Clinical and economic analysis in medicine. VEN analysis
Authors describe main methods of clinical and economic analysis. They state that quantitative record of correlation between spent resourses and gained result, based on the study of quality of life of patients before and after the treatment allows gaining additional arguments for adequate planning of the ophthalmologic aid.
financing ophthalmology injection costs
Under the real conditions of resource constraints, healthcare organizers are forced to constantly redefine the priorities of their tasks. However, some obviously important activities are postponed or canceled due to lack of funds. At the same time, well-funded programs do not always give the expected effect. A very striking and sad example is ophthalmology: despite the obvious importance of protecting vision for everyone, priorities are given to other branches of medicine. One of the reasons for this imbalance is the weak interaction of doctors, organizers and economists due to their insufficient acquaintance with the specifics of the work of the "subcontractors". Doctors and financiers speak different languages. At the same time, the development of economic approaches by physicians is still slightly more realistic than the development of medicine by economists.
The importance of making the right choice priority directions work has been especially growing in recent years, when the number of tasks facing health care and the volume of its funding are rapidly (and not always coordinated) increasing. A natural criterion for choosing priorities is the ratio of the cost of the proposed activities and the expected effect. The problem often lies in the inability to adequately express the medical effect in financial and economic terms. Therefore, techniques that allow to correctly substantiate the need and, most importantly, the profitability of the costs of preserving and restoring vision, deserve special attention of ophthalmologists.
In accordance with the industry standard "Clinical and Economic Research. General Provisions", approved by the order of the Ministry of Health of the Russian Federation No. 163 dated May 27, 2002, clinical and economic analysis is a methodology for comparative assessment of the quality of two or more methods of prevention, diagnosis, drug and non-drug treatment based on a comprehensive interrelated accounting of the results of medical intervention and the costs of its implementation. The methodology of clinical and economic analysis is applicable to any medical interventions - medicinal and non-medicinal methods of treatment, methods of diagnosis, prevention and rehabilitation - to determine the economic feasibility of their use.
The main methods of clinical and economic analysis are cost-effectiveness analysis, cost-minimization analysis, cost-benefit analysis, cost-benefit analysis (utility).
Cost-effectiveness analysis (CEA) is a type of clinical and economic analysis in which the results and costs of two or more interventions are compared, the effectiveness of which is different, and the results are measured in the same units (millimeters mercury column, hemoglobin concentration, number of patients cured, etc.). The results are presented in the form of corresponding indicators of the ratio of costs and the achieved effect and / or the coefficient of cost increment (additional costs attributable to achieving an additional effect). With the help of the CEA, you can compare the effectiveness of different programs, as a result of the implementation of which common goals should be achieved. For example, it is possible to compare programs aimed at treating ophthalmic and cardiac diseases, provided that they result in comparable goals - an increase in working life years or quality years of life.
Cost minimization analysis (CMA) is a special case of cost-effectiveness analysis, in which two or more interventions are compared that are characterized by identical effectiveness and safety, but different costs. The identity of the effectiveness must be proven by the results of clinical trials. The method provides for the calculation of all costly components of medical technology (the number of examinations by a doctor, laboratory tests, the cost of equipment, etc.). It is advisable to apply this method in a comparative analysis of various forms or conditions of use of one drug, medical service or one medical technology. For example, a comparison of costs when examining patients with diabetes mellitus by an ophthalmologist in a local polyclinic, in a specialized ophthalmological center and on the road as part of a mobile team.
Cost-benefit analysis (CBA) is a type of clinical and economic analysis in which both costs and results are expressed in monetary terms. This makes it possible to compare the cost-effectiveness of different interventions with the results expressed in different units (for example, an influenza prevention program with the organization of an intensive care system for myocardial infarction). The main advantage of the method is the ability to compare programs aimed at achieving qualitatively different results: reducing morbidity, reducing the number of days of disability, prolonging life, etc. The main disadvantage of the method is the inability to assess changes in the patient's quality of life (cessation of pain, overcoming anxiety, etc.) from the point of view of economic efficiency.
Cost-utility analysis (CUA) is a variant of cost-effectiveness analysis in which the results of an intervention are evaluated in terms of “utility” from the point of view of a health care consumer, family member or specialist. The separation of this specific method from the cost-effectiveness method is associated with the development in the 1980s of the integral indicator Quality Adjusted Life Years (QALY) as a criterion for assessing the consequences of medical interventions. This indicator contributed not only to the development of clinical and economic analysis as a cost limiter, but also to improve the quality of medical services. The QALY indicator has changed the view of the problem of disease and the patient, using the concept of quality of life.
The quality of life is an integral characteristic of the patient's physical, psychological, emotional, social functioning, based on his subjective perception.
Cost-benefit analysis has two main advantages over other methods of pharmacoeconomic analysis: first, it makes it possible to combine life expectancy and its quality; second, the use of a standard effect criterion allows one to compare the cost effectiveness of treatment methods for completely different diseases, the course of which is assessed using different clinical criteria. For example, the method allows to identify the cost of 1 QALY unit when using various surgical interventions for cataract, taking into account the preservation of the effect for a certain period of time, and to determine the most effective method of surgical treatment.
To determine specific QALY values for different situations of health / illness / treatment / rehabilitation, various methods are used: direct assessment method (visual scale method, standardized speculative method, time-cost comparison method), quality of life questionnaires, matrix method. Due to the high variability and individuality of the estimates for determining the QALY, there are some differences in indicators depending on the determination method with a spread of values of the order of 0.07-0.17.
The QALY score can range from 1.0 (full health) to 0.0 (death). The socio-economic significance of the QALY indicator does not depend on gender, age, place of residence, profession, etc. (for example, 1 year of quality life of a child and an elderly person has the same social significance). In addition, the value of 1 QALY for one person is equal in significance to the indicator 1 QALY, obtained as the sum of the indicators of several people (for example, two years of life, estimated as 0.45 and 0.55, are equal to 1 year of quality life, i.e. 1 , 0 QALY). This is the limitation and convention of this indicator, but this is also its advantages: versatility, integrity, adequacy when used in economic calculations.
The economic meaning of QALY is closely related to the concept of "gross domestic product"(GDP, GDP) is the main indicator of economic activity and economic activity in a country or region (GRP).
GDP is calculated using a number of different methods as the total market value of the total volume of final goods and services produced (consumed) in the economy over a certain period of time (usually a year). When calculating gross domestic product using the "cost estimate" method, the costs of all economic agents for the purchase of final products are summed up, namely: consumption expenditures, investments, government purchases of goods and services, and net exports.
In the context of this article, special attention should be paid to one of the components of the GDP formula, namely, "consumption expenditures". In countries with developed economies, this component reaches 2/3 of GDP, which means that the ability of the population to buy large amounts of goods and services makes a significant (if not the main) contribution to the development of the economy. The concept of "quality of life" acquires a direct financial meaning: the longer the life expectancy and the higher the quality of life of an individual, the greater the individual contribution to the formation of GDP, i.e. - v economic development state. At the same time, the QALY indicator is convenient in that it allows you to take into account both the number of life years and their quality. From the point of view of the contribution to the formation of GDP, the "weight" of 10 years of life with a quality of 0.5 is equivalent to the "weight" of 5 years of life with a quality of 1.0. Specific values of the indicators of the quality of life of the population acquire specific economic meaning. To ensure GDP growth, it is necessary not only to increase the production of goods and services, but also (or more importantly!) To ensure an increase in the quality and life expectancy of the population.
Naturally, the values of the individual contribution to GDP can differ significantly in different population groups (age, economic, educational, cultural, etc.), but this does not detract from the value of the QALY indicator for clinical and economic research. With certain assumptions and limitations, it provides an opportunity for objective, economically convincing argumentation when considering the organization of medical care, the distribution of financial and technological resources.
In order to assess the socioeconomic performance of a health initiative, it is desirable to obtain data on specific QALYs directly related to specific interventions. This is not always realistic. At the same time, the use of QALY indicators obtained in other settings (in different countries, when analyzing different treatment methods and health programs) can also give a lot. useful information, although the accuracy of such calculations and the reliability of forecasts will correspondingly decrease.
Objective assessment of medical technologies (Health Technology Assessment), based, among other things, on the study of QALYs, has been widely used abroad since the 80s of the last century, allowing social and economic decisions in the field of health care to be taken (SBU agencies in Sweden (1987) , NICE in the UK (1999), IQWiG in Germany (2005), etc.). Modern conditions require similar approaches in our country, in particular for a comparative assessment of ophthalmic technologies and programs.
One of the options for assessing the feasibility of using a particular medical technology is to calculate the cost of maintaining 1 QALY based on information about the impact of this technology on the quality of life of patients (in a specific subpopulation or according to the literature) and data on the cost of treatment.
From the point of view of the macroeconomics of a country (region), measures aimed at GDP growth are expedient if the costs of their implementation do not exceed the economic effect associated with these measures. In this regard, the costs of medical services that improve the quality and duration of life of the population can be considered economically justified if the effect obtained exceeds the costs. The QALY indicator makes it possible to objectify the process of such an assessment.
Most developed countries as a criterion for the appropriateness of the use of medical technologies, the threshold for the cost of preserving 1QALY was adopted. This figure depends on the cost of providing the corresponding medical service and the number of QALYs saved as a result of its provision (taking into account the degree and duration of restoration of lost functions, the degree of social adaptation before and after treatment, prognosis, etc.). Naturally, the higher the patient's quality of life as a result of treatment and the lower the cost of this treatment, the more economically feasible medical technology is.
Currently, in the United States, a medical technology (technique) is considered cost effective if it maintains 1QALY for less than $ 20,000. If the cost of maintaining 1 QALY is between $ 20,000 and $ 40,000, then this technology is considered economically viable. $ 60,000 is the borderline. Saving 1 QALY for an amount from $ 60,000 to $ 100,000 is considered expensive, and over $ 100,000 is economically unacceptable. In the UK, the threshold is 30,000Ј per 1 QALY.
Considering the impossibility of direct transfer of indicators from one country to another, a much more convenient and reliable criterion was proposed. As a reference scale, the World Health Organization (2003) recommended the ratio of the cost of maintaining 1 QALY to the share of GDP per capita (one of the official and generally accepted macroeconomic indicators). According to these recommendations, the cost of maintaining 1QALY should not exceed 3 times GDP per capita.
Within the framework of this approach We propose for practical use the following gradation of threshold values for the cost of maintaining 1 QALY: if the cost of maintaining 1QALY is less than one-time GDP (GRP) per capita, the medical service is economically highly efficient, maintaining 1 QALY for an amount up to 2 times per capita GDP (GRP) is economically acceptable, up to 3 times GDP per capita (GRP) is a borderline level, more than 3 times GDP per capita (GRP) is economically unacceptable.
