An order is an order – Newspaper Kommersant No. 59 (7504) dated 04/06/2023

The Ministry of Health accepted only one of 23 proposals submitted by patients, doctors and community members in the course of finalizing the mechanism for providing care for hepatitis C according to mandatory medical insurance in a hospital setting. In the list of those who are entitled to such assistance, the department added patients with a number of concomitant diseases – for example, cancer and HIV. Experts believe that in this form, the order deprives a significant part of patients with hepatitis C of care and only partially meets clinical recommendations.

The order of the Ministry of Health of the Russian Federation on the criteria for providing medical care to patients with hepatitis C in a hospital was approved by the Ministry of Justice at the end of March. As Kommersant said, patients and public organizations asked the department to finalize it. It followed from the document that only patients in the late stages of fibrosis and with cirrhosis of the liver can count on treatment at the expense of compulsory medical insurance. The patient community asked for a review of the order “in the direction of expanding access to therapy.” They mentioned in particular patients with moderate fibrosis; people 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 a year; women of childbearing age, including those undergoing or planning an IVF procedure. As a result, the Ministry of Health took into account only one of the 23 proposals, Kommersant was told in the Treatment Preparedness Coalition (ITPC): patients with a risk of rapid development of liver disease due to concomitant diseases were added to the list. The Ministry of Health clarified that this also applies to patients receiving immunosuppressive therapy and cancer patients. “The order in no way limits the circle of patients with hepatitis C who receive medical care on an outpatient basis,” the department said.

It should be noted that before the order came into force, only patients with hepatitis C, who also had HIV, received treatment at the expense of the federal budget.

The rest could count on therapy at the expense of the regions, compulsory medical insurance and “other budgets”. As patient organizations point out, resources have always been limited, so patients with fibrosis were treated first, and the rest waited in line – sometimes for years, or purchased drugs on their own. So, in 2021, 28.5 thousand people received therapy at the expense of the state – only 1% of the total estimated number of people with chronic hepatitis C living in Russia.

Treatment Preparedness Coalition expert Daria Mikulich says the order still ends up excluding the majority of patients and only partially aligns with clinical guidelines: “This could lead to patients with moderate fibrosis not being able to expect a full cure. There is also no clear understanding of how such an important category as women of reproductive age planning pregnancy will be provided with drugs.”

Among the proposals for finalizing the order was a comment by Yulia Sozinova, deputy head physician for the medical department of the Republican Clinical Infectious Diseases Hospital named after Agafonov (Kazan). She noted that most of the patients who need antiviral therapy in the day hospital do not have cirrhosis. According to her, there are more than 2,000 CVHC patients on the Kazan waiting list (including 39 children) and only 445 patients (about 20%) have F3-4 fibrosis stage. At the same time, 70–80% of those who have the disease in the early stages are “young, able-bodied, fertile people who, after receiving effective treatment, want to start a family and give birth to children without the threat of infecting loved ones.” Without timely effective therapy, the risk of hepatitis progression and the formation of cirrhosis or fibrosis within five to ten years in this group of patients is 30%, and they have no opportunity to pay for treatment at their own expense. 80% of patients with chronic hepatitis C are at risk of not falling under the criteria of the Ministry of Health, this will create social tension and at least increase the number of patients’ appeals to the authorities, and in the longer term will affect economic indicators due to disability, an increase in mortality among the working population and a worsening demographic situation, noted Yulia Sozinova .

According to the head of the interregional public organization “Together Against Hepatitis” Nikita Kovalenko, the Ministry of Health again made it clear that only patients with risks of negative developments in the foreseeable future will be treated as part of the basic compulsory medical insurance program. The rest will continue to receive assistance under targeted regional programs. Before the entry into force of the document, continues Mr. Kovalenko, a larger number of patients actually received therapy at the expense of the regions, and only about 23% of drugs were purchased from the federal budget. He noted that there are regions that for many years have been providing their patients with hepatitis C with therapy only at the expense of compulsory medical insurance – the Chelyabinsk, Tula, Oryol regions. “For example, Orla, where for ten years now they have been treated at the expense of compulsory medical insurance and have already treated all patients with severe liver damage, in fact cut off the opportunity to help other patients,” says Mr. Kovalenko. Regional budgets for 2023 have already been formed, and in these regions they do not provide for financing the treatment of hepatitis C, says Mr. Kovalenko: “If such regions act solely within the framework of the order, it will be a disaster.”

The Ministry of Health, commenting on the concerns of patients, said that the criteria were developed by “leading professional communities, including taking into account the necessary medical care, which can only be provided in a day hospital and inpatient conditions under the supervision of medical workers.”

Natalia Kostarnova