Currently, in treatment of patients with urothelial transitional cell carcinoma resistant to platinum-based regimen, only Javlor (vinflunine) shows the best evidence when using in second-line chemotherapy scheme.Vinflunine shows the advantage over best supportive care during a randomized Phase III study.The aim of this study is to compare Javlor therapy in combination with the best supportive therapy and the best supportive therapy alone in terms of pharmacoeconomic analysis.Budget impact analysis shows that the treatment of urothelial transitional cell carcinoma with Javlor requires additional expenses.Cost-effectiveness analysis shows that the ICER does not exceed "willingness-to-pay" threshold which means that from the point of view of incremental analysis the therapy in patients with urothelial transitional cell carcinoma using Javlor is cost-effective.
As of now, vinflunine is the only second-line chemotherapy drug showing an advantage over the best maintenance therapy in a Phase III randomized study treating patients with urothelial transitional cell carcinoma. Due to the advent of this drug, it was relevant to make a pharmacoeconomic analysis comparing therapy with vinflunine in combination with the best maintenance therapy and the latter only. A budget impact analysis showed that the use of the new drug required additional expenditures. The ICER reflecting the cost of one additional year of life and estimating vinflunine therapy as cost-effective was determined by the results of a cost-effectiveness analysis.
To determine the preferable treatment scheme for breast cancer (BC) from the pharmacoeconomic perspective by the comparison of subcutaneous (SC) and intravenous (IV) administration. The following pharmacoeconomic methods were used: cost-minimization analysis, budget impact analysis. For cost-minimization analysis the following costs were included: cost of testing on tumor expression of HER2, the main drug therapy, concomitant therapy (medical services and drugs), introduction, services provided by medical personnel and the conditions of administration (in case of hospitalization or outpatient). Total costs per 1 patient with BC for treatment course with trastuzumab for subcutaneous administration were 1 314 181 RUB/21 863 EUR and 1 503 716 RUB/25 016 EUR of trastuzumab for IV administration. Cost-minimization analysis revealed treatment change from trastuzumab for IV administration on trastuzumab for SC administration gave economy of 189 535 RUB/3 153 EUR per 1 patient for treatment course. According to budget impact analysis it was revealed that trastuzumab for SC administration allows to make economy of 175 508 955 RUB/2 919 796 EUR. During cost-minimization analysis it is determined that trastuzumab for IV allows to obtain economy compared with IV dosage form. Budget impact analysis reveals that change of BC treatment from trastuzumab for IV administration on trastuzumab for SC one give monetary economy.
To determine the most cost-effective treatment scheme for transitional cell carcinoma of the urothelial tract (TCCU) in second line through the comparison of vinflunine+ best supportive care (BSC) and BSC from a payer perspective. Cost-effectiveness and budget impact analysis were performed. Efficacy data came from phase III clinical trial. The economic perspective was the one of the Russian national health system. Results are expressed in RUB, year 2015. Sensitivity analysis were conducted to check the robustness of our findings. ICER was calculated: 1 114 504 RUB/18 541 EUR life-year gained (LYG). Budget impact analysis revealed that, a treatment with vinflunine+BSC required additional costs: 332 944 RUB/5 539 EUR for a 3-cycle treatment course. According to the budget impact analysis, shifting from a vinflunine+BSC treatment to BSC alone requires additional costs of 241 384 391 RUB/4 015 711 EUR for TCCU patients after failure of a prior platinum-containing regimen in Russia for a fulltreatment course. Vinflunine+BSC is cost-effective, as ICER does not exceed the willingness-to-pay threshold of Russia, which equals 1 481 749 RUB/24 651 EUR. And this ICER per LYG is lower than the ones calculated for the other chemotherapies used in oncology.
Herceptin IV.For example, the drug dosage does not depend on the patient's body weight and a standard fixed dose of 600 mg/5 mL is used for each SC administration that is much easier compared to IV formulation.When Herceptin IV is used, the dosage is calculated based on the patient's body weight leading to loss of medicinal substance, at least in 15% of cases.This loss is due to "disposal" of the drug remained in the vial, which may not be used as drug is compromised [9,13].The next important advantage of Herceptin SC compared to IV formulation is time saving which has been defined for Russia in the study " Time&Motion" [16].This saving was considered from the point of view of both patients and medical staff.Due to detailed description of time spent on each procedure performed with the patient in the hospital, it was possible to express time saving in monetary units, which clearly demonstrated the benefit of Herceptin SC. Study methodologyThe study compared pharmacoeconomics of Herceptin in a new formulation for subcutaneous administration versus intravenous formulation for Breast cancer patients in conditions of the equal prices of these drugs.These alternative regimens were used for one year.Herceptin IV dosages depended on the patient's body weight and were 8 mg/kg (single loading dose) and 6 mg/kg (maintenance dose) (17 infusions).Herceptin SC regimen consisted of 18 injections at a standard dose independent of the patient's body weight.Then, based on the costs associated with diagnosis, treatment and pharmacotherapy, the expenses were analysed to determine the total cost of the therapies compared.The expenses analysis also took into account the costs related to patient's hospitalization, services provided by the medical personnel and mandatory testing for HER2-expression [6].Summary: Breast cancer is a global problem due to its wide prevalence which is increasing every year.The comparative pharmacoeconomic study of Herceptin in subcutaneous and intravenous formulations was conducted for optimization of drug supply for this nosology.Direct medical expenses without taking into account the drug price were compared.As a result of pharmacoeconomic evaluation of the alternative treatment options, it was established that subcutaneous Herceptin saves 39,806 roubles per patient during one treatment year due to the cost differences related to administration, medical staff, as well as hospitalization.Moreover, when IV formulation is used for one treatment year per patient, the medicinal substance is lost due to « throwing out» the remaining part of the drug in the vial, which may not be used in connection with breach of sterile dosage forms.The loss is as high as 166,208 roubles; this translates into 11% monetary loss from the whole treatment cycle.
