Therapeutic Passage: multiple sclerosis patients lack medications
In at least five Russian regions, patients have ceased to receive the full amount of multiple sclerosis medications issued to them, Izvestiya has found out. The drugs in question are immunosuppressors with the active substances teriflunomide and ocrelizumab, which alleviate the course of the disease. Both drugs are included in the list of vital and essential drugs. Atthe same time, it is now almost impossible to buy these drugs on your own - the editorial team managed to find them only in pharmacies in three Russian regions. In November, the Ministry of Health announced six tenders for the purchase of these drugs: one for teriflunomide and five for ocrelizumab. On why there could be a shortage - in the material "Izvestia".
Where the drugs disappeared
In the Moscow, Novosibirsk and Volgograd regions in medical institutions there were interruptions with the drug with the active ingredient teriflunomide, patients who receive this drug at the expense of the budget told "Izvestia".
Since 2018, this drug has been included in the program "14 High-Cost Nosologies" ("14 High-Cost Nosologies"), i.e. it is purchased centrally by the Ministry of Health. In addition, the drug is also included in the list of vital and essential drugs (VED), which allows regions to announce relevant purchases.
- The outpatient clinic has not given me the drug since the beginning of the fall, citing its absence and delays in supply," one of the patients living in the Moscow region told Izvestia. - They promise that the drug will be available again in December.
Another patient added that in case of interruptions, patients usually help each other by borrowing medicine. But now, she said, people have less and less of such supplies on hand.
According to the State Register of Medicines, drugs with the active ingredient teriflunomide are produced in Russia by nine companies, including Biocad, PSK Pharma and Technologiya Drugs, part of R-Pharm. "Izvestia" sent inquiries to these companies asking them to report the volumes of supplies.
Biocade said that production and supplies of theriflunomide drugs are carried out in accordance with the plan for 2024. But this year the company does not participate in the Ministry of Health tenders. The other companies did not respond.
According to the analytical company Headway Company, in January - October 2024, the Ministry of Health announced four auctions for teriflunomide - for 1.3 billion rubles - as part of the procurement of drugs under the program "14 VZN". But, according to the final documentation, 50.5 million rubles was purchased.
Two auctions for the supply of the drug to the Ministry of Health were won by Primafarm LLC. Both times the price of the initial bid was reduced dozens of times compared to the final contract. For example, the cost of one of the tenders was initially 997.2 million rubles, but a contract for 35 million rubles was concluded with the supplier company. Another auction - for 8.2 million rubles has not been closed yet. It was announced by the Ministry of Health in late November.
At the same time, according to the analytical company RNC Pharma, a total of 46.4 thousand packages of drugs with teriflunomide were supplied to hospitals and pharmacies in January-October 2024, which is almost twice higher than the same indicator last year. Then 24.3 thousand packages of the drug were put into circulation.
In the Sverdlovsk and Tomsk Regions patients complained about the shortage of the drug with the active substance ocrelizumab. Only Ocrevus from the Swiss company Roche is registered in Russia. The drug is included in the "14 VZN" and the list of vital and essential drugs.
- We applied to the pharmaceutical company and were told that they will resume supplies from 2025," one of the patients told Izvestia. - That is, in December there will be no treatment scheme with "Ocrevus", this is very bad.
In Roche "Izvestia" was told that for the company is extremely important for the uninterrupted supply of patients with vital and innovative drugs.
"All supplies of the drug "Ocrevus" are carried out by the company without interruptions and in full volume in accordance with the declared need by the Ministry of Health", - emphasized there.
According to the RNC, in 2023 and 2024 a comparable amount of the drug - 28 thousand packs each - was supplied to pharmacies and hospitals.
According to the unified information system, the last purchase of "Ocrevus" was under the tender of the Ministry of Health, which was announced at the end of December 2023 - for 13.16 billion rubles. The supplier was the company R-Pharm. In early November 2024, the Ministry placed a tender for the purchase of the drug for more than 2 billion rubles, but it has not yet been closed.
Drugs with teriflunomide and ocrelizumab are available for sale only in three regions, Izvestia found out after patients' complaints. The drugs are available in a small number of pharmacies in Moscow, St. Petersburg and Bashkiria, according to aggregators.
Deliveriesof the drug with teriflunomide were made in 2024 to the Volgograd region on January 17, April 22 and November 13, the press service of the Ministry of Health told Izvestia. In the Novosibirsk region, they added, were January 17, April 23, and the next delivery is expected no later than December 20.
Deliveries of the drug with ocrelizumab were made, the Ministry's press service said, to the Tomsk region in 2024 on February 3 and 24. To the Sverdlovsk region - on February 9 and 23. This amounted, they said, to 97% of the annual need for the drug.
It also noted that the "Federal Center for planning and organization of drug supply of citizens" of the Ministry of Health is now concluding state contracts in order to purchase drugs for 2025.
"According to the data of the drug labeling system, the balance of drugs with teriflunomide as of November 27, 2024 is more than 27 thousand packages, which covers more than half a year's need for the drug. The introduction of drugs into civil circulation since the beginning of the year exceeded the total volume of input for the whole 2023 year by 20%," - follows from the response of the press service of the Ministry of Health.
According to Roszdravnadzor, ocrelizumab drug input for the past year exceeded the figures for 2022 and 2023, and according to the drug labeling system, the drug residue is more than 14 thousand packs, which is more than one third of the average annual need.
The Ministry of Health also reminded that the Ministry applies the mechanism of redistribution of drugs to the regions with the lowest balance. And when new contracts are signed, they added, new supplies are prioritized in the regions with the lowest drug stock.
Why the disruptions occurred
Nerve fibers of the central nervous system are affected by multiple sclerosis. As a result, nerve impulses are transmitted with malfunctions or cease to be transmitted altogether, recalled neurologist laboratory "Hemotest" Ekaterina Demyanovskaya.
Characteristic signs of the disease, she added, are motor disorders, decreased sensitivity, fatigue, numbness in the hands and feet, visual impairment. Also, according to her, with a long history of the disease can affect the brain areas that are responsible for thinking, there will be problems with memory and concentration.
Teriflunomide was purchased under the "14 VZN" program six months ago, Nikolai Bespalov, development director of the analytical company RNC, told Izvestia. He suggested that now the stock of the drug could have run out, which was the reason for the disruptions. He also assumes that the stock of ocrelizumab purchased earlier simply ran out.
Nikolai Bespalov noted that disruptions may occur due to uneven distribution of drugs in the regions.
- Since the drug is provided to patients under the federal benefit, it should not be in large quantities in pharmacies," he added.
Co-chairman of the All-Russian Patients' Union Yan Vlasov noted that the drugs, the shortage of which was reported by multiple sclerosis sufferers, are very important for them - they ease the course of the disease by affecting the immune system.
- Skipping treatment threatens to exacerbate the disease," the expert emphasized.
There is no universal cure for multiple sclerosis, emphasized Ekaterina Demyanovskaya. But, she said, some disease-modifying drugs, among them the shortages patients have complained about, help slow the progression of the disease and improve quality of life.
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