Novikov Igor Valerievich

Kulikov A.Y., Novikov I.V. 1848

The goal of this analysis is to evaluate the incremental cost-utility of insulin degludec compared with glargine in patients with type 2 diabetes receiving basal-only therapy in addition to metformin as per prescribing conditions in the Russia. Total medical costs and effectiveness in terms of QALY were collected and analysed for insulin degludec and insulin glargine, both in combination with metformin. Sources of data: the effectiveness - the analysis of publications of clinical studies, drug prices - register for the prices of the VED, the cost of health care resources - standard providing outpatient services. Results: The analysis illustrates that insulin degludec for type 2 diabetes provides a significant health improvement expressed in quality adjusted lifeyears. The ICUR of insulin degludec in combination with metformin compared to insulin glargine, both added to metformin was estimated at 337 112 rub for QALY which demonstrates its cost-effectiveness.

Kulikov A.Y., Novikov I.V. 1760

Study purpose: To determine preferential medicinal products for the treatment of diabetes mellitus type 2 in terms of pharmacoeconomic analysis based on comparative cost and efficacy, safety and quality of life ratio between the modern insulin analogues.

Materials and methods: Study design – retrospective, modeling. Methods of pharmacoeconomic analysis - cost-effectiveness, costutility. Alternatives compared – insulin aspart (NovoRapid®), insulin lispro (Humalog®), insulin glulisine (Apidra®), premix insulin aspart 30/70 (NovoMix® 30), premix insulin lispro 25/75 (HumalogMix® 25), insulin detemir (Levemir®) and insulin glargine (Lantus®).

Data sources: efficacy – analysis of publications on clinical studies performed; medicinal product prices – registry of quoted prices for vital and essential medicines; cost of healthcare resources – outpatient and polyclinical assistance standards.

Study results: Among short-acting insulin analogues, CER value was 1091.84 rub.; 1133.55 rub. and 1175,27 rub. for NovoRapid®, Humalog® and Apidra®, respectively. Among premix insulin analogues, CER value was 1418.47 rub. for NovoMix® 30 and 1512.08 rub. for HumalogMix® 25. Among basal insulin analogues CER value was 2084.39 rub. for Levemir® and 2471.23 rub. – for Lantus®. Costutility analysis for NovoRapid®, Humalog®, Apidra®, NovoMix® 30, HumalogMix® 25, Levemir® and Lantus® CUR value was 84463.04 rub., 87689.69 rub., 90917.35 rub., 99573.21 rub., 106144.38 rub., 79269.45 rub. and 93981.16 rub. for 1 QALY, respectively. Therefore, in terms of costutility, when insulins were added to OAD treatment, NovoRapid® is the preferable drug because of the lowest CUR value. Among premix and basal insulin analogues, NovoMix® 30 and Levemir® were preferable drugs because of the lowest CUR values in their group.

Arinina E.E., Kulikov A.Y., Novikov I.V., Tolkushin A.G. 1675

Study objective: To perform a comparative pharmacoeconomic analysis of the therapy combinations: sitagliptin with metformin, and sulfonylureas with metformin in patients with type 2 diabetes on metformin monotherapy whose target glycemic goal is not reached with diet and exercise.

Materials and methods: A time horizon of 10 years was used to conduct the comparative pharmacoeconomic analysis. The following were used as reference data for the calculations: drug prices, as registered in the VED [Vital Essential Drugs]; earlier publications on the cost of complications; and data on treatment outcomes and hypoglycaemia rates in comparator groups from the JADE modelling study, based upon the data from clinical study 024 for the Russian patient population.

Results: Total medical expenditures for one patient came to 449,927 rubles in the sitabliptin+metformin group, and 415,385 rubles in the sulfonylurea+metformin group – a difference of 7.7%. Within this, the share of costs for the actual drugs was 53% and 11%, respectively, indicating a greater burden due to longterm consequences (hypoglycaemia, complications from type 2 diabetes, transitioning to insulin) for the sulfonylurea group. When converted to 10,000 patients, the cost of the drugs in the sitagliptin group was 2,149 million rubles higher, and the expenditures for complications, including hypoglycaemia and insulin therapy, were 1,559 million rubles lower. Thus, in the sitagliptin group – unlike the sulfonylurea group – 410,000 cases of hypoglycaemia were prevented, as well as 40 cases of macro- and microvascular complications. Conclusion: the results suggest that the combination use of sitagliptin + metformin is pharmacoeconomically justified when compared to sulfonylurea + metformin to treat type 2 diabetes patients.

