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FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology

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Vol 7, No 3 (2014)
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Methodology

3-11 984
Abstract

the concept of the relations between public health and national economy has appeared long time ago, but the development of quantitative methods started only in the middle of the XXth century. Until now there are no uninamioulsly accepted methods and approaches for this type of research. The cost of illness method (assessment of social and economic burden of disease) is one of the most widely used. Our objective was to analyze the methodologic characteristics of researches on the cost of illness in Russia for the development of the standard methodology on evaluation of the social and economic burden related to cancers to be used further for the health technology assessment. Materials and methods. Based on the results of studying foreign and national guidelines and publications devoted to the methodological issues of the cost of illness methods, we worked out the criteria list for analysis of the methodological characteristics of this type of research. Further the developed criteria list was used to study the publications on the results of cost of illness studies in Russia. Results. In total we have analyzed 6 publications on cost of illness related to cancers and 10 publications on assessement of burden related to other diseases. The analysis was considerably hampered by the insufficient description of used methods in the majority of publications. Nethertheless we have discovered major discrepancies in the choice of methods and approaches to the assessment of the disease burden, which makes impossible comparison or use of their results for the health technology assessment. Conclusions. The undertaken analysis highlightened the need for development of standardised methods as well as standardised reporting, which would allow use of research results for health technology assessment and decision making on the financing and health care management. 

Russian Studies

12-19 369
Abstract

weakening of immune status under the influence of some diseases or types of treatment could result in the activation of the present latent tuberculosis infection (LTBI). Recently it was suggested to use the immunoenzymometric interferon-gamma tests, T-SPOT.TB among them, but their costs are substantially higher than cost of the traditionally used tuberculin skin test (TST), thus the need for efficiency assessment arises. The aim of the study was to evaluate the cl inical and economic outcomes of testing
for LTBI with T-SPOT.TB in immunocompromised children. Methods: we develope d a model, forecasting the testing results, probable cases of tuberculosis activation and related costs for scenarios with alternative use of T-SPOT.TB and TST for diagnosing LTBI in immunocompromised children. Parameters for mo deling were derived from published data on sensitivity and specificity of tests and prevalence of LTBI in Russia. Costs were estimated from the position of overall government budget and included costs of
prim ary LTBI testing, additional testing to exclude active tuberculosis in case of positive result, preventive chemotherapy and costs of treatment for cases of tuberculosis activation. Results: there would be 20 tr ue positive and 80 true negative tests in the cohort of 100 patients if the test's sensivity and specificity were 100% and prevalence of LTBI was 20%. When testing with TST 100 immunocompromised children we expected that there would be 40 positi ve tests (among them 7 true positive, meaning that only 7 out of
20 children with LTBI would be found in the developed model), and 3 cases of tuberculosis activation. When using T-SPOT.TB in the same cohort there were 19 positive tests in the developed model (14 out of 20 LTBI cases detected), tuberculosis activation was possible in 2 cases. The total costs per cohort were 1.71 mln RUR. in case of TST testing (including primary testing costs – 7,900 RUR) and 1.07 mln RUR for scenario with T-SPOT.TB testing (including primary testing costs – 250,000 RUR). Conclusions: The use of T-SPOT.TB for LTBI detection in immunocompromised children is efficient, as additional costs for primary testing could be compensated by the following decrease of costs related to additional testing and preventive chemotherapy.

20-25 778
Abstract

this article considers the appropriateness of surrogate points and endpoints utilization as evaluation criteria for rehabilitation programs efficiency in patients after stroke, craniocerebral injury or other CNS diseases (e.g. tumors, neuroinfections etc.) in Russian Federation. The purpose of this study is to evaluate surrogate and final outcomes of neurorehabilitation program in patients after stroke and craniocerebral injury. Materials and methods. The study was carried out using data provided by the Center of speech pathology and neurorehabilitation. A notion of Social status recovery was selected as an economically significant surrogate outcome which was evaluated by physicians at the end of the rehabilitation course. A notion of Disability conferred by the Federal State Institutions of Disability Evaluation was selected as an economically significant final outcome. Surrogate and final outcomes comparison was performed based on the regulatory materials. Results. Surrogate outcomes evaluation revealed that at the end of rehabilitation course most patients (86.64%) reached the level of social and living needs, i.e. they have an ability to live and to take care for themselves without assistance. Final outcomes evaluation revealed that proportion of patient without disability decreased by 4-fold between the first and second visits and that total changes in disability degree by the time of the last visit were significantly smaller in comparison with the second patient's visit to the Center. Comparison of surrogate and final outcomes revealed significant discrepancy between the patient's status characteristics. Thus, in the disability group I only 7.66% of patients were actually unable to perform activities of daily living without assistance, while 90.46% of patients were able to live without assistance, that corresponds to the disability group II. Conclusion. Established degree of disability often does not correspond to the actual patient's state. The analysis based on the disability group changes is not sensitive enough for the evaluation of rehabilitation programs efficacy. Therefore, the use of indirect signs of economically significant recovery seems to be more appropriate for the efficacy evaluation of such technology. 

