Clinical and economic analysis in a medical organization (a practical guide for decision makers). Clinical and economic analysis in a medical organization What clinical and economic analysis evaluates

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One of the most important areas in increasing the efficiency of medical care has become the optimization of costs while observing state guarantees of providing free medical care to citizens of the Russian Federation. The basis for solving these issues was clinical and economic analysis.

Clinical and economic analysis is understood as 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. This methodology is applicable to any medical technologies: medicinal and non-medicinal treatment, methods of diagnosis, prevention and rehabilitation. In the field of drug supply, clinical and economic analysis is called “ pharmacoeconomics ».

Principles of clinical and economic analysis

The basic principle of clinical and economic analysis is that any medical intervention must be considered in comparison with an alternative, and when making a decision, preference is given to the one (or those) of them that achieve the optimal medical and economic result. Economic evaluation of the effectiveness of CVD treatment methods is based on clinical data obtained in studies carried out in accordance with the requirements of evidence-based medicine. Transparency and reproducibility of results should be considered important principles of clinical and economic analysis. It is mandatory to adhere to an analytical position that reflects the economic interests of the payer bearing the analyzed costs (state, society, medical insurance organization, patient, medical institution, charitable society, patient family members, etc.). The analytical horizon implies a time interval covering the main clinical and economic results of the treatment methods being studied.

Methods of clinical and economic analysis

Clinical and economic analysis is carried out using the following main methods:

cost-effectiveness analysis (CEA - cost-effectiveness analysis);

cost minimization (CMA - cost-minimization analysis);

cost-utility analysis (CUA - cost-utility analysis);

cost-benefit analysis (CBA - cost-benefit analysis).

Economic evaluation is carried out on the basis of data on results and costs obtained in the course of special clinical and economic studies or clinical and economic modeling.

results

When assessing the result of using the analyzed methods, they take into account effectiveness [for example, relieving an attack of angina, increasing left ventricular ejection fraction (LV)], efficiency, utility, profit or other parameters that are expressed in very specific units of measurement. The choice of the effectiveness criterion and the method of its measurement is carried out depending on the problem posed and the drugs being compared, as well as the method of clinical and economic analysis.

Expenses

Calculation of costs for each of the compared medical interventions includes financial costs over a period of time, distinguishing direct and indirect, medical and non-medical (required in connection with the disease). It is important to observe the rule of a single time slice: costs are determined simultaneously for all types of costs and in relation to a specific location of the study.

S.G. Gorokhova
Clinical and economic analysis in cardiology

Pharmacoeconomics is a scientific and practical discipline that studies in comparative terms the relationship between costs, effectiveness, efficiency and safety of alternative treatment (prevention) regimens for the disease.

An integrated approach to assessing the feasibility of using medical technologies involves an interconnected assessment of the consequences (results) and cost of medical interventions. The most important thing in this definition is the interrelated assessment, that is, we are talking not just about comparing costs, but about assessing the relationship between costs and results obtained.

From the point of view of a practicing physician, this means that pharmacoeconomics is not about finding the cheapest drugs and justifying their use, but about calculating the costs required to achieve the desired effectiveness and relating these costs to capabilities.

In global practice today, the following methods of pharmacoeconomic analysis are most widely used:

. cost of illness analysis

. "cost minimization" analysis

. cost-effectiveness analysis

. cost-utility analysis

. cost-benefit analysis

Cost of illness analysis

A method for studying all costs associated with the management of patients with a certain disease, both at a certain stage (period of time) and at all stages of medical care, as well as with disability and premature mortality. This analysis does not involve 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 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:

Costs of diagnostic, therapeutic, rehabilitation and preventive medical services, manipulations and procedures, including those provided at home (including payment for the working hours of medical workers);

Drug costs;

Costs of maintaining a patient in a medical institution;

Costs of transporting a patient by ambulance;

Payment for the use of medical equipment, space and facilities (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);

Costs of non-medical services provided to patients in the home (eg, social services);

Costs of moving patients (by personal transport, public transport - not sanitary), etc.;

INDIRECT (ALTERNATIVE) COSTS (lost opportunity costs):

Costs for the period of absence of the patient from his workplace due to illness or disability, including costs for payment of certificates of incapacity for work, disability benefits and other social benefits provided for by current legislation;

- the “cost” of time away from work for members of his family or friends associated with his illness;

Economic losses from decreased productivity at the place of work;

Economic losses from premature death;

INTANGIBLE (INTANGABLE) COSTS - costs associated with pain, suffering, discomfort experienced by the patient as a result of the course of treatment he undergoes - due to difficulties with precise quantitative measurement in monetary terms, today they usually remain outside the scope of the analysis.