Follicular lymphoma is a disease requiring effective therapy that helps to improve a patient's quality of life.In this study, a comparative analysis of subcutaneous administration of MabThera versus intravenous MabThera was performed.Considering that the formulations are equally effective, a cost minimization analysis was carried out, which showed that transition from intravenous to subcutaneous MabThera resulted in savings of 35,847 rubles per one patient during the treatment course due to the decreased drug administration expenses, medical staff costs, and expenses for hospitalization or day-time staying.The use of the subcutaneous formulation can also prevent economic damage caused by loss of the drug remaining in the vial with the use of the intravenous formulation where the dose depends on the body surface area.
Breast cancer is a malignant neoplasm that develops from the epithelial cells of ducts and lobules of the glandular parenchyma, which according to the World Health Organization (WHO) is the most common form of cancer among women (16% of all cases) in the world.In 2014, in Kaluga, Lipetsk, Smolensk and Tula regions the mortality from breast cancer reached 3.2%, 3.1%, 4% and 4.7%, respectively.One of the aggressive forms of breast cancer is a HER2positive (HER2+) subtype (14 to 20% of all subtypes), which is treated with targeted therapy.The appearance of trastuzumab for subcutaneous administration has a number of advantages compared to the intravenous formulation.A pharmacoeconomic analysis of treatment of HER2+ breast cancer was performed by comparing trastuzumab in two formulations in Kaluga, Lipetsk, Smolensk and Tula regions.According to the "cost minimization" analysis in the analyzed regions, the use of trastuzumab for subcutaneous administration compared to intravenous administration saves from 29.7 to 34% of funds.The forecasted budget savings as a result of the budget impact analysis for 10 patients is 8,068,360 rubles in Kaluga region,7,047,430 rubles in Lipetsk region,6,534,750 rubles in Smolensk region,and 7,188,980 rubles in Tula region for the treatment course with trastuzumab in subcutaneous formulation as compared to the intravenous formulation.The results showed that the use of trastuzumab therapy in the subcutaneous formulation allows treatment of 4 additional patients with HER2+ breast cancer in Smolensk region, and 5 patients in Kaluga, Lipetsk and Tula regions within a fixed budget.
According to the World Health Organization, breast cancer is the most common form of cancer in women worldwide.The steady increase in the prevalence of breast cancer, followed by an increase in the state budget expenditures on drug supply for this category of patients, determines the relevance of pharmacoeconomic evaluation of treatment of HER2-positive breast cancer using a combination of lapatinib and capecitabine and trastuzumab emtansine monotherapy.A subgroup analysis of the therapeutic outcomes in patients with HER2+ breast cancer conducted by the EMILIA study failed to find a statistically significant difference in median overall survival in patients receiving either trastuzumab emtansine or a combination of lapatinib and capecitabine as second-line treatment, or in patients with non-visceral metastases.Analysis of overall survival of the entire population of patients in the EMILIA study revealed that trastuzumab emtansine is more effective than a combination of lapatinib and capecitabine.Despite this, NICE does not recommend treatment with trastuzumab emtansine due to high cost of treatment.The EMILIA study results were used as a basis for pharmacoeconomic models for HER2+ breast cancer therapy, using such methods of pharmacoeconomic analysis as budget impact analysis, cost-effectiveness analysis, and costminimization analysis for these subgroups of patients.Result of budget impact analysis revealed that the use of the lapatinib and capecitabine combination can reduce health system expenditures by 3,985,271 rubles per patient per year or by 5,851,484 rubles over three years per one patient, which allows treating 4 additional patients given the fixed budget.Cost-effectiveness ratio of lapatinib + capecitabine equals to 869,705 rubles and 3,461,960 rubles with LYG and QALY as efficacy endpoints, respectively, which identifies this therapy as cost-effective in pharmacoeconomic terms.Cost-minimization analysis of lapatinib+capecitabine patient groups in the second-line treatment, and a group of patients with non-visceral metastases showed that the use of this treatment may reduce costs by 78% in comparison with trastuzumab emtansine.
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