Forum "Clinical Puzzle: Allergy and Multimorbidity"

The following acted as chairpersons:

• Alexander Rumyantsev , Academician of the Russian Academy of Sciences, Doctor of Medical Sciences, Chairman of the Expert Council of the National Research Electro-Hematological Center of Hematology, Oncology and Immunology, President of the Federal State Budgetary Institution “D. Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology” of the Ministry of Health of the Russian Federation, Member of the State Duma Committee on Health Protection;
• Musa Khaitov , Academician of the Russian Academy of Sciences, Doctor of Medical Sciences, President of the Russian Association of Acquisitions, Director of the Federal State Budgetary Institution “State Research Center Institute of Immunology” of the Federal Medical and Biological Agency of Russia, Chief Allergist-Immunologist of the Ministry of Health and the Federal Medical and Biological Agency of Russia;
• Natalia Ilyina , MD, Professor, Vice President, Director General of the Russian Academy of Agrarian and Cultural Institutions (RAAKI), Chief Physician of the Federal State Budgetary Institution “State Research Center Institute of Immunology” of the Federal Medical and Biological Agency of Russia

The main topics of the forum were:

• Current issues in allergology, immunology and related disciplines (including issues of diagnosis and treatment, multimorbidity of allergy as a systemic inflammation, problems of immunodeficiency and autoinflammatory diseases, etc.);
• Regulatory and economic aspects of medical care provision;
• Organization of specialized care for patients in the conditions of modern reality, issues of providing effective medicines;
• Participation of patient organizations in the provision of specialized care to patients with allergic and immune-mediated diseases.

Key session of the National Institute of Allergology and Immunology: "Regulatory aspects of activities in the field of allergology and immunology"

The following presented their reports:

• Natalia Ilyina , MD, Professor, Vice President, Director General of the Russian Academy of Agrarian and Infectious Diseases (RAAKI), Chief Physician of the Federal State Budgetary Institution “State Research Center Institute of Immunology” of the Federal Medical and Biological Agency of Russia — “Current issues of drug provision for patients with immunodeficiency states”;
• Elena Latysheva , MD, Head of the Immunopathology Department of the Clinic of the Federal State Budgetary Institution “State Research Center Institute of Immunology” of the Federal Medical and Biological Agency of Russia — “Current issues of drug provision for patients with immunodeficiency states”;
• Olesya Mishina , PhD, President of the Association for Support of Citizens with Skin, Pulmonary, Allergic and Immune-Mediated Diseases “The Path to Health” — “Barriers to Realizing the Patient’s Right to Medical Care”;
• Maria Sura , PhD, Associate Professor of the Department of Healthcare Organization and Public Health with a course in health technology assessment at the Federal State Budgetary Educational Institution of Higher Professional Education “RMANPO” of the Ministry of Health of the Russian Federation — “Issues of payment for drug therapy for patients with secondary immunodeficiencies at the expense of compulsory medical insurance funds”;
• Polina Gabay , PhD in Law, attorney, chair of the board of founders of the ANO "NAECZ", assistant to a State Duma deputy - "The legal field of allergology and immunology: from clinical guidelines to tariffs."

Main accents

In her presentation, Natalia Ilyina focused on current issues related to medication provision for patients with immunodeficiencies. The professor noted that most patients with congenital immune defects require replacement therapy with normal human immunoglobulin.

According to Natalia Ilyina, major problems currently arise with the system for paying for intravenous immunoglobulin administration to patients with PID in hospitals using compulsory medical insurance funds. The rates do not cover the cost of the medications. Depending on the dosage, the average cost per administration can range from 173,800 rubles to 347,700 rubles, with a rate of 145,200 rubles for 24-hour inpatient care.

The professor reported that proposals for improving approaches to medical care payment are being discussed today at the Expert Council meeting with representatives from the Ministry of Health and the Federal Compulsory Medical Insurance Fund. It is proposed to split the day hospital KSG (DS 36.001) into two levels based on dosage and increase the KZ of the 24-hour hospital KSG ( ST 36.001) to increase the tariff.

Elena Latysheva continued the topic. The expert noted that although primary immunodeficiencies are listed as rare (orphan) diseases, they are not included in the list of life-threatening diseases or in any other federal or regional subsidized drug provision programs. Patients are effectively denied access to medications without the "disability" status in most regions. Furthermore, denials of disability status to patients in remission are common.