“Cost minimization” analysis

A special case of cost-effectiveness analysis, in which a comparative assessment of two or more interventions is carried out, characterized by identical effectiveness and safety, but different costs. It is recommended to use cost minimization analysis in a comparative study of different forms or different conditions of use of one drug or one medical technology. When conducting such studies, all types of medical care that are attributed to each treatment method are taken into account and their costs are determined.

Cost minimization analysis is calculated using the following formula:

SMA = DC1 - DC2 or SMA = (DC1+ IC1) - (DC2 + IC2), where

SMA is an indicator of the cost difference,

DC1 - direct costs when using 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, number of complications prevented, years of life saved, etc.) . P.).

Synonyms - cost-benefit analysis; cost efficiency; costs and efficiency; cost-effectiveness.

Typically, cost-benefit analysis is calculated using the formula: CEA= (DC+IC)/Ef, where

CEA - cost/effectiveness ratio (reveals the costs required per unit of effectiveness, for example, per patient treated),

DC - direct costs,

IC - indirect costs,

Ef - treatment effectiveness (relative number of patients cured).

Clinical and economic studies assessing cost-effectiveness have serious theoretical prospects, but in practice their use is limited. Prospective developments can be costly and time consuming. For example, in chronic diseases, research must continue until the end of treatment, although this may take a long time. In addition, it is quite difficult to form groups of patients with precise comparison criteria. The costs of monitoring a comparison group of patients can be reduced if reliable data on the costs of treatment are available, for example information on the results of previous clinical trials based on the minimum cost criterion. However, data from a retrospective comparison group may reduce the validity of the conclusions drawn from 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 being studied (patient, disease, epidemiological situation) and its dynamics when using medical interventions.

Cost-benefit analysis is a very effective method for the economic evaluation 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 path of action, the method does not allow one to determine its social utility.

However, to make a decision on including a medicine in the list of “Life-Saving and Essential Medicines” (VED), its availability in published form is mandatory!

Cost-utility analysis

A variant of cost-effectiveness analysis (cost-effectiveness / CEA), in which the results of an intervention are assessed in terms of “utility” from the point of view of the health care consumer (for example, quality of life / QoL); in this case, the integral indicator “quality life years saved” (QALY) is most often used. Synonym: cost-utility analysis; costs-utility.

Cost-utility analysis is a type of clinical trial based on cost-effectiveness criteria that translates the clinical outcome of a treatment into the plane of its 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 allows the treatment to be characterized by predicting the features and quality of life that can be expected during the predicted survival period. In other words, this is a comparison of the number of years of life with the level of its quality for a given period.

When conducting studies, treatment costs are compared with a utility criterion (QALY). For example, researchers may determine that a new technology will cost $100,000 per QALY derived from the analysis. If such data are available, it becomes possible to compare different courses of treatment, based on taking into account the costs of treatment (cost savings) in relation to the QALY criterion.

Cost-utility analysis is calculated using the following formulas:

CUA =((DC1 + IC1) - (DC2 + IC2))/(Ut1 - Ut2)

or

CUA = (DC + IC)/Ut, where

CUA is 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 treatment method,

DC2 and IC2 - direct and indirect costs for the 2nd treatment method,

Ut1 and Ut2 - utility in the 1st and 2nd treatment methods.

Cost-benefit analysis

A type of clinical and economic analysis in which both costs and outcomes 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 the organization of an intensive neonatal care system for caring for children born with low birth weight).

Cost-benefit analysis (synonym: cost-benefit analysis) compensates for one of the shortcomings of cost-effectiveness analysis (CEA), caused by the inability to assess the social value of a drug. In this case, the monetary equivalent is taken as the unit for assessing the clinical results obtained using any treatment method. In this way, the direct costs of treatment can be compared with the monetary value of the direct effect obtained from the clinical trial. This method of comparison seems logical, but there are difficulties in assessing such results: how, for example, do we 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 use of analytical and statistical models. The analytical model makes it possible to understand the phenomenon in general terms and outline the outline of the main patterns. Any refinements can be obtained using statistical models. Also, when conducting pharmacoeconomic studies, simulation modeling is often used, one of the representatives of which is the Monte Carlo method. By design, the most common models in pharmacoeconomics can be divided into the Markov model (describes several discrete states and transitions between them over time) and the “decision tree” (illustrates all possible outcomes in relation to a specific specific situation).

When conducting pharmacoeconomic studies, one often encounters a situation where the available clinical data are insufficient to directly compare the medical technologies being evaluated. However, in some cases, the lack of clinical data can be filled 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 phenomena of interest to the researcher. Modeling of economic objects is necessary when conducting pharmacoeconomic studies in cases where the available clinical data are not sufficient for comparative analysis. Modeling in pharmacoeconomics is relevant for specialists in the field of health economics, especially for those whose professional activities involve conducting pharmacoeconomic studies and making decisions about 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, and must comply with calculated practical formulas.

