Научно-практический журнал Медицинские технологии. Оценка и выбор
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Issue № 31 | 2018 (1)

Abstract

Introduction. In December 2015, preliminary results of the study of clinical effectiveness and safety of afatinib compared with gefitinib as a first-line therapy of locally advanced or metastatic non-small cell lung carcinoma (NSCLC) and activating mutations in the EGFR gene were published. Based on these data, a pharmacoeconomic study of the use of afatinib and gefitinib in treatment of lung cancer was performed. The main limitation was the lack of the full data of LUX-Lung 7 study and of the final data on overall survival rate (OSR). LUX-Lung 7 study is now completed, and its results were published. This provides an opportunity to adjust the results of the previously conducted pharmacoeconomic study, and to model the impact of the increase of share of afatinib as a first-line therapy of NSCLC on the budget of the Russian health care system.

The aim was to update the results of the previously performed pharmacoeconomic study, and to assess the budget impact of the use of afatinib as a first-line therapy in prolonged treatment of locally advanced or metastatic NSCLC, and of partial replacement of gefitinib with afatinib in patients with frequent activating mutations of the EGFR gene.

Materials and methods. Pharmacoeconomic analysis was performed using budget impact method based on Markov model of the first, second and third line of NSCLC therapy. The results of LUX-Lung 7 clinical trials, data of state statistical monitoring, and literature data were used to create the model. The following direct medical costs were considered: first and second line drug therapy of NSCLC; palliative care; addressing adverse events; and observation of patients during the treatment. In a basic scenario, financial implications of the use of afatinib as the first line therapy in prolonged treatment of NSCLC were assessed irrespective of the frequency of mutations; the cost of treatment of patients with Del19 mutation was additionally analyzed. A probabilistic analysis of the sensitivity of the results to fluctuations of initial parameters was performed.

Results. Budget impact analysis of a more extensive use of afatinib in a target population of 1 382 patients demonstrated that this approach resulted in 23,553,000 RUB less total cost of NSCLC treatment in the second year, and 43,310,000 RUB in the third year. If the average annual cost of therapy with afatinib was 968,857 RUB per patient, this would enable to treat additional 24 patients in the second year, and 45 patients in the third year of the modeled therapy. It was also shown that the change of the share on afatinib from 13% of patients in the first year of therapy to 30% in the first year and 50% in the third year reduced the total cost of treatment of patients with NSCLC for 66,800,000 RUB in the basic scenario. This would enable to treat additional 69 patients. The total budget cost of treatment of the subpopulation of patients with Del19 mutation of the EGFR gene reduced by 34,200,000 RUB, which would enable to treat additional 35 patients.

Conclusions. The use of afatinib is cost-effective for the health care system.

Keywords

afatinib, gefitinib, Del19 mutation of EGFR gene, budget impact analysis.

For citations

Fedyayev D. V., Zyryanov S. K. Pharmacoeconomic Analysis of Afatinib and Gefitinib for the Treatment of Lung Cancer. Medical Technologies. Assessment and Choice. 2018; 1(31): 68–83.

Issue № 31 | 2018 (1)

Abstract

Aims. 1. To assess the economic effectiveness of the use of ixazomib combined with lenalidomide and dexamethasone in patients with multiple myeloma (MM), who received at least one line of prior therapy. 2. To analyze the impact of the introduction of ixazomib into the Program of State Guarantees for Free Medical Care on the budget of health care system of the Russian Federation.

Methods. The cost-utility analysis of the use of ixazomib with lenalidomide and dexamethasone from the point of Russian health care was performed using a global model created for the United Kingdom and filled with Russian data. The difference between direct medical costs and the incremental cost-effectiveness for a quality-adjusted life-year was calculated for each of the triple treatment schedules (ixazomib + lenalidomide + dexamethasone, and carfilzomib + lenalidomide + dexamethasone) compared with lenalidomide + dexamethasone schedule.The model created in Microsoft Excel assessed the impact of the introduction of ixazomib on the Russian health care budget. The data from government statistics; expert survey of hematologists; registered prices of drugs included on the List of Vital and Essential Drugs (LVED); estimated price of ixazomib provided by the manufacturer for the application for the inclusion into LVED; the prices of state procurement of drugs; and standard financial costs of medical care in Russia in 2017 were used.

Results. The cost of a quality-adjusted life year in patients with MM, who received at least one line of prior treatment, was lower in case of a triple schedule with ixazomib than in case of the schedule with carfilzomib, compared with the combination of lenalidomide and dexamethasone (7.01 and 7.92 million RUB; and 2.07 and 9,08 million RUB in the population with a high risk of chromosome aberrations, respectively).The results of the budget impact analysis showed that the introduction of ixazomib into the clinical practice would save 992.09 million RUB (4.18%)in the first three years. The sensitivity analysis showed that the results of modelling were robust to the changes of the input parameters.

