Pharmacoeconomics: theory and practice
This article touches upon the main methodological aspects of conducting pharmacoeconomic analysis of treatment of spasticity in patients with cerebral palsy. The authors evaluated the relevance of conduct of such studies basing on epidemiological and social and economic data. The stages of information retrieval and inclusion criteria in the effectiveness analysis are covered in detail. Special attention is paid to assessing the methodological quality of the studies. The authors highlighted the components of the cost analysis and assessment of the economic burden of this disease and describes the features of assessing the quality of life in children with cerebral palsy using a variety of methods.
This article compares for the first time in the Russian-speaking literature two approaches of survival modeling in pharmacoeconomic studies. Markov model and partitioned survival model were examined. The following text contains methodological issues, key differences and selection guideline.
Pharmacoeconomic analysis of combination of daclatasvir and sofosbuvir in treatment of chronic hepatitis C(genotype 3) in the Russian Federation: among treatmentexperienced patients
The objective of this study was to conduct cost-effectiveness analysis and budget impact analysis of antiviral drug treatment of chronic hepatitis C (peginterferon alfa + ribavirin 24 weeks (F0-F4), daclatasvir + sofosbuvir 12 weeks (F0-F3), daclatasvir + sofosbuvir + ribavirin 12 weeks (F4), sofosbuvir + ribavirin 24 weeks (F0-F4)) among treatment-experienced patients (HCV genotype 3). Both analyses were based on the developed pharmacoeconomic model (Markov model). Literature review showed absence of clear effectiveness data on using of peginterferon alfa + ribavirin in the targeted group therefore subsequent pharmacoeconomic analysis for this comparator was aborted. Obtained results showed that daclatasvir + sofosbuvir and daclatasvir + sofosbuvir + ribavirin was dominant in compares with sofosbuvir + ribavirin in the F0-F3 and F4 groups. In budget impact analysis total costs per one patient decreased on 283 623 rubles and 290 168 rubles in case of using daclatasvir + sofosbuvir instead of sofosbuvir + ribavirin among F0-F3 patients and daclatasvir + sofosbuvir + ribavirin instead of sofosbuvir + ribavirin among F4 patients, respectively.
Assessment of clinical and economic effectiveness of apremilast in the treatment of psoriatic arthritis
Psoriatic arthritis (PsA) can develop at any age and often affects the workingage population. In the course of the disease, physical activity of patients decreases, which leads to a drop in performance and absence from work due to treatment. If untreated, this can lead to disability and loss of function of the locomotive system structures. Strategy to combat PsA requires focus on the most effective prevention and control of both the progression of psoriasis, and arthritis associated therewith. It is equally important to minimize the risks associated with major organ toxicity and the development of side effects. In this context, the emergence of drugs for the treatment of psoriasis belonging to a new class of signaling pathways inhibitors seems to be highly relevant both from scientific and practical points of view. In general, biological products, which are antibodies that selectively bind to receptors or proteins on the extracellular membrane, block one biological marker (e.g., TNF-a, IL-17) participating in the immunopathogenesis of psoriasis, thus interrupting further inflammatory cascade of pathological processes leading to the formation of psoriatic efflorescence. Apremilast, which belongs to a new group of drugs - selective inhibitors of signaling pathways - has a fundamentally different mechanism of action. With targeted effect, the drug modulates intracellular signaling, eventually corresponding to the control of the expression of genes mediating key pro- and anti-inflammatory factors (e.g., release of cytokines) in myeloid, lymphoid and other cells involved in the “orchestration” of epidermis inflammation and hyperproliferation. The drug is administered orally, which eliminates additional costs for administering an injection, as is the case with biological drugs. The emergence of a new drug for the treatment of psoriatic arthritis, lack of proper control over the course of the disease, as well as limited healthcare system resources resulted in the pharmacoeconomic assessment of the priority drugs Apremilast compared to ustekinumab, adalimumab and infliximab using cost, cost-effectiveness and budget influence analysis methods. The cost analysis results showed that Apremilast treatment costs for the entire study period - 2 years - are on average 27% lower than the cost of treatment with ustekinumab, adalimumab and infliximab. Otezla treatment is characterized by a lower cost per unit of effectiveness - QALY, when considering the cost for the entire time horizon, as compared to Humira, Stelara and Remicade. Furthermore, the use of Apremilast leads to cost savings if administered for either 2 years or 1 year, in comparison with the alternative regimens.