Modeling types .

Due to the polysemy of the concept “model,” there is no unified classification of types of modeling. Classification can be carried out according to 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 its own advantages and disadvantages.

Analytical models are more “rough”, take into account fewer factors, and always require many assumptions and simplifications. Nevertheless, the results of calculations based on them are easier to see and more clearly reflect the basic patterns 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, and allow one to take into account a larger (in theory, unlimited in size) number of factors. But they also have their drawbacks: bulkiness, poor visibility, high demands on computer computing power, and most importantly, the extreme difficulty of finding optimal solutions. The best option is the combined use of analytical and statistical models. The analytical model makes it possible to understand the phenomenon in general terms, to outline, as it were, the outline of the main patterns. Any refinements can be obtained using statistical models.

Also, when conducting pharmacoeconomic studies, simulation modeling is often used, one of the representatives of which is the Monte Carlo method. The Monte Carlo method is a numerical method for solving mathematical problems by modeling random variables.

Simulation modeling is applied to processes in which a decision maker may intervene from time to time. With regard to pharmacoeconomics: a specialist leading the treatment of a certain disease can, depending on the current situation, make certain decisions. Then a mathematical model is put into action, which shows what changes in the situation are expected 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, etc. As a result of repeated repetition of such a procedure, the subject making the decision, as it were, “gains experience”, learns from his own and others’ 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 in economic modeling. The solution to this problem of economic modeling is associated with the development and use of functional mathematical models and methods for modeling economic objects. The peculiarity of functional modeling is that it is based on the fundamental laws of economic functioning, and the advantage is that functional models fully satisfy the requirements and have high cognitive functions. Therefore, in the history of economic modeling, the following stages can be distinguished: - formation and application of simulation mathematical models of economic objects based on individual patterns 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 operation, functional models and methods of modeling economic systems.

Model design .

By design, the most commonly used models in pharmacoeconomics can be divided into Markov models and decision trees. A 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 probabilities of outcomes. In this case, the probability of each outcome is known and the cost of each outcome is known or possible to calculate.

"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 no longer 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. Unlike the alternatives that decision trees focus on, 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”, “Disease”, “Death” and the probability of transition from one state to another over 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 previously known moments in time - clock cycles (1, 2, 3, 4, ...). The transition occurs at each clock cycle, 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 occurred. 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 occurred. If the transition probability does not depend on time, then the Markov chain is called homogeneous.

Modeling process

The modeling process includes three elements:

1) subject (researcher);

2) object of study;

3) a model that defines (reflects) the relationship between the cognizing subject and the cognizable object.

The first stage of building a model assumes some knowledge about the original object. The cognitive capabilities of the model are determined by 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 specific analysis. Obviously, a 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 excessive difference from the original in all significant 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. It follows from this that for one object several “specialized” models can be built, concentrating attention on certain aspects of the object under study or characterizing 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 conducting “model” experiments, in which the operating conditions of the model are deliberately changed and data on its “behavior” are systematized. The end result of this stage is a set (set) 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, a transition occurs from the “language” of the model to the “language” of the original. The process of knowledge transfer is carried out according to certain rules. Knowledge about the model must 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 build a general theory of the object, its transformation or control.

Modeling is a cyclical process. This means that the first four-stage cycle may be followed by a second, third, etc. In this case, knowledge about the object under study is expanded and refined, and the original model is gradually improved. Deficiencies discovered after the first modeling cycle, due to poor knowledge of the object or errors in model construction, 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 of the nature of chance, others, who are often called fatalists, are confident in the predetermination, the regularity of occurring phenomena. Probably, as often happens, the truth is somewhere in the middle: random processes are influenced by patterns. The task of scientists is to find, describe, explain these patterns and, if possible, learn to control them.

Perhaps the most famous example of the transformation of chaos into a system is the creation of D.M. Mendeleev's Periodic System: the variety of chemical substances was known long before Dmitry Mikhailovich, and they were classified in one way or another (for example, by 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 identify patterns that were subsequently used in the study of isotopes and rare earth elements, and the synthesis of new substances.

The Russian Society for Pharmacoeconomic Research was created several years ago. During this time, members of the society conducted a large number of studies on clinical and economic analysis of various medical technologies. In the process of these studies, information was collected on the volume of resources used, which was of an applied nature - as a rule, the results of its processing were used in the compilation of clinical and economic models or in the calculation of cost/effectiveness indicators for individual medical technologies. At the same time, this information is of independent interest, since for the first time researchers are getting data on how patients with different diagnoses are actually treated in different clinics.