Conclusion. The cost of a quality-adjusted life year is lower for the schedule with ixazomib than for the schedule with carfilzomib compared to lenalidomide and dexamethasone combination. This suggests that the inclusion of ixazomib into the LVED will be a cost-effective solution. The introduction of ixazomib into the clinical practice will reduce the burden of additional costs connected with the use of novel drugs for the treatment of MM.

Keywords

multiple myeloma (MM), ixazomib, carfilzomib, lenalidomide, budget impact analysis, cost-utility analysis.

For citations

Pyadushkina E. A., Boyarskaya T. V. Pharmacoeconomic Analysis of Ixazomib Combined with Lenalidomide and Dexamethasone in
Adult Patients with Relapsed or Refractory Multiple Myeloma. Medical Technologies. Assessment and Choice. 2018; 1(31): 52–67.

Issue № 30 | 2017 (4)

Abstract

Introduction. Breast cancer (BC) is one of the most prevalent malignant neoplasms (MNs) and the leading cause of mortality from MNs among women in Russia. HER2-positive subtype of BC has one of the most unfavorable prognoses without targeted treatment. Dual-targeted therapy proposed for early stages of HER2+ BC includes a combination of trastuzumab, pertuzumab, and docetaxel in a neoadjuvant regimen. It was found to be a cost-effective solution in a previously published pharmacoeconomic analysis. However, due to the changing conditions, particularly a significant reduction of drug prices, it is necessary to update the results of the previously conducted research.

The aim of the study was to reassess the cost efficiency of neoadjuvant therapy of Russian women with HER2+ BC with pertuzumab and trastuzumab.

Material and methods. We used the Markov model created for the initial analysis in 2016. The prices of drugs were defined on the basis of government procurements in 2017. We also updated the parameters of chemotherapy in female patients with progressive BC. The discount rate was increased from 3.5 to 5%.

Results. Both the initial analysis and the present study demonstrated that neoadjuvant therapy with a combination of pertuzumab and trastuzumab in patients with locally advanced, infiltrative or early HER2+ BC was more effective than trastuzumab only, but it required more costs. However, additional costs per additional quality-adjusted life year were significantly lower that it was shown previously (0.78 million RUB and 1.25 million RUB, respectively; the discount rate in the initial study was 5%). The reduction of additional costs may be explained both by a significant reduction of the price of pertuzumab, and a higher rate of avoided costs of progressive BC (577.9 thousand RUB compared to 398.5 thousand RUB in the initial study without discounting).

Conclusion. The reassessment confirmed that the use of dual-targeted neoadjuvant therapy in females with HER2+ BC in conditions of Russian health
care system is with a high probability a cost-effective solution.

Keywords

breast cancer, neoadjuvant therapy, dual-targeted therapy, pertuzumab, pharmacoeconomic assessment.

For citation

Ignatyeva V. I., Derkach E. V. Dual-Targeted Neoadjuvant Therapy of Breast Cancer: an Update of the Results of Pharmacoeconomic Analysis. Medical Technologies. Assessment and Choice. 2017; 4(30): 76–83.

Issue № 29 | 2017 (3)

Abstract

Introduction. Immunization is one of the most effective means of prevention of influenza. Trivalent vaccine, which is currently used in Russia, includes only one of two lineages of type B flu. This reduces the effectiveness of immunization if the lineage circulating in population is different from that included into vaccine. In the nearest future, introduction of quadrivalent vaccines with both lineages of type B flu, is expected into the Russian market.

The aim of the study was to evaluate the maximum price of one dose of quadrivalent flu vaccine that will be considered rational for the national immunization calendar.

Materials and methods. The study adapted a published dynamic model of type B flu transmission. Morbidity for different age groups was established on its basis in case of trivalent vaccine for the whole population and in case of its substitution with quadrivalent vaccine in children < 18 y. o. Expected mortality and life years lost were calculated, and direct medical costs and indirect costs of type B influenza were estimated. The ceiling price of quadrivalent vaccine for different thresholds of willingness to pay for a saved life year was calculated. Results. The use of quadrivalent vaccine in children would reduce the morbidity from influenza from 28,003 to 6,114; the total cost of this disease will reduce by 630.1 million RUB; 26 lethal cases would be prevented, and 376 years of life would be saved. The maximum price of one dose of quadrivalent vaccine fluctuated from 158.6 to 266.22 RUB depending on the threshold willingness to pay for a life year saved (0 to 4.5 million RUB).

