, an independent public procurement expert. However, he emphasizes, on July 15, the Ministry of Health closed the acceptance of new applications for drug provision under the VZN program for 2024, and it is planned to protect applications in the fall. That is, drugs declared for inclusion in the lists and not considered by the commission will not be taken into account in applications, the expert explains.

Divozilimab (Ivlizi) and sampeginterferon beta-1a (Tenexia) registered by Biocad in the spring of 2023, which are used for multiple sclerosis, are among the candidates for inclusion in the lists. The VZN program is the main channel for obtaining subsidized medicines for patients with this disease.

According to Biocad estimates, in 2022, the Ministry of Health purchased drugs, which include divozilimab, for 6.6 billion rubles, and interferons like Tenexia for 1 billion rubles. Without being included in the VED and VZN lists, drugs can be purchased mainly for individual indications by decision of the medical commission.

Ofatumumab Sanofi, used in multiple sclerosis, will not be included in the VZN program. And the AstraZeneca Alexion structure may not return to the program in 2024 with the new drug ravulizumab (Ultomiris) for atypical hemolytic uremic syndrome. Back in 2019, the company’s former drug eculizumab for this disease was supplanted in the state program by the Russian analogue of Generium. In 2022, centralized purchases of eculizumab reached 8.6 billion rubles, according to Headway Company.

The Ministry of Health told Kommersant that they are preparing additional materials and information on proposals recommended by the commission for inclusion in the lists. Updating is needed “taking into account the current situation” and the readiness of manufacturers to ensure the production and supply of drugs to Russia. The Ministry of Health promises to publish the date of consideration of the rescheduled meetings within a reasonable time frame.

Yuri Zhulev, co-chairman of the All-Russian Union of Patients, says that the delay in the process of expanding the lists of vital and essential drugs and VNZ may also be caused by funding problems – the desire to save the budget.

Biocad hopes that the Ministry of Health can still hold a meeting of the commission before the end of 2023. AstraZeneca is pushing for a meeting “as soon as possible” once technical issues are resolved. “The emerging practice of postponing commission meetings in the absence of dialogue with business creates a situation of uncertainty,” the company says. They added that this violates the planning of the schedule for the production and supply of drugs declared for inclusion in the lists, and increases the risk of possible defects.

Yuri Zhulev notes that the rescheduling of meetings and the possible absence of drugs from the lists threatens to reduce patients’ access to modern innovative therapy, since they are purchased “very poorly” outside the lists.

Polina Gritsenko