Medical care primarily includes the provision of medical services and the administration of medications. It is difficult to say based on the results of the studies done on what basis the doctor chooses this or that technology. Probably, education, traditions or “schools,” personal preferences and the influence of all kinds of advertising, including not always conscientious scientific publications, play a role. In any case, the event occurs: the doctor prescribes something. If you interview experts what they will prescribe to a patient in a given case, then, as studies show, the answers will not differ significantly from what is used in practice. Doctors know what is right and what is wrong, and will give the correct answers, but during the survey we will talk about 3-5, less often 7-10 drugs for one disease, when copied from medical records it turns out there are 90-100 of them, and in some cases even 150 titles.

The presented research results do not answer 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 an ABC analysis, medical technologies are tabulated, initially in alphabetical order. Next, the costs for each technology are calculated. For medicines, this is a labor-intensive 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 for all patients studied. Calculating the costs of services is simpler - the number of services of each type performed is determined, and then, having found out the cost of each individual service, the total costs for it.

Typically, to analyze the cost of medicines, the calculation is based on the average wholesale prices of distributors if the drugs were used in an inpatient setting, and the average prices in pharmacies if patients received treatment on an outpatient basis. To determine prices for medical services, prices for paid services of one of the large medical institutes of federal subordination were most often used. At the same time, it was believed a priori 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 tariffs of the compulsory health insurance system, multiplied by 3: compulsory health insurance funds, both according to our research and other sources, amount to about 1/3 of all healthcare funds (excluding patients’ personal funds).

The next step is to rank medicines or medical services from most expensive to least expensive. It is calculated what percentage of the total costs of medicines falls on each medicine (or service, respectively). At the same time, 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 expensive technologies - 5% of all costs - make up group “C”.

The frequency of use of each technology - medicine or service - is entered in a separate column. Comparing the degree of cost and frequency of use allows us to say what money is mostly spent on - on rare but expensive technologies or on cheap but widespread ones. Thus, in the treatment of agranulocytosis, the main money spent on drugs was 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 index N (non-essential) - minor technologies. Typically, the latter group includes drugs or services whose effectiveness has not been proven or whose use for the present disease is not justified. A drug can be classified into group V according to a formal criterion: for example, by its presence in the list of vital and essential medicines or formulary. With this formal approach, a drug can have only two indices V and N. Such dualistic coding is sufficient for making administrative decisions. For a 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, the use of which is not indicated for a given disease. Ideally, group V should include only drugs with proven effectiveness, but there is currently very little evidence to rely solely on them when making decisions. Assigning VEN indices to medical services is currently only possible through expert examination. However, as a large number of patient management protocols appear, it will become possible to conduct a VEN analysis based on a formal sign of the presence of a medical service in the protocol.

ABC, VEN and frequency analyzes are applicable not only to drugs and medical services, but also to diseases themselves. In fact, from the point of view of public health, 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, and epidemically dangerous diseases. However, no ranking or assessment of diseases according to the criteria adopted in clinical and economic analysis has been carried out: but it is possible to study the frequency of certain diseases in healthcare (and not in the population), determine the most costly and least costly (ABC analysis), and assess the life expectancy the importance of diseases (in fact, VEN analysis). Such an analysis is important from the point of view of cost planning and their rational use. Example: influenza and acute respiratory infections are widespread diseases, they can be classified as non-dangerous diseases (index N), and assigned category B in ABC analysis. AIDS is a rare disease with index V (potentially fatal), which will be in the cost structure in group “B” (and possibly in group “A”, since huge amounts of money are spent on diagnostics). However, this is only an example based on inferences that does not have any factual confirmation. Moreover, the criterion of importance in this example was chosen from the socio-economic point of view of society as a whole. But there may also be a patient’s point of view, for whom the immediate task of alleviating suffering comes first, and then the vital importance will change.

Stages of pharmacoeconomic analysis

Each method of economic analysis necessarily includes several main stages:

1. formulation of the problem under study, determination of the “point of view” of the researcher (whose interests will be taken into account);

2. selection of alternative technology for comparison;

3. analysis of the effectiveness and safety of the interventions being studied; selection of criterion (parameter) for assessing effectiveness;

4. calculation of costs associated with the use of the study interventions;

5. calculation and analysis of pharmacoeconomic indicators themselves.

Choosing a pharmacoeconomic analysis method

The choice of pharmacoeconomic analysis method depends on the results obtained during clinical studies. Each time a pharmacoeconomic analysis is conducted, the choice of method is determined by the researchers. In table Table 1 provides information on the results of the evaluated medical interventions using various methods of pharmacoeconomic analysis.

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 is Desirable, preferably)

Typically used in medicine (pharmacy) and manufacturing. In 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), essential (Essential or E) and secondary (Non-essential or N) (Table 2 ).

table 2

Identification of priority drugs (VEN analysis)

Based on the results of the ABC-VEN analysis, the following questions can be answered:

Is it advisable to spend financial resources on drugs in a specific health care facility (mainly, which drugs are in group A and B)?

