Affordable American drug Zepatir against hepatitis C leaves Russia
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The American pharmaceutical manufacturer MSD will stop deliveries to Russia of Zepatier, one of the most popular drugs against hepatitis C. This drug accounts for almost 20% of all public procurement of drugs for this disease – more than 1 billion rubles are spent annually on this. There are no analogues of the drug in the country yet, although, according to experts, there are enough other drugs on the market. But Zepatier is one of the most affordable treatment regimens.
At the disposal of Kommersant was a letter in which the Ministry of Health warned federal medical institutions to stop the supply and production of a number of drugs in the country, including Zepatira. The letter was later withdrawn by the ministry. But Roszdravnadzor confirmed to Kommersant that the manufacturer of the zepatira, the American MSD, notified the service of the termination of supplies. The company is obliged to do this at least a year before the actual stop of imports. The company indicated in the letter that the decision will not affect deliveries planned for 2024, the service stressed. MSD and Akrikhin (engaged in drug packaging in the Russian Federation) did not respond to Kommersant’s request.
MSD has been reducing its portfolio in Russia since 2022. Thus, the company stopped supplying vaccines against chickenpox, measles, rubella and mumps, and the HIV drug raltegravir. MSD said it would focus on supplying life-saving supplies and vaccines for which there are no alternative products or treatments available in the Russian Federation.
Zepatier is used to treat hepatitis C genotypes 1, 3 and 4 in adults. In recent years, WHO and the Ministry of Health have given priority to pangenotypic schemes (that is, suitable for any type of virus), which include AbbVie’s maviret and Gilead’s epclusa.
Nevertheless, Zepatier is one of the three most popular treatment regimens after pangenotypic agents. In 2022, the share of this drug in treatment regimens paid for by the state accounted for 19%, in the first half of 2023 – 18%, the Zdravresurs expert group reported.
Last year, state customers purchased zepatier for 1.06 billion rubles, which is a third less year on year. This is due to a decrease in the marginal cost of the drug at the end of 2021 by 34%, to 81.5 thousand rubles. for packaging with VAT, according to the Zdravresurs report. Since the beginning of 2023, the volume of purchases of Zepatier, according to analysts, amounted to 718 million rubles.
This medicine has no analogues in Russia. As Kommersant was told in the Ministry of Industry and Trade, the drug is protected in the Russian Federation by a patent until 2030. At the same time, a number of Russian companies are developing generics, the ministry said.
In April 2023, Promomed received permission to conduct a bioequivalence study of the Zepatira analogue. The company did not tell Kommersant about the timing of the withdrawal of the drug, citing the confidentiality of information on developments.
The departure of the zepatier will not be critical for patients, there are several more schemes for the first genotype, says Natalia Egorova, an analyst at Zdravresurs. But on the condition that the use of pangenotypic drugs will be expanded, she adds.
Zepatier is one of the most affordable remedies, according to the company. The course of treatment with the drug costs the budget 240 thousand rubles, while the cost of treatment with pangenotypic regimens starts from 370 thousand rubles. The Vikeyra Pak course is the cheapest – 205 thousand rubles, but it will not be delivered by December 2023, Pharmvestnik previously reported. AbbVie, the manufacturer of this product, explained this decision by stopping its production.
DSM Group CEO Sergey Shulyak believes that, if necessary, Russian companies will be able to produce analogues by circumventing a patent or obtaining a compulsory license. The Ministry of Industry and Trade also talks about the possibility of generic manufacturers to enter into a licensing agreement with the originator or obtain a compulsory license by government decision, but they call such a step an exceptional measure.
Russian companies are preparing analogues of pangenotypic drugs, despite the presence of patent protection for original drugs. Since the end of 2022, Pharmasyntez, Geropharm and Pharmstandard have received permission to study generics for Maviret and Epclusa.
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