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 document
Guidelines 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 authors
Center for Healthcare Quality Assessment and Control of the Ministry of Health of the Russian Federation  
Purpose of the document
Provide 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 included
Yes 
Disclosure
Yes 
Target audience of funding/ author's interests
Decision-makers, healthcare authorities, researchers, pharmaceutical companies  
Perspective
Healthcare payer  
Indication
Approved indication   
Target population
Relevant groups or sub-groups need to be defined and justified  
Subgroup analysis
Yes 
Choice of comparator
The 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 horizon
Clinical 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 required
Yes, should be justified  
Preferred analytical technique
The main method of pharmacoeconomic studies is CEA; CUA and CMA also can be used  
Costs to be included
Direct 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 costs
The identification and measurement of costs should be consistent with the perspective of the Russian healthcare payer   
Modeling
Yes; 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 evidences
Yes, 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 efficacy
No 
Preferred outcome measure
No 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 utility
N/A 
Equity issues stated
N/A 
Discounting costs
5% 
Discounting outcomes
N/A 
Sensitivity analysis-parameters and range
It 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-methods
Not regulated 
Presenting results
Special 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 analysis
Yes; 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 analysis
Yes; budget impact analysis is mandatory 
Mandatory or recommended or voluntary
Recommended  

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

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