Pharmacoeconomics: theory and practice
№3, 2016, Vol.4
Pharmacoeconomic analysis of the use of a fixed dose combination of metformin and glibenclamide in the therapy of diabetes mellitus type 2
Retrospective analysis of using fixed combinations of metformine and glibenclamide against separate scheme was carried out using the following methods: “cost-effectiveness”, “budget impact” and “sensitivity analysis”. For assessment of long-term impact of the compared methods of therapy on the results of the cost-effectiveness analysis, in terms of QALYs, and cost analysis, a Markov model with a 20-year model horizon was used. The compared alternatives were a fixed dose combination (FDC)of metformin and glibenclamide (Glucovance) and non-fixed dose combinations (nFDC) of glibenclamide (Maninil) and each of the three generics of metformin, consumption of which took a leading position in consumption in the Russian Federation (Siofor, Metformin-Richter and Formetine). The effectiveness analysis showed that the total QALY for 20 years made 6.7121 and 6.2416 for the therapy with metformin FDC and nFDC respectively. And the cumulative cost made 2,512 thousand roubles, 2,687 thousand roubles, 2,690 thousand roubles and 2,696 thousand roubles for the therapy with Glucovance and combinations of Maninil and Formetine, Metformin-Richter and Siofor respectively.
Melanoma is a malignant tumor that develops from transformed melanocytes, located mainly in the skin. According to Russian statistics, the incidence of melanoma in 2014 was 9,390 new cases . In 2004-2014, melanoma prevalence rate per 100,000 population increased on average by 4.2% per year. High prevalence of melanoma and frequent poor prognosis necessitate search of innovative treatment methods and use of high-tech drugs.
Pharmacoeconomic assessment of hepatoprotectors used for prevention of developing post-resection acute liver failure after extensive hemihepatectomy due to colorectal cancer metastases
During the current study, a pharmacoeconomic assessment of liver failure prevention after using Remaxol® (succinic acid, N-methylglucamine, inosine, methionine, nicotinamide – hereinafter SMIMN) vs. ademetionine was performed in patients with extensive liver resection. As a primary efficacy endpoint, a number of patients needed to treat (NNT) to reach a Child-Pugh Grade A liver functional state was used while analyzing therapeutic efficacy. In the clinical study, Khoronenko et al. demonstrated, that efficacy of SMIMN was higher than ademetionine in restoring liver functional state. On Day 5 and 12 after liver resection cost-effectiveness ratio measured in SMIMN vs. ademetionine groups was 39,624 vs. 96,634 Rub and 34,661 vs. 55,236 Rub, respectively, favoring conclusion that use of SMIMN exhibiting higher efficacy is a dominant approach for preventing acute liver failure (ALF) after extensive liver resection. Budget Impact Analysis revealed that budget savings after treatment with SMIMN vs. ademetionine were 11,831,861 Rub per 1,083 patients, and within a fixed budget, it allowed additionally to treat up to 427 patients
Pharmacoeconomic analysis of medicines used in the treatment of pulmonary hypertension in the Russian Federation
This article provides a comparative pharmacoeconomic evaluation of ambrisentan and bosentan used in the treatment of patients with functional class II or III pulmonary arterial hypertension (PAH) in Russia. The evaluation included methods of cost analysis, cost -minimization analysis, cost-utility analysis and budget impact analysis. The cost analysis revealed that the Volibris (ambrisentan) and Tracleer (bosentan) – associated costs, based on the per-patient per year treatment cost for one patient with PAH regardless of its functional class, were 1 585 649 rubles and 2 488 878 rubles, respectively. The results of cost-minimization analysis, based on the assumption of equal effectiveness of compared drugs, have shown that the per-patient per year treatment costs for Volibris (ambrisentan) allow cost savings of 909 789 rubles as compared to Tracleer (bosentan). The values of a cost-utility analysis for Volibris (ambrisentan) appeared to be lower than those for Tracleer (bosentan). For the former, depending on the functional class of the disease and drug dosage, the values of a cost-utility analysis varied from 2 321 771 rubles to 3 535 685 rubles per QALY, whereas for Tracleer (bosentan) the corresponding values were 4 335 477 rubles and 5 718 143 rubles per QALY in patients with functional class II PAH and functional class III PAH, respectively. The budget impact analysis, based on the estimated number of patients with PAH in RF of 3292 subjects, has shown that the total annual costs for Tracleer (bosentan) would be 8,193 billion rubles versus 5,219 billion rubles had the same patients been treated with Volibris (ambrisentan). Therefore, the possible cost savings with Volibris (ambrisentan) would be 2,973 billion rubles had it been used instead of Tracleer (bosentan), thus indicating that from the pharmacoeconomic perspective treatment with Volibris (ambrisentan) is a dominant choice.