What steps need to be taken to streamline drug procurement?

Which drugs should be considered first for inclusion (exclusion) in the formulary list?

Do the financial costs correspond to the data from the analysis of the morbidity structure?

The publication was prepared based on Wikipedia materials.

After studying Chapter 11, the student should:

know

• the concept of clinical and economic analysis (CEA);
• selection criteria and basic methods of CEA in medical practice;
• calculation formulas for the applied method of clinical and economic analysis;

be able to

• determine the appropriate method of clinical and economic analysis;
• make management decisions in order to improve the efficiency of medical care;
• summarize and carefully evaluate the results obtained by domestic and foreign researchers, identify promising areas, draw up a research program in the field of clinical and economic analysis;

own

• the ability to independently master new methods of clinical and economic analysis, change the scientific and scientific-production profile of their professional activities;
• criteria for choosing a method and the scope of its application in clinical trials;
• skills of public and scientific speech, formed, among other things, on the basis of the results of an independently conducted clinical and economic study.

Factors that determine the effectiveness of medical care. Cost of illness calculation method

One of the foundations of national security is the health of the population, therefore the quality of medical care is the principle of the development of healthcare in the Russian Federation. “The customer is central to the key aspects of the quality system of any organization producing products or services, and his assessment serves as the ultimate measure of the quality of the service or service and the effectiveness of the system as a whole.” In healthcare, only that which gives a good clinical effect is cost-effective. Thus, “each process is evaluated, first of all, from the standpoint of its result and is considered as a continuous increase in “value” from the beginning of the process to its completion.”

The effectiveness of medical care is the degree of the patient’s level of health achieved at the optimal level of material, labor, and financial costs. In efficiency analysis, the result is understood as a medical effect, characterized as the degree of achievement of the set goal in the field of prevention, diagnosis and treatment.

The World Health Organization (WHO) has identified effective health care as one of the main strategic directions of its policies relating to social issues, economics and the environment. In this regard, the main subject of the healthcare system is the citizen, whose health status determines economic efficiency and, as a final result, the economic well-being of society. “Each patient obviously requires an individual set of medical services, which are based on many medical technologies, and it is natural that this particular set of services should be provided to him and it is they, and not something in between, that should be paid for by the insurance organization. For this, the compulsory medical insurance system, the priority direction of which is to fulfill obligations to the multi-million contingent of insured people in relation to the range and quality of medical services provided, i.e., claiming a sufficiently high level of socio-economic efficiency, should be focused on an optimal management system supported by modern technologies."

To implement priority programs to protect public health at an ever-increasing cost of medical care, an optimality criterion is required as a quantitative indicator expressing the maximum measure of the economic effect of a decision for a comparative assessment of possible solutions (alternatives) and selection of the best one.

The criteria for the socio-economic efficiency of managing financial resources and assessing the activities of various subjects of the compulsory health insurance system are based on the principle of dominance of the interests of end users - the insured. The same criterion is the basis for assessing the effectiveness of various medical technologies.

Economic evaluation involves the analysis of medical alternatives, for each of which it is necessary to compare the benefits (results) and costs assessed in one way or another. “The basis for coordinating interests should be a focus on the final results of activities.” This applies to all subjects of the healthcare system, including medical workers, healthcare organizers, and managers, who need practical skills and knowledge in the field of clinical and economic analysis to carry out their professional activities in order to more rationally use the available resources of a healthcare organization and ensure quality medical care. help.

Thus, clinical-economic analysis is a comparative analysis of various methods of diagnosis, prevention, drug and non-drug treatment, rehabilitation, and surgical methods used in medical practice, performed with the aim of determining the most clinically effective and economically feasible from the set of methods under consideration.

Analysis (from Greek. analysis - decomposition) is a method of scientific research (cognition) of phenomena and processes, which is based on the study of the components, elements of the system under study (for example, a system for providing quality medical care).

Analysis of the total cost of illness (economic burden of disease, cost of illness - COI) - This is a type of economic analysis that determines all costs (total cost) incurred by society, a specific healthcare institution, or family in connection with all therapeutic and diagnostic measures during the treatment of a disease of any nosological form. This type of analysis does not involve calculating and determining the effectiveness of medical care provided. But when analyzing the “total cost of illness,” it is possible to identify the disease for which the largest amount of financial resources is spent, and to determine the greatest economic damage caused to society, family, and individual in connection with the morbidity of the population. The analysis allows you to make a management decision on the optimal distribution of financial resources in a separate unit of a healthcare organization, for the organization as a whole (polyclinic, day hospital, 24-hour hospital), as well as identify costs at the level of the family and society as a whole.