Conclusion. The introduction of quadrivalent influenza vaccine into national immunization calendar for children before 18 y. o. would significantly reduce type B influenza morbidity and mortality. In case of threshold willingness to pay for a life year saved equal to 3 per capita GDP (1.76 million RUB in 2016), the reasonable maximum price of one dose of a new vaccine included into the calendar would be 200,69 RUB.

Keywords

influenza, vaccination, trivalent influenza vaccine, quadrivalent influenza vaccine, modeling, economic analysis.

For citations

Ignatyeva V. I., Boyarskaya T. V., Avxentyeva M. V., Omelyanovsky V. V., Tsybalova L. M, Stolyarov K. A. National Immunization Calendar. How Much Quadrivalent Influenza Vaccine May Cost? Medical Technologies. Assessment and Choice. 2017; 3(29): 81–94.

Issue № 29 | 2017 (3)

Abstract

The authors calculated the cost of inpatient treatment of exacerbations of bronchial asthma (BA) taking into account the rate of achieving a positive clinical outcome on the background of starting therapy and the absence of positive dynamics with the additional treatment. The calculation was performed in the decision tree model, information on the therapy, dosing regimens and rate for the lack of positive dynamics on the background of starting therapy were abstracted from medical records of 608 children hospitalized with acute BA in 2014 – 2015. Regimens with the lowest total cost were identified.

Keywords

bronchial asthma; children; hospital treatment; cost of treatment; decision tree.

For citations

Zhukova O. V., Kononova S. V. Cost of Anti-Asthmatic Therapy at Children’s Hospital. Medical Technologies. Assessment and Choice. 2017; 3(29): 76–80.

Issue № 29 | 2017 (3)

Abstract

Objectives. A multicenter trial conducted in four hospitals in St. Petersburg revealed that in 90,8% of cases treatment of community acquired pneumonia (CAP) used in common practice did not follow the national clinical practice guidelines for CAP treatment. The aim of study is to evaluate the burden of CAP treatment in common practice compared to national recommendation.

Methods. Budget impact analysis was performed. Rate of recovery was chosen as endpoint.

Results. Budget impact analysis demonstrated that cost of treatment of 300 000 hospitalized patients with CAP in Russian Federation was RUB 18 108 191 678,17 per year if the treatment followed the guidelines and RUB 20 916 258 911,61 in common practice. Difference of RUB 2 808 067 233 would allow treatment of additional 46 521 hospitalized patients with CAP.

Conclusions. Treatment of CAP regarding national recommendation is reasonable due to lower cost and the best effectiveness.

Keywords

mcommunity-acquired pneumonia, budget impact analysis, antibacterial treatment.

For citations

Gomon Y. M., Kolbin A. S., Balykina Yu. E., Sidorenko S. V., Ivanov I. G., Lobzin Yu. V. Economic Consequences of Common Practice Community Acquired Pneumonia Treatment Based on Epidemiological Study at Multidisciplinary Hospitals. Medical Technologies. Assessment and Choice. 2017; 3(29): 65–75.

Issue № 28 | 2017 (2)

Abstract

Ibrutinib monotherapy and the combination of obinutuzumab + chlorambucil are approved for previously untreated chronic lymphocytic leukemia (CLL). No trials directly comparing their efficacy are available. Therefore a matching-adjusted indirect comparison (MAIC) was performed to provide insight into their relative efficacy. MAIC attempts to adjust for between-trial differences in factors known or suspected to influence treatment effects, to minimize bias. A MAIC within a Bayesian framework was conducted using individual patient data from the RESONATE-2 study and published data from the CLL11. MAIC results in terms of progression-free survival (PFS) and overall survival (OS) are:
● In a traditional indirect comparison, ibrutinib showed favorable results when compared with obinutuzumab + chlorambucil for both PFS and OS outcomes.
● When matching on patient baseline characteristics an even greater improvement in survival outcomes for ibrutinib versus obinutuzumab + chlorambucil was shown:
■ For PFS, ibrutinib was shown to have at least a 95% probability of being superior to obinutuzumab + chlorambucil;
■ For OS, ibrutinib was shown to have a 79% probability of being superior, albeit with more uncertainty on this treatment effect due to low number of events accrued in the trial.
● The treatment effect of ibrutinib versus chlorambucil is larger in a population more comparable to the CLL11 study.
● Ibrutinib is likely to provide greater progression-free and overall survival benefit than the combination of obinutuzumab + chlorambucil in elderly/unfit patients with previously untreated CLL.

