PHARMACOECONOMICS. Modern pharmacoeconomics and pharmacoepidemiology

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Vol 10, No 3 (2017)
View or download the full issue PDF (Russian)

Original Article

3-10 114

To date, several options for starting and intensifying insulin therapy in patients with type 2 diabetes mellitus (T2DM) have been proposed. Meta-analyzes of the recent results shows that, with adequate use, all these regimens have the similar efficacy and safety; therefore, when choosing a therapeutic approach, the patient’s requirements and preferences become highly significant. The aim of this study was to assess how changes in the current practice of insulin therapy in patients with T2DM can impact the federal healthcare budget. Materials and Methods. Based on the results of the DURABLE clinical trial, we created a “decision tree” model that allowed us to calculate the costs of 48-week insulin therapy in 1000 T2DM patients who had never received insulin before that trial. The cases selected for modeling included patients on one of two starting regimens – basal insulin (glargine) or a ready-made mixture (biphasic lispro 25). After 24 weeks, upon achieving or not achieving the target HbA1c values, a decision was made whether to intensify the therapy by using the basal bolus therapy (glargine and lispro) or the ready-made mixtures (biphasic 25 or 50 lispro). The weighted average price of 1 IU insulin (according to public procurement data) was used for calculations. Results. Within the current practice of prescribing ready-made mixtures at the start and the intensification rate of 20%, the annual cost of purchasing insulin for the model population of 1,000 patients was 22.5 million rubles. If the use of ready-made mixtures increased to 35% at initiation and to 50% with intensification, the costs would be reduced by by 1.9 million rubles. In the cases when only basal insulin was prescribed for the start, the annual costs amounted to 23.8 million rubles (if only 20% of patients received a ready-made mixture with intensification) and to 22.8 million (if 50% of patients received a ready-made mixture with intensification). Conclusion. As a result of this analysis, an increase in the number of patients who use a ready-made mixture for the initiation or intensification of insulin therapy can lead to reducing the budget costs for purchasing insulin analogues for patients with type 2 diabetes mellitus.

12-21 205

Recently, an increase in the incidence of severe forms of prostate cancer, in particular castration-resistant prostate cancer (CRPC) has been noticed. Treatment of CRPC patients is associated with increasing expenses and thus impacts the healthcare budgets at various levels. The aim was to study the pharmacoeconomic aspects of using enzalutamide, cabazitaxel and abiraterone for the second-line therapy of CRPC (after treatment with docetaxel) in the Russian Federation. Materials and Methods. A cost effectiveness analysis of patient management was conducted for each of the three drugs. The direct costs included the costs of visiting the doctor, the diagnostic tests and procedures, the best supportive therapy with other drugs in accordance with the standards, the treatment of adverse events, the end-of-life palliative therapy in hospital, and the costs of prescribing one of the three drugs in question. Results. The expenses for diagnosing, maintaining the treatment regimen, consulting, monitoring and nurse caring in patients with CRPC were 15-20% lower with enzalutamide compared to abiraterone and two-fold lower than that with cabazitaxel. The general assessment of direct costs without the cost of the above drugs showed that the use of enzalutamide was 10% less expensive than abiraterone and 35% less expensive than cabazitaxel. The pharmacoeconomic advantages of enzalutamide over the two other agents are supported by the «decision tree» model and by the cost/effectiveness ratio. Conclusion. The use of enzalutamide is associated with lower direct costs of care, treatment, diagnostic and supportive procedures as compared with abiraterone and cabazitaxel. 

22-27 86

Multiple sclerosis (MS) remains one of the most expensive diseases in the Russian healthcare system due to its early onset, increasing life expectancy of the patients, and the use of costly diagnostic methods and medical treatment. According to experts, even a slight reduction in direct (medical) expenses leads to a sharp increase in indirect costs; this situation necessitates an updated assessment of the number of MS patients, the degree of their disability, and the epidemiological dynamics of the disease. The aim of the study was to assess the economic damage associated with MS using the clinical, epidemiological, medical, and social data available for the city of Ufa. Materials and Methods. Direct medical expenses (outpatient care, visits to specialists, inpatient care, medications for outpatients), direct non-medical costs (temporary disability benefits, disability pensions, social services) were analyzed as well as the losses in the regional gross domestic product (GDP) due to temporary or permanent disability and premature mortality (indirect costs). Results. Because of MS only in the city Ufa, the Russian economy loses 428,222,026.35 rubles per year, mostly due to direct medical costs; of those, almost 50% is spent for immunomodulatory therapy (202,787,862.81 rubles). Annually, 4 596 245.76 rubles are spent for the hospital 24-hour treatment of MS patients, 916,154.28 rubles – for the daycare treatment, and 505,914.56 rubles – for outpatient care. Economic losses from premature death of MS patients in Ufa amounted to 21,570,999.52 rubles per year, and the lost GDP profit was estimated at 328,783,783 rubles. Conclusion. MS remains the leader of high-cost diseases and requires significant expenses from the state-run healthcare system in the Russian Federation. Epidemiological and pharmacoeconomic studies can help planning and modernizing the medical care for patients with multiple sclerosis. 

