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The real practice of clinical and economic research of drugs included in the Federal Program of High-Cost Nosologies

https://doi.org/10.17749/2070-4909/farmakoekonomika.2022.107

Abstract

Objective: to assess the compliance of the actual practice of conducting clinical and economic research with the requirements applicable in the Russian Federation (RF) when including drugs in the Federal Program of High-Cost Nosologies (HCN).

Material and methods. In the CyberLeninka and eLibrary databases, a search was made for clinical and economic studies of medicines included in the HCN list published in the RF in the period from 2011 to June 2021.

Results. Information was obtained on 23 published clinical and economic studies of the effectiveness of drugs, which is less than 30% of all drugs included in the HCN program during the specified period. More than half of the studies of chronic disabling diseases had a modeling horizon of 1 year. The sensitivity analysis of the results in over 1/3 of cases considered only the deviation of the price of the strategies under consideration, and in a quarter of cases it was not carried out at all. Only 4 studies evaluated the increase in quality-adjusted life year, although, for chronic disabling diseases, quality of life is one of the key performance indicators.

Conclusion. In the RF, less than 30% of the results of pharmacoeconomical studies of drugs included in the HCN Program are published, which does not allow to make adequate evaluation of pharmacoeconomical approaches to its formation. To analyze the effectiveness of the tools used in assessing the economic efficiency of expensive medical technologies, a further retrospective research of the studies conducted in the RF is required.

About the Authors

A. S. Kolbin
Pavlov University; Saint Petersburg State University
Russian Federation

Dr. Med. Sc., Professor, Chief of Chair of Clinical Pharmacology and Evidence-Based Medicine, 6-8 Lev Tolstoy Str., Saint Petersburg 197022;

Professor, Chair of Clinical Pharmacology, 7-9 Universitetskaya Emb., Saint-Petersburg 199034



Yu. M. Gomon
Pavlov University; St. George the Martyr City Hospital
Russian Federation

Dr. Med. Sc., Associate Professor, Chair of Clinical Pharmacology and Evidence-Based Medicine, 6-8 Lev Tolstoy Str., Saint Petersburg 197022;

Clinical Pharmacologist, 1 Severnyy Ave., Saint Petersburg 194354



A. R. Kasimova
Pavlov University; Vreden National Medical Research Center of Traumatology and Orthopedics
Russian Federation

MD, PhD, Assistant Professor, Chair of Clinical Pharmacology and Evidence-Based Medicine, Pavlov University; Clinical Pharmacologist, 

6-8 Lev Tolstoy Str., Saint Petersburg 197022;

8 Academician Baykov Str., Saint Petersburg 195427



A. A. Kurylev
Pavlov University
Russian Federation

MD, PhD, Assistant Professor, Chair of Clinical Pharmacology and Evidence-Based Medicine,

6-8 Lev Tolstoy Str., Saint Petersburg 197022



A. E. Bem
Pavlov University
Russian Federation

MD, PhD, Researcher, Chair of Clinical Pharmacology and Evidence-Based Medicine, 

6-8 Lev Tolstoy Str., Saint Petersburg 197022



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Review

For citations:


Kolbin A.S., Gomon Yu.M., Kasimova A.R., Kurylev A.A., Bem A.E. The real practice of clinical and economic research of drugs included in the Federal Program of High-Cost Nosologies. FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology. 2022;15(1):87-105. (In Russ.) https://doi.org/10.17749/2070-4909/farmakoekonomika.2022.107

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ISSN 2070-4909 (Print)
ISSN 2070-4933 (Online)