The analysis of the total cost of illness (total burden of disease) is carried out using the formula

Where C01 - cost of illness indicator; OS - direct costs (costs); 1C - indirect (non-medical and indirect, alternative) costs (costs).

The grouping of costs depends on what particular problem is being solved using economic analysis.

Direct costs (OS)- these are the expenses of a healthcare institution that are directly related to the treatment process. Types of direct costs primarily include:

• salaries of medical personnel (basic and additional);
• accruals for the salaries of medical personnel;
• costs of a healthcare institution for medications, soft equipment, patient nutrition (in a hospital);
• depreciation of medical equipment (i.e. the amount of wear and tear on medical equipment expressed in monetary terms).

Indirect (indirect, opportunity and non-medical) costs (1C) - These are expenses that are not directly related to the treatment process, but create the conditions for it. Indirect costs should also include opportunity cost, which are otherwise called opportunity costs, or opportunity costs. In English-language literature the term is applied to opportunity costs "indirect costs" (indirect cost - IC). It is permissible to combine the overhead costs of a healthcare institution and the so-called indirect costs (or, otherwise, opportunity costs, opportunity costs) into indirect costs (expenses 1C).

Different groupings of costs associated with the provision of health care should serve specific purposes of economic analysis. Since, in the interpretation of economic theory, direct costs include those that are directly related (involved) in the production of a product (goods, work, services), in this case direct costs are associated with the provision of medical care at all its stages - diagnosis, direct treatment and rehabilitation . Such costs are designated as DC.

Indirect costs (or expenses, expenses) include those that are not directly involved in the production of a product, but without which this product also cannot be produced. Indirect costs (or in the accounting interpretation - overhead costs) make up, as a rule, the majority of the costs of a healthcare organization, but they are not directly related to the treatment process. Any organization, not just a medical organization, has such expenses, so it is proposed to designate them as “indirect non-medical costs.” Also, the provision of medical care is associated with such concepts as incapacity, disability, underproduction of GDP due to loss of health of the working population, “implicit” costs of the family budget, i.e. costs to society as a whole due to morbidity and premature mortality, all of which are also indirect costs.

All of the above costs are objectively of a social nature and are considered social costs. In practice, there is often a need to know which costs dominate in order to take effective measures to reduce them. In this case, for the completeness of the clinical and economic analysis, it is necessary to divide the costs into groups within which the costs are united by common features. Thus, to DC we attribute direct costs, and to 1C - indirect costs as the sum of “indirect non-medical costs of a healthcare facility” (or overhead costs) and “indirect costs”, to which the term “opportunity costs” also applies. Opportunity costs

In the case of indirect non-medical costs to the health care facility (or overhead costs), 1C relate:

• wage costs (basic and additional) for administrative and economic personnel;
• accruals for salaries of administrative and economic personnel;
• costs for utilities, cleaning supplies;
• transport maintenance costs;
• current repairs of buildings and premises;
• costs of personnel training at the expense of the healthcare institution;
• travel expenses;
• advertising costs;
• loan payment (for medical institutions);
• entertainment expenses;
• office expenses;
• expenses for communication services;
• other expenses for the economic needs of Ukrzaliznytsia, etc.

In the case of indirect (imputed) costs, 1C additionally include costs associated with temporary loss of ability to work, permanent loss of ability to work, and death due to illness. The following aspects are considered.

Clinical and economic analysis is a relatively new area of ​​research, the need for which is determined by:

• rapid growth in the cost of treatment of the most common diseases and the general increase in the cost of medical services;
• the emergence of alternative methods of treatment (but not cure) for the same disease, the choice of which must take into account not only their clinical effectiveness, but also cost;
• the existing gap in all countries between the possibilities of financing high-tech and expensive treatment methods and the pace of their creation.

Such an analysis makes it possible to assess the clinical effectiveness of treatment in terms of the cost of treatment for society, healthcare institutions, in the context of clinic departments and individual patients. The analysis focuses on solving the question of how much the desired treatment outcome costs the patient, the medical institution, and/or society. Methods for obtaining information for clinical and economic analysis: clinical studies, computer modeling, retrospective analysis of databases, or a combination thereof.

In our country there is an industry standard "Clinical and economic studies. General provisions" (OST 91500.14.0001-2002), approved. by order of the Ministry of Health of Russia dated May 27, 2002 No. 163.

A clinical-economic analysis evaluates an intervention or technology by comparing the effects of the following criteria:

1. Measured in natural units:
   • the frequency of deaths, life-threatening and disabling complications, the frequency of re-hospitalizations, etc.;
   • duration of treatment;
   • survival, mortality, etc.
2. Measured in conventional units of “utility”:
   • healthy year equivalents (HYEs),
   • years of regained ability to work (DALYs - disability adjusted life years),
   • returned years of full life (QULYs - quality adjusted life years), correlated with indicators in monetary terms.

