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FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology

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Vol 15, No 2 (2022)

ORIGINAL ARTICLES 

175-186 152
Abstract

Objective: evaluation of the pharmacoeconomic feasibility of using benralizumab in the form of autoinjector (pen-injector device) in outpatient facilities compared with its use in the form of a syringe in hospital settings for the treatment of severe asthma (SA).

Material and methods. The cost minimization and budget impact analysis methods were used. The current practice of treating patients with SA with benralizumab in hospital settings at the expense of compulsory medical insurance funds was compared with the simulated practice. The simulated price was calculated as half patients receiving benralizumab in the hospital transferred to outpatient facilities at the expense of regional funds for 3 years. Direct medical costs included drug cost and outpatient patient monitoring services cost.

Results. The direct medical costs associated with benralizumab therapy in outpatient facilities were lower than the costs required for benralizumab therapy in the hospital settings and amounted to 0.99 million rubles versus 1.17 million rubles per one patient per year, respectively. Thus, the use of benralizumab in outpatient facilities leads to savings of 185 thousand rubles (16%). In 2021, 93 patients were prescribed benralizumab in hospital settings. The expansion of the application of benralizumab use in outpatient facilities will lead to a reduction in medical costs in the first year of therapy (when switching 16.7% of patients) by 5.9 million rubles (4,9%). The consistent expansion of the practice of benralizumab use in outpatient facilities over a 3-year horizon (when switching 50% of patients) will lead to a reduction in medical costs by 46.6 million rubles (12.1%).

Conclusion. Expansion of benralizumab use in outpatient facilities with a new form of autoinjector (pen-injector device) will lead to savings in medical costs and reduce the burden on the health care system, thus it is economically feasible.

188-198 155
Abstract

Objective: to evaluate the pharmacoeconomic effectiveness of the use of a fixed double combination of tiotropium bromide + olodаterol in order to treat chronic obstructive pulmonary disease (COPD) in comparison with less expensive monotherapy with long-acting beta-2-agonists (LABA) or long-acting anticholinergics (LAAC) with its insufficient effectiveness.

Material and methods. The analysis of the impact on the health care system budget of the use of a fixed double chemical combination was carried out. The combination used was the one of tiotropium bromide + olodаterol in patients suffering from COPD who do not achieve effective disease control during LABA or LAAC monotherapy. We used published data on the distribution of patients into groups according to the classification of the Global Initiative for Chronic Obstructive Lung Disease (GOLD), also according to the therapy used and the frequency of exacerbations with hospitalization, obtained in a Russian epidemiological study. Direct and indirect costs associated with basic therapy and treatment of exacerbations requiring hospitalization were estimated as well.

Results. Previously, it was shown that about 21.8% of patients with GOLD D severity of COPD receive therapy of insufficient efficacy (LABA monotherapy or long-acting M-cholinolytics). The use of a fixed combination of tiotropium bromide + olodaterol in such patients instead of monotherapy will reduce the direct costs of hospitalization by 21.1%, and the total costs (direct and indirect) – by 4.6%. On the scale of the Russian Federation, this will save 17.2 billion rubles a year.

Conclusion. The results obtained showed that, despite the reasonably high cost of a fixed double combination in comparison with monopreparations, the use of double bronchodilating therapy allows to achieve more effective treatment and reduces both direct medical costs associated with hospitalization of patients with exacerbations of COPD, and direct non-medical and indirect costs associated with absenteeism of patients to work due to temporary disability as a result of hospitalization.

199-208 124
Abstract

Background. The cost-of-illness (COI) analysis allows to estimate and plan costs for calculations between the subjects of the health care system and medical insurance organizations. The primary morbidity of the population with diseases of the circulatory system increased from 4,784 thousand people in 2018 to 5,136 thousand in 2019. A growth in the number of cases resulted in an increase in the demand for drugs for the treatment of cardiovascular diseases.

Objective: to perform a pharmacoeconomic study of the treatment of arterial hypertension in children and adolescents by COI-analysis.

Material and methods. The source of information for COI-analysis was the real clinical practice – medical records of sick children and adolescents. A pharmacoeconomic study using COI-analysis was carried out at the inpatient and outpatient stages of care and included the calculation of direct medical costs (the costs of laboratory, instrumental medical services, non-drug and drug antihypertensive therapy). The study included 102 children diagnosed with arterial hypertension. The average stay of patients in the hospital was 10 (10.4±0.35) bed-days and treatment on an outpatient basis varied from 3 months to 1 year.