Various techniques can be used to assess changes in quality of life as a result of treatment. Obtaining the most accurate data is possible when conducting special studies among the target group of patients in a given region who received treatment according to a specific method in certain socio-economic conditions. For practical application, such an approach may be costly and not always possible, although it is most preferable. In real conditions, you can sufficiently rely on various external data, modeling on their basis situations close to real.
The Samara region has accumulated significant experience in the use of modern ophthalmological technologies, which, despite their significant cost, provide an exceptionally high social effect due to the favorable cost-benefit ratio. Illustrative examples are ultrasonic phacoemulsification of cataract according to the current federal standard and intravitreal administration of an anti-proliferative drug for the treatment of subretinal neovascularization in age-related macular degeneration.
The use of modern devices and consumables requires significant costs for cataract surgery. Therefore, when compared in terms of cost, phacoemulsification is clearly inferior to other ophthalmic techniques. However, if, when calculating the QALY, we take into account the sharp increase in the quality of life after surgery, the low number of complications and the exceptional duration of the phacoemulsification effect, then modern cataract surgery turns out to be one of the most profitable types of medical care. Thus, the estimated cost of maintaining 1 QALY as a result of successful phacoemulsification of a complete complicated cataract in the Samara region is 6242 rubles (if we take the duration of the operation effect equal to 10 years for calculations). Considering that in 2010 the gross domestic product of the Samara region amounted to about 240,000 rubles per capita, modern "expensive" cataract surgery is an extremely effective socio-economic measure, as it ensures the preservation of 1 QALY for an amount 38.5 (!) Times less threshold.
An example of another option for clinical and economic assessment is the treatment of wet age-related macular degeneration (AMD) using intravitreal injections of ranibizumab. The extremely high cost of the drug makes this type of treatment virtually unaffordable for the vast majority of the population in the absence of government funding. The use of the less expensive bevacizumab is illegal and is therefore not being considered. At first glance, the inclusion of intravitreal injections of ranibizumab in the compulsory medical insurance system is completely unjustified, since the cost of one hospitalization is comparable to the cost of an average vitreoretinal surgery. However, taking into account the pronounced irreversible decrease in the quality of life of patients with AMD and the absence of a real alternative, in the Samara region, since 2010, injections of ranibizumab have been included in the Territorial program of state guarantees for the provision of medical care under compulsory medical insurance in the clinical-statistical group of vitreoretinal surgery (taking into account the intravitreal nature of the intervention and the high cost treatment). Clinical and economic analysis also became the basis for the application of this technique.
The data from the literature and the results of the first injections of ranibizumab in the Samara Clinical Ophthalmological Hospital named after T.I. Eroshevsky. This model assumed the following parameters (for greater reliability of the estimate, slightly redundant values were used). Taking into account the dynamics and nature of vision loss due to the wet form of AMD, 0.099 QALY is lost per 1 patient annually; within 6 years, more than 50% of patients lose their eyesight, while their QALY value decreases from 0.986 (value typical for the state of "minor visual impairment") to 0.390-0.416 ("blindness", "severe visual impairment"). Before treatment, the average visual acuity was taken equal to 0.3. During the first year, 8 Lucentis injections were planned, in the next 5 years - 6 injections. As a result of treatment, visual acuity is stabilized at an average of 0.4. With this input, a loss of 2.27 QALYs per patient is prevented over 6 years of treatment.
Comparison of this parameter with the value of GRP per capita allows us to assess the feasibility of the estimated costs of the regional budget to maintain 1 QALY of the region's population. The result of the assessment depends on the value of the adopted threshold of socio-economic expediency: threefold per capita GRP (“at the border of expediency”), two times (“expedient”), or one-time (“highly effective preservation of QALY”). A simple formula calculates the possible number of injections of ranibizumab over a 6-year course of treatment for a given cost per injection:
n = k * PVRP * 2.27 / ivL,
n is the number of injections, k is the threshold multiplicity of per capita GRP to maintain 1 QALY, PVRP is the regional GRP per capita, and L is the cost of 1 intravitreal injection of Lucentis.
If a single per capita GRP is chosen as the threshold of economic feasibility, then the permissible number of Lucentis injections within 6 years is 19.7; with a double GRP, it is permissible to make 39.4 injections, with a three-fold GRP - 59.1. In the model under consideration, the estimated number of injections is 38, that is, from a socio-economic point of view, treatment with ranibizumab can be assessed as “expedient”.
In reality, the number of injections is often 5-7 per year, which additionally increases the feasibility of anti-vasoproliferative therapy, which on the socioeconomic scale is between “expedient” and “highly effective”.
Output
The above calculations are purely indicative, as they are based on extrapolation and expert analysis of unsystematic literary and statistical data. At the same time, they are informative enough to show the importance and prospects of clinical and economic analysis in ophthalmology.
The choice of appropriate medical technologies based only on the cost of treatment or only on the expected clinical results does not meet modern criteria for assessing effectiveness. With an adequate clinical and economic analysis, the usual inexpensive methods may turn out to be ineffective or simply useless waste of budgetary funds, and vice versa, "unacceptable" expensive treatment can, due to the highest efficiency, provide such an increase in the quality of life (and, therefore, the prevention of GDP losses), which will pay off many times over. the most daring expenses. A quantitative account of the ratio of the resources expended and the result obtained, based on the study of the quality of life of patients before and after treatment, allows obtaining additional arguments for adequate planning of ophthalmic care.
Literature
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Clinical and economic analysis is a methodology for comparative assessment of two or more medical technologies (methods of diagnosis, prevention, treatment, rehabilitation) based on a complex interrelated accounting of the results of their application and the costs of their implementation. The methodology of clinical and economic analysis is described in the OST “Clinical and economic research. General Provisions "(approved by the order of the Ministry of Health of the Russian
these from 05/27/02? 163). The term “pharmacoeconomic analysis” is often used in relation to the drug component.
Clinical and economic analysis is a tool for choosing the most appropriate of several technologies that can be used in the same situation, based on a comparative assessment of their effectiveness and cost. The results of clinical and economic analysis are used in the formation of standards of medical care, formulary lists of drugs, determination of priority areas for health care development. The purpose of using clinical and economic analysis is the rational use of health care resources: to obtain the best result within a known (fixed) budget.
Allocate basic (basic) and helper methods clinical and economic analysis. The main methods are reduced to calculating the ratio between costs and results obtained. The results reflect the dynamics of clinical symptoms, demographics, patient or community preferences, including those expressed in terms of money.
Analysis cost-effectiveness(eng. cost-effectiveness analysis- CEA) - a type of clinical and economic analysis, in which a comparative assessment of the ratio of costs and effect (result) is made for 2 or more medical technologies, the effectiveness of which is different, but the results are measured in the same units (indicators of clinical effectiveness or life expectancy as a result of the application of technology).
When conducting the analysis for each medical technology, the cost-effectiveness ratio is calculated using the formula:
Where CER (cost-effectiveness ratio) is the cost-effectiveness ratio (shows the costs per unit of effectiveness, for example, how much it costs to reduce blood pressure by 1 mm Hg); DC - direct costs; IC - indirect costs; Ef is the effectiveness of medical technology application.
When analyzing cost efficiency increments difference between costs 2 alternative options treatment is divided by the difference in their effectiveness:
Where: CER incr - an indicator of an increase in cost effectiveness (an incremental or marginal indicator of the ratio of costs and effectiveness, in fact, demonstrates what additional investments are required to achieve 1 additional unit of efficiency when using a more efficient technology); DC 1 - direct costs when using technology 1; IC 1 - indirect costs when using technology 1; DC 2 and IC 2 - respectively, direct and indirect costs for technology 2; Ef 1 and Ef 2 - respectively, the effects of treatment when using technologies 1 and 2.
The cost increment analysis is only necessary if technology 1 is more efficient than technology 2, but its costs are higher. If technology 1 is more efficient than technology 2 and costs are lower, then technology 1 is dominant.
Analysis minimizing costs(cost-minimization analysis - CMA)- a special case of cost-effectiveness analysis, in which two or more technologies are compared that have identical effectiveness and safety, but different costs. It is recommended to use cost minimization analysis when comparing the use of different dosage forms or different conditions for the use of the same drug or the same medical technology (for example, the use of the same treatment regimen in inpatient and outpatient settings). This methodology is unacceptable when comparing generic analogs of drugs, as they are often not equivalent in therapeutic effect.
Analysis cost-utility (utility)(cost-utility analysis - CUA)- a variant of cost-effectiveness analysis, in which the results are evaluated in units of "utility" from the point of view of the consumer of medical care. As an indirect criterion of usefulness, the patient's quality of life is most often used and the indicator "years of life saved, adjusted for quality of life" (eng. quality-adjusted life-years- QALY).
The calculation of the cost-utilitarian ratio (utility) is carried out using a formula similar to the cost-effectiveness analysis, but instead of the efficiency values, the utility value is substituted:
Where CUR is an indicator of the cost per unit of utility (utility), the cost-utility ratio (i.e. the cost of a utility unit, for example, 1 year of quality life); CUR incr - an indicator of the increment of costs per unit of utility when comparing 2 technologies (utilitarian), the cost-utility ratio (i.e. the added value of an additional unit of utility, for example, 1 year of quality life); DC 1 and IC 1 - direct and indirect costs for technology 1; DC 2 and IC 2 - direct and indirect costs for technology 2; Ut 1 and Ut 2 - utility for technology 1 and 2.
To assess utility, QALY indicators are most often used.
Analysis cost-benefit(cost-benefit analysis- CBA), in contrast to the previous options, assumes an assessment of both costs and effectiveness (benefits, benefits) in monetary terms. This is the only true economic analysis - "in its purest form." It is recommended to present the results of the cost-benefit analysis as an indicator of the ratio of benefits and costs:
BCR = B / C (8.5)
or the absolute difference between costs and benefits in monetary terms:
CBD = C - B, (8.6)
where BCR (benefit-cost ratio)- cost-benefit ratio; B - benefit (in monetary terms); C - costs; CBD (cost-benefit difference) - absolute difference between costs and benefits in monetary terms.
Several approaches are used to determine the monetary expression of the “benefit” from the use of medical technologies: the “human capital” methodology, the assessment of “revealed preferences” and the assessment of “willingness to pay”.
