Pharmacoeconomics: theory and practice
The article aims to review issues of choice of drugs clinical effectiveness evaluation during pharmacoeconomic studies. It also includes effectiveness criteria classification in pharmacoeconomics. Special attention is paid to the description of the effectiveness criteria using both duration and quality of life: description of their methodological basis, advantages and limitations. The authors provide recommendations for the choice of effectiveness criteria, depending on pharmacoeconomic analysis method; the target audience for results of pharmacoeconomic analysis, and the characteristics of nosology.
This article focuses on pharmacoeconomical analysis of effectiveness in the treatment of arterial hypertension(AH). This article describes the main stage of the effectiveness analysis which is information research, and the criteria for including publications in effectiveness analysis. The articles includes the rationale for using the effectiveness endpoints for this nosology, and the use of questionnaires for effectiveness analysis.
The most dangerous consequences of the global diabetes epidemic are diabetes-related complications. A wide variety of treatment options is currently available for patients with type 2 diabetes mellitus. However, the existing treatments have proven effective for no more than half of diabetic patients who managed to compensate the occurring complications, which is the reason for introducing novel glucose-lowering medicines into practice. Sodium-glucose cotransporter 2 (SGLT2) inhibitors are a new class of innovative medicines. Dapagliflozin was the first medicine in this group to be registered on the territory of Russia. Numerous trials have confirmed the efficacy of dapagliflozin at any stage of type 2 diabetes mellitus, both as monotherapy and in combination with metformin, sulfonylureas, dipeptidyl peptidase 4 inhibitors (iDPP-4) and insulin. Thus, the wide range of available glucose-lowering drugs, lack of adequate control over the disease and introduction of novel medicines warrant a new pharmacoeconomic study. The purpose of this study was to perform a pharmacoeconomic evaluation of dapagliflozin as a preferential medicine used to treat patients with type 2 diabetes mellitus, as compared to monotherapy or combined use of medicines of the sulfonylureas, metformin, glyptins, glyflozins and insulin group, by means of a cost analysis, and cost-effectiveness and budget impact analysis. Based on the results of the cost-effectiveness analysis, the dapagliflozin treatment scheme was reported to have the lowest cost of type 2 diabetes therapy to quality adjusted life-year (QALY) ratio compared to therapy regimens involving metformin, sulfonylureas, iDPP-4, basal and bolus insulins. The budget impact analysis demonstrated that treatment using Forxiga would result in budget savings of 31 million rubles over five years, if 1000 patients were to hypothetically switch over from other treatment regimens.
Pharmacoeconomic analysis of continuation of use of symbicort® turbuhaler® as the sole inhaler for bronchial asthma therapy
Control of bronchial asthma (BA) is a key principle of disease treatment. One of the factors resulting in uncontrolled BA is incorrect use of an inhalation device and, as a consequence, low adherence to therapy. According to research data, up to 94% of patients, depending on the type of delivery system, make mistakes during application, resulting in inconsistent dosage and reduced efficacy. These factors may contribute toward an increase in costs of the healthcare system and decrease in the quality of life of patients. For example, an unapproved change of the inhaler may lead to reduced BA control and, as a result, growing expenses for medical services despite lower initial costs of pharmacotherapy. Availability of a wide range of medications and devices for delivering them, as well as limited financial resources of the healthcare system inspired a pharmacoeconomic assessment of various schemes of BA therapy. According to the cost analysis results, the provided amounts of direct and indirect costs for one-year therapy with Symbicort® Turbuhaler® as the sole inhaler is on average 4.5% lower than the costs of treatment with DuoResp Spiromax®, Formisonid-Nativ®, Foradil Combi®, Foster®, Seretide® and Seretide® Multidisk®. A budget impact analysis demonstrated that switching of patients from therapy with budesonis/formoterol Turbuhaler® as the sole inhaler to therapy with DuoResp Spiromax®, Formisonid-Nativ®, Foradil Combi®, Foster®, Seretide® and Seretide® Multidisk® entails additional average budget expenditures of RUB 4 mln per annum due to increased hospitalization frequency per 106 cases, more frequent calls for ambulance per 364 cases, more frequent visits to outpatient settings and polyclinics per 180 cases, as well as more days of temporary disability per 1 862 days - every figure given per 1,000 patients with BA. It is, therefore, clinically and economically reasonable that patients initially receiving Symbicort® Turbuhaler® as a support maintenance therapy to continue therapy using the same medication.
