FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology

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Vol 9, No 1 (2016)
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Original Article 

3-14 1399

Objective: to perform cost-effectiveness analysis of brentuximab vedotin (BV) in patients with relapsed or refractory CD30-positive Hodgkin’s lymphoma (HL).

Materials and methods. This study was performed in two parts in 2015. In the first part Markov model was built on the basis of the results of cohort prospective and retrospective studies and clinical expert survey to assess cost-effectiveness of BV in patients with relapsed or refractory CD30-positive HL. Time horizon of the model was 40 years. The model simulated transition between three health states: progression-free, post-progression and death for patients with relapsed or refractory CD30-positive HL after autologous stem cell transplantation (ASCT). Three alternatives were analyzed: 1) chemotherapy with or without radiotherapy (Ch ± RT), 2) Ch ± RT with allogeneic stem cell transplantation (alloSCT) and 3) BV. The economic evaluation was made from the Russian healthcare system point of view. Incremental cost-effectiveness ratio (ICER) for BV vs Ch ± RT and Ch ± RT + alloSCT vs Ch ± RT per life year (LY) and quality-adjusted life year (QALY) was calculated. In the second part we calculated ICER for BV vs standard treatment based on drugs costs only and compared it with ICER for some other costly oncologic drugs, calculated by the same approach. Drugs used for ICER comparison were: bevacizumab for metastatic renal cell carcinoma, eribulin for metastatic breast cancer, panitumumab for adenocarcinoma of the colon or rectum and cabazitaxel for metastatic castration-resistant prostate cancer. ICER was calculated separately for each single drug as the ratio of increment costs of analyzed drug vs the comparator and the increment overall survival; data was derived from clinical trials.

Results. In patients with relapsed or refractory CD30-positive HL after ASCT ICER was 5,8 million rub. per LY for BV vs Ch ± RT and 6,4 million rub. for Ch ± RT + alloSCT vs Ch ± RT. Cost of additional month of life for BV in patients with relapsed or refractory CD30-positive HL after ASCT was 524 thousand rub. that was lower than for bevacizumab for metastatic renal cell carcinoma and eribulin for metastatic breast cancer, both drugs included into 2016 Essential and Vital Drugs List: 2,5 million rub. and 923 thousand rub., respectively.

Conclusion. In patients with relapsed or refractory CD30- positive HL after ASCT BV is an appropriate alternative as ICER per LY is lower than for standard treatment Ch ± RT + alloSCT vs Ch ± RT. Cost of additional month of life is lower than for other oncologic drugs included into Russian Essential and Vital Drugs List.

15-22 900
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.
24-32 1150

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.

39-48 1599

Objective. Carrying out of the comparative clinical and economic analysis of treatment of patients with rheumatic diseases (RD) by genetically engineered biological agents (GEBA) in conditions of round-the-clock and day-time in-patient departments.

Materials and Methods. In a basis pharmacoeconomic calculations on a method "cost minimization" was put the actual quantity of patients (57 persons) with RD who had previously been initiated and carried out GEBA therapy in conditions of round-the-clock in-patient department, and then the patients for eight months were observed and treated GEBA in day-time in-patient department of budgetary establishment of public health services of Omsk region "Clinical Cardiology Clinic".

Results. It demonstrated clinical efficiency of application of GEBA in conditions of a day-time in-patient department in the form of statistically significant decrease of the activity of rheumatoid arthritis, psoriatic arthritis on index DAS28 and stable effect on index BASDAI at ankylosing spondylitis with achievement of stable remission of diseases. Adverse events and adverse drug reactions of GEBA were recorded regardless of the conditions of stay of patients that testifies to identity of parameters of safety of carrying out of genetically engineered biological therapy (GEBT) in a day-time in-patient department. The economic effect of application of hospitalization replacement technologies within 8 months at 57 patients amounted to 2 072 934,1 rbl. In recalculation on quantity of patients in Omsk region (120) sum of economy of system of obligatory medical insurance will amount 4 361 142 rbl.

Conclusion. The parameter of a difference of costs at treatment by GEBA of patients with RD in conditions of round-the-clock and day-time in-patient departments in system of obligatory medical insurance testifies to necessity of wide introduction for a clinical practice of hospitalization replacement technologies at treatment by GEBA of patients with RD.

50-57 2321

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.

58-68 997

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.

69-78 907

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.


79-83 752
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)