The President is invited to the consultation – Newspaper Kommersant No. 31 (7476) dated 20.02.2023

The public organization “Together Against Hepatitis” asked President Vladimir Putin to check the “legitimacy and legitimacy” of the draft order of the Ministry of Health, which establishes the criteria for providing medical care to patients with hepatitis C. The agency offered to treat only patients in the late stages of fibrosis and liver cirrhosis at the expense of compulsory medical insurance . The patient community calls this approach discriminatory and warns that as a result, the amount of therapy may be reduced. Now it is received by less than 1% of the estimated number of Russians living with hepatitis C.

The interregional public organization for assistance to patients with viral hepatitis “Together Against Hepatitis” sent a letter to President Vladimir Putin (Kommersant has it). The activists asked to “instruct us to check the legality and legitimacy” of the draft order of the Russian Ministry of Health on establishing criteria for the provision of medical care to patients with hepatitis C in a day hospital and inpatient conditions. Earlier, the medical department published an order on the portal of regulatory legal acts, according to which children under 18 years of age and adults with severe liver damage (fibrosis above F3 on the METAVIR scale and cirrhosis) can count on treatment under compulsory medical insurance. Deputy Prime Minister Tatyana Golikova instructed officials to develop the criteria.

In the patient organization, the proposed approach is considered “discriminatory”: “A significant part of young, able-bodied, highly motivated patients, including women of childbearing age, whose health hepatitis C has not yet had time to cause significant harm, in fact, are cut off from treatment in a day hospital within the framework of the state guarantees program,” the letter to Vladimir Putin says. The patient community insists that the order of the Ministry of Health not only “discriminates against the rights” of Russians to free medical care, but also violates the norms of the Constitution of the Russian Federation and the federal law on health protection, runs counter to the initiatives of the president and the government regarding increasing efforts to achieve the goals of eliminating hepatitis C in the Russian Federation by 2030, and also contradicts the current clinical recommendations of the Russian Ministry of Health. Thus, paragraph 3.1 of the recommendations states that antiviral treatment is recommended for all patients with chronic viral hepatitis C, regardless of the presence of liver cirrhosis.

The Together Against Hepatitis organization asked the president to recommend that the Ministry of Health revise the criteria for providing medical care to patients with hepatitis C “in the direction of expanding access to therapy.” Activists urge Minister of Health Mikhail Murashko to mention patients with moderate fibrosis in the draft order (in the absence of patients with fibrosis above F3 on the waiting list); patients on the waiting list for organ transplants; patients with concomitant oncological diseases; observed on the profile of “chronic viral hepatitis C” in a specialized medical institution for more than one year; women of childbearing age, including those undergoing or planning an IVF procedure.

It should be noted that the treatment of hepatitis C was included in the program of state guarantees of free provision of medical care to citizens for 2023 and for the planned period of 2024 and 2025, adopted in December last year. And now it should be carried out “at the expense of compulsory medical insurance within the framework of the basic CHI program.” Until now, patients with hepatitis C have been treated at the expense of regional budgets. According to “Together Against Hepatitis”, regional programs were accepted only in those subjects whose leaders “understood the importance” of such medical care and where there were “active chief infectious disease specialists”. As a result of such a policy, as reported by the experts of the Treatment Preparedness Coalition project (which monitors public procurement and availability of medicines), in 2021, 28.5 thousand people received treatment at the expense of the state – 1% of the total estimated number of patients with chronic hepatitis C living in Russia.

“Unfortunately, the opportunity to “limit by law” the range of patients is used very often,” comments Nikita Kovalenko, chairman of the Together Against Hepatitis organization. “We are afraid that in regions that have treated hepatitis C well, the volume of therapy may be reduced, and we want so that groups of patients without serious liver damage are already added to the order. This will give the regions and doctors some freedom and at least maintain treatment coverage.” Mr. Kovalenko notes that “serious doubts” are raised about the economic feasibility of the proposed criteria – in fact, he believes, before treating a patient, it is proposed to wait until the disease causes him maximum harm. “The liver rarely fully recovers from the stage of cirrhosis, and many health problems, including the risk of developing liver cancer, will remain with the patient for life even after successful treatment of hepatitis C. But in a person with moderate liver damage, treatment of hepatitis C in most cases leads to the “rollback” of fibrosis and restoration of the liver,” says Mr. Kovalenko.

Vyacheslav Morozov, an infectious disease specialist and member of the European Association for the Study of the Liver, draws attention to the fact that this is not the first time the regulator has offered priority treatment for severe patients “with cirrhosis as a result of hepatitis C”. 15 years ago, according to Mr. Morozov, although the medical community did not support, they understood this approach: either there were no drugs at all, or they were very expensive. Later, when treatment became more accessible, infectious disease specialists “moved away from this point of view.” “Now the drugs are also not cheap, but not so cheap,” continues Vyacheslav Morozov. “I don’t know why we returned 10-15 years ago. This will certainly limit access to therapy.” He notes that the situation should be considered “not only from a clinical point of view, but also from an epidemiological point of view”: without treatment, patients with early stages of fibrosis remain sources of infection, “and they are initially more active than people with cirrhosis, they continue to go to medical facilities, nail salons, to dentists, and thus the virus persists in the population. Therefore, at the first opportunity, when a hepatitis C virus is detected, regardless of what stage it is in, it must be sanitized.”

“Kommersant” sent a request to the Ministry of Health of the Russian Federation, but at the time of publication did not receive a response.

Natalia Kostarnova