Kulikov A.Y., Novikov I.V. 1174

Title: “Pharmacoeconomic Analysis of Ryzodeg®, a Combination of Soluble Ultra-long-acting Human Insulin Analogue (Insulin Degludec) and Ultra-short Insulin Analogue (Insulin Aspart), Use in Therapy of Type 2 Diabetes” Study objective: The objective of this study was to evaluate, whether the use of the combination of basal ultra-long insulin (degludec) and ultra-short insulin (aspart) in the ratio of 70% and 30% in one injection is pharmacoeconomically justified choice for insulin therapy with basal and prandial components for type 2 diabetes mellitus patients with insufficient glycemic control, treated with maximum tolerated doses of metformin in monotherapy.
Materials and methods: Study design – retrospective, modeling. Methods of pharmacoeconomic analysis used are “cost-effectiveness” (“cost–utility”). The modeling horizon was 10 years; the discounting rate was 3%. Alternative comparators included combination of insulin degludec/insulin aspart (Ryzodeg®) and biphasic insulin aspart (NovoMix® 30).
Results: Calculated ICUR ratio showed that incremental cost of 1 additional QALY gained as a result of switching from NovoMix® 30 therapy to Ryzodeg® in addition to metformin therapy equals 519,896 rub. Comparing ICUR with WPS in the RF it can be concluded that Ryzodeg® insulin use is clinico-economically effective in comparison with biphasic insulin aspart. Pharmacoeconomic benefit of Ryzodeg® insulin reflects clinical superiority of the new insulin over the conventional biphasic insulin analogue: possibility to achieve control with a significantly better safety profile, a lower dose of insulin, less pronounced body weight changes and a flexible dosage regimen.

Kulikov A.Y., Novikov I.V. 1062

Study purpose: to determine whether canagliflozin is a pharmacoeconomically justified option to be included into therapy for patients with insufficient glycemic control and treated with metformin either as monotherapy administered in the maximum tolerated dose or as a part of a combined therapy with sulfonylurea derivatives taking into account the conditions existing in the Russian Federation.

Novikov I.V., Yagudina R.I. 503

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.

Kulikov A.Y., Makarova E.I., Novikov I.V. 47

The most dangerous consequences of the global diabetes epidemic are diabetes-related complications. A wide variety of treatment options is currently available for patients with type 2 diabetes mellitus. However, the existing treatments have proven effective for no more than half of diabetic patients who managed to compensate the occurring complications, which is the reason for introducing novel glucose-lowering medicines into practice. Sodium-glucose cotransporter 2 (SGLT2) inhibitors are a new class of innovative medicines. Dapagliflozin was the first medicine in this group to be registered on the territory of Russia. Numerous trials have confirmed the efficacy of dapagliflozin at any stage of type 2 diabetes mellitus, both as monotherapy and in combination with metformin, sulfonylureas, dipeptidyl peptidase 4 inhibitors (iDPP-4) and insulin. Thus, the wide range of available glucose-lowering drugs, lack of adequate control over the disease and introduction of novel medicines warrant a new pharmacoeconomic study. The purpose of this study was to perform a pharmacoeconomic evaluation of dapagliflozin as a preferential medicine used to treat patients with type 2 diabetes mellitus, as compared to monotherapy or combined use of medicines of the sulfonylureas, metformin, glyptins, glyflozins and insulin group, by means of a cost analysis, and cost-effectiveness and budget impact analysis. Based on the results of the cost-effectiveness analysis, the dapagliflozin treatment scheme was reported to have the lowest cost of type 2 diabetes therapy to quality adjusted life-year (QALY) ratio compared to therapy regimens involving metformin, sulfonylureas, iDPP-4, basal and bolus insulins. The budget impact analysis demonstrated that treatment using Forxiga would result in budget savings of 31 million rubles over five years, if 1000 patients were to hypothetically switch over from other treatment regimens.

