Results of Methodological Quality Assessment of Budget Impact Analysis: Main Mistakes

2018 ◽  
pp. 11-18
Author(s):  
Oxana Ivakhnenko ◽  
Georgii Khachatryan ◽  
Maria Sura ◽  
Maria Avxentyeva ◽  
Vitaly Omelyanovskiy
Keyword(s):  
Quality Assessment ◽  
Russian Federation ◽  
Methodological Quality ◽  
Impact Analysis ◽  
Budget Impact ◽  
Budget Impact Analysis ◽  
Essential Drug List ◽  
The Russian Federation ◽  
The Government

The article provides the results of the assessment of methodological quality of budget impact analysis (BIA) submitted as a justification for the inclusion/exclusion of drugs into the drugs lists for medical use (Vital and Essential Drug list, List of Drugs for Certain Categories of Citizens, List of High-Cost Drugs) in 2018.The assessment was performed by the Center of Healthcare Quality Assessment and Control of the Ministry of Health of the Russian Federation according to the requirements, described in the Order of the Government of the Russian Federation, № 871 (version from 29.10.2018), which consist of 11 criteria. The information on distribution of BIA studies in regards to the number of criteria not meeting the requirements and proportion of mistakes on every criterion is presented. Besides, the authors analyzed main causes of non-meeting the requirements for methodological quality of BIA studies described in the Order of the Government of the Russian Federation, № 871.

scholarly journals Budget Impact Analysis of Inclusion in the Expensive Drugs List of Canakinumab for Treatment of Systemic Onset Juvenile Arthritis

2019 ◽  
pp. 66-73
Author(s):  
Elena Derkach
Keyword(s):  
Russian Federation ◽  
Impact Analysis ◽  
Budget Impact ◽  
Systemic Juvenile Idiopathic Arthritis ◽  
Federal Budget ◽  
Target Population ◽  
Budget Impact Analysis ◽  
Selling Price ◽  
The Russian Federation ◽  
The Government

Introduction. In 2018 the Federal Order of 03.08.2018 No. 299-FO was adopted, whereby the provision of drugs for the treatment of systemic juvenile idiopathic arthritis (sJA) was delegated to the federal level. Aim. In accordance with the requirements for the development of formularies of medicines, approved by Decree of the Government of the Russian Federation No. 871, the budget impact analysis of inclusion in the expensive drugs list of canakinumab for the treatment of sJA was conducted. Material and methods. The drug costs were calculated based on the manufacture`s maximum selling price inclusive of all taxes and additional charges according to the legislation of the Russian Federation. Characteristics and the size of the target population of patients diagnosed with sJA were determined based on the data from different sources – clinical trials, registries, standards, of medical care, experts` judgment. The time horizon of the analysis is 1 year and 3 years. The sensitivity analysis was performed to test how results affected by changes in key assumptions such as drug price and size of the target population. Results. The budget impact analysis revealed that provision for the target population of canakinumab for the treatment of sJA does not require a significant increase in the programme budgeting of costly diseases. The insignificant increase is required for the programme budgeting equal to the amount of 1,588 billion per year, which is 4% less than the 2018 budget. Conclusions. Assurance of centralized purchasing of canakinumab from federal budget resources is in harmony with the financing capacity of costly diseases programme, extended from 2019, to cover canakinumab reimbursement for patients with sJA.

scholarly journals Assessment of the Methodological Quality of Economic Evaluations: Main Mistakes

2019 ◽  
pp. 8-17
Author(s):  
Georgii Khachatryan ◽  
Oxana Ivakhnenko ◽  
Maria Sura ◽  
Maria Avxentyeva
Keyword(s):  
Russian Federation ◽  
Methodological Quality ◽  
Healthcare Quality ◽  
Economic Evaluations ◽  
Expensive Drug ◽  
Drug List ◽  
The Russian Federation ◽  
The Government ◽  
And Control

Results of the assessment of methodological quality of economic evaluations (EE), submitted to justify the inclusion/exclusion of drugs in the lists of drugs for medical use (list of vital and essential drugs, additional medication supply list and expensive drug list), are given in the article. The study was conducted in 2018 in the FSBI “Center for healthcare quality assessment and control” of the Ministry of Health of the Russian Federation. Assessment was performed based on 12 criteria in accordance with the requirements to the methodological quality of economic evaluations, described in the draft Order of the Government of the Russian Federation, No. 871, and then were approved in the Order of the Government of the Russian Federation, No. 871, state on 20.11.2018. The distribution of EE based on the number of criteria they did not meet, and also the frequency of made mistakes for each criterion are presented. Main reasons for EE not meeting the requirements to methodological quality, prescribed by the Order of the Government of the Russian Federation, No. 871, are analyzed.

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