Keywords

Chlorambucil, Chronic Lymphocytic Leukemia, CLL, Ibrutinib, Indirect comparison, MAIC, Matching adjusted indirect comparison, Obinutuzumab, Overall survival, Progression-free survival

For citations

Van Sanden S., Diels J., Cote S., Baculea S. Comparative Efficacy of Ibrutinib Monotherapy Versus Obinutuzumab Plus Chlorambucil in the Treatment of Chronic Lymphocytic Leukemia: A Matching-Adjusted Indirect Comparison. Medical Technologies. Assessment and Choice. 2017; 2(28): 58–65.

Issue № 28 | 2017 (2)

Abstract

The article contains the results of the analysis of the «cost of disease» among patients with atrial fibrillation (AF), observed as outpatients. 98 out-patient’s cards were selected and the data was noted down in a special card. Among the patients, 67,4% were women, 32,6% – men, average age 74,4 ± 8,8 years, the average length of AF 9,9 ± 6,1 years, the proportion of patients with permanent AF was 55,6%, with non-regular forms – 44,4%. Total direct costs amounted to 18 298,2 ± 9440,4 Rb. per person in a year. 66,4% of finance was spent on drugs, while on hospitalization 16,5%, and visits to specialists 6,7%, on diagnostic procedures 5,7%, the challenges of ambulance 4,7%. Among the drugs cardiological drugs were most costly (76%), the margin medications for treatment of other diseases – 15%, the secondary – 9%. Total indirect costs amounted to 93 732,4 rubles per 1 patient. Of these, 87,5% came from economic losses due to foregone social product and 12,5% – to the payment on sick-leave certificates. Average full cost of outpatient treatment of AF was 25 370,7 rubles per 1 patient in a year. The direct costs came out at 84,9% of all expenditures, the indirect – 15,1%. The largest contribution to the increase in the cost of treatment a patient with AF make the indirect costs, such as loss of GDP due to the lack of personnel in the workplace. Among the direct costs the medication costs are greatest.

Keywords

atrial fibrillation, costs of illness, direct costs, indirect costs.

For citations

Korobeynikova A. N., Malchikova S. V. Accounting for Direct and Indirect Costs in the Analysis «Cost of Illness» in Patients with Atrial Fibrillation. Medical Technologies. Assessment and Choice. 2017; 2(28): 49–57.

Issue № 28 | 2017 (2)

Abstract

The health care measures directed to the reduction of morbidity, mortality and disablement of population are substantiated by the assessment of their medical, social, and economic impact. The effect of these measures may be expressed as the increase of the duration of healthy and/or good quality life of population as well as the amount of avoided losses for country’s economy. This article discusses officially recommended approaches to the evaluation of economic losses connected with the morbidity of population and provides available information sources for necessary calculations. General economic losses of the Russian Federation in 2012-2014 caused by the morbidity of population were calculated based on the data of the Russian Federal State Statistics Service.

Keywords

economic losses from the morbidity of population, gross domestic product, working-age population, economic loss.

For citations

Brutova A. S., Obukhova O. V., Bazarova I. N. Economic Losses of the Russian Federation Caused by the Morbidity of Population in 2012-2014. Medical Technologies. Assessment and Choice. 2017; 2(28): 44–48.

Issue № 27 | 2017 (1)

Abstract

The paper presents the study of the typical practice of the managing patients with chronic obstructive pulmonary disease (COPD) on the outpatient and in-patient treatment stages in health care organizations of Kirov region. 67 ambulatory medical records and 143 clinical records were studied. Analysis of ABC/VEN, ATC/DDD and DU90% wese performed. While ABC-analysis of the pharmacotherapy on in-patient treatment stage there was found that the share of the medications in groups A, B and C conforms to the recommended. VEN-analysis results show the insufficient using of life-saving drugs, and expanded using of secondary drugs. Recommended drugs of baseline therapy are preferred in the therapy of patients with COPD on the outpatient treatment stage, most expenses are spent for them. However, the 3-fold prevalence of secondary drugs without proven effectiveness was detected in the structure of drug prescriptions on the outpatient and in-patient treatment stages. Rational baseline therapy, timely effective treatment of exacerbations allow to improve the therapy effectiveness, to increase the longevity and quality of patients’ life, to reduce the economic burden of COPD on healthcare budget.

Keywords

chronic obstructive pulmonary disease; pharmacoeconomics; AВS; VEN; stationary phase, outpatient treatment.

For citations

Vidyakina Ye. E., Malchikova S. V. The Use of Pharmacoeconomic Analysis in the Evaluation of the Typical Practice of the Managing Patients with Chronic Obstructive Pulmonary Disease. Medical Technologies. Assessment and Choice. 2017; 1(27): 67–76.