Results. The leading place in the structure of costs for antihypertensive therapy is occupied by the beta-blockers pharmacological group (35%). The total cost of arterial hypertension in children and adolescents in inpatient and outpatient settings was 4,459.00 and 29,638.90 rubles, respectively.

Conclusion. The COI-analysis of arterial hypertension confirms the need for timely diagnosis and treatment and preventive measures for high blood pressure in children and adolescents to reduce the development of risk factors for such serious cardiovascular complications as stroke and myocardial infarction in adulthood, the treatment of which requires large cash costs.

209-220 140
Abstract

Background. One of the priorities of health care is the balance between the financial resources and the availability of effective medical care. The current approach of access to cancer medicines limits the timeliness and availability of treatment. At the same time, financial support from the government provides great costs on cancer drugs. However, these great costs are not rational.

Objective: to assess the financing needs of the complete transfer of financial support of medical care in the field of oncology to the Compulsory Health Insurance (CHI) system by means of optimizing the functions of the day hospital.

Material and methods. The achievement of the goal is planned to be reached by eliminating the unusual functions of oncological day hospital. We analyzed the regulatory legal documents regulating drug care and drug provision in the Russian Federation, data from depersonalized (anonymized) registers of the structure of hospitalizations in a day hospital for 2021. The methods of expert assessments, mathematical modeling, as well as literature data analysis were used. The study developed a model for assessing the need to finance the full transfer of medicine provision to the CHI system, including taking into account the hidden deficit.

Results. The total amount of funds released from the reduction of irrational hospitalizations in day hospital conditions amounted to 2.08% of the funding level of the analyzed schemes. Taking into account the data of hospitalizations in oncological day hospital for 2021, the number of irrational hospitalizations in case of transfer of selected schemes to the outpatient stage will decrease by 16.1%. The transfer of all the medicine therapy to financing from the CHI funds will require significant additional budget expenditures in the amount of 62.5 billion rubles or 2.65% of the total costs of the State Guarantees Program for Provision of Free Medical Care to Citizens.

Conclusion. Despite the rationality of the proposed changes in the field of improving access to medicine provision concerning cancer drugs and the identified justifications for changing the distribution of financial resources within the State Guarantees Program, there are difficulties. In order to solve this problem, a coordinated consideration of potential strategies to address the access to cancer medicines is needed.

221-229 138
Abstract

Background. Omega-3 polyunsaturated fatty acids (ω-3 PUFAs) are widely used in modern cardiology. The anti-inflammatory effect of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) is realized, in particular, by modulating the activity of the arachidonic acid (ARA) cascade.

Objective: to conduct biophysical analysis of the interactions of various forms of PUFAs (ARA, EPA, DHA, EPA and DHA ethyl esters) with three target proteins-enzymes of the ARA cascade (cyclooxygenase-1 (COX-1), COX-2, 5-lipoxygenase (5-LPOG)).

Material and methods. The minimization of the energy of the ligand-receptor complexes at various initial positions of the molecule relative to the receptor pocket and the molecular energy profiles of the protein (the energy of side chain transfer from solvent to protein) were calculated using the ECMMS package.

Results. EPA and DHA ethyl esters were characterized by significantly higher absolute values of specific binding energies of target proteins than ARA or simply EPA/DHA. For example, in the case of COX-2, EPA, DHA and EPA ethyl ester had similar ∆∆G values (–3.0...–3.1 kcal/mol), while the COX-2 complex with DHA ethyl ester was somewhat more stable (∆∆G = –3.4 kcal/mol). In the case of the 5-LPOG enzyme, the complex with EPA ethyl ester was the most stable (∆∆G = –1.62 kcal/mol). Higher absolute binding energies indicate a higher affinity of EPA and DHA ethyl esters to enzymes of the ARA cascade.

Conclusion. The results suggest that the high affinity of EPA and DHA ethyl esters to the enzymes of the ARA cascade is one of the molecular bases of therapeutic efficacy of ω-3 PUFAs with high degree of standardization.

230-236 109
Abstract

Objective: development and validation of a reverse transcription polymerase chain reaction (RT-PCR) test kit for SARS-CoV-2 ribonucleic acids (RNA) qualitative detection adapted for using with automated station for RNA extraction.

Material and methods. Assessment of clinical performance was carried out on biological samples (nasal and oropharyngeal swabs and sputum) obtained during the diagnostic procedure. The presence of novel coronavirus RNA was established using a reference kit. Sensitivity was evaluated on standard SARS-CoV-2 sample (EDX SARS-CoV-2 Standard, Bio-Rad Laboratories, USA).