The auxiliary types of clinical and economic analysis include, first of all, analysis "Cost of illness"(cost of illness - COI) - a method that involves the calculation of all costs associated with the management of patients with a certain disease at a certain stage (period of time) or at all stages of medical care. This analysis does not imply a comparison of the effectiveness of medical technologies and is used to study the typical practice of managing patients with any disease. Historically, the first attempts at economic analysis in medicine were associated precisely with the calculation of the "cost of disease"; this analysis is widely used to solve certain problems, such as planning costs, determining tariffs for settlements between the subjects of the health care system and health insurance, etc. In some countries (eg the United States), a “cost of illness” has been calculated for most diseases, and these calculations have been used to justify a system of standards for diagnostic-related groups; in other countries (in Europe) the “cost of disease” has been studied for the most common diseases.
In the context of Russian healthcare, the calculation of the “cost of illness” is necessary due to the fact that the costs of providing medical care to patients with many diseases have not yet been determined. Huge data on the “cost of illness” have been accumulated by the health care organizations working in the compulsory medical insurance system, and especially the voluntary health insurance, but these data are not analyzed or published; it is likely that some of them have been irretrievably lost.
At the same time, if you have access to these data, you should keep in mind their unreliability - doctors, health care managers in non-state, and often in state medical organizations, are engaged in registering services and drugs in order to "master" the largest possible amount of financial resources, and insurance companies in most cases have no influence on this process. At the same time, the indicators of the volume of medical services and drugs are far from optimal.
ABC analysis- distribution (ranking) of individual medical technologies according to the share of costs for each of them in the overall structure of costs - from the most costly to the least costly with the allocation of 3 groups. Group A includes technologies that account for 80% of costs (naturally, the group includes 10-15% of all technologies used), group B includes technologies that require 15% of funds (up to 20-30% of the total), and group C - technologies, the implementation costs of which amounted to 5% of the costs (usually more than 50% of the assortment under study). The method is used to prioritize and determine the appropriateness of spending based on a retrospective estimate of real costs.
Frequency analysis- a retrospective assessment of the frequency of application of a particular technology, which, combined with the cost of each type of service,
gi or drugs allows you to determine which types of assistance spend the bulk of the cost - massive and cheap or rarely used but expensive.
VEN analysis- distribution of medical technologies according to their degree of importance: V (vital) - vital, E (essential) - important, N (non-essential) - minor (unimportant, insignificant).
All 3 analyzes complement each other and, as a rule, are carried out simultaneously. ABC and VEN analyzes were initially recommended to be used at the health facility level to assess cost structures and identify cases of inefficient allocation of funds. For example, the predominance of minor drugs (N) in group A is considered irrational. Based on the results of ABC, frequency and VEN analyzes, recommendations can be developed for the preparation and further improvement of the form. medical organization or a list of preferential drug dispensing.
Modeling- a method of studying various objects, processes and phenomena based on the use of mathematical (logical) models, which are a formalized description of the object under study (patient, disease, epidemiological situation) and its dynamics when using medical technologies.
Discounting- the introduction of a correction factor when calculating costs (and sometimes efficiency) taking into account the influence of the time factor: the costs to be incurred in the future are less significant than those incurred today, and, on the contrary, the benefits acquired today are more valuable than the future ones.
Sensitivity analysis establishes the extent to which the study results will change when the initial parameters change (for example, fluctuations in drug prices, changes in the frequency of side effects, etc.).
All of the techniques described above are not specific to clinical and economic analysis and are widely used in various types of epidemiological, economic and management studies.
Research using basic methods of clinical and economic analysis is carried out mainly by research organizations and the Society for Pharmacoeconomic Research. In medical organizations, specialists more often use auxiliary methods: calculating the "cost of illness", ABC, frequency and VEN analyzes of the cost structure. In addition, in medical organizations it is necessary to be able to interpret the results of clinical and economic studies in order to use them for the formation of standards and forms.
PRINCIPLES OF CLINICAL AND ECONOMIC ANALYSIS
AND PROSPECTS FOR USING ITS RESULTS
IN HEALTHCARE OF THE REPUBLIC OF BELARUS
Belarusian Center for Medical Technologies, Informatics,management and economics of health care, Minsk
Currently, the methodology of clinical and economic analysis (CEA) is used as a methodcomprehensive accounting of the results of medical interventions and the costs of their use and allows you to make decisions about the appropriateness of using certain (mainly new) technologies in health care. The principles are determined, the stages of FEA are highlighted. It is emphasized that the development of CEA methods as the main tools for the proper use of medical technologies should be accompanied by the development of uniform requirements for conducting research on the comparative assessment of various medical interventions. The creation and implementation in the Republic of Belarus of a practical guideline (similar to the national guidelines adopted in many countries), regulating the work on the clinical and economic assessment of medical interventions, will unify the approaches to the conduct and use of the results of clinical and economic research. The necessary work is being carried out at BELCMT in the framework of scientific research.
The World Health Organization (WHO) has set a goal: “By 2010, health management in the participating countries should be carried out as efficiently as possible, starting with programs public health and ending with the method of treatment of each individual patient. " All WHO member countries should have a government mechanism for monitoring and developing health care quality that includes ways to measure treatment efficacy, patient satisfaction and cost effectiveness. When choosing an alternative solution during the treatment of specific patients, the main attention should be paid to assessing the ratio of the therapeutic effect and the cost of treatment.
Today, the process of improving healthcare continues in the republic, the main activities of which are designed to optimize the provision of quality medical care to the population. The implementation of state guarantees in the field of providing the population with affordable and high-quality medical care implies the use of medical technologies and medicines (drugs) with an optimal ratio of efficiency, safety and cost, and the modern scientific solution here is the use of methods of clinical and economic analysis (CEA).
CEA is an integral part of health care economics, the purpose and task of its implementation is, first of all, to assess the effectiveness of medical technologies. CEA is the most important tool for managing the quality of medical care, since it allows you to correlate clinical results with costs, and find ways to optimize the use of resources. This determines its central place in the activities of healthcare organizations to continuously improve the quality of medical care.
The public awareness of the growing cost of medical care, in turn, increased interest in assessing both the economic and clinical benefits of medical technologies, and the continuing rise in prices for medical services and medicines in the 1990s. led to the idea of the need to develop price control mechanisms. In the process of discussing the problem of reducing the cost of medical care, the term "economic efficiency" appeared, which initially meant a simple ratio of input costs and output results (for example, the number and, accordingly, cost, bed-days per operation). The first examples of economic analysis, later called "cost of illness analysis" (COI - cost of illness), belonged to the American scientists Clarmann, Fane and Rice and were devoted to calculating the cost of the "disease burden" for society, in particular road traffic injuries, mental infectious diseases. In the 1970s. economists have begun to make attempts to adapt the cost benefit analysis, traditionally used in economics, to the needs and characteristics of health care. The essence of the analysis was to determine the relationship between costs and the effect obtained. Later, in parallel with the clinical effect, they began to use a medical and social indicator - the number of years of life saved. Finally, in the 1980s. the development of a new integral criterion for assessing the consequences of medical interventions - QALY (quality-adjusted life years - saved years of quality life), which combined quantitative and qualitative aspects, led to the emergence of a separate specific type of cost-utility analysis (CUA) - calculation of the costs attributable to the achievement of "useful" from the point of view of the patient or society (utilitarian) result).
Today, there is a rapid increase in interest in the problem of complex clinical and economic analysis in all countries, which, in particular, is characterized by a steady increase in the number of pharmacoeconomic studies (IPPE). At the same time, the results of clinical and economic analysis are used in the development of clinical guidelines and formulary, in determining the price and reimbursement of costs for drugs, for information purposes, etc. (Table 1).
Currently, the CEA methodology is used as a method of comprehensive accounting of the results of medical interventions and the costs of their use and allows making decisions on the advisability of using certain (mainly new) technologies in health care. We are talking about some compromise between the effectiveness of treatment and its cost. CEA allows making decisions taking into account both the effectiveness and the cost of treatment. The essence of this analysis is very simple and consists in calculating the cost / effect ratio. It is based on the results of special studies, during which both clinical and economic results of medical activity are assessed, and in fact combines three clearly delineated processes:
1. Analysis of costs when using alternative options.
2. Analysis of the effectiveness of each of the alternative options.
3. Analysis of the relationship between the costs and effectiveness of each of the alternatives, usually expressed as a ratio of cost and effectiveness.
The FEA methodology is based on the concept of “opportunity cost” (opportunity cost): money spent on one thing could always be spent on something else. When spending on the purchase of a specific product or service is directed, the opportunity to purchase or do something else is lost (hence, "missed opportunities"). Therefore, when directing costs to solving specific problems, decision-makers must assess what is more valuable for society at the moment. The concept of “lost opportunity costs” necessitates the use of CEA to make decisions on the allocation of resources in the health care system.
In Russia, the development of the CEA methodology led to the creation in 2002 of the OST "Clinical and Economic Analysis. General Requirements". In its main provisions, this OST corresponds to the established international practice of clinical and economic analysis.
Incomplete economic assessment of research results, reflecting the most important parts of the economy (economic advantage) of new medical technologies.
The effectiveness of the introduced medical technologies is determined by economic assessment of costs and losses for the compared options. For this, it is recommended to use one of three methods of researching the results of new medical technologies: 1) the method of the control group; 2) the method of auto-control; 3) the method of economic assessment of costs and losses.
It should be noted that a separate problem is the requirements for the quality of the IPPE and the guidelines for the IPPE. As noted in his speech at the 1st International Congress "Development of Pharmacoeconomics and Pharmacoepidemiology in the Russian Federation", which was opened on December 18, 2006, President of the International Society for Pharmacoeconomic Research (ISPOR), Director of the Center for Health Economics at York University (UK) prof. M. Drummond, the degree of consistency of the methodology for conducting IPPE in different countries is about 75%. The main reason for these differences is methodological errors, the development of guidelines for outdated methods, etc. Therefore, the National Institute for Health and Clinical Excellence (NICE, UK) in 2004 began developing a "standard case" of IPPE requirements, using the following methodological principles: indirect comparisons (in the absence of clinical studies with direct comparison); extrapolation beyond the duration of clinical trials; analysis of international clinical and economic research; consideration of aspects of justice (socio-economic status and health status of the patient).
For Belarus, the need to introduce clinical and economic research is currently acquiring special significance, since the state's resources are not unlimited.
It is clear that conducting a full-fledged CEI requires time, money and proper qualifications of researchers and decision-makers. What can help you save money today without compromising the effect of treatment? This can be facilitated by more rational therapy regimens; use of generics with proven therapeutic efficacy. Sometimes the use of drugs with a significant difference in effectiveness (compared to analogs) leads to an additional economic effect due to a lower need for additional treatment or a lower frequency of complications, the use of drugs with a lower frequency of side effects. Another direction to objectify decisions on the use of certain medical interventions is a systematic study of the cost structure, the use of ABC - (activity-based costing) and VEN - (Vital - vital, Essential - important, Non-essential - insignificant drugs and interventions) analyzes. The introduction of a formulary system also contributes to the rational use of resources. All of the above really allows you to save money without sacrificing quality.