The treatment of multiple sclerosis (MS) is a formidable healthcare challenge the world over. Because MS is a progressive chronic disease, patients living with this diagnosis require treatment for life. The high prevalence of the disease among young people significantly affects patients’ quality of life and exacerbates the socioeconomic burden of the disease. Glatiramer acetate (Copaxone) is a synthetic analogue of the myelin protein that can influence MS pathogenesis with its immunomodulatory and neuroprotective effect. Copaxone has been continuously, safely used in clinical practice for more than 20 years. In terms of tolerance of Copaxone, the main challenge has been the adverse injection reactions associated with daily subcutaneous injection of a 20 mg/mL dose of the drug. To address this, a new pharmaceutical form was developed – Copaxone 40 mg/mL, which requires subcutaneous injection only three times a week. Both dosage regimens have comparable clinical efficacy, but differ in tolerance. Use of Copaxone 40 versus Copaxone 20 was associated with 50% fewer adverse injection reactions . This suggested a need to conduct pharmacoeconomic research with the goal of producing a pharmacoeconomic assessment of Copaxone 40 versus Copaxone 20. The analysis that was conducted using the “cost minimization” analysis determined that the Copaxone 40 treatment method had lower associated costs than did the Copaxone 20 treatment method. The results of a budget impact analysis indicated that, if all patients in the RF [Russian Federation] currently receiving Copaxone 20 were to switch to therapy using the drug Copaxone 40, a cost savings of 812 million roubles would result in lower adverse reaction treatment costs. These savings would be due to the 209 fewer injections per patient per year that would be achieved by prescribing Copaxone 40, and consequently, the lower number of injection reactions.
Analysis of costs of medicinal product lanreotide (somatuline® autogel®) in the treatment of pnet degree grade 1 or 2 (with tumor proliferation index [KI-67]<10%), in adult patients with non-functioning non-metastatic or metastatic tumors
Analysis of costs of using lanreotide in patients with GEP-NETs grade 1 or 2 originating from the pancreas(with tumor proliferation index of [Ki-67] <10%) was carried out in this study. Targeted drugs with indications for treatment of pancreatic NETs in the Russian Federation were used for comparison: sunitinib and everolimus. Pharmacoeconomic study was carried out using methods of «cost-effectiveness» analysis including a sensitivity analysis. The study considered the direct costs which included the costs of treatment and the methods of diagnosis according guidelines of RUSSCO (MRI, biopsy and biochemistry blood analysis). As a result, it was found that the average cost of main pharmacotherapy per patient annually using lanreotide is lower than the average cost of treatment using sunitinib or everolimus by 55.2% and 51.9% (845 000 roubles, 1,886,991 roubles and 1758 443 roubles), respectively. This pharmacoeconomic analysis showed that the average total cost of the main drug treatment and medical care services in the treatment of pancreatic NETs using lanreotide is 886,036 roubles. That is lower than the total cost of treatment using sunitinib (1,928,027 roubles) or everolimus ( 1,799,479 roubles) by 54.0% and 50.8%, respectively. When analyzing the ‘cost effectiveness’, progression-free survival (PFS) was chosen as an efficiency criterion. Considering the results of «cost - effectiveness» analysis, the use of lanreotide for the treatment of pancreatic NETs has a significant advantage over therapy using sunitinib or everolimus in terms of median progression-free survival (PFS), CER of lanreotide is lower than CERof sunitinib and CER of everolimus (73 836 rub/month, 160 660 rub/month and 149 957 rub/month respectively) i.e., lanreotide is the option in treatment. This study has limitations due to study design (lareotide open label study) and difference in population between lanreotide study and sunitinib and everolimus studies.
Methodological basis of assessment of quality of scientific evidence using the grading of recommendations assessment, development and evaluation approach
Grading of Recommendations Assessment, Development and Evaluation approach is a method of assessing the certainty in evidence and it is used in systematic reviews, health technology assessment and clinical guidelines development. In this article authors cover the process of making this assessment, the criteria of grading the evidence, determining the quality and strength of evidence.