26-29 288
Abstract

to assess the effectiveness of medicines the retrospective observational study of 1343 case of hospitalization (case reports) of 214 colorectal cancer patients treated with oxaliplatin at the St. Petersburg State Health Care Institution «City Clinical Oncology Dispensary» in 2008-2010 was done. Pharmacoeconomic analysis of application of oxaliplatin in colorectal cancer was performed. Cost-effectiveness analysis was used. Calculation of direct medical costs, direct non-medical costs and indirect costs was performed. Three trade names of oxaliplatin was used: eloxatin – 42.2%; platikad – 31.6%; eksorum – 26.2%. Middle cover price of case report
was 252,294 rubles. In average oxaliplatin therapy was effective in 83.1%. ICER for eloxatin was 8,801 and 18,162 compared to eksorum and platikad respectively. As a result it was shown that the treatment with eloxatin was clinical and cost-effective.

30-35 241
Abstract

in this article we analysis possibility of application telemedical technologies for regular medical examination, among the adult population living far from hospitals in the Khanty-Mansi Autonomous Okrug – Yugra. The model developed medicoeconomic assumes comparison of two possible strategy of carrying out medical examination of patients with application of telemedical technologies and without it and estimates funds volume of the compulsory health insurance which came for to medical institutions. Results of research show that application of a telemedical complex allows to return costs of its acquisition due less than one and a half years to coverage increase by medical care of the handicapped and removed population of Khanty-Mansi Autonomous Okrug – Yugra.

Drug Utilization

36-43 359
Abstract

the article presents the results of cost calculation on the drug supply of the patients with orphan diseases, included in the list of orphan diseases (24 diseases) by the RF Government Regulation of April 26, 2012 № 403. Calculation was performed based on the data of registered patients with orphan diseases (OD) in 83 territorial entities of the Russian Federation in 2013 and based on the average-weighted costs of their drug therapy. Data on registered patients with OD was obtained because of the official request of the Expert Board on Healthcare of the Council of the Federation Committee on Social Policy that was sent to healthcare regulatory bodies of the 83 territorial entities of the Russian Federation. Average-weighted cost calculation of drug treatment (or of specialized nutrition care) of the patients with OD was carried out in accordance with medical care standards and expert assessment. As part of the analysis of the standards the search for pathogenic therapy medications was carried out, in the absence of which – there was a search for supportive care medications that critically affect survivability of the patients with OD. According to the selected list of drugs, information about duration, frequency of prescription, average daily and course dose, was analyzed. In the absence of medical care standards, and in order to verify some questions concerning drug therapy of patients with OD consultations with experts were held. Because of conducted calculation, total average-weighted costs of pharmacotherapy for 24 orphan diseases were 15.73 bln rubles per year (6.36 bln rubles for children and 9.37 bln rubles for adults) for 11 173 registered patients that by 3.3 exceeds current amount of finance. Pathogenetic pharmacotherapy of Mucopolysaccharidoses type VI and II proved to be the most expensive treatment per one patient per year: average-weighted costs per one child with Mucopolysaccharidoses type VI amounted to 40.90 mln rubles, per one adult – to 71.50 mln rubles; for Mucopolysaccharidoses type II costs were 29.60 and 51.83 mln rubles respectively. In order to increase effectiveness of the system of drug supply of the patients with OD and to optimize state expenses for this group of patients it is necessary to approve the entire range of financially balanced and science based medical care standards, to define the legal status of orphan drugs and to carry out state regulation of prices, to ensure increase of regional funding supported by involvement of federal budget funds, to define the list of orphan drugs, to implement state regulation measures to create incentives for pharmaceutical companies to reduce prices for orphan drugs.

44-50 479
Abstract

spasmodic abdominal pain is a common complaint. Dysmenorrhea is one of the most important problems not only from medical, but also social point of view. Drotaverine hydrochloride is a potent smooth muscle spasmolytic agent. Objective: To evaluate the effectiveness of drotaverine in the daily practice management of spasmodic abdominal pain due to gastrointestinal, biliary, urological tract conditions and dysmenorrhea. Material and Methods: a multicenter, prospective, cross-sectional and longitudinal product registry (3 visits), non-interventional on the therapeutic strategy was conducted in Mexico, Kazakhstan, and Russia. Each investigator contributed at the 2 sequences: one cross-sectional, assessing physicians' interest for and knowledge of spasmodic abdominal pain management [Prescription Registry, PR] and longitudinal registry [LREG]: data on 25 consecutive eligible patients with spasmodic pain were recorded in the PR, and 5-day (+3) follow-up on the first 5 consecutive eligible patients receiving NOSPA ® . Pain was evaluated asking patients to rate the worst abdominal pain over the past 12 hours (11-point Numerical Pain Rating Scale, NPRS) and a Visual Analogue Scale (VAS) to evaluate the drotaverine onset of action. Only spontaneous adverse events reports were collected. Results: 208 physicians participated and included 5507 patients. 75% of them received drotaverine. Treatment was mostly prescribed in monotherapy (72%). From these patients, 1116 were included in the Longitudinal Registry (881 in the PP population) with a mean age of 34.2 ± 12.5 years. 86 % were females. Most suffered from dysmenorrhea (53%). They received drotaverine for 5.7±4 days. 89% were responders. Compared to the first evaluation, a statistical difference was observed in patients suffering from dysmenorrhea (p<0.0001). Conclusion: Results show that pain rapidly improves in patients suffering from spasmodic abdo minal pain when taking drotaverine in this open product registry conducted under conditions of real life. It is possible to discuss introduction of drotaverine in national guidelines for management of dysmenorrhea patients.



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