In world practice, 5 main methods of clinical and economic analysis are used (Drummond M.E. et al, 1999, Gray J.A.M., 1977, Jefferson T. et al, 2000, Principles of Phamacoeconomics, 1996):

• Cost minimization analysis
• Analysis "cost (cost) - effectiveness"
• Analysis "cost (cost) - benefit (benefit)"
• Analysis "costs (value) - utility (utility)"
• Economic modeling methods - Markov model, decision tree

In Russia, there are four methods of clinical and economic analysis, the main of which is formally the “cost-effectiveness” analysis, in which cost and effectiveness are simultaneously analyzed. The remaining methods are its special cases.

1. Analysis "cost (cost) - effectiveness"(cost effectiveness analysis) - a type of economic analysis in which a comparative assessment of the costs of two or more interventions is made, the result of which is measured in the same units (years of life saved, survival rate, number of complications prevented, etc.).
2. Cost minimization analysis(cost miniminization analysis) is a type of economic analysis that compares the cost of two or more interventions that have an identical clinical outcome. These studies take into account all types of medical care associated with each treatment method and determine their costs. In medical socio-economic systems, this type of analysis is rarely used, since more often than not both types of treatment differ in both cost and clinical outcomes.
3. Analysis "cost (cost) - benefit (benefit)" cost benefit analysis is a type of economic analysis in which both costs and benefits are expressed in monetary terms, allowing the cost-effectiveness of different interventions to be compared with different outcomes. From the point of view of economic evaluation, this is the most accurate type of analysis. Unfortunately, it is not always possible to apply this type of analysis in medical systems.
4. Analysis "costs (value) - utility (utility)"(cost utility analysis) - a type of economic analysis in which the results of interventions are assessed in units of “utility”, of which quality-standardized life years are most often used.
   Utility - usefulness (preference) of the state. Broadly speaking, in economics, utility refers to the level of satisfaction an individual receives from a product or service once the characteristics of the product or service are defined. Utility in a narrow special meaning, considered in health economics, is a numerical value measured in a state of uncertainty and reflecting the degree of preference or desire of the patient to have a given health state or a given outcome (during the course of the disease).

Table 1 summarizes the features of all four methods of clinical and economic analysis.

Basic methods of clinical and economic analysis

In addition to the main ones, auxiliary methods of clinical and economic analysis are distinguished:

• Discounting- bringing future cash flows to the current period, taking into account changes in the value of money over time
• Cost of illness analysis(“all costs”) - is a basic economic assessment of the disease necessary for making management decisions on the allocation of health care resources, which calculates the total cost (the so-called “economic burden”) of a specific disease, taking into account various types of costs (medical and non-medical, direct , indirect).
• Sensitivity Analysis- analysis that allows us to determine to what extent the results obtained will change when the initial parameters change (for example, fluctuations in prices for drugs, changes in the frequency of side effects, etc.).

Methods such as ABC and VEN analysis are considered separately in foreign literature. In Russia, due to their widespread use in the formulary system, these methods are often indicated together with the main methods of clinical and economic analysis or pharmaco-epidemiological analysis.

Main stages of clinical and economic analysis

Using methods of clinical and economic analysis

Methods of clinical and economic analysis can be used to prepare information materials for choosing management decisions and funding priorities. However, the methodological complexity of this approach prevents its widespread use. Quite often there is simply no or little evidence to support such an analysis. In addition, information obtained on the basis of clinical and economic analysis does not fully describe the system of organization of medical care. Costs that arise outside the health care sector may not typically be included in clinical and economic analyzes but can have a significant impact on the social value of treatment.

For example, today a patient’s payment for travel from regions remote from a specialized clinic or co-payment for treatment (expensive imported consumables - stents, prostheses, pacemakers, medications, etc.) may exceed the cost of the operation itself. This reduces the burden on the healthcare budget and reduces the costs of the medical institution, but such a shift in costs turns out to be ineffective from a social point of view. Both on the part of patients and on the part of the development of domestic import-substituting technologies. The latter is of particular importance for the state, since money for paying for the treatment of Russian patients goes to the further development of foreign manufacturing companies. Consequently, factors such as access to expensive diagnostic equipment, existing principles and traditions of patient management can significantly influence the decision-making process regarding the choice of medical intervention.

In addition, the results obtained in the process of performing clinical and economic analysis based on data from different countries and different clinics may differ. The duration of hospitalization, the frequency of complications, medical infrastructure, and payment mechanisms for care can significantly influence the ratio of the cost of treatment by different methods and, therefore, lead to the formation of one or another clinical practice.

Table 2 clearly shows differences in the costs of treatment with the same method according to studies conducted in different clinics and different countries.