Conclusion
A systematic study of the problem of a comprehensive assessment of technologies in health care within the framework of a unified quality management system for medical care in the Republic of Belarus should ensure the adaptation of existing theoretical and organizational and methodological approaches to a comprehensive assessment of medical technologies for use in practice at all levels of the health care system:
1. When forming the industry budget in the context of a specific financial and economic situation, cost-effectiveness analysis can act as a method of control over the expenditure of funds, ensuring their most rational use:
2. At the level of therapeutic and prophylactic organizationsnizations:
a) when choosing one of the methods of treatment, allowing to achieve unequal clinical results (cost-effectiveness analysis);
b) when comparing the cost of various treatment methods, provided they are of equal effectiveness and safety (cost minimization analysis);
c) to clarify the cost of treatment until a certain therapeutic effect is achieved (recovery, improvement of the patient's condition), that is, analysis of cost clarification;
d) when comparing treatment alternatives in terms of costs and outcomes of the disease (reduction in mortality, reduction in morbidity) (cost-utility / value analysis);
e) to optimize the treatment process (cost-benefit analysis).
3. For the pharmaceutical sector:
a) when calculating the cost of drug provision (comparing the price of one dose, packaging of drugs from different manufacturers and the cost of a full course of treatment with these drugs, as well as assessing the cost limits for state registration and re-registration of drugs and their selection during purchases);
b) when conducting clinical trials of new drugs (assessing the limits of their cost, beyond which they lose their attractiveness; determining the added value measured in years of quality life, which allows determining the advantages of a new drug, i.e., cost benefit analysis).
The development of CEA methods as the main tools for the proper use of medical technologies should be accompanied by the development of uniform requirements for conducting research on the comparative assessment of various medical interventions. The creation and implementation of a practical guideline (similar to the national guidelines adopted in many countries), regulating the work on the clinical and economic assessment of medical interventions, will unify the approaches to the conduct and use of the results of clinical and economic research. Such a document should contain a set of rules for conducting and using the results of CEI, as well as documenting and presenting their results. The specified Guidelines (instructions for use "Procedure for conducting clinical and economic research") should be developed in 2007 as part of the research work carried out at BELCMT. As a result of the introduction into practice of this regulatory and methodological document, the clinical protocol (a technical regulatory legal act approved by the Ministry of Health and determining the requirements for the provision of medical care to a patient with a certain disease) will include medical technologies with proven clinical, social and economic efficiency, corresponding to the possibilities the state and its obligations within the framework of territorial programs of state guarantees for the provision of medical care at the expense of the budget.
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Decision making should be based on facts. They can, of course, be obtained from literature, but much can be learned from your own practice. So, for example, having studied the practice of using drugs in your own organization, you can draw many of the most unexpected, and often unpleasant conclusions. For clarity, we will comment on some positions with a real example. A charitable organization that pays for medicines for pensioners (charitable donation) turned to us at RSPOR for help. Elderly patients come to the office of the organization with a prescription from their attending physician, the manager of the organization draws up an order form for them. This order is “stocked up” at a pharmacy with which there is a certain agreement and to which the organization transfers funds. In 2003, the organization spent 5,118,764 rubles to pay for prescriptions, paying for 859 names of medicines.
Stage one: planning
The first stage of clinical and economic analysis is the development of a research protocol, even if the research is purely applied and not scientific in nature. Strict adherence to all the proposals made here is a guarantee of the accuracy of the results and their further use in practice. Clinical and economic analysis implies transparency and reproducibility, repeatability of the study both in time (for example, once a year) and locally (for example, in a neighboring similar organization). The research (analysis) protocol must contain the following information (except for mandatory items, the number of which can be expanded or worded, their possible decoding is given)
The relevance of research- why the clinical and economic analysis was started, the description of the problem. Problems may include thoughtless medical prescriptions and polypharmacy, cost overruns, poor quality of treatment due to the use of outdated, ineffective drugs, patient adherence to incorrect treatment regimens, over-prescribing unnecessary diagnostic measures and treatment procedures, cost estimates by type of care and nosology, analysis costs by item of expenditure, changing the spectrum of diseases or patient groups, increasing the number of citizens with benefits, etc. It is possible to study the spectrum of all drugs used in a particular patient group. Grouping of patients is possible on the basis of nosological criteria, according to their stay in a certain department, according to the treatment with a certain doctor, etc. The grouping depends on the objectives of the study, on the questions that the researcher asked when creating a protocol for clinical and economic analysis. In our example, the main problem is that even with a cursory analysis it becomes clear that many payments are inexpedient - for dietary supplements, cheap analgesics and multivitamins, which patients can easily pay for themselves. A reasonable question arises that by saving some amounts on cheap and unnecessary drugs and on surrogates for drugs, it is possible to redistribute the "earned" money for more necessary drugs.
The relevance of the study determines research position, which it is desirable to formulate in this way, in a separate line: research position - cost analysis from the point of view of the chief physician or analysis from the point of view of an insurance medical organization. Research position. is primarily determined by the payer, who bears the analyzed costs. The payer is a charitable organization, whose budget is strictly limited and cannot be released for medicines more money than available. Consequently, the position of this study is the interests of a charitable organization. Relevance predetermines purpose and objectives of clinical and economic analysis analysis of costs, putting order in doctors' appointments, justifying the development of a hospital formulary, saving money in optimizing spending, calculating tariffs for medical services, introducing a quality management system. In this case, the purpose of the study is a clinical and economic analysis of medicines subsidized by a charitable organization. The objectives of the study were: conducting ABC analysis, VEN analysis and frequency analysis of subsidized drugs, making recommendations for compiling a formulary list of drugs subsidized at the expense of a charitable organization, compiling the formulary list itself.
Analyzed period(quarter, year, month, comparison of winter and summer months, etc.) In our example, the analysis is carried out for the whole period of 2003, during which the subsidies of drugs to pensioners took place. Already at the first stage should be clearly defined sources of information: Laws On Medicines, On Medical Services, On Prices For Medicines, On Prices For Medical Services.
In the considered example, the drugs subsidized by the organization are analyzed. Therefore, the analysis includes a summary printout of all drugs paid for during the analyzed period. The sale of medicines is envisaged through a pharmacy, therefore the analysis included prices for medicines in the pharmacy network. Who conducts the clinical and economic analysis, and with the participation of several specialists - the distribution of areas of responsibility. For example, a resident enters information into a table, a computer operator - into an Excel table, and the head of a department generates a report. In this case, the author of this example, who determined the technology of the work, was responsible for the implementation of the project, the calculations were carried out by the RSPOR staff, and the managers of the charitable organization - the customer of the work and the management of the company supplying subsidized drugs - were involved as experts. Description of the method... It should be clearly stated in advance how the study will be conducted: a continuous sample of inpatient cards for a certain period of time, a sample of 10 patient cards per month who received treatment from the 1st day of each month of the year (in total, it is desirable to collect 120 cards, although, obviously, it can turn out to be even less), all invoices for accounting for medicines for the year, all extracts from laboratory research journals, etc., the estimated number of observations: 100 cards, 200 cards, 40 invoices, etc. What indicators will be selected and in what form The methodology of this study consists in sampling data from the provided list of drugs subsidized by the customer in 2003, the information of this list in table (matrix) of formal VEN-, ABC- and frequency analyzes, development of rules for the choice of drugs for the formulary of a charitable organization, writing a draft formulary, its examination and creation of the final version of the formulary. Who and how conducts VEN-analysis, which method to choose - expert, formal, by individual drugs or by groups; at the same time, for a formal VEN analysis, it is necessary to stipulate in advance the source of information - with which regulatory documents will be compared. It is also important who will be the expert in conducting a VEN assessment by an expert method, it is desirable that such an assessment be independently given by several people. this example will be carried out in a formal manner in comparison with the federal List of vital and essential medicines by the staff of the RSPOR.
Researcher's primary documentation- cards to be filled in, their forms, types of tables (matrices), columns and their names. Tables may already contain certain columns, but always at least 10% of the table field should be given to the researcher for self-completion (“other positions, specify”). It is advisable to personalize the cards, indicating who collected the information and when. Usually, one card corresponds to one source of information (for example, a card is filled out for each medical history, or a card is filled in for each invoice, each register). The primary documentation will be a file transmitted by the organization to the researcher containing information on drugs and the frequency of their dispensing (more precisely - the number of applications written out for each drug). The file was compiled by the customer's accounting department on the basis of their primary documents for the accounting of payments for medicines. The material submitted for analysis looked as follows (table):
Table Distribution by the number of drugs received in 2003 (extract)
P / p No. | Name | Quantity | Sum |
1 | Cavinton 5mg Tab. X50 (R) | 2370 | 308198 |
2 | Preducted Tab. X60 | 1254 | 466655 |
3 | Nootropil 400mg Caps | 889 | 73808 |
69 | Monopril 20mg Tab. X28 | 68 | 12784 |
70 | Monopril 10mg Tab. X28 | 67 | 11055 |
71 | No-shpa 40mg Tab. X100 (R) | 66 | 7812 |
138 | Movalis 7.5mg Tab. X20 (R) | 37 | 11507 |
139 | Actovegin 2ml Amp. X25 B | 37 | 21101 |
How the results of the clinical and economic analysis will be taken into account and applied: in the work of the administration, communicate to doctors, discuss with insurance companies, in what form - messages, conversations, memos, signing a contract, issuing a document (order, form), etc. The results of the study will be issued in the form of a form of a charitable organization, according to which the distribution company will purchase medicines and pay for medicines (mutual settlements between the charitable organization and the supplier of medicines).
Second stage: collecting information
The selection of drugs can be carried out from the records of an inpatient or outpatient patient (medical records or outpatient cards), from overhead pharmacies. A sample of medical services - either from case histories (outpatient cards) or from journals kept in the departments of functional diagnostics, laboratories, operating rooms, etc., or from databases of medical insurance organizations. The source of information is determined by the angle of view of the study, since all costs, or costs associated with a certain pathology, or the costs of a department can be studied. Carefulness, correct filling of the primary documentation is the main guarantee of the correctness of further clinical and economic analysis. In the study, the primary information was selected from accounting documents. employees of the customer using a continuous method, therefore, it should be assumed that the documents include all the names of drugs paid by the customer for the specified period of time.