Results. Presence of SARS-CoV-2 RNA is detected by two genome regions. Sensitivity determined by testing SARS-CoV-2 standard was 250 copies/ml. Coefficient of variation during the testing of samples with the concentration of 104 copies/ml did not exceed 5% in different conditions. Diagnostic sensitivity against reference test was 100% (95% confidence interval (CI) 95.6–100) for nasal and oropharyngeal swabs and 100% (95% CI 94.8–100) for sputum. Diagnostic specificity was 100% (95% CI 95.6–100) for nasal and oropharyngeal swabs and 100% (95% CI 94.8–100) for sputum. The turnaround time for test from RNA extraction till obtaining results was about 3 hours when testing 96 samples using automated stations for RNA extraction.

Conclusion. Using the kit together with automated station for RNA extraction will increase laboratory testing capacity in pandemic conditions.

237-249 117
Abstract

Objective: to evaluate the effectiveness of changes in the legal framework that regulates medical rehabilitation (MR) in the Russian Federation.

Material and methods. We analyzed the valid Order of the Ministry of Health of the Russian Federation of June 31, 2020 No. 788n “Organization of medical rehabilitation of adults”, which came into legal power on January 1, 2021. It was proposed for public discussion on the introduction of amendments (project of amendments). The changes proposed in the project were compared with the original text of the document. Besides, other legal documents on the organization of medical rehabilitation were analyzed.

Results. Order No. 788n regulates the stages of MR, specifies the formation and realization of an individual plan for a multi-disciplinary rehabilitation team based on the evaluation by Rehabilitation Routing Scale. The document includes in-house protocols of profile inpatient and outpatient departments of medical institutions, standards for doctor’s offices equipment, organization of day-time inpatient department, and regulations for MR centers. The project of amendments contains a variant of involvement of the existing additional Groups 1 and 2 medical divisions for the organization of MR, and limitation for the Stage 2 of MR in inpatient settings, which is now possible only for patients who need 24-hour care.

Conclusion. The proposed changes have evolutionary character. A lot of issues in the regulatory framework of MR remain unsolved. It is necessary to improve the state policy for MR and perform further clinical studies of its benefits.

250-258 106
Abstract

Objective: implementation of value-based approach and development of adherence to treatment in patients with non-melanoma cancer.

Material and methods. The observational, single-arm, prospective, long-term single-center study of the quality of life and patients’ experience was performed. It included 42 patients aged from 42 to 82 years. Validated questionnaires were used: Patient-Reported Outcome Measures (PROMs) (as a decision support tool), Patient-Reported Experience Measures (PREMs) (3 months after treatment to assess the patient's experience).

Results. Mean concern about appearance was 43.5 points (Rasch psychometric model). Younger patients (r=–0.398, p=0.009) and female patients (r=–0.475, p=0.001) were more concerned about appearance. In 10 cases (24%), the involvement was estimated as 4 points, in 18 cases (43%), it was 3 points, in 14 cases (33%), it was 2 points. Older patients were less involved in the choice of treatment method (r=–0633, p<0.001). The level of satisfaction with communications was more than 50 points. The use of a patient-oriented algorithm of communication has a positive effect on a patient's experience.

Conclusion. The heads of oncological care are recommended to evaluate the patient's experience on a regular basis, create conditions for patients to choose treatment methods according to their individual needs, analyze the outcomes obtained by the introduction of validated questionnaires on the appropriate nosological profile and take these results into account in treatment. Further studies of the degree of influence of different factors on a patient’s choice of treatment method are needed, as well as conducting studies among other groups of patients with non-melanoma skin cancer (located in other parts of the body, larger than 2 cm).

259-266 124
Abstract

Objective: to identify factors and barriers for the development of medical services export (MSE) in the Russian Federation (RF), to establish recommendations for its stimulation, and to promote Russia as an exporter of medical services in the international arena.

Material and methods. An analysis of the practice of MSE organizing and regulatory documents of 2018–2021 was carried out, as well as the quantitative sociological survey of 184 doctors, healthcare managers and experts and the in-depth semi-structured interviews with 8 high-level healthcare experts conducted in 2020. The survey was performed using the “snowball” method. To increase the level of representativeness of the survey results, doctors, organizers and healthcare experts with current work experience in organizations and government bodies in the healthcare sector (Ministry of Health of the RF, Roszdravnadzor, Central Research Institute of Organization and Informatization of Public Health, etc.) were involved as respondents including practicing physicians and heads of medical organizations.

