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- They will take into account: the cost of treatment for hepatitis C may be reduced in the Russian Federation
In Russia, the cost of hepatitis C treatment may be reduced: the authorities are preparing to forcibly license domestic analogues of imported drugs. The measure is being worked out by the Federal Antimonopoly Service, which has already agreed on prices for generic drugs Velpatasof and Pigleria — their cost will be 40% lower than the original. Due to the increased affordability, it can be expected that 25% more patients will receive treatment this year compared to 2024, the chief freelance infectious disease specialist at the Ministry of Health told Izvestia. At the same time, experts remind that generics, as a rule, cannot 100% replace the original and their quality may vary. Whether the forced legalization of such drugs will help reduce the incidence and make them more accessible to patients is discussed in the Izvestia article.
Why can't hepatitis C medicine be released to Russian companies yet?
Hepatitis C medicines may become more affordable for Russians. As Izvestia found out, the FAS has agreed on prices for domestic analogues of medicines for this disease and is working on the issue of their legalization and launch into circulation. This may happen after the government issues a permit for the sale and production of generics, the press service of the antimonopoly authority told Izvestia.
Currently, only imported drugs protected by manufacturers' patent law are allowed in Russia for the treatment of hepatitis C. Among them are the Irish "Epclusa", "Maviret", "Vieira Pack", "Sovaldi" and others. Until 2023, the American drug Zepatir, which left the Russian Federation due to sanctions, was in demand, accounting for 20% of government purchases.
Since the end of 2022, the Russian companies Pharmasynthesis, Geropharm and Pharmstandard have received permission to research generics for Maviret and Epclusa, despite the patent protection of the original drugs.
— The Service agreed on prices for the domestic drug Velpatasof under the international nonproprietary name (INN) Velpatasvir+Sofosbuvir." They have been reduced by 40% relative to the registered price of the foreign reference Epcluse," the FAS told Izvestia.
They also noted that the price for a package of this domestic generic of 28 tablets in a dosage of 100 mg + 400 mg is agreed at 68.7 thousand rubles, and the price of the original drug in the same volume is 114.5 thousand rubles.
In addition, the FAS reported that the service had agreed on the cost of the first domestic generic drug Pigleria within the framework of the INN Glecaprevir + Pibrentasvir. Prices have also been reduced relative to the registered price of the foreign reference drug Maviret by 40%. The cost of packaging this drug from 84 tablets in a dosage of 100 mg + 40 mg is agreed at the level of 103 thousand rubles. And for the same packaging of the original medicine, you will now have to pay 171.7 thousand rubles.
— The reference medicines "Epclusa" and "Maviret" are currently protected by patents. Therefore, Russian manufacturers of generics cannot put them into circulation. To do this, they must obtain a voluntary production license from a foreign company or a compulsory one when the government gives permission for this. If such licenses are obtained, pharmaceutical companies guarantee their sale at even lower prices than those agreed by the service," the FAS explained to Izvestia.
They also noted that the service is working on such a measure for Russian generics as issuing a compulsory license, that is, obtaining government permission for their production and launch into circulation.
— This will reduce the cost of treating the disease, as well as increase the availability and expand the choice of such drugs for citizens. In medical organizations, they will have to be provided free of charge as part of the state guarantees program for free medical care," the FAS stressed.
It should be noted that earlier the Russian government issued similar permits for the production of analogues of imported drugs for covid (American Remdesivir) and diabetes (Danish Ozempik).
Izvestia sent a request to the government with a request to comment on the prospects for supporting the FAS proposal.
Will domestic drugs increase the availability of treatment
The financing of hepatitis C treatment costs in Russia is taking place within the framework of a new project at the expense of federal funds, regional programs and funds from the Compulsory Medical Insurance Fund, Professor Vladimir Chulanov, chief freelance specialist of the Ministry of Health for infectious Diseases, explained to Izvestia.
