Moscow, Russian Federation

It is essential to unite countries with the similar level of HTA in communities to share experience and knowledge, regardless geographic location and economic advancement”
Prof. Vitaly Omelyanovskiy, General Director, CHQAC

History and Structure

The Center for Healthcare Quality Assessment and Control of the Ministry of Health of the Russian Federation is a federal state budgetary institution, which implements government healthcare policy and provides information and methodological support for the Ministry of Health of the Russian Federation, being engaged in healthcare activities for more than 17 years.

Principle activities of the Center are:

  • Comprehensive health technology assessment of medicines (HTA);
  • Development and assessment of medical care standards and clinical guidelines
  • Monitoring of KSG (DRG) payment system.
  • Development and assessment of quality control criteria.

Mission

To increase transparency and efficiency of decision-making through HTA system implementation on financing of medical technologies to improve quality and availability of medical care in the Russian Federation.

How CHQAC Works

The Center for Healthcare Quality Assessment and Control of the Ministry of Health of the Russian Federation analyses methodological quality of pharmacoeconomic studies (cost-effectiveness/cost-utility studies, budget impact analysis) and additional consequences of a drug use within the procedure of comprehensive health technology assessment (HTA) of drugs, which is a part of decision-making system in Russia regarding inclusion (exclusion) of drugs in federal reimbursement lists, including vital and essential drug list. Besides our institution, there are also a number of expert organizations and chief clinical specialists, which take part in comprehensive HTA analyzing data from the dossier using the scales and formulating scientific recommendation on inclusion (exclusion) of the drugs, respectively.

After that, the decision regarding inclusion (exclusion) of the reviewed drug is made during meeting of the Committee, which includes members of different ministries, clinical and pharmacoeconomic experts. The submitted dossier of the reviewed drug includes general part (information about the drug, drug indications, etc.), value of assessed drug (including advantages in terms of unmet therapeutic needs, advantages regarding mechanism of action, volume of regional procurement, localization of manufacturing of the drug) clinical part (epidemiology, clinical studies), economic part (pharmacoeconomic studies, price offer), data on pharmacovigilance.

Dissemination Activities

Our institution develops methodology for comprehensive assessment of medicines, performs analyses of methodological quality of clinical and economic research as well as materials on assessment of clinical effectiveness, safety and economic evaluation of health technologies. Moreover, we develop methodology and analyze guidelines in their relation to medical care standards, prepare information materials on adapting guidelines in health care system. The results of our work are presented at national and international scientific conferences, workshops, seminars and panel discussions.

Our center has also developed the following methodological guidelines:

  1.  Assessment of comparative clinical efficacy and safety of drugs;
  2.  Budget impact analysis within the program of state guarantees of the Russian Federation;
  3.  Assessment of comparative clinical and economic effectiveness;
  4.  On multi-criteria decision analysis (MCDA);
  5.  Comprehensive assessment of a drug for decision-making on the possibility of its inclusion in a pilot project on drug procurement mechanisms introduction on innovative contract models in the Russian regions;
  6.  Quality assessment of statistical analysis in clinical trials;
  7.  Conducting a meta-analysis;
  8.  Conducting an indirect comparison;
  9.  Cost calculation for clinical and economic studies of drugs;
  10.  Assessment of comparative clinical efficacy and safety of drugs, economic and additional consequences of a drug use based on ranked scales;
  11.  Use of modeling in pharmacoeconomic studies;
  12.  Conducting a network meta-analysis.

Current Projects (A Selection)

  • Development of approaches to estimating cost-effectiveness threshold
  • EQ5D23L evaluation study for Russian population
  • HTA process for orphan drugs
  • HTA for medical devices
  • HTA of gene and cell therapies
  • Measurement for level innovativeness of health technologies
  • Methodology guidelines on economic modeling
  • Development of new approaches to pharmaceutical price regulation connected with HTA (value-based pricing, managed-entry agreements, risk sharing agreements)
  • Monitoring system for the years of life lost
  • Value-Based Healthcare

Agency Information

Country: Russian Federation
Description of population served: National
Population served (mil): 147.7
Current HTA budget (mil USD): 2.0
Permanent staff: 160
Consultants: Variable
Ongoing TA projects:


Contact information

Director: Vitaly Omelyanovskiy
Contact person: Nuriya Musina, Nelly Gilyazetdinova

The Center for Healthcare Quality Assessment and Control
Khokhlovsky lane 10, bldg. 5
Moscow, Russia 109028

Tel: +7 (495) 783-19-05
Internet: www.rosmedex.ru
Email: musina@rosmedex.ru
Gilyazetdinova@rosmedex.ru