PE Guidelines logo
Pharmacoeconomic Guidelines Around The World

Country/Region: Russian Federation

Published PE Recommendations
Guidelines for conducting a comparative clinical and economic evaluation of drugs
PDF in Russian
Guidelines for assessing the budget impact in the framework of the Programm of the State Guarantee of Free Medical Care in the Russian Federation
PDF in Russian

Published PE Recommendations Source:
https://rosmedex.ru/en/

Additional Information:
Guidelines for assessing a comparative clinical efficacy and safety of drugs
PDF in Russian

Last Webpage Update: Thursday, February 15, 2018

Published PE Recommendations Key Features:

Key Features:  
Title and year of the documentGuidelines for conducting a comparative clinical and economic evaluation of drugs (2016); Guidelines for assessing the budget impact n the framework of the Programm of the State Guarantee of Free Medical Care in the Russian Federation (2016)  
Affiliation of authorsCenter for Healthcare Quality Assessment and Control of the Ministry of Health of the Russian Federation  
Purpose of the documentProvide a common methodology for conducting pharmacoeconomic studies, a common form of presenting and assessing results for drugs submitted for inclusion in restrictive (reimbursement) lists  
Standard reporting format includedYes 
DisclosureYes 
Target audience of funding/ author's interestsDecision-makers, healthcare authorities, researchers, pharmaceutical companies  
PerspectiveHealthcare payer  
IndicationApproved indication   
Target populationRelevant groups or sub-groups need to be defined and justified  
Subgroup analysisYes 
Choice of comparatorThe most relevant alternative treatment for comparison is a drug included in restrictive lists of drugs for medical use and intended for use at same indications as the drug submitted for inclusion in restrictive lists; OR a combination of such drugs; OR a scheme of drug combination, some of which are included in restrictive lists of drugs for medical use  
Time horizonClinical and economic evaluation: the time horizon should be determined taking into account objective factors, such as duration of treatment or patient life expectancy and should be indicated and justified; Budget impact analysis: the time horizon can be from 1 to 5 years, it is necessary to present the results of the first year separately 
Assumptions requiredYes, should be justified  
Preferred analytical techniqueThe main method of pharmacoeconomic studies is CEA; CUA and CMA also can be used  
Costs to be includedDirect medical costs are mandatory; accounting for other types of costs remains at the discretion of researchers and different types of costs are indicated separately  
Source of costsThe identification and measurement of costs should be consistent with the perspective of the Russian healthcare payer   
ModelingYes; a model should be justified and described in detail (indication(s), application conditions (outpatient or inpatient), choice of comparator, target population, criteria for evaluating the efficacy and safety, method of pharmacoeconomic study, time horizon, calculation of costs, sensitivity analysis-method), a software product should be described in Russian and be available for analysis  
Systematic review of evidencesYes, systematic review of the existing clinical studies of the medical intervention, including unpublished studies and studies with negative results. The search strategy should be reproducible and selection criteria and procedures clearly presented  
Preference for effectiveness over efficacyNo 
Preferred outcome measureNo mandatory requirements; clinical outcomes are preferred, surrogate outcomes can be used if there is evidence of association with the clinical outcomes  
Preferred method to derive utilityN/A 
Equity issues statedN/A 
Discounting costs5% 
Discounting outcomesN/A 
Sensitivity analysis-parameters and rangeIt is necessary to conduct sensitivity analysis of results to variations in the initial parameters (variations of drug prices, change in the value of efficacy, frequency of side effects)  
Sensitivity analysis-methodsNot regulated 
Presenting resultsSpecial form with the following parameters: a name of the submitted drug, formulation(s), indication(s), application conditions and funding sources, the time horizon, the target population, criteria for evaluating the efficacy and safety, costs, method of pharmacoeconomic study (CEA, CUA, CMA), results (ICER, ICUR), sensitivity analysis, conclusion  
Incremental analysisYes; if not only direct medical costs were used the incremental cost-effectiveness ratio should be presented separately: for direct medical costs; for direct medical and non-medical costs; for overall costs  
Total costs vs effectiveness (cost/effectiveness ratio)Yes; if not only direct medical costs were used the cost-effectiveness ratio should be presented separately: for direct medical costs; for direct medical and non-medical costs; for overall costs  
Portability of results (Generalizability)N/A 
Financial impact analysisYes; budget impact analysis is mandatory 
Mandatory or recommended or voluntaryRecommended  

Acknowledgement: ISPOR Russia HTA Regional Chapter highly contributed to the Published PE Recommendations in Russia and the key feature form.

Country Selection Page | PE Guidelines Index Page