Stage three: calculations
At this stage, it is necessary to write down in the table all the analyzed indicators in natural units: make a list of services, drugs, diseases. It is better, for ease of filling, to build this list in the form of a table and in alphabetical order. It is advisable to write out information from the primary documentation in the formulations in which it was entered there.
If drugs are analyzed, then all trade
Name | Quantity | Sum | |
1 | Cavinton 5mg Tab. X50 (R) | 2370 | 308198 |
2 | Preducted Tab. X60 | 1254 | 466655 |
3 | Nootropil 400mg Caps | 889 | 73808 |
69 | Monopril 20mg Tab. X28 | 68 | 12784 |
70 | Monopril 10mg Tab. X28 | 67 | 11055 |
71 | No-shpa 40mg Tab. X100 (R) | 66 | 7812 |
138 | Movalis 7.5mg Tab. X20 (R) | 37 | 11507 |
139 | Actovegin 2ml Amp. X25 B | 37 | 21101 |
the names of drugs that are encountered by the researcher. Then, non-proprietary names are assigned to trade names in a separate column according to the State Register of Medicines. If the registry is not in hand, then this information can be obtained on the Internet. The procedure is necessary for further analysis - you can group all synonyms by generic name (for example, if different generics of enalapril were used in the clinic), or all therapeutic analogues in a large group (for example, all ACE inhibitors, or all antiarrhythmics, or all cardiovascular drugs ). Such enlargement may be due to the angle of view of the study (table).
Relationship between trade and non-proprietary name
In our example, there were 859 trade names in the list, but quite a few of them - 96 drugs - have a common generic name. At the same time, from 2 to 6 trade names were listed under a common generic name. For example: enap, renitek, ednit, enam, enalapril, or aspirin-cardio and thrombosis. For further analysis, it was necessary to isolate these groups, united by a common name, which is done automatically in the Excel table by sorting international names alphabetically - all drugs are collected to each other.
Medical services are written out in the same way: in the form as they are entered in the primary card. In this case, the second column is allowed, leading the service to the formulations included in certain classifiers, tariffs, etc. For example, in the primary documentation, an ultrasound of the abdomen is recorded (most often ultrasound is written "at all" without indicating, but only implying that this is the abdominal cavity), the researcher must decipher this as an ultrasound examination of the abdominal organs or as an ultrasound of the liver and gallbladder. It is desirable, when interpreting certain records, not to stray too far from the truth, using the elements of logical modeling.
Further, quantitative indicators are entered into the table. For drugs, this is a dosage form, doses of drugs (daily, then, if necessary for further analysis, total for the course of treatment). Such a procedure is carried out in the case of a selection of information from patient records (table). The last part is not needed at a different angle of view of the study, if the information was sampled from accounting documents.
Table Evaluation of the drugs used
In the example under discussion, the task of determining the daily or course dose was not necessary, so the table took the form (table).
Medication Information Conversion Table
Table "Frequency response of the drugs used"
Generic name | Trade name | Dosage forms and release forms | Frequency response |
enalapril | enap H L | 10 mg / 12.5 mg Tab. | 624 |
enalapril | renitek | 5 mg Tab. X14 | 228 |
enalapril | ednite | 5 mg Tab. X 28 | 38 |
enalapril | enalapril | 5 mg Tab. X 20 | 70 |
enalapril | enam | 10 mg Tab. X 20 | 6 |
After all the previous information has been entered, you can begin to enter the cost indicators. For this, several sources of information are used. If drugs are used on an outpatient basis, then the costs must be calculated at retail prices. It is advisable to use the average prices of pharmacies, since the difference in price can be significant (average or median). More often, all prices for the analyzed drug are written out and the arithmetic mean is taken. Or - the price in the middle of the price matrix (median). The use of the median is justified if there is a bimodal price distribution curve: prices turn out to be in a very expensive and very cheap group. The following table gives such a fictitious example, where the prices for one drug are, as it were, two price groups - from 21 to 28 rubles. and from 38.5 to 41.5 rubles. In this situation of prices, it is more correct to use the median, rather than the average. Table Example of bimodal drug price distribution
Name of the drug | Pharmacy | Price, rub.) |
Enalapril 5 mg No. 20 | Home No. 1 | 21,0 |
Enalapril 5 mg No. 20 | Pay and take | 21,5 |
Enalapril 5 mg No. 20 | Like in a pharmacy | 27,0 |
Enalapril 5 mg No. 20 | 37,5 | 28,0 |
Enalapril 5 mg No. 20 | You can't buy health | 39,5 |
Enalapril 5 mg No. 20 | 5th city at the morgue | 39,0 |
Enalapril 5 mg No. 20 | Orderly | 41,0 |
Enalapril 5 mg No. 20 | All without a prescription | 40,5 |
Enalapril 5 mg No. 20 | Judicial | 41,5 |
Enalapril 5 mg No. 20 | №16 No discount | 38,5 |
average price | 33,75 | |
Median | 31,5 |
At the same time, it is advisable, for further sensitivity analysis, to write out the largest and smallest values of the price of the drug. What it is and how to do a sensitivity analysis will be discussed later. However, in the absence of personalized accounting of the costs of subsidized drugs, if these data are not computerized, it makes little sense to engage in such a thorough analysis. Clinical and economic analysis is not accounting, but the identification of patterns and trends in order to change the current situation. If you are analyzing the use of drugs in a hospital, then you can:
Make a copy of the invoices and invoices, putting down the real prices at which the medicines were purchased.
Sample the prices of the price lists of several distributors and set the average prices.
In either case, the prices are not accurate, since even when copying, it turns out that drugs were used that were recently purchased and purchased a year or two ago (and these can be expensive, but rarely used funds), the prices of which are currently have changed a lot. General rule is a one-time choice of prices: all drug prices must be determined in a short period. For the type of analysis under discussion, it is precisely the one-off time that is important, not the accuracy. However, if a medical organization keeps a computerized record of drug therapy, then this data can be used, since the chronological change in prices has already been included in the database. In the analyzed example, the calculation of costs has already been carried out by the customer, since he used the accounting documents for the payment of drugs. Consequently, for the researcher, the task was already facilitated. It is likely that the accounting department reflected real costs, rather than calculating on average prices, price changes during the year, etc. Several approaches can be used to obtain indicators of the price of a medical service. You can use CHI tariffs for services, but, as it turned out, not all regions have such tariffs. In a number of regions, payments are made on a per visit basis or per treated patient (which, in general, in the context of clinical and economic analysis, is the same as “per bed day”). In addition, the CHI tariff today includes only 4-5 items, from which the cost of the service is formed, for example, wages, charges for it, medicines, food, soft inventory (which includes dressings, syringes, etc.). The ratio between budget expenditures on medical care and compulsory medical insurance funds has fluctuated around 3: 1 for many years, i.e. To determine the cost of a service, you can triple the CHI tariff in order to get a more or less correct figure for the real costs of medical services. You can use tariffs for paid medical services. However, they can differ quite significantly in government and commercial organizations, and therefore, if possible, it would be more correct to make the average value of the price for a service. Prices paid services are largely influenced by market relations, supply and demand, the factor of competition. Just don't think that somewhere there are “correct” prices - as in the non-medical market, the correctness of prices is determined by the laws of the market, its saturation with certain services, the factor of monopolization of certain segments, and not by some economic calculations. This fact - “correct prices” - has been proven: even in large clinics in Moscow that use high medical technologies, prices are usually set arbitrarily, without economic calculations. Although such a "manual" was issued by the Ministry of Health of the Russian Federation and the Russian Academy of Medical Sciences, surveys of clinics' economists showed that they used pricing methods that were far from exact science: a survey of expert doctors, analogies with other clinics or departments, etc. Therefore, for clinical and economic analysis, it is important that prices should be taken from one source, at the same time, so that comparisons can be made.
Another way to determine the price of a service is to use the methodology given in the Nomenclature of Works and Services in Health Care, approved by the Deputy Minister of Health and Social Development in 2004 (see the relevant section). The method for calculating the price is based on taking into account the conventional unit of labor costs as the main factor, and the introduction of various coefficients. In this case, the conventional unit of labor costs is 10 minutes and its "cost" is easy to calculate, knowing the length of the working time per month and the wages of the personnel. However, this method is hardly suitable for routine research in a medical organization due to its high labor intensity - you need to calculate the cost of all services, and in the future this information will not be used. Another thing is to calculate tariffs for services in this way and use it in the future to optimize payments for medical care. The next step is to recalculate the price of a drug or medical service into the cost of using medical technology. To do this, it is necessary to calculate the cost per unit of the drug (tablets, ampoules or mg of the active principle). Then superimpose this figure on the course dose, calculated in the same way in tablets, ampoules or mg, respectively. Information on the costs of drugs obtained from the analysis of accounting documents can be entered into a table without intermediate calculations and analysis of daily and course doses. For medical services, this action is simpler - the number of services is multiplied by the cost of each service. Depending on the angle of view of the study, the costs are calculated for an individual patient or for the entire set of patients. The implementation of these various calculations is carried out by drawing up maps, matrices and tables at the first stage of the study - planning.
You can calculate the cost of a particular drug for a particular patient. Adding the costs for individual patients, you can get the total costs for each drug in a group of patients of the same type. An important, but not always taken into account, source of additional costs for drugs is drug delivery systems - syringes, droppers, nebulizers, syringe pumps, etc. In addition to the actual price of these devices, it is necessary to take into account the cost of labor costs of medical personnel for injections, collection and installation of the transfusion system. Prices for syringes and systems are not difficult to clarify according to price lists, other means are often reusable and their cost, even being initially significant, becomes a negligible component in the costs of each procedure due to depreciation (for example, the depreciation rate of the infusamate in such calculations tends to 0). In such cases, this cost can be neglected. However, the cost of syringes relative to the cost of the drugs administered by them is so small that it can also be neglected (unless we are talking about very cheap drugs, where this ratio may not be so small). The reverse situation with implantable prostheses: their price can be so high that it covers several times the cost of the installation procedure. For example, expensive implants are artificial pacemakers, joint prostheses, vascular shunts and vascular "patches", disposable materials for endovascular surgeries.
