scholarly journals The Rules for Creation of Federal Drug Lists: Current State and Development Prospects

2018 ◽  
pp. 9-17
Author(s):  
Vitaly Omelyanovskiy ◽  
Maria Sura ◽  
Maria Avxentyeva ◽  
Georgii Khachatryan
Keyword(s):  
Impact Analysis ◽  
Budget Impact ◽  
Evaluation Criteria ◽  
Legal Regulation ◽  
Pharmacoeconomic Evaluation ◽  
Budget Impact Analysis ◽  
Essential Medicines ◽  
Current State ◽  
Complex Evaluation

The paper discusses the issues of normative and legal regulation for creation of drug lists (List of Vital and Essential Medicines, List of Medical Drugs for Certain Categories of Citizens, List of High-Cost Medical Drugs (Seven Nosologies list). It also considers historical aspects, current state and planned changes of these rules. The stages of expertise, evaluation criteria, and rules of decision making in the process of inclusion of medical drugs (MD) into the lists according to the RF Government Decree no. 871 on 28 August 2014 and the project on the amendment of this decree are thoroughly considered. The proposed changes address the terms of submission of proposals for the inclusion and exclusion of MDs into the lists, and the terms of expert procedures. Changes in expert procedures (complex evaluation) of MD are proposed; a new stage (analysis of methodological quality of pharmacoeconomic studies and budget impact analysis) is introduced. Integral scales of clinical and pharmacoeconomic evaluation of MD are substituted with complex evaluation scales. The requirements for ethodological quality of pharmacoeconomic studies and budget impact analysis are created. A further stage of the development of the rules for creating the lists can be the performance of complex evaluation within a single expert body with the participation of expert organizations and leading specialists.

scholarly journals COMPARATIVE PHARMACOECONOMIC ANALYSIS OF RIVAROXABAN AND WARFARIN USAGE IN PATIENTS WITH NON-VALVULAR ATRIAL FIBRILLATION

2020 ◽  
Vol 26 (3) ◽  
pp. 37-47
Author(s):  
V. V. Arkhipov ◽  
D. A. Sychev
Keyword(s):  
Atrial Fibrillation ◽  
High Risk ◽  
Impact Analysis ◽  
Budget Impact ◽  
Pharmacoeconomic Analysis ◽  
International Normalized Ratio ◽  
Cardiovascular Complications ◽  
Pharmacoeconomic Evaluation ◽  
Budget Impact Analysis ◽  
Number Of Patients

Objective: complex pharmacoeconomic evaluation of warfarin replacement with rivaroxaban one of the direct oral anticoagulant (DOAC) for the treatment of patients with non-valvular atrial fibrillation and high risk of thromboembolia with poor international normalized ratio control.Materials and methods: A pharmacoeconomic model was designed to evaluate clinical outcomes of rivaroxaban therapy in compare with warfarin (with poor international normalized ratio control), economic impact was also calculated using budget impact analysis. Direct medical costs included drug costs, inpatient costs and costs of patient rehabilitation with cardiovascular complications. Moreover, indirect costs were simulated, including Gross Domestic Product loss due to disability or mortality of patients. Results were calculated on total number of patients from Russian Federation with non-valvular atrial fibrillation and high risk of thromboembolism, receiving rivaroxaban and warfarin (total of 278,175 patients). Patients with non-valvular atrial fibrillation on other anticoagulant therapies (130,305 patients) were not included in the analysis. Modeling horizon was 12 months.Results: in the analyzed population replacement of warfarin with poor international normalized ratio control with rivaroxaban makes it possible to additionally prevent 3,778 stroke events (-33% in compare with warfarin), 170 events of systemic thromboembolisms (-31%), 1,977 events of fatal bleeding (-11%) and 247 events of myocardial infarctions (-6%). Generally, patients transfer to rivaroxaban therapy reduces mortality by 30% (2,908 cases). Budget impact analysis demonstrated, that despite of the increased drug therapy costs by 2,306.1 million RUR, replacement of warfarin in the part of patients with rivaroxaban reduces costs, related to the complications treatment by 543.0 million RUR, rehabilitation costs - by 461.6 million RUR, INR control costs - by 480.3 million RUR, decline in GDP due to disability and mortality - by 2,988.5 million RUR. Thereby, replacement of patients with poor international normalized ratio control from warfarin to rivaroxaban reduces costs, related to the complications treatment of atrial fibrillation and GDP loss by 2,174.0 million rub.Conclusion: Warfarin replacement with rivaroxaban in patients with non-valvular atrial fi brillation and high risk of thromboembolism with poor international normalized ratio control is the most efficient from clinical and economic points.

scholarly journals Pharmacoeconomic aspects of macitentan in the therapy of pulmonary arterial hypertension

2017 ◽  
Vol 89 (3) ◽  
pp. 72-77
Author(s):  
O M Moisseeva ◽  
A V Rudakova
Keyword(s):  
Cost Effectiveness ◽  
Pulmonary Arterial Hypertension ◽  
Arterial Hypertension ◽  
Impact Analysis ◽  
Budget Impact ◽  
Functional Class ◽  
Budget Impact Analysis ◽  
Essential Medicines ◽  
Pulmonary Arterial ◽  
The Cost

