At the Expert Session «Healthcare Technology Assessment – from Drug Provision to Real Clinical Practice» held as part of the 13th St. Petersburg International Health Forum, the leading industry experts discussed how modern approaches to the Healthcare Technology Assessment (HTA) help build an effective and economically sound system of drug provision from the federal level to the specific-clinic one.

The general line was set by reports on the system vision of the HTA. Professor, Doctor of Medicine Vitaly Omelyanovsky, CEO of the Centre for Expertise and Quality Control of Medical Care of the Ministry of Healthcare of the Russian Federation, Head of the Department of Healthcare Organization and Public Health with the Course to Healthcare Technology Assessment at the Federal State Budgetary Educational Institution of Additional Professional Education «Russian Medical Academy of Continuing Professional Education» of the Russian Ministry of Healthcare, indicated key drivers of developing the HTA in Russia: from the evaluation of expensive innovations with incomplete evidence base to the task of technological sovereignty.

He stressed that the HTA has long gone beyond purely academic interest and is now an integral part of practical healthcare. «The results of the comprehensive assessment are applied in a wide variety of areas», he noted, «from improving clinical practice and developing recommendations to pricing, reimbursing drug costs and distributing resource at the regional and even hospital levels».

Vitaly Omelyanovsky outlined promising areas for developing the HTA in Russia. They include introducing the assessment of additional therapeutic value, creating a separate public procurement track for innovative drugs, formalizing the pricing negotiation process based on the HTA data, as well as establishing regional HTA centres, for supporting local management decisions.

Professor Aleksey Kolbin, Doctor of Medicine, Head of the Department of Clinical Pharmacology and Evidence-based Medicine at Pavlov First Saint Petersburg State Medical University, dedicated his presentation to the key trend in the global healthcare economy – using real-world data (RWD) and the real-world evidence (RWE). In 2017, only six agencies from six countries had the RWE Use Policy, and by 2022 this practice had already spread to 22 agencies from 21 countries. «Not each RWD will turn into RWE», warned the speaker. «The key point is transforming unprocessed data into reliable evidence». He noted that the EAEU has already been creating the roadmap for RWE guidelines, which opens up new opportunities for drug registration and evaluation.

Kirill Matrenin, Deputy Head of the Department of Development and External Communications at the Centre for Expertise and Quality Control of Medical Care of the Ministry of Healthcare of the Russian Federation, illustrated the scale of the problem requiring the HTA use by giving the example of obesity. He cited data that about 40 million Russians suffer from this disease, and the total cost of the state reaches 500 billion rubles a year, which makes the fight against obesity a federal task.

The regional view: from theory to practice

The block of speeches related to St. Petersburg was devoted to practical aspects of introducing the HTA in the field. Tatiana Teptsova, Deputy Head of the Department of the HTA Methodological Support at the Centre for Expertise and Quality Control of Medical Care of the Ministry of Healthcare of the Russian Federation, considered in detail tasks and the structure of regional HTA centres, which should become an analytical resource for making informed management decisions. She also noted the importance of the new Government Resolution No. 871, which from 2024, gives regions the right to vote when forming the list of vital and essential medicines.

The urgent need to establish such a unit in the Northern Capital was proved by specific cases by Andrey Pavlysh, Doctor of Medicine, Chief Freelance Specialist in Clinical Pharmacology at the Healthcare Committee of the St. Petersburg Government, Professor at the Department of Internal Diseases, Nephrology, General and Clinical Pharmacology with a pharmacy course, Mechnikov Northwestern State Medical University of the Ministry of Healthcare of the Russian Federation.

He began with the thesis that St. Petersburg, as the flagship of Russian healthcare, cannot afford to make decisions on financing medical technologies without its own research-based regional analysis. He supported his statement with the analysis of three practical cases. The first one was devoted to improving the system of extemporal pharmacy production. Andrey Pavlysh pointed out that establishing the network of pharmacy production centres (PPC) could solve the problem of the shortage of «niche» medicines, provide considerable budget savings and increase the city’s drug sovereignty.

The most revealing case was treating multiple sclerosis with expensive genetically engineered biological drugs (GEBD). «Despite its high efficiency and minimal costs, divozilimab was appointed in 2025 to about 7% of the patients», cited Andrey Pavlysh the data. He proved that the non-optimal allocation of patients for therapy with other, less effective drugs led to additional budget expenditures of 12 million rubles, which would have been enough to treat 15 more patients with the targeted drug.

«Initiating the work on establishing the healthcare technology assessment unit in the structure of the St. Petersburg Government’s Health Committee will be a serious step towards building the research-based, financially sustainable and patient-oriented decision-support system for healthcare in the Northern Capital of Russia», concluded Andrey Pavlysh.

Dmitry Lisovets, Director of the St. Petersburg Territorial Compulsory Medical Insurance Fund, shared their experience of using big data for managing finances in compulsory medical insurance. The implemented system for analyzing 500 million records helped, among other things, to reduce the cost of inter-territorial settlements by 43% – from 1.03 billion to 585 million rubles.

Economy and accessibility: the view of manufacturers and customers

Financing and logistics issues took central stage in another group of presentations. Aleksander Bykov, Director of Healthcare Economy at the R-PHARM Group of Companies, pointed out a key problem: the gap between the registration of a drug and its full availability in the compulsory medical insurance system can reach 7 years. He proposed specific legislative initiatives aimed at synchronizing these processes.

Konstantin Perov, Director of the Autonomous Non-Profit Organization of Additional Professional Education «Institute of Competitive Technologies», dispelled a popular myth, stating that «the purchase of non-VED (not vital and essential drugs) does not require a medical commission’s decision in advance». He presented to the audience practical algorithms of purchasing innovative drugs under Law 44-FZ, including urgent purchases for a specific patient.

Dmitry Yurochkin, Deputy Head of the Laboratory for Regulatory Relations and Good Practices at the Federal State Budgetary Educational Institution of Higher Education «Saint Petersburg State Chemical Pharmaceutical University» of the Ministry of Healthcare of the Russian Federation, justified the economic feasibility of developing extemporal production. His calculations showed that organizing the centralized manufacturing of 15 drugs can save in the budget of St. Petersburg up to 96.4 million rubles per year.

Evidence-based medicine: methods and patients

The Session ended with reports focused on substantive research for those initiated into science. Eva Kovaleva, Senior Lecturer at the Department of Pharmacy Management and Economy of St. Petersburg State Chemical Pharmaceutical University of the Russian Ministry of Healthcare, presented the results of the meta-analysis on childhood obesity therapy, pointing out the similar safety profile of GLP-1 analogues and the need for expanding the tools used by pediatricians. Olga Mironenko, Healthcare Technology Assessment Manager at BIOCARD LLC, immersed the audience in the complex world of parametric survival models, explaining that this is not a «magic crystal», but a tool for predicting long-term outcomes that requires critical reflections and external data for validation.