Stage four: ABC analysis
Fifth stage. VEN analysis
This is already the basis for seeking a reduction in the burden of spending on non-essential drugs. However, simply excluding all drugs with index N from the list of subsidized ones can cause an ambiguous reaction from consumers - it is necessary to keep in mind the facet of subject-object interaction in the decision-making square rule (see the section "Decision Making"). Each, having analyzed the presented VEN analysis table subsidized drugs will find positions in it that raise fair questions. For example, no-shpa, a drug that is certainly necessary to eliminate spasms, which happens with renal and hepatic colic, but is hardly so necessary on an outpatient basis. Preductal is positioned as an effective drug, it is very well known to doctors and patients, although there are reasonable doubts about its effectiveness. At present, attempts are being made to conduct scientific justification for the choice of certain drugs when assigning VEN indices to them. This approach implements the principles of evidence-based medicine: a proven effect that allows a drug to be attributed to group V is the result of reliable studies (however, a drug with proven efficacy may also appear in group E, if indications for this pathology are relative, and in group N, if it is contraindicated). Thus, evidence of efficacy is not an absolute condition for assigning an index to drugs V. It should be noted that there are absolute truths for which evidence is not required at the level of randomized or placebo-controlled trials. Anesthetic drugs cause anesthesia, and muscle relaxants relax the muscles. Iron preparations, of course, help with iron deficiency, B12 preparations - save lives with a deficiency of this vitamin, as well as folic acid - with its deficiency. However, the question of using the same drugs for prophylactic purposes (for example, during pregnancy) in the process of rigorous research was resolved with a minus sign - there is no effect. There is no convincing evidence of the need for the use of these antianemic drugs in chronic renal failure. So the level of evidence largely depends on the hypothesis that is being proven.
Sixth step: frequency analysis
The final stage in the formation of the matrix for the cumulative analysis of medical technologies is the introduction of information on the frequency of use of medical technology. It is easy to do this, since the generated documents indicate who used this technology. Information is entered not on the number of technologies used, but on the number of patients in whom this technology was applied. However, if the source of information is accounting documentation, then this information - about the frequency of use of the technology - cannot be found. Information on the incidence of the disease is collected from primary documentation. In this case, it is necessary to enter into the table only the basic diagnoses (although under certain conditions and a certain interest - and data on concomitant pathology or data on complications.
As a result of entering information into the table, information is obtained about each studied technology, containing an economic assessment, a professional assessment of the utility (necessity) of the technology and a mathematical assessment of the frequency of application of this technology. Further, the analysis of the obtained results is carried out.
Seventh stage: cumulative analysis
What conclusions can be drawn by looking at the information collected in the table? First, what the main money is spent on. Secondly, how necessary and important are the technologies for which the money is spent. Finally, how often are certain technologies used, especially expensive ones. How to relate to certain results is a question of the research point of view
Eighth step: sensitivity analysis
Whether the data obtained is accurate and how much they can be trusted is a common question when critically analyzing the results. Sensitivity analysis can help here, which for a medical organization consists in the fact that data on the maximum and minimum prices for certain drugs or medical services are entered into a table. If price changes do not change the identified trends, then the conclusion is considered justified, if price changes lead to contradictory or opposite results, then there is little confidence in such data, although they can be taken into account.
Making a decision on the formation of the form
After a clinical and economic study has been carried out, its results should serve for making certain decisions based on and scientifically substantiated by the results obtained. We will use a decision-making algorithm based on evidence and objective criteria described earlier in the form of the “decision-making square rule”. For objectification and consensuality of the decisions made, a mechanism of collective creativity is used - the formulary commission of a medical organization. She is the “decision maker” and her decisions are approved by the administration in the form of orders or orders. The easiest way to start this section is based on the example discussed. The first side is informational. We select relevant information from the documents submitted by the organization for analysis and for the analysis we use the List of Vital and Essential Medicines approved by the government. The second facet is analysis and modeling. ABC-, VEN- and frequency analyzes have already been carried out, now it is the turn of modeling. To create a model, the simulation conditions are set:
The formulary list should cover the range of drugs for the main diseases that older persons receiving subsidies from the organization may have.
Diseases that will potentially be treated with drugs included in the formulary list should be dangerous, vital in terms of life expectancy and severe, significantly limiting the life activity of symptoms (heart failure, rhythm disturbances, angina pectoris, bacterial chronic infections, liver and kidney failure, inflammatory diseases of the joints, specific problems of the elderly - constipation and dyspepsia, prostate adenoma, dizziness).
Medicines included in the formulary list should not be used to eliminate symptoms (for example, only an analgesic effect), but to influence the pathogenetic mechanisms of the disease.
Medicines included in the formulary list can be used at the outpatient stage of treatment.
Medicines included in the formulary list must have evidence of their effectiveness.
The formulary list should not duplicate those drugs that are paid for by the state unconditionally (cytostatics, drugs for the treatment of diabetes mellitus, psychotropic drugs). The thesis is controversial, since the state restricts access to drugs due to a small budget, besides, as the practice of DLO has shown, they unexpectedly change the “rules of the game”, for example, since November 1, 2006, the list of drugs in DLO has decreased by 25%.
The list should not include cheap medicines whose cost (one package) does not exceed 50 rubles (or 2 dollars, which is more convenient for further work).
If drugs are often prescribed, are expensive, but do not have evidence of effectiveness, it is necessary to provide for a mechanism for their partial subsidies. First, it is necessary to consider those drugs that were actually prescribed to patients. In this case, generic forms must be combined into one column. Next, we analyze the utility of drugs. We create a list of diseases (problems) that need to be solved on an outpatient basis in the alleged contingent of elderly patients with the help of drugs included in the formulated list and assign a number to each of them (it is obvious that this list can and should be continued): 1. heart failure 2. hypertension 3. rhythm disturbances 4. angina pectoris 5. bacterial chronic infections 6. failure of liver function 7. failure of kidney function 8. inflammatory diseases of the joints (rheumatoid arthritis) 9. constipation 10. dyspepsia 11. prostate adenoma 12. dizziness 13. B12 deficiency anemia 14 iron deficiency anemia 15. osteoporosis 16. condition after stroke 17. ischemia of the lower extremities 18. bronchial asthma 19. COPD 20. diabetes mellitus type 2 21. venous insufficiency 22. glaucoma 23. cataracts 24. fistulas and stomas 25. ulcers and other purulent lesions of the skin and subcutaneous tissue 26. osteoarthritis
Of course, instead of numbers, you can set disease indices, according to ICD-10, but for simplicity we will leave the numbers. Let's insert the indices of utility and evidence: Uv1A - the drug is vital for heart failure and its effectiveness is absolutely proven, Ue1B - the drug can be used as an adjuvant in heart failure and the strength of the convincing evidence is not high, Un1C - the drug is not needed for heart failure, evidence its effectiveness is absent. Maybe the situation is Uv1C - the drug is positioned by the manufacturer as very important for heart failure, but there is no convincing evidence for this statement.
If the form reaches the size of 200-250 drugs (optimal list), then its use in the form of an unstructured document will become impossible. Medicines can be systematized in three ways: anatomical-chemical-therapeutic principle (nitrates, barbiturates, sulfonamides, penicillins), pharmacological (calcium channel inhibitors, beta-blockers, diuretics) and pharmacotherapeutic (antianginal drugs, antihypertensive drugs, drugs used in heart failure etc.). Currently, there is no single classification of medicines in Russia, the pharmacotherapeutic classification, which is most understandable for a doctor, is used in the List of Vital and Essential Medicines, in the formularies of medical institutions in other countries, and by WHO. Mixed classifications, for example, the long-outdated classification of M.D. Mashkovsky, which includes all three criteria in different proportions, confuse the doctor and pharmacist completely and should not be used. Along with the pharmacotherapeutic classification, a unified alphabetical list of all drugs given in the formulary is desirable, both by generic names and by patented ones. Maybe a tabular presentation of information in the form of several columns, for example, as in tab.
Example of presenting information in a form
Along with a positive formulary, a negative formulary should be formed, which will include drugs that were unambiguously rejected by the formulary commission. This will help doctors refuse to prescribe outdated, ineffective, dangerous drugs, convince patients that prescribing these drugs is not advisable. expanded in accordance with the needs of the medical organization.
Pharmacoeconomics is a scientific and practical discipline that studies, in a comparative way, the relationship between costs, effectiveness, efficiency and safety in alternative treatment (prevention) regimens of the disease.
An integrated approach to assessing the feasibility of using medical technologies involves an interconnected assessment of the consequences (results) and the cost of medical interventions. The most fundamental in this definition is precisely the interrelated assessment, that is, it is not just about comparing costs, but about assessing the relationship between costs and the results obtained.
From the point of view of a practitioner, this means that pharmacoeconomics is not about finding the cheapest drugs and justifying their use, but about calculating the costs necessary to achieve the desired efficiency and correlating these costs with opportunities.
In global practice, the following methods of pharmacoeconomic analysis are currently most widely used:
... disease cost analysis
... cost minimization analysis
... cost-effectiveness analysis
... cost-benefit analysis
... cost-benefit analysis
Disease cost analysis
A method of studying all the costs associated with the management of patients with a specific disease both at a certain stage (time interval) and at all stages of medical care, as well as disability and premature mortality. This analysis does not imply a comparison of the effectiveness of medical interventions, it can be used to study the typical practice of managing patients with a specific disease and is used to achieve certain tasks, such as cost planning, determining tariffs for mutual settlements between the subjects of the health care system and health insurance, etc.
Direct, indirect, indirect and intangible costs are calculated:
DIRECT MEDICAL COSTS (includes all costs incurred by the healthcare system), for example:
The costs of diagnostic, treatment, rehabilitation and preventive medical services, manipulations and procedures, including those provided at home (including the payment of working hours of medical workers);
Drug costs;
The costs of maintaining a patient in a medical institution;
The cost of transporting the patient by ambulance;
Payment for the use of medical equipment, space and funds (distribution of fixed costs from budget items), etc .;
DIRECT NON-MEDICAL COSTS:
Cash ("pocket") expenses of patients (for example - payment for services in a medical institution);
The cost of non-medical services provided to patients at home (for example, social services);
The costs of moving patients (by personal transport, public transport - not sanitary), etc.;
INDIRECT (ALTERNATIVE) COSTS (costs of lost opportunities):
Costs for the period when the patient is absent from his workplace due to illness or disability, including the cost of paying sick leave, disability benefits and others social payments stipulated by the current legislation;
- the "cost" of the time away from work of his family members or friends associated with his illness;
Economic losses from reduced productivity at the workplace;
Economic losses from premature death;
INTANGIBLE COSTS - costs associated with pain, suffering, discomfort that a patient experiences as a result of the course of treatment he undergoes - due to the difficulties with an accurate quantitative measurement in monetary terms, today usually remain outside the scope of the analysis performed.
Cost-minimization analysis
A special case of cost-effectiveness analysis, in which two or more interventions are compared that are characterized by identical efficacy and safety, but different costs. It is recommended to use cost minimization analysis when comparative studies of different forms or different conditions of use of one drug or one medical technology. Such studies take into account all types of medical services that are attributed to each method of treatment, and determine the costs of them.