Aim. To provide a pharmacoeconomic estimate of macitentan versus bosentan in therapy for pulmonary arterial hypertension (PAH). Subject and methods. An analysis was carried out on the basis of a social perspective for patients, whose mean age was 50 years. A budget impact analysis was performed without discounting; with the time horizon of the study being 5 years. Assessing the cost- effectiveness of endothelin receptor antagonists used a Markov model based on the meta-analysis of clinical trials. The cost of bosentan was calculated from the 2016 registered prices with VAT. That of macitentan was estimated from the expected price of 170,000 rubles per 10-mg dose pack №28 if the drug is included in the List of Essential Medicines with VAT. The cost of sildenafil and iloprost was consistent with the January-to-November 2016 auction results. At cost-effectiveness assessment costs and outcomes were both discounted at an annual rate of 3,5%. Results. After 5 years of therapy with macitentan in patients with baseline Functional Class (FC) II PAH, the proportion of patients with FC I-II was shown to be 2.6% more than that during therapy with bosentan (20.1 and 17.5%, respectively), and that of the died patients was 1.5% lower (69.5 and 71%, respectively). In baseline FC III PAH following 5 years, the proportion of patients with FC III PAH on initial macitentan treatment was 1% more than that on bosentan therapy (8.1 and 7.1%, respectively), and that of the died patients was 0.5% lower (87.2, and 87.7%, respectively). The cost-effectiveness analysis shows that therapy with macitentan versus bosentan not only causes some increase in life expectancy in terms of quality of life (by 0.414 and 0.230 QALYs in FC II and III PAH, respectively), but also results in a small cost decrease in FC II and III PAH (by 11,000 and 16,000 rubles per patient, respectively). Thus, macitentan is a dominant alternative versus bosentan. The budget impact analysis indicates that when bosentan is replaced with macitentan, the reduction in health care costs in the Russian Federation will amount to 1.9 million rubles over 5 years, and in all budgetary costs will be 14.7 million rubles. Conclusion. Treatment with macitentan in patients with FC II-III PAH is more cost-effective than that with bosentan and does not require an increase in budget costs.

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 PIN150 Economic VALUE of Treatment and Vaccine Technologies to Address the COVID-19 Pandemic: A Cost-Effectiveness and Budget IMPACT Analysis

2020 ◽  
Vol 23 ◽  
pp. S568
Author(s):  
W. Padula ◽  
S. Malaviya ◽  
N. Reid ◽  
F. Chingcuanco ◽  
J. Ballreich ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Impact Analysis ◽  
Budget Impact ◽  
Economic Value ◽  
Budget Impact Analysis

scholarly journals AB0634 BUDGET IMPACT ANALYSIS OF BIOLOGICAL THERAPY COMPARED TO CONVENTIONAL SPONDYLOARTHRITIS TREATMENT, IN A FOURTH LEVEL HOSPITAL IN BOGOTA COLOMBIA

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1612.2-1613
Author(s):  
J. M. Bello-Gualtero ◽  
O. J. Calixto ◽  
G. Salguedo ◽  
Y. M. Chamorro-Melo ◽  
C. A. Camargo Rodríguez ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Annual Cost ◽  
Impact Analysis ◽  
Budget Impact ◽  
Biological Therapy ◽  
Biologic Therapy ◽  
Disease Diagnosis ◽  
Budget Impact Analysis ◽  
Military Hospital ◽  
Number Of Patients

Background:Spondyloarthritis refers to a family of diseases, of which ankylosing spondylitis and non-radiographic axial spondyloarthritis are responsible for axial impairment. Previously, the only treatment available were NSAIDs, which control activity and stop radiological progression, but at the expense of increased adverse effects, such as cardiovascular risk, dyspepsia and chronic renal failure. For the past 2 decades, biological therapy has been available, which means an increase in care costs.Objectives:The objective of this study is to perform a budget impact analysis of biologic therapy.Methods:To do a budget impact analysis from the perspective of the payer, comparing biological therapy with coventional therapy for the treatment of spondyloarthritis. Demographic characterization of the population attended at the Central Military Hospital. Time horizon from 2012 to 2018, taking the activity count according to the hospital’s billing and the prices of the activities of the state body SISMED. Exchange rates at the end of 2018.Results:The patients attended were 117, mostly men (63, 25%), average age 46, 4 years (SD 13), with disease diagnosis time of 9, 8 years (SD 9, 6). In the budget impact analysis, it is observed that 25% of patients were on DMARDs therapy, 22% with NSAIDs and 96% with biologic therapy. The average year/patient cost with NSAIDs alone would be EUR 381, with DMARDs only EUR 9,318 and, if only biological therapy was used, EUR 423. Within the total number of patients, the average annual cost, including the possibility of combining these drugs, amounted to EUR 5,403Conclusion:Including biological therapy in the care of patients with spondyloarthritis can increase up to 24 times the annual cost per patient. This increase is not only due to higher market value, it also relates to the need for more medical procedures and diagnostic follow-up tests.References:[1]Strömbeck, et al. Cost of Illness from the Public Payers’ Perspective in Patients with Ankylosing Spondylitis in Rheumatological Care. J Rheumatol 2010;37;2348-2355.Disclosure of Interests:None declared

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