Table 2. Comparative cost of treatment of CABG and SCA (ART, ERACI-II, SoS)

In the Russian Federation, unlike European countries and the USA, the cost of coronary artery stenting even during the primary intervention is almost equal to the cost of CABG, despite the long duration of inpatient treatment for CABG (due to the disproportion in the cost of imported consumables and wages of medical personnel). Consequently, given the need for repeated revascularizations, stenting in current practice appears to be a cost-ineffective technology. Differences in the results of clinical and economic analyzes are one of the reasons why new technologies cannot be transferred from one country to another on the basis of publications alone, without assessing country or even regional acceptability.

With the rapid development of medical technologies, it has become clear that financial support for all medical developments is simply impossible. There is a need to conduct a serious assessment of the clinical, economic and social effectiveness of any technology before deciding on its future fate. The history of clinical and economic research begins in the 70s of the 20th century. Over the past 40 years, their importance has increased significantly and at the moment clinical and economic assessment is mandatory. In 1995, the non-profit International Society for Pharmacoeconomic Research (ISPOR) was organized with the main goal of ensuring the rational use of limited resources in health care. In the Russian Federation, by order of the Ministry of Health No. 163 dated May 27, 2002, the industry standard “Clinico-economic studies. General provisions” (OST 91500.14.0001-2002) was adopted, which sets out the methodology of such studies.

This standard identifies the following types of clinical and economic analysis:

• 1. cost-effectiveness analysis (CEA), which compares the clinical results and economic costs of two or more interventions,
• 2. cost minimization analysis (CMA) - a special case of cost-effectiveness analysis, when two or more interventions are evaluated, with the same effectiveness and safety, but different costs,
• 3. cost-utility analysis (CUA) - in which the results of the intervention are presented in units of "utility" for the consumer of medical care (the integral indicator "quality life years saved" - QALYs is often used),
• 4. Cost benefit analysis (CBA) assumes that the results of interventions should be presented in monetary terms.

Which analysis option is most appropriate for evaluating robot-assisted operations?

First of all, it is necessary to determine on the basis of what clinical data we will conduct the assessment. It all depends on the goals of the researcher and depending on them, it can be either retrospective data from one particular institution or the results of scientific studies (mainly RCTs, meta-analyses, systematic reviews). The first option is justified if the goal is to assess the clinical and economic efficiency of using the technology in a single organization. Based on the results of such a study, it is possible to make decisions on optimizing further work with this technology or even raise the question of the advisability of its further use in principle. Practical recommendations can also be developed for other organizations that are just starting to use the technology or are at the stage of making a decision about its implementation. A serious limitation of the use of retrospective clinical data from a single institution is the virtually obligatory presence of systematic error in their collection and analysis. The organizational features of a particular institution, the level of professionalism of the staff, differences in the interpretation of the same facts, the scrupulousness and honesty of researchers in collecting and analyzing clinical results - all this highly influences the final indicators. To make an objective decision at a higher level, state or regional, it is necessary to use data from RCTs, meta-analyses and systematic reviews. A big mistake could be accepting funding for a technology based on excellent results obtained in only one clinic, even a large and reputable one. In this situation, there is too high a risk that this technology will be deeply unprofitable in economic terms and ineffective in clinical terms.

An objective assessment of the clinical and economic effectiveness of RCC is completely impossible precisely due to the lack of a sufficient number of good quality clinical studies. Based on the data presented in the previous chapter, we can reliably judge only that if the indications for robot-assisted interventions are followed, their results are no worse than those obtained with other methods. The superiority of using RHC has not been proven.

In this regard, the most appropriate method for assessing economic efficiency is cost minimization analysis (CMA). However, to assess the effectiveness of using RHC in a particular institution, we have the right to conduct cost-effectiveness analysis and cost-utility analysis.

Regarding the cost-utility analysis, it is worth mentioning separately. The use of the QALY indicator for robotic surgery of the pancreas, liver, and spleen does not have serious limitations and therefore is not used in studies. The patient’s quality of life after removal of part of the pancreas or liver will depend to the greatest extent on factors unrelated to the operating technique. Thus, for the pancreas, the volume of resection and the initial state of the pancreatic parenchyma will be of key importance, an objective quantitative assessment of which is virtually impossible. Thus, it is not possible to conduct a cost-utility analysis for the robotic surgeries that are the subject of our study. For the evaluation of other robotic interventions, such as RA prostatectomy, this analysis can be very useful. For this procedure, there is low-grade evidence of better recovery of erectile function and a lower percentage of patients with urinary incontinence, which has a direct impact on quality of life.

To assess the clinical and economic effectiveness of RA operations in abdominal surgery, the “cost minimization” analysis is most suitable.

To assess the clinical and economic efficiency of operating a chemical treatment system in a single organization, it is possible to perform a cost-effectiveness analysis.