Kulikov A.Y., Novikov I.V. 1848

The goal of this analysis is to evaluate the incremental cost-utility of insulin degludec compared with glargine in patients with type 2 diabetes receiving basal-only therapy in addition to metformin as per prescribing conditions in the Russia. Total medical costs and effectiveness in terms of QALY were collected and analysed for insulin degludec and insulin glargine, both in combination with metformin. Sources of data: the effectiveness - the analysis of publications of clinical studies, drug prices - register for the prices of the VED, the cost of health care resources - standard providing outpatient services. Results: The analysis illustrates that insulin degludec for type 2 diabetes provides a significant health improvement expressed in quality adjusted lifeyears. The ICUR of insulin degludec in combination with metformin compared to insulin glargine, both added to metformin was estimated at 337 112 rub for QALY which demonstrates its cost-effectiveness.

Arinina E.E., Kulikov A.Y., Novikov I.V., Tolkushin A.G. 1675

Study objective: To perform a comparative pharmacoeconomic analysis of the therapy combinations: sitagliptin with metformin, and sulfonylureas with metformin in patients with type 2 diabetes on metformin monotherapy whose target glycemic goal is not reached with diet and exercise.

Materials and methods: A time horizon of 10 years was used to conduct the comparative pharmacoeconomic analysis. The following were used as reference data for the calculations: drug prices, as registered in the VED [Vital Essential Drugs]; earlier publications on the cost of complications; and data on treatment outcomes and hypoglycaemia rates in comparator groups from the JADE modelling study, based upon the data from clinical study 024 for the Russian patient population.

Results: Total medical expenditures for one patient came to 449,927 rubles in the sitabliptin+metformin group, and 415,385 rubles in the sulfonylurea+metformin group – a difference of 7.7%. Within this, the share of costs for the actual drugs was 53% and 11%, respectively, indicating a greater burden due to longterm consequences (hypoglycaemia, complications from type 2 diabetes, transitioning to insulin) for the sulfonylurea group. When converted to 10,000 patients, the cost of the drugs in the sitagliptin group was 2,149 million rubles higher, and the expenditures for complications, including hypoglycaemia and insulin therapy, were 1,559 million rubles lower. Thus, in the sitagliptin group – unlike the sulfonylurea group – 410,000 cases of hypoglycaemia were prevented, as well as 40 cases of macro- and microvascular complications. Conclusion: the results suggest that the combination use of sitagliptin + metformin is pharmacoeconomically justified when compared to sulfonylurea + metformin to treat type 2 diabetes patients.

Kulikov A.Y., Novikov I.V. 1760

Study purpose: To determine preferential medicinal products for the treatment of diabetes mellitus type 2 in terms of pharmacoeconomic analysis based on comparative cost and efficacy, safety and quality of life ratio between the modern insulin analogues.

Materials and methods: Study design – retrospective, modeling. Methods of pharmacoeconomic analysis - cost-effectiveness, costutility. Alternatives compared – insulin aspart (NovoRapid®), insulin lispro (Humalog®), insulin glulisine (Apidra®), premix insulin aspart 30/70 (NovoMix® 30), premix insulin lispro 25/75 (HumalogMix® 25), insulin detemir (Levemir®) and insulin glargine (Lantus®).

Data sources: efficacy – analysis of publications on clinical studies performed; medicinal product prices – registry of quoted prices for vital and essential medicines; cost of healthcare resources – outpatient and polyclinical assistance standards.

Study results: Among short-acting insulin analogues, CER value was 1091.84 rub.; 1133.55 rub. and 1175,27 rub. for NovoRapid®, Humalog® and Apidra®, respectively. Among premix insulin analogues, CER value was 1418.47 rub. for NovoMix® 30 and 1512.08 rub. for HumalogMix® 25. Among basal insulin analogues CER value was 2084.39 rub. for Levemir® and 2471.23 rub. – for Lantus®. Costutility analysis for NovoRapid®, Humalog®, Apidra®, NovoMix® 30, HumalogMix® 25, Levemir® and Lantus® CUR value was 84463.04 rub., 87689.69 rub., 90917.35 rub., 99573.21 rub., 106144.38 rub., 79269.45 rub. and 93981.16 rub. for 1 QALY, respectively. Therefore, in terms of costutility, when insulins were added to OAD treatment, NovoRapid® is the preferable drug because of the lowest CUR value. Among premix and basal insulin analogues, NovoMix® 30 and Levemir® were preferable drugs because of the lowest CUR values in their group.