The correct treatment of bronchial asthma is a difficult task not only for patients and healthcare professionals but for healthcare authorities as well. The economic burden of the disease is equal to the burden of diabetes mellitus and arterial hypertension. Nearly all indirect costs and not less than a third of direct costs of the treatment of the disease are related to management of exacerbations and poor asthma control. In recent years, there has been a considerable improvement in the treatment of asthma associated with emergence of new medicinal products and delivery devices. Unfortunately, not every patient is able to achieve the optimal disease management level. For this reason, technologies for creation of an effective treatment method for bronchial asthma are undergoing continual improvement nowadays. One of the solutions in this field was the development of inhaler devices producing extrafine aerosol with particle diameter under 2 µm. Such aerosols make it possible for inhalation medicines to reach the small airways, which are the principal site of inflammation in a number of bronchial asthma phenotypes (including bronchial asthma in smokers). The objective of this study was to determine the advantageous medicinal product for bronchial asthma using pharmacoeconomic analysis, on the basis of comparison between costs and effectiveness, safety, and quality of life in treatment with fixed combinations of inhaled glucocorticosteroids and long-acting β2agonists: medicinal products (MP) Foster®, Symbicort® Turbuhaler®, Seretide®, and Seretide® Multidisk. According to the results of the cost-utility analysis, it was determined that the therapy with Foster® is dominant and characterized by the lowest costs with reference to QALY compared to Symbicort® Turbuhaler® and is cost-effective compared to Seretide® and Seretide® Multidisk, on the basis of the obtained values of the incremental cost-utility analysis, which are significantly lower than the willingness-to-pay threshold in the Russian Federation. The budget impact analysis demonstrated that using Foster® for therapy results in budget savings compared to Symbicort® Turbuhaler®, Seretide®, and Seretide® Multidisk when transferring an additional number of patients (21 %) to Foster®.
Validation of the “budget impact analysis” model of the introduction of dolutegravir drug into the public procurement of antiretroviral drugs in the Russian Federation
The article demonstrates validation results of the “budget impact” model of introduction of the drug dolutegravir into the public procurement of antiretroviral drugs on the territory of the Russian Federation provided by ViiV Healthcare.
Pharmacoeconomic analysis of immunoglobulin medicinal products efficacy for intravenous infusion in treatment of primary immunodeficiencies with antibody formation defects in the Sverdlovsk region health care system
This work included a pharmaeconomic study of the efficacy of treatment of primary immunodeficiencies (PID) with antibody formation defects using normal human immunoglobulin medicinal products for intravenous administration in the Sverdlovsk Region health care system. Four treatment regimens were compared: 10% intravenous immunoglobulin (IVIG) Privigen and 5% IVIGs Octagam, Intratect, I.G.Vena. It appeared that, from the pharmacoeconomic analysis point of view, the use of 10% normal human immunoglobulin for intravenous administration, Privigen, is the most cost-effective regimen (per patient) of primary immunodeficiency therapy among the pediatric (n=9) and adult (n=20) populations of PID patients with impaired antibody formation in the Sverdlovsk Region. In per annum terms, one pediatric patient switched to Privigen from Octagam saves 65 605 roubles; from Intratect, 183 625 roubles; from I.G.Vena, 68 949 roubles. Over the same period, one adult patient switched to Privigen from Octagam saves 170 870 roubles; from Intratect, 459 911 roubles; from I.G.Vena, 68 958 roubles. The budget impact analysis, within the Sverdlovsk Region health care system, showed that a 70% increase in Privigen procurement due to 70% reduction in Intratect procurement for PID patients helps save a total of 6 076 471 roubles per year. The lost opportunity analysis showed that the 70% increase in Privigen purchases would have provided additional funding for treatment of 11 pediatric or 3 adult PID patients with antibody formation defects.