Results. The aim of MSE state regulation and stimulation is to choose the optimal model for supporting inbound medical tourism (IMT) in the RF. At the moment, three models of supporting foreign citizens in the medical services market are developing: 1) creating expert medical consortia of leading medical clinics; 2) forming an infrastructure for agency support in the Russian IMT market, including the development of infrastructure in regional IMT markets with high, medium and low export potential; 3) paid medical services in all types of medical care are successfully provided in public and private clinics to foreign citizens who live, work or study in the RF on a permanent or temporary basis. The third model is а self-organizing patient flow of foreign citizens, uncontrolled by Russian medical organizations.

Conclusion. The main strategic directions of MSE development for the growth of an organized and controlled patient flow in the RF are medical care services in the field of neurosciences, high-tech surgery and rehabilitation, reproductive medicine, immunotherapy of oncological diseases, and cross-border diagnostic services. It is necessary to take certain measures to stimulate MSE, including the introduction of international standards for the safety and quality of medical care, increasing the service component of the provision of medical services, building channels of marketing communications with foreign patients and the promotion of Russia as an exporter of medical services in the international arena.

267-283 162
Abstract

Objective: to assess the current state of the veterinary medical product market in the Tyumen Region.

Material and methods. The objects of the study included data from the State Register of Medicinal Products for Veterinary Use for 2019–2022; veterinary pharmacy organizations and veterinary clinics in the Tyumen Region (33); price lists of veterinary pharmaceutical organizations; questionnaires of veterinary specialists (69) and consumers of medicinal products for veterinary use (93).

Results. An analysis of the Register of Medicinal Products for Veterinary Use registered in the Russian Federation revealed a positive trend in the registration of new positions: with 2190 registered drugs about 300 more positions are registered annually. It was determined that the ratio of veterinary drugs of various pharmacotherapeutic groups is critically uneven (31.05% – antibacterial agents; 28% – immunobiological drugs; 0.46% – cardiovascular drugs; 0.14% – antitumor drugs). The study of the wholesale segment of the veterinary drugs market on the territory of the Tyumen Region showed that the range of wholesale trade organizations in veterinary drugs mainly consists of products for animals (at the largest one veterinary drugs account for only 16%). As a result, low indicators of the assortment are observed (breadth and completeness coefficients for pharmacotherapeutic groups), and there are problems with the availability of veterinary drugs. The analysis of the assortment of veterinary pharmaceutical organizations and clinics (retail segment of the market) revealed low breadth coefficients for medicinal products for veterinary use (median 0.09). A sociological survey showed a low level of awareness of all veterinary drugs consumer groups about the scope of their circulation.

Conclusion. The study of the current state of the veterinary medicinal product market in the Tyumen Region identified the problems of their availability both in the wholesale and retail segments, which need to be addressed with the help of state regulation (including the introduction of a minimum range of drugs for veterinary use) and normalization of the assortment policy at the level of veterinary pharmacies and clinics. Because of the lack of registration for some drugs necessary for the treatment of animals, veterinarians are forced to put into practice drugs for medical use, deliberately violating the law. Given the experience of many foreign countries, we consider it expedient to allow the use (in special cases) of medical drugs in veterinary medicine. This will solve the problem of pharmacotherapy availability and allow veterinarians to provide better care to animals.

REVIEW ARTICLES 

284-293 92
Abstract

Insomnia is the most common form of sleep disturbance in childhood. Sleep disorders and a decrease in its duration and quality lead to the development of cognitive disorders, change emotional and behavioral functions of the developing organism, and negatively affect medical and psychological aspects that require medical correction. The article provides an overview of current literature data on pharmacological approaches to insomnia therapy in childhood. The general principles of treatment and the use of various pharmacological groups of drugs are discussed. It is shown that pharmacotherapy of childhood insomnia should be carried out based on knowledge about the age characteristics of patients, efficacy, safety, analysis of pharmacodynamic and pharmacokinetic parameters of the drugs used. Drug therapy should be combined with cognitive behavioral techniques, including adherence to sleep patterns and hygiene.

294-303 100
Abstract

The influence of epigenetic processes on the development of malignant diseases, including gynaecological cancers, is now beyond doubt. DNA methylation, histone modification and post-transcriptional regulation by microRNAs lead to changes in the activity of various genes, contributing to female genital cancers (cervix, endometrium, ovarian). It should be noted that disruptions in gene expression do not only occur in malignant cells, but also in the tumour microenvironment, resulting in disease progression and relapse. However, “epigenetic markers” of carcinogenesis can be useful in the treatment and rehabilitation of patients, making a personalized approach possible.



ISSN 2070-4909 (Print)
ISSN 2070-4933 (Online)