FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology

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Vol 9, No 1 (2016)
View or download the full issue PDF (Russian)

Original Article 

15-22 993
Among epileptic encephalopathies, the Lennox–Gastaut syndrome is considered to be one of the most severe. It is a childhood-onset disease that leads to early disability and mental retardation and is associated with significant costs of medical care and patient nursing. In the Russian Federation, the supposed number of patients with the Lennox–Gastaut syndrome is between 1400 and 9240 people. Rufinamide is one of the most powerful agents being used for the adjuvant therapy of this syndrome. In order to evaluate the efficacy of the drug in this pathology, a systematic review of publications of the results of the respective clinical studies was performed. Eleven articles were selected for generation of pooled groups and meta-analysis. Rufinamide used as an adjunctive therapy has been shown to substantially increase the chances of successful result (HR=3.1 [2.0; 4.9], p=0.000). Pharmacoeconomic modelling (a decision tree type) allowed revealing that the use of rufinamide adjunctive therapy for the Lennox–Gastaut syndrome reduces total costs of treatment and nursing of these patients with minimum effect on the budget.
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Objective: to conduct a pharmacoeconomic analysis of lenvatinib (Lenvima) in advanced progressive radio iodine refractory differentiated thyroid cancer in the Russian Federation.

Methods. Cost-effectiveness ratio (CER) and budget impact analysis (BIA) were performed. All calculations were made in the MS Excel model. CER compared lenvatinib 24 mg/daily, sorafenib 800 mg/daily and Other chemotherapies mix. BIA compared two scenarios: 1) common practice consisting of sorafenib and Other chemotherapies mix; 2) new practice where lenvatinib is used in 6.25% patients. Costs of drugs, visits to oncologist and hospitalization were calculated both in CER and BIA. Time horizon was 2 years for CER and 5 years for BIA.

Results. Lenvatinib is a new highly effective target drug for the monotherapy of the radioiodine refractory differentiated thyroid cancer. Lenvatinib significantly increases progression free survival, thus providing in the proposed model, 1628 additional years of life for patients per 5 years. Additional costs at the same time constitute 5 213 900 000 rub. (670.5 to 1184.3 million rubles per year). Calculated unit lenvatinib efficiency stands at 64.95% less than that of the comparisons targeted drug (sorafenib).

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Background: In 2014 we firstly analyzed the formalized system (points and expert opinions) of drug inclusion and exclusion into the reimbursement lists in Russian Federation. The liner mathematical model of decision making was developed and adopted.

Aim. Update the existing model using the results of reimbursement procedures acting from 2106.

Material and methods. The linear models developed and adopted in 2014 were used. In 2015 we included data on 141 drug dossiers. We analyzed the decision of the expert body, chief Ministry of Health expert and the final committee decision.

Results. 43 new drugs were included into the reimbursement lists acting from 2016. The model of expert body decision had an error 7,09% (12,4% in 2014). The model of chief Ministry of Health expert decision had an error – 7% (10% in 2014). The above mentioned experts became more experienced in the formalized procedure of decision making. The model of final decision had an error about 42% (35% in 2014). Conclusion. Linear models are working tools for modelling reimbursement system decisions. At the mean time the existing system of decision making needs more formalization.

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Objectives. There is no consistent evidence of clinical efficacy of Pentaglobin for reducing mortality in newborns and older children with bacterial infections and sepsis. The aim of the study was to update evidence by considering recent clinical trials and analyzing age populations and comparators separately.

Methods. We searched publications in PubMed and the Cochrane Library in December 2014 and in October 2015. All-cause mortality was analyzed, and systematic review using meta-analysis and indirect comparison was carried out.

Results. Three meta-analyses and 7RCTs were considered, including 6 trials studied the effect of Pentaglobin in newborns, and one in children 1-24 months old. All interventions were applied with basic therapy (BT). In newborns mortality is lower in Pentaglobin than in all comparators groups, RR 0.51 [0.32; 0.82], and in BT with or without placebo, RR 0.56 [0.34; 0.91]. Children under 24 months receiving Pentaglobin also had lower mortality than in all comparators group, RR 0.51 [0.36; 0.72]. Indirect comparison of IgM and IgG in adults showed no differences, in newborns the difference is in favor of IgM, RR 0.51 [0.32; 0.82].

Conclusion. Pentaglobin is effective in reducing all-cause mortality in newborns with bacterial infection or sepsis in comparison with any comparators (BT with or without placebo, albumin, IgG), in children under 24 months in comparison to BT with or without albumin. Further head-to-head clinical trials are needed to enhance evidence.

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Objective. Determine if dapagliflozin use is pharmacoeconomically reasonable option for patients with inadequate glycemic control compared with basal insulin.

Materials and Methods. The study was conducted according to standard pharmacoeconomic methods: cost-utility analysis (CUA), budget impact analysis (BIA).

Results. The use of dapagliflozin as an alternative to basal insulin can reduce health system costs, improves the quality of life of patients, adding 0.73 QALY per patient. Modelling suggests that dapagliflozin introduction could delay the start of insulin treatment by an average of 6.5 years that in turn will allow achieving cost savings and improving the quality of life of patients.

Conclusions. Dapagliflozin therapy is the preferred alternative to basal insulins, due to lower costs and improvement in the quality of life of patients.

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Objective. To examine approaches to organization and planning as well as expenditures of inpatient care in countries outside of Russia.

Methods. A narrative review of published articles and legal documents was conducted. The review focused on health systems organization, planning volumes and costs associated with inpatient care in nine foreign countries (Germany, France, Denmark, Norway, Austria, Great Britain, Canada, Belarus and Kazakhstan) was conducted.

Results. In all countries, there is a growth in health care costs both in monetary terms and as a percentage of GDP. The primary policy responses to expenditure growth have focused on outpatient pharmaceuticals, evaluation of medical technologies and reducing volumes of provided hospital care by providing assistance in day hospitals, outpatient or with home-visiting teams. In most countries, responsibility for the organization and planning of inpatient care rests with regional authorities. In all of countries, quality measures are regularly taken as a means to optimize or reduce numbers of beds, reduce hospital length of stay or increase turnover as a means to reduce transaction costs and costs of infrastructure maintenance. The main method of payment for acute care services is based on per case of treatment for a relevant group of diseases (diagnosis related group (DRG)). Planning of medical care in many of these countries is based on financial capacity and performance of previous years. Approaches to planning are typically part of political decision-making, developed at regional or municipal level, leading to variable approaches in health systems characterized by a federation of health regions.


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The article describes a new approach to the use of economic evaluation at the stage of planning and organization of clinical trials and considers the examples of studies which undertook this approach. The use of economic evaluation before clinical trials enables to assess the necessity of undertaking of the clinical trial and formulate the recommendations regarding the appropriate trial design, increasing its costeffectiveness.

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