Pharmacoeconomic analysis of nivolumab in treatment of nonresectable stage III-IV melanoma among treatment-naive BRAF-mutated patients in the Russian Federation
In conducted pharmacoeconomic study we analyzed treatment of nonresectable stage III-IV melanoma among BRAF-mutated treatment-naïve patients: monotherapy with nivolumab, scheme dabrafenib + trametinib and scheme vemurafenib + cobimetinib. Cost-effectiveness analysis and budgetimpact analysis were based on a modeling approach. Progression free survival (PFS) was used as an effectiveness criteria. Only direct costs of medical help at first-line of antitumor treatment were taken into account. Time horizon was equal to PFS of mentioned treatment schemes. Results of cost-effectiveness analysis showed that the lowest CERPFS was on the monotherapy with nivolumab. In budget-impact analysis using of nivolumab instead of dabrafenib + trametinib and vemurafenib + cobimetinib leaded to decrease of both antitumor treatment costs and total medical costs of first-line treatment of melanoma, resulting in possibility of treatment in 3,3 and 3,6 times more patients within equal budget, respectively (in case of treatment with nivolumab). Obtained results of costeffectiveness analysis were stable to increase of nivolumab price within 1,5-2,0 or to decrease of alternative schemes prices within 1,5-2,0.
Pharmacoeconomic evaluation of infusion-detoxification therapyfor poisoning with psychoactive substances in narcological hospitals of the republic of Tatarstan
Twelve traditional therapeutic schemes of infusion-detoxification therapy of budget narcological hospitals of the Republic of Tatarstan and also an innovative scheme with greater efficiency were evaluated and compared from the viewpoint of pharmacoeconomics in this research. Analysis of effectiveness showed that innovation scheme, one bed in resuscitation of narcological hospital can serve the needs of 93 patients per year, i.e. bedspace will be in use more intensively. During treatment according to traditional schemes the indicator of the “function hospital bed” was equal to 56 and 70 patients a year. The analysis of the cost showed that the maximum annual budget of traditional therapy is represented on the scheme №3 (1 050 560 RUB), and the minimum one is on the scheme №9 (893 200 RUB). The budget of innovative scheme was 1 452 906 RUB. The innovative scheme of infusion-detoxification therapy according to the analysis was more effective, but the therapy was more expensive. During the research of the cost of the structure with innovative treatment scheme it was found out that the greatest part of the cost (38%) is the cost of pharmacotherapy. The analysis of “cost minimization” allowed choosing among the traditional schemes of infusion-detoxification therapy the most optimal variant. According to “budget impact” analysis the transfer of 50% of patients to the innovative therapies, would require a budget increase to 2,2%, and for transfering 100% of patients on the new scheme of the IDT the budget increase must be 6% relative to 100% applications of traditional schemes in regional narcological hospital.
Pharmacoeconomic assessment of the use of dalbavancin (xydalba) in the treatment of skin and soft tissue infections in hospital settings in the Russian Federation
This article is devoted to the evaluation of the use of dalbavancin (Xydalba) in the treatment of skin and soft tissue infections in hospital settings in the Russian Federation. The main methods of pharmacoeconomic analysis in the study were the following: cost-minimization analysis and budget impact analysis. The results of the pharmacoeconomic evaluation of dalbavancin treatment of patients with skin and soft tissue infection in Russia hospitals showed its stable advantage from the point of view of cost analysis and budget impact analysis in comparison with telavancin and tigecycline. The results of the cost-minimization analysis indicate of the dominance of dalbavancin in comparison with telavancin. At the same time, a comparative cost-minimization analysis of dalbavancin and tigecycline showed the advantage of the former, which, however, is not preserved when assessing the stability of the results through a one-factor sensitivity analysis with an increase in the price of dalbavancin by 15%. In accordance with the quantitative assessment of clinical and economic effectiveness, regulated by Decree of the Government of the Russian Federation N871 dated August 28, 2014, dalbavancin obtains +8 points on the pharmacoeconomic criterion.
Pharmacoeconomic analysis of a medicinal product neoton (phosphocreatine) in perioperative management of cardiac surgery patients with extracorporeal circulation, with ischemic heart disease or with chronic heart insufficiency
Cardiovascular disease (CVD) is the main mortality factor and the main reason of disability of the working-age population both in the Russian Federation and in the world. Due to the state statistical data, 1,878 persons per every 100,000 population died in Russia in 2014. 50.1 % of these deaths have been caused by CVD and more than half of them (52.3 %) have been caused by ischemic heart disease (IHD). The aim of this study was to determine the preferential scheme of medical therapy in perioperative management of cardiac surgery patients with extracorporeal circulation, with IHD or with chronic heart insufficiency (CHI) from the point of view of pharmacoeconomic analysis by comparing ratios between expenses and efficacy, safety and quality of life associated with the use of Neoton (phosphocreatine) in comparison with the control group. Due to the efficacy analysis, the scheme “standard therapy + phophocreatine” is more effective. Cost-effectiveness analysis has shown that the standard therapy + phosphocreatine is a preferable method of treatment in comparison with the standard therapy as it shows better clinical efficacy and lower “costeffectiveness ratio. Results of the budget impact analysis have shown that the use of the standard therapy + phosphocreatine instead of the standard therapy itself in perioperative management of cardiac surgery patients with extracorporeal circulation, with IHD or with CHI has saved money.