The cost minimization analysis is calculated using the following formula:
СМА = DC1 - DC2 or СМА = (DC1 + IC1) - (DC2 + IC2), where
SMA - an indicator of the difference in costs,
DC1 - direct costs when applying the 1st method,
IC1 - indirect costs when applying the 1st method,
DC2 and IC2 - direct and indirect costs when applying the 2nd method.
Cost-effectiveness analysis
A type of clinical and economic analysis, in which a comparative assessment of the results and costs of two or more interventions is carried out, the effectiveness of which is different, and the results are measured in the same units (millimeters of mercury, hemoglobin concentration, the number of complications averted, years of life saved, etc.) . NS.).
Synonyms - cost benefit analysis; cost effectiveness; cost and efficiency; cost-effectiveness.
Typically, a cost-benefit analysis is calculated using the formula: CEA = (DC + IC) / Ef, where
CEA - cost / effectiveness ratio (identifies the costs required per unit of efficiency, for example, per one cured patient),
DC - direct costs,
IC - indirect costs,
Ef is the effectiveness of treatment (the relative number of patients cured).
Clinical and economic studies to assess the effectiveness of costs have serious theoretical prospects, however, in practice, their use is limited. Prospective developments can be costly and time consuming. For example, in chronic conditions, research should be continued until the end of treatment, although this may take a long time. In addition, it is rather difficult to form groups of patients with precise comparison criteria. Surveillance costs for a selected comparison group of patients can be reduced if there is reliable data on the cost of treatment, for example, information on the results of previous clinical trials according to the criterion of minimal costs. However, data from the retrospective group selected for comparison may diminish the validity of conclusions about the clinical trial.
Therefore, in practice, modeling is more often used - a method of studying various objects, processes and phenomena based on the use of mathematical (logical) models, which are a simplified formalized description of the object under study (patient, disease, epidemiological situation) and its dynamics when using medical interventions.
Cost-benefit analysis is a very effective method of economic valuation of medicines. But at the same time, it has two main disadvantages that limit its use in certain conditions:
1) being one-dimensional, the method cannot be used to compare different types of medical interventions that had different effects on health;
2) indicating the most effective way of action, the method does not allow to determine its public utility.
However, in order to make a decision on the inclusion of a medicine in the list of “Vital and Essential Medicines” (VED), its published form is mandatory!
Cost-utility analysis
A variant of cost-effectiveness (cost-benefit / CEA) analysis, in which the outcomes of an intervention are measured in terms of “utility” from the point of view of the health care consumer (eg, quality of life / QoL); the integral indicator “quality life years saved” (QALY) is most often used. Synonym - cost utility analysis; cost-utility.
A cost-benefit analysis is a type of clinical trial based on a cost-benefit criterion that translates the clinical outcome of a treatment into a utility. It is defined as a certain preference (preference, advantage) of the patient. To measure the utility of costs, the criterion of the ratio of the number of years of extended life to its quality (Quality-Adjusted-Life-Years - QALY) is widely used. This makes it possible to characterize the ongoing treatment by predicting the characteristics and quality of future life that can be expected during the predicted survival period. In other words, it is a comparison of the number of years of life with the level of its quality for a given period.
In studies, treatment costs are weighed against a benefit criterion (QALY). For example, researchers may determine that the cost of a new technology will be US $ 100,000 in relation to the analysis's QALY criterion. If such data are available, it becomes possible to compare different courses of treatment, relying on the accounting of treatment costs (savings) in relation to the QALY criterion.
The cost-benefit analysis is calculated using the following formulas:
CUA = ((DC1 + IC1) - (DC2 + IC2)) / (Ut1 - Ut2)
or
CUA = (DC + IC) / Ut, where
CUA - an indicator of the increase in costs per unit of utility, the cost / utility ratio (that is, the cost of a unit of utility, for example, one year of quality life),
DC1 and IC1 - direct and indirect costs for the 1st method of treatment,
DC2 and IC2 - direct and indirect costs for the 2nd method of treatment,
Ut1 and Ut2 - utility for the 1st and 2nd methods of treatment.
Cost-benefit analysis
A type of clinical and economic analysis in which both costs and results are presented in monetary terms. This makes it possible to compare the cost-effectiveness of different interventions with results expressed in different units (for example, an influenza vaccination program with an intensive neonatal care system for caring for low birth weight infants).
Cost-benefit analysis (synonym: cost-benefit analysis) compensates for one of the disadvantages of cost-benefit analysis (CEA), due to the inability to assess the social value of a medicine. In this case, the monetary equivalent is taken as the unit of assessment of clinical results obtained using any method of treatment. Thus, the direct cost of treatment can be compared with the monetary value of the direct effect obtained from a clinical trial. This method of comparison seems logical, but there are difficulties in assessing such results: how, for example, to represent the saved life or additional years of life in monetary terms? Because of these and many other difficulties, cost-benefit analysis is rarely used.
Modeling
Modeling of economic objects is an integral part of pharmacoeconomic research. In pharmacoeconomics, both analytical and statistical models are widely used. The best option is the combined application of analytical and statistical models. The analytical model makes it possible to understand the phenomenon in general terms, to outline the outline of the main regularities. Any refinements can be obtained using statistical models. Also, when conducting pharmacoeconomic research, simulation modeling is often used, one of which is the Monte Carlo method. By design, the models most frequently encountered in pharmacoeconomics can be divided into a Markov model (describes several discrete states and transitions between them over time) and a “decision tree” (illustrates all possible outcomes in relation to a specific specific situation).
When conducting pharmacoeconomic studies, it is often necessary to face a situation where the available clinical data is insufficient for direct comparison of the evaluated medical technologies. However, in some cases, the lack of clinical data can be compensated for by modeling. Modeling is the study of objects of knowledge on their models; construction and study of models of real-life objects, processes or phenomena in order to obtain explanations of these phenomena, as well as to predict the phenomena of interest to the researcher. Modeling of economic objects is necessary when conducting pharmacoeconomic studies in cases where the available clinical data is not sufficient for comparative analysis. Modeling in pharmacoeconomics is relevant for specialists in the field of health economics, especially for those whose professional activities are related to conducting pharmacoeconomic research and making decisions on drug provision. The objects of modeling research in pharmacoeconomic analysis are any economic objects. Mathematical models of economic systems must meet the requirements of adequacy, universality, completeness and simplicity, must comply with the calculated practical formulas.
Modeling types .
Due to the ambiguity of the concept of "model" there is no single classification of types of modeling. Classification can be carried out by the nature of the models, the nature of the objects being modeled, the modeling application, etc. For example, the following types of modeling can be distinguished:
Computer modelling
Math modeling
Analytical modeling
Statistical modeling
Simulation modeling
Other types of modeling
In pharmacoeconomics, both analytical and statistical models are widely used. Each of these types has advantages and disadvantages.
Analytical models are more "coarse", take into account fewer factors, and always require many assumptions and simplifications. Nevertheless, the calculation results for them are easier to see and more clearly reflect the main regularities inherent in the phenomenon. The use of analytical models makes it easier to find the optimal solution.
Statistical models, in comparison with analytical ones, are more accurate and detailed, do not require such rough assumptions, allow taking into account a larger (in theory, unlimited in size) number of factors. But they also have their drawbacks: cumbersomeness, poor visibility, a large requirement for the computing power of a computer, and most importantly, the extreme difficulty of finding optimal solutions. The best option is to use analytical and statistical models together. The analytical model makes it possible to understand the phenomenon in general terms, to outline, as it were, the outline of the basic laws. Any refinements can be obtained using statistical models.
Also, when conducting pharmacoeconomic studies, simulation modeling is often used, one of which is the Monte Carlo method. The Monte Carlo method is a numerical method for solving mathematical problems by simulating random variables.
Simulation is applied to processes in which a decision-maker may interfere from time to time. With regard to pharmacoeconomics: a specialist conducting therapy for a certain disease can, depending on the current situation, make certain decisions. Then a mathematical model is set in motion, which shows how the situation is expected to change in response to this decision and what consequences it will lead to after some time. The next "current decision" is made taking into account the real new situation, and so on. As a result of repeated repetition of such a procedure, the subject making a decision, as it were, “gains experience”, learns from his own and others’s mistakes and gradually “learns” to make the right decisions - if not optimal, then almost optimal.
The history of modeling in pharmacoeconomics is the history of simulation mathematical models that only partially satisfy the requirements and do not have cognitive functions. Dissatisfaction with the degree of fulfillment of the requirements is the main problem of modeling the economy. The solution to this problem of modeling the economy is associated with the development and use of functional mathematical models and methods for modeling economic objects. A feature of functional modeling is that it is based on the fundamental laws of the functioning of the economy, and the advantage is that functional models fully meet the requirements and have high cognitive functions. Therefore, in the history of economic modeling, the following stages can be distinguished: - the formation and application of simulation mathematical models of economic objects based on individual laws of the economy; - formation and application of functional mathematical models of economic objects based on the laws of economic systems. Modern concepts of functional modeling of economic objects are expressed in the laws of functioning, functional models and methods of modeling economic systems.
Model design .
By design, the models most frequently encountered in pharmacoeconomics can be divided into the Markov model and the “decision tree”. Decision tree is a diagram illustrating all possible outcomes in relation to a specific specific situation. Markov model - describes several discrete states and transitions between them over time.
Decision tree .
The decision tree model is commonly used to describe the treatment process for an acute illness. This type of model implies the presence of several alternatives with different probability of outcomes. In this case, the probability of each of the outcomes is known and the cost of each outcome is known or possible.
"Markov model" .
As practice shows, it is very convenient to describe the treatment of a chronic disease in the form of probabilities of transitions from one state to another, while it is believed that, having passed into one of the states, the model should not further take into account the circumstances of how it got into this state.
Markov models have become widely used in pharmacoeconomic analysis due to their more flexible structure than the “decision tree” structure. In contrast to the alternatives, on which "decision trees" are concentrated, Markov models are built from states and probabilities of transition from one state to another during a given time interval (Markov cycle).
A random process is called a Markov process (or a process without aftereffect) if for each moment in time the probability of any state of the system in the future depends only on its state in the present and does not depend on how the system came to this state.
There are several states: "Health", "Illness", "Death" and the probability of transition from one state to another during a certain time period is known. The duration of the time cycles depends on the characteristics of the disease and the proposed treatment. There are two options for describing Markov processes - with discrete and continuous time. In the first case, the transition from one state to another occurs at a predetermined time instants - ticks (1, 2, 3, 4, ...). The transition is carried out at each step, that is, the researcher is only interested in the sequence of states that a random process goes through in its development, and is not interested in exactly when each of the transitions took place. In the second case, the researcher is interested in both the chain of states changing each other and the moments in time at which such transitions took place. If the transition probability does not depend on time, then the Markov chain is called homogeneous.