Elena Latysheva emphasizes that there are currently no registered, affordable medications for self-administration in Russia. Immunoglobulins are designated "for inpatient use," which hinders their availability. Russian Ministry of Health Order No. 100n, dated March 7, 2025, came into effect on September 1, 2025. According to this order, pharmacies are prohibited from dispensing immunoprophylaxis medications intended for "inpatient use only." Furthermore, some medications lack "outpatient alternatives." Due to this order, many regions are "centralizing" replacement therapy, selecting a few medical institutions to purchase immunoglobulins. This entails new costs for healthcare facilities, preventing patients from choosing where to receive therapy, and more. All of this ultimately leads to a decline in the quality of medical care.

The expert offers, among other things, the following solutions to existing problems:

• Decentralization of hospitals designated for substitution therapy and the possibility of receiving therapy at the place of residence;
• Development of a general profile CSG for substitution therapy;
• Possibility to redistribute funds from regional benefits and compulsory medical insurance;
• Inclusion of PID in the List of Life-Threatening Diseases;
• The possibility of “auto-extension” of disability benefits for patients with immunodeficiencies, taking into account the severity of the disease, the presence of concomitant diseases, and the need for lifelong treatment.

Olesya Mishina shared the results of a 2025 survey of patients with chronic spontaneous urticaria conducted by the Path to Health Association. The expert explained that the following factors influence patients' access to medical care:

1. Almost 70% of patients do not receive a diagnosis of CSC from their first doctor.
2. 43.3% of respondents did not receive assistance in specialized (federal and regional) centers.
3. Almost one percent of patients waited 4-6 months for a consultation at specialized centers, 1.2% - more than 6.
4. 42.7% of respondents spoke negatively about the availability of telemedicine in specialized centers.
5. The average time from the onset of CSC symptoms to diagnosis is about 2 years.

Olesya Mishina also emphasized that problems remain today with the shortage of specialized medical care in the field of "allergology and immunology" in the compulsory medical insurance system and the funding of patient care on a residual basis.

Maria Sura's report focused on the payment of drug therapy for patients with secondary immunodeficiency conditions using compulsory medical insurance funds. The expert noted that for hospitalizations requiring intravenous immunoglobulin, there are currently three payment options: the CCG for "Allergology and Immunology," the CCG for "Other," and the CLP for accompanying therapy (for malignant neoplasms in adults). However, each of these options is imperfect.

Tariffs for specialized KSG ds03.001 and st03.001 are clearly in short supply. Moreover, they can vary significantly between regions. For example, many regions have introduced lower rates (0.80–0.85) for specialized KSG.

Hospitalization cases for the "Other" profile are coded using the ICD-10 code in conjunction with the service. However, for example, for day hospitalization, codes D84.8 and D89.8, which correspond to secondary immunodeficiencies, cannot be used.

In the case of KSLP, the problem lies in their low value, which increases the tariff by less than 50,000 rubles in both types of hospitalization. The description of the drug administration regimen is also incomplete—it does not correspond to the information provided in the KYG and the instructions for the drug.

In her final presentation, Polina Gabay highlighted the key legal issues faced by physicians in their daily practice. The expert noted that the modern system of legal regulation of medical care, including in the fields of allergology and immunology, is formed at the intersection of clinical practice, regulatory requirements, and financial and pricing mechanisms. Today, physicians are simultaneously participants in the treatment process and subjects of legal relations, where every action must be lawful and documented. There are high risks of various types of legal liability for both the physician and the medical organization.

Polina Gabay presented answers to doctors' practical questions about how to act within the legal framework when making clinical decisions, prescribing therapy, managing special patient categories, and resolving non-standard situations.

Among other things, the following issues were discussed:

• mandatory clinical guidelines;
• actions of a physician in the event of contradictions and errors in clinical recommendations;
• new rules of work and powers of the medical commission;
• drug provision (including the legality of prescribing off-label drugs to adults and children; the legality of prescribing drugs not provided for in clinical guidelines; mechanisms for paying for medical services and drug therapy under the state guarantees program, etc.);
• features of providing medical care to minors and elderly patients.

Results

Following the session, a resolution will be prepared with proposals for government agencies aimed at improving legal regulation and mechanisms for providing assistance to patients with allergic and immune diseases.