— For the treatment of hepatitis C at the outpatient stage, a subsidy is allocated to the regions from the federal budget and the regions' own funds are used, day hospital treatment is carried out at the expense of compulsory medical insurance. The Circle of Goodness Foundation allocates funding for the treatment of children. Drugs for patients infected with both hepatitis C and HIV are purchased centrally from the federal budget," Vladimir Chulanov said.
According to him, the emergence of Russian generics will undoubtedly have a positive impact not only on the development of domestic pharmaceutical production, but also on the availability of medical care.
"On the one hand, this guarantees that our patients will not be left without the necessary treatment in any situation, and on the other hand, even now, when using original drugs, it helps to reduce its cost," explained the specialist of the Ministry of Health.
According to him, as the experience of many countries shows, the effectiveness of treatment with generics is not inferior to the effectiveness of treatment with original drugs.
— Over the past two years, the cost of treating patients with hepatitis C has decreased by more than 35%. Due to the increased affordability, 25% more patients can be expected to receive treatment this year compared to last year. A further reduction in the cost of treatment when the expected results of the screening program are achieved will allow us to count on achieving all the targets of the federal hepatitis C control project," he explained to Izvestia.
According to official data from Rospotrebnadzor for 2024, 1.3 million people die from hepatitis annually in the world — 3.5 thousand per day. Every year, 2.2 million people become infected with viruses C and B. More than 300 million people live with this chronic disease. In Russia, according to the Ministry of Health, about 620 thousand patients are registered. At the same time, as Izvestia reported, the real number of carriers may be higher — from 2.2 million to 4.9 million. The fact is that the disease has been asymptomatic for a long time and people may simply not be aware of their status by transmitting the virus to others.
In 2024, Vladimir Putin instructed to reduce the number of hepatitis C diseases to a minimum by 2030. Earlier, the president announced the need to take measures back in 2021 during his address to the Federal Assembly.
Will generics be able to replace imported drugs
The global goal declared by WHO is the complete disappearance of chronic hepatitis C (HCV) by 2030 as one of the main threats to public health in the world. A similar task is possible for Russia, but in this case it is necessary to change the approach and make patient treatment as accessible as possible, Oleg Astafurov, Vice president for government Relations at Pharmasynthesis, told Izvestia.
According to him, every year the government increases the financing of purchases of expensive foreign medicines for the treatment of this disease.
— In 2024, about 17.5 billion rubles were allocated from the budget, while only 14% of the total number of patients registered at the dispensary received treatment. We believe that it is possible to make treatment more affordable by introducing domestic generics of foreign drugs into circulation, because their prices are significantly lower," explained a representative of the pharmaceutical industry.
According to him, the drug with the trade name "Pigleria" (INN "Glecaprevir+Pibrentasvir"), which is a copy of the foreign drug Maviret, has a maximum selling price 40% lower than the price of the original foreign drug. At the same time, in the procurement structure, only this drug provides the maximum share of 25% of the total number of purchased packages of foreign original drugs, Oleg Astafurov said.
However, Alexander Seversky, president of the League of Patient Defenders, believes that it is premature to evaluate the effectiveness of domestic analogues of hepatitis C drugs.
— We do not know which components they are made of, which have been tested. It may be like assembling a Toyota from domestic spare parts. If it is the same as with covid in an accelerated manner, then it is unlikely that this will help patients with this disease much," Alexander Seversky explained.
Chairman of the State Duma Committee on Health Protection, Candidate of Medical Sciences Sergey Leonov noted that all drugs that are put into circulation must first confirm their effectiveness. According to him, the emergence of new generics for hepatitis C speaks to the development of the domestic pharmaceutical industry. This means that the prices of these drugs will be reduced, he noted. Whether they will be able to 100% replace imported drugs is a question for the scientists who developed them, and the arguments of ordinary people on this topic are unfounded, the deputy believes.
Переведено сервисом «Яндекс Переводчик»