Simulation process
The modeling process includes three elements:
1) subject (researcher);
2) the object of research;
3) a model that defines (reflects) the relationship between the cognizing subject and the cognized object.
The first stage of building a model presupposes some knowledge of the original object. The cognitive capabilities of the model are due to the fact that the model displays (reproduces, imitates) any essential features of the original object. The question of the necessary and sufficient degree of similarity between the original and the model requires a specific analysis. Obviously, the model loses its meaning both in the case of identity with the original (then it ceases to be a model), and in the case of an excessive difference from the original in all essential respects. Thus, the study of some aspects of the modeled object is carried out at the cost of refusing to study other aspects. Therefore, any model replaces the original only in a strictly limited sense. From this it follows that for one object, several "specialized" models can be built that focus on certain aspects of the object under study or characterize the object with varying degrees of detail.
At the second stage, the model acts as an independent object of research. One of the forms of such research is the conduct of "model" experiments, in which the conditions for the functioning of the model are deliberately changed and the data on its "behavior" are systematized. The end result of this stage is a set (body) of knowledge about the model.
At the third stage, knowledge is transferred from the model to the original - the formation of a set of knowledge. At the same time, there is a transition from the "language" of the model to the "language" of the original. The process of transferring knowledge is carried out according to certain rules. Knowledge about the model should be adjusted taking into account those properties of the original object that were not reflected or were changed during the construction of the model. The fourth stage is the practical verification of the knowledge obtained with the help of models and their use to construct a generalizing theory of an object, its transformation or control.
Modeling is a cyclical process. This means that the first four-stage cycle can be followed by the second, third, etc. In this case, the knowledge about the investigated object is expanded and refined, and the original model is gradually improved. Disadvantages discovered after the first simulation cycle, caused by little knowledge of the object or errors in building the model, can be corrected in subsequent cycles.
ABC-, VEN- and frequency analyzes in healthcare
There are two worldviews, two positions: some believe that all events in the world are random, others, who are often called fatalists, are confident in the predetermination, regularity of the phenomena occurring. Probably, as is often the case, the truth is somewhere in between: random processes are subject to the influence of patterns. The task of scientists is to find, describe, explain these patterns and, if possible, learn how to manage them.
Perhaps the most famous example of the transformation of chaos into a system is the creation of D.M. Mendeleev of the Periodic System: the variety of chemical substances was known long before Dmitry Mikhailovich, and they were classified in one way or another (for example, according to their physical properties - gases, liquids and solids), although there was no universal system. A sudden insight made it possible to build not just another classification, but to reveal patterns, which were subsequently used in the study of isotopes and rare earth elements, the synthesis of new substances.
The Russian Society for Pharmacoeconomic Research was established several years ago. During this time, members of the society have carried out a large number of studies on the clinical and economic analysis of various medical technologies. In the course of these studies, information was collected on the amount of resources used, which was of an applied nature - as a rule, the results of its processing were used when drawing up clinical and economic models or when calculating cost / efficiency indicators for individual medical technologies. At the same time, this information is of independent interest, since for the first time in the hands of researchers get data on how patients with different diagnoses are actually treated in different clinics.
Medical care mainly includes the provision of medical services and the use of medicines. On what basis the doctor chooses certain technologies, it is difficult to say from the results of the research done. Probably, education, traditions or "schools", their own preferences and the influence of all kinds of advertisements, including not always conscientious scientific publications, play a role. In any case, an event occurs: the doctor prescribes something. If you ask experts what they will prescribe to a patient in this or that case, then, as studies show, the answers will not be strikingly different from what is used in practice. Doctors know what is right and what is wrong, and they will give the correct answers, but during the survey it will be about 3-5, less often 7-10 drugs for one disease, when copied from medical records they turn out to be 90-100, and in some cases even 150 items.
The presented research results do not allow answering the question "why", they represent only a statement of facts. But the statement is also important, since these facts were not previously known.
When conducting ABC analysis, medical technologies are summarized in tables, at first - in alphabetical order. Next, the costs for each technology are calculated. For medicines, this is a laborious process, since it is necessary to calculate the daily dose, the total dose of the drug received by all patients, then determine the cost of the daily dose and the total costs for the entire treatment period in all studied patients. The calculation of costs for services is simpler - the number of services performed for each type is determined, and then, having found out the cost of each individual service, the total costs for it.
Usually, for the analysis of the cost of medicines, the calculation is based on the average wholesale prices of distributors, if the drugs were used in inpatient conditions, and average prices in pharmacies, if the patients received treatment on an outpatient basis. To determine prices for medical services, the prices for paid services of one of the major medical institutions of federal subordination were most often used. At the same time, it was a priori believed that these prices most fully reflect the true costs of medical care, that they were calculated by the economists of this organization. The second approach is to use the rates of the compulsory health insurance system multiplied by 3: the compulsory health insurance funds, both according to our research and other sources, make up about 1/3 of all health care funds (excluding personal funds of patients).
The next step is to rank medicines or medical services from the most expensive to the least expensive. It is calculated how many percent of the total cost of medicines falls on each medicine (or, accordingly, for a service). In this case, the most expensive technologies are combined into a group that accounts for 80% of all costs (group “A”). The second group - group “B” - are less expensive technologies, which account for 15% of all costs. And, finally, the least costly technologies - 5% of all costs - make up the “C” group.
A separate column records the frequency of use of each technology - drug or service. Comparison of the degree of cost and frequency of use allows us to say what money is mainly spent on - on rare but expensive technologies or on cheap but massive ones. So, in the treatment of agranulocytosis, the main money spent on drugs turned out to be paid for an antiviral drug prescribed to a small number of patients. But maybe these patients need the drug?
The answer to this question is provided by VEN analysis. Each technology is assigned an index of vital importance: V (vital) - vital technologies, E (essential) - important and, finally, the N (non-essential) index - secondary technologies. Usually, the latter group includes drugs or services whose effectiveness has not been proven or the use of which in a real disease is not justified. A drug to group V can be classified according to a formal criterion: for example, by its presence in the list of vital and essential medicines, formulary. With such a formal approach, a drug can have only two indices V and N. Such a dualistic coding is sufficient for making administrative decisions. For the clinician, the expert method is more understandable, in which group V includes drugs that are absolutely indicated for a given pathology, E - important drugs whose use is considered possible but not necessary, and N - drugs whose use in this disease is not indicated. Ideally, only drugs with proven efficacy should be in group V, but there is currently very little evidence to base decisions on them. Assigning VEN Indexes medical services possible at the present time only by expert means. However, with the emergence of a large number of Patient Management Protocols, it will become possible to conduct a VEN analysis based on the formal indication of the presence of a medical service in the protocol.
ABC, VEN, and frequency analyzes are applicable not only to drugs and health services, but to the diseases themselves. In fact, from the point of view of public health, the disease acts as a criterion, a sign of the use of certain medical technologies, society bears the costs of their use. The social significance of diseases is known, it has been studied a lot, especially with regard to infectious, contagious, epidemically dangerous diseases. However, ranking, assessment of diseases according to the criteria adopted in clinical and economic analysis, was not carried out: after all, you can study the frequency of certain diseases in health care (and not in the population), determine the most costly and least costly (ABC analysis), evaluate the life the importance of diseases (actually VEN-analysis). This analysis is important from the point of view of cost planning and their rational use. Example: influenza and acute respiratory infections are massive diseases, they can be classified as non-dangerous diseases (index N), and assigned category B in the ABC analysis. AIDS is a rare disease with an index V (potentially fatal), which will be in the cost structure in group “B” (and possibly in group “A”, since huge funds are spent on diagnostics). However, this is just an example, built on inferences, without any factual confirmation. Moreover, the criterion of importance in this example is chosen from the point of view of socio-economic, society as a whole. But there may be a patient's angle of view, for whom the immediate task of alleviating suffering is in the first place, and then the vital importance will change.
Stages of pharmacoeconomic analysis
Each of the methods of economic analysis necessarily includes several main stages:
1. the formulation of the problem under study, the definition of the "point of view" of the researcher (whose interests will be taken into account);
2. choice of alternative technology for comparison;
3. analysis of the effectiveness and safety of the investigated interventions; selection of a criterion (parameter) for evaluating effectiveness;
4. calculation of the costs associated with the use of the investigated interventions;
5. calculation and analysis of pharmacoeconomic indicators proper.
The choice of the method of pharmacoeconomic analysis
The choice of the method of pharmacoeconomic analysis depends on the results obtained in the course of clinical trials. Each time a pharmacoeconomic analysis is performed, the choice of method is determined by the researchers. Table 1 provides information on the results of the evaluated medical interventions using various methods of pharmacoeconomic analysis.
Result |
Method |
Indicators reflecting the clinical effectiveness of treatment or the number of years saved |
"Cost-effectiveness" (or "minimizing costs" with identical effectiveness of comparable interventions) |
"Usefulness" of medical interventions (years of quality life - QALY) |
"Cost-utility" |
Cost of lost working time "Willingness (willingness) to pay" |
"Cost benefit" |
Limited resources and time. Finding data from various sources |
Modeling |
VEN analysis
VEN (EnglishVital Essential Non- essential) - vital, necessary, secondary) - directive segmentation of the "necessity" of the assortment.
The term VED is often used (the last letter D - Desirable, desirable)
Usually used in medicine (pharmacy) and manufacturing. In real life, it is used in conjunction with ABC analysis.
VEN analysis is carried out in parallel with ABC analysis and allows you to determine priority drugs in accordance with international practice of dividing them into vital (Vital or V), necessary (Essential or E) and minor (Non-essential or N) (Table 2 ).
table 2
Determination of Priority Medicines (VEN Analysis)
Vital |
Life-saving medicines (such as vaccines); having a life-threatening withdrawal syndrome that is constantly needed to maintain life (insulins, steroids, antibiotics, etc.) |
Essential |
Medicines that are effective in treating less dangerous but serious diseases |
Non-essential |
Medicines for the treatment of "mild" diseases; drugs with dubious effectiveness; expensive with symptomatic indications |
Based on the results of the ABC-VEN analysis, the following questions can be answered:
Is it reasonable to spend funds on drugs in a particular health facility (mainly, which drugs are in groups A and B)?
What steps need to be taken to rationalize drug procurement?
What drugs should first be considered for inclusion (exclusion) in the formulary list?
Are the financial costs consistent with the morbidity structure analysis?
The publication was prepared based on the materials of Wikipedia.
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