28-33 134

Aims. To analyze the costs of pharmacotherapy in children hospitalized with bronchial asthma exacerbations. Materials and methods. The data from 336 medical reports were used. In this study, patients with severe bronchial asthma were analyzed separately from those with moderate asthma. The economic analysis of pharmacotherapy was carried out in accordance with the ABC guidelines for an international non-proprietary name. In relation to the field of medicinal use, the analyzed drugs were distributed into three classes (A, B and C) according to the selected criteria. In the present study, the selection criterion was the amount of expenses needed to purchase the given medicine. Results. The ABCanalysis showed that about 80% of the amounts spent for the treatment of moderately severe asthma were due to the costs of medications. Among them, Montelukast – 31.27%; Budesonide – 28,49%; Umifenovir – 5.69%; Azithromycin – 5.50%; Salmeterol / fluticasone propionate – 4.74%; Formoterol / budesonide – 3.32%; Ipratropium bromide / fenoterol hydrobromide acetylcysteine – 3.20%; (In total, the percentage amounts to 82.15%). In the treatment of severe asthma, the same 80% of the costs consisted of: Montelukast – 28.13%; Salmeterol / fluticasone propionate – 25.54%; Formoterol / budesonide – 13.51%; Acetylcysteine 6.64%; Budesonide – 5.67% (in total, the percentage amounts to 79.48%). In moderately severe asthma, the largest part of the costs is due to inhaled glucocorticosteroids – budesonide (28.42%), while in severe cases, it is due to combined salmeterol / fluticasone propionate (25.54%) and formoterol / budesonide (13.51%). In the treatment of asthma of moderate severity, a certain part of segment A is taken by macrolide antibiotics of the azithromycin group (they account for 5.50% of the total costs) and antiviral drugs – umifenovir (5.59%). The introduction of antibiotics and anti-viral drugs is rationalized by asthma exacerbations developing on the background of viral and / or bacterial, often “atypical” infections. Conclusion. This pharmacoepidemiological analysis shows that the costs of treatment with Montelukast of moderate (31.27%) and severe (28.13%) bronchial asthma are comparable. For other drugs, the treatment costs significantly differ between the moderate and severe asthma therapies. 

34-46 109
The report reviews the options of drug supply for patients with chronic hepatitis C in the Russian Federation and elsewhere. The results of the Moscow regional program aimed at improving the quality of medical care in such patients are discussed. The proposed measures contribute to the reduced mortality rate in patients suffering from infections. The prospects of further improvements in the availability of antiviral medications for patients with chronic viral hepatitis C are outlined. 

Review articles

47-58 137

The process of decision modelling in diabetes mellitus (DM) is often complicated by comorbidity among diabetic patients, complexity of endpoint selection, and unclear time horizons. Aim. To review the available recommendations, relevant methods and mathematical approaches to decision modelling in DM. Materials and Methods. We searched through the PubMed database using the ResearchGate and Mendeley networks; we also collected data from the websites of the key opinion leaders in the field of pharmacoeconomics and decision modelling. Results. This review contains up-to-date information on the validity of the most common DM decision models and on the validity of extrapolating the type 2 DM models to patients with type 1 DM. We also provide some clinically relevant comments on the American Diabetes Association’s requirements concerning the decision models in DM. The review incorporates data on the current mathematical approaches to modelling the changes in glycated hemoglobin levels, the body mass index and the quality-adjusted life expectancy – for both type 1 and type 2 DM. Conclusion. Despite recent successes in DM decision modelling, the existing approaches are not always relevant to some groups of DM patients or to some aspects of the disease. Thus, the use of the novel anti-diabetic drugs (liraglutide, semaglutide, empagliflozin) capable of significantly reducing cardiovascular risks in DM patients, require new approaches to decision modelling in diabetes mellitus. 

59-65 98

The article reviews national and international publications on various issues of the free healthcare system. We present and discuss recommendations of the UN, the World Health Organization and the International Labor Organization on full coverage of the population with free medical care. 

Foreign Experience

66-74 127

A set of criteria for assessing the innovative potential of drugs (therapeutic value) have been developed and are widely used elsewhere. These approaches allow the state (the payer) to assess the clinical significance of a new medical product and make an educated decision on the reimbursement, cost and priority at the stage of registration. In the Russian Federation though, such criteria and methods are not sufficiently developed. This review describes the principle approaches to assessing the drug innovative potential in countries outside Russia. 

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