Kulikov A.Y., Novikov I.V. 1062

Study purpose: to determine whether canagliflozin is a pharmacoeconomically justified option to be included into therapy for patients with insufficient glycemic control and treated with metformin either as monotherapy administered in the maximum tolerated dose or as a part of a combined therapy with sulfonylurea derivatives taking into account the conditions existing in the Russian Federation.

Kulikov A.Y., Novikov I.V. 1174

Title: “Pharmacoeconomic Analysis of Ryzodeg®, a Combination of Soluble Ultra-long-acting Human Insulin Analogue (Insulin Degludec) and Ultra-short Insulin Analogue (Insulin Aspart), Use in Therapy of Type 2 Diabetes” Study objective: The objective of this study was to evaluate, whether the use of the combination of basal ultra-long insulin (degludec) and ultra-short insulin (aspart) in the ratio of 70% and 30% in one injection is pharmacoeconomically justified choice for insulin therapy with basal and prandial components for type 2 diabetes mellitus patients with insufficient glycemic control, treated with maximum tolerated doses of metformin in monotherapy.
Materials and methods: Study design – retrospective, modeling. Methods of pharmacoeconomic analysis used are “cost-effectiveness” (“cost–utility”). The modeling horizon was 10 years; the discounting rate was 3%. Alternative comparators included combination of insulin degludec/insulin aspart (Ryzodeg®) and biphasic insulin aspart (NovoMix® 30).
Results: Calculated ICUR ratio showed that incremental cost of 1 additional QALY gained as a result of switching from NovoMix® 30 therapy to Ryzodeg® in addition to metformin therapy equals 519,896 rub. Comparing ICUR with WPS in the RF it can be concluded that Ryzodeg® insulin use is clinico-economically effective in comparison with biphasic insulin aspart. Pharmacoeconomic benefit of Ryzodeg® insulin reflects clinical superiority of the new insulin over the conventional biphasic insulin analogue: possibility to achieve control with a significantly better safety profile, a lower dose of insulin, less pronounced body weight changes and a flexible dosage regimen.

Novikov I.V., Yagudina R.I. 503

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.

Kulikov A.Y., Makarova E.I., Novikov I.V. 47

The most dangerous consequences of the global diabetes epidemic are diabetes-related complications. A wide variety of treatment options is currently available for patients with type 2 diabetes mellitus. However, the existing treatments have proven effective for no more than half of diabetic patients who managed to compensate the occurring complications, which is the reason for introducing novel glucose-lowering medicines into practice. Sodium-glucose cotransporter 2 (SGLT2) inhibitors are a new class of innovative medicines. Dapagliflozin was the first medicine in this group to be registered on the territory of Russia. Numerous trials have confirmed the efficacy of dapagliflozin at any stage of type 2 diabetes mellitus, both as monotherapy and in combination with metformin, sulfonylureas, dipeptidyl peptidase 4 inhibitors (iDPP-4) and insulin. Thus, the wide range of available glucose-lowering drugs, lack of adequate control over the disease and introduction of novel medicines warrant a new pharmacoeconomic study. The purpose of this study was to perform a pharmacoeconomic evaluation of dapagliflozin as a preferential medicine used to treat patients with type 2 diabetes mellitus, as compared to monotherapy or combined use of medicines of the sulfonylureas, metformin, glyptins, glyflozins and insulin group, by means of a cost analysis, and cost-effectiveness and budget impact analysis. Based on the results of the cost-effectiveness analysis, the dapagliflozin treatment scheme was reported to have the lowest cost of type 2 diabetes therapy to quality adjusted life-year (QALY) ratio compared to therapy regimens involving metformin, sulfonylureas, iDPP-4, basal and bolus insulins. The budget impact analysis demonstrated that treatment using Forxiga would result in budget savings of 31 million rubles over five years, if 1000 patients were to hypothetically switch over from other treatment regimens.