Pochuprina Anastasia Alexandrovna
Recent market entry of disease-modifying anti-rheumatic drugs (DMARDs) for patients with rheumatoid arthritis (RA) who had an inadequate response to methotrexate in Russia has secured patient access to highly effective treatment options. Access to effective treatment options are of particular importance for highly prevalent conditions with early function impairment such as RA. Innovative medicines, such as DMARDs, are however typically characterized by high treatment costs and require pharmacoeconomic assessment as part of the decision making process regarding federal reimbursement. In the present study, adaptation of an Italian health economic model was performed with the aim to compare cost-efficacy of subcutaneous abatacept versus adalimumab from the Russian Federation national health care system perspective. Clinical efficacy data as well as patient characteristics were based on the AMPLE trial patient population, which was a direct headto-head comparison of subcutaneous abatacept and adalimumab in RA. The time horizon was set at 2 years, which corresponds with the length of the AMPLE study. Direct medical costs included pharmaceutical costs based on the registered maximum selling prices, cost of adverse event treatment, outpatient and inpatient treatment, and diagnostic and laboratory monitoring costs (Rubles, 2015). Results showed that the total 2-year costs of treating 100 patients were 143,750,205.87 rubles for abatacept compared with 165,749,479.26 rubles for adalimumab, at a total cost-savings of treating an entire cohort with abatacept equal to 21,999,273.38 rubles or 219,992.73 rubles per patient. The cost-effectiveness ratios across all disease activity measures (ACR 20, 50, 70, 90; DAS-28; HAQ-DI; CDAI; SDAI) demonstrated that abatacept compared to adalimumab had a lower cost per health outcome. Therefore, from a pharmacoeconomic point of view, subcutaneous abatacept is most likely a preferable alternative compared with adalimumab for the treatment of RA patients in the Russian Federation.
In this study we conducted pharmacoeconomic assessment of the use of canakinumab in patients with cryopyrin-associated periodic syndromes (CAPS) versus the symptomatic treatment alone. Incidence of remission in the treatment group was selected as the efficacy endpoint, and superior efficacy of canakinumab was demonstrated in the treatment group as compared to the symptomatic treatment. Based on cost-effectiveness analysis, it was determined that canakinumab treatment required considerable expenses; however, due to the small number of patients the impact on overall budget will be insignificant. It should also be noted that the treatment with this medicinal product will help reduce the costs of out-patient and policlinic care, in-patient medical care, as well as administration-related and complications management costs.
Main presentations and educational seminars which took place during Annual European congress of International Society For Pharmacoeconomics and Outcomes Research (ISPOR) are covered
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease, which, in the cases of high activity, results in extensive damage to various tissues and organs, as well as promotes early patient disability. Most drugs used for the treatment of SLE are currently prescribed off-label, since this specific indication is not reflected in their prescribing information. At the same time, the advent of belimumab (Benlysta®), an innovative biological product for the treatment of SLE, which represents the most severe connective tissue disorder, provided patients with an access to a highly effective targeted therapy, which specifically impacts one of the main mechanisms of the disease. The innovative and proprietary product, Belimumab, has a relatively high cost, which, as the healthcare budget is restricted, requires that a pharmacoeconomic evaluation be completed of combined use of belimumab with standard of care (SoC) versus SoC alone. The present study showed that the use of belimumab combined with SoC in patients with SLE was, clearly, associated with additional costs compared to SoC alone. However, given low incidence of the condition, the overall increase in costs is unlikely to be significant. On the other hand, it was noted that the high belimumab efficacy resulted in lower direct costs of treating the SLE (cardiovascular, cutaneous, and pulmonary) complications, as well as the costs of hospital care. A comparative analysis has demonstrated that the annual cost of treatment with belimumab was similar to the cost of other genetically engineered biological products, which have already been included into the List of Vital and Essential Drugs used for rheumatic diseases, particularly rheumatoid arthritis. In this view, the use of belimumab, which represents the only targeted drug for SLE, could be considered during the review of policy for subsidised drug provision to patients with this condition.
Pharmacoeconomic evaluation of patients with BRAF mutation-positive melanoma treatment with dabrafenib and vemurafenib was conducted in the present study. When analyzing the costs required per one year of the therapy with the drugs being compared, it was established that treatment with dabrafenib was 28% less expensive in comparison with vemurafenib, and the differences in the cost per patient per year was 1,633,622 RUB. The budget impact analysis has shown that dabrafenib comparing to vemurafenib treatment to may reduce budget costs by 1,268,108 RUB per patient within first one year. The results based on data from previous clinical studies have shown that treatment with dabrafenib reduces costs by 35% as compared to the therapy with vemurafenib. Analysis demonstrated that throughout the projected cohort of patients (1245 patients), requiring BRAF-kinase inhibitors treatment, dabrafenib treatment allows to treat additional 680 patients in comparison with vemurafenib within the period before the beginning of progression. Therefore, dabrafenib therapy is preferred treatment option for patients with BRAF mutation-positive advanced and unresectable melanoma in Russian Federation.
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
Basal cell carcinoma (BCC) is the most common non-melanocytic skin cancer and is a tumor of the basal layer of the epidermis and hair follicles. Patients with a history of locally advanced or metastatic forms of BPC, undergo surgical treatment or radiation therapy. Until now, in the absence of the effectiveness of these methods, palliative medical care was provided to the patient with CCB. The emergence of a molecular-directed drug, vismodegib (Erivedge ™), opens up new prospects for the treatment of these forms of BPC and requires justification of its use in BPC patients with the help of health technology assessment (HTA). In the decision-making process regarding the implementation of this treatment method for patients with locally advanced and metastatic BPC, it is necessary to take into account both economic, clinical components and social significance, since the use of vismodehyb represents the only possibility of treating patients with these forms of BPC, surgical method and radiation therapy is not applicable.
Main presentations and educational seminars which took place during Annual European congress of International Society For Pharmacoeconomics and Outcomes Research (ISPOR) are covered
In this study we conducted pharmacoeconomic assessment of the use of canakinumab in patients with cryopyrin-associated periodic syndromes (CAPS) versus the symptomatic treatment alone. Incidence of remission in the treatment group was selected as the efficacy endpoint, and superior efficacy of canakinumab was demonstrated in the treatment group as compared to the symptomatic treatment. Based on cost-effectiveness analysis, it was determined that canakinumab treatment required considerable expenses; however, due to the small number of patients the impact on overall budget will be insignificant. It should also be noted that the treatment with this medicinal product will help reduce the costs of out-patient and policlinic care, in-patient medical care, as well as administration-related and complications management costs.
Recent market entry of disease-modifying anti-rheumatic drugs (DMARDs) for patients with rheumatoid arthritis (RA) who had an inadequate response to methotrexate in Russia has secured patient access to highly effective treatment options. Access to effective treatment options are of particular importance for highly prevalent conditions with early function impairment such as RA. Innovative medicines, such as DMARDs, are however typically characterized by high treatment costs and require pharmacoeconomic assessment as part of the decision making process regarding federal reimbursement. In the present study, adaptation of an Italian health economic model was performed with the aim to compare cost-efficacy of subcutaneous abatacept versus adalimumab from the Russian Federation national health care system perspective. Clinical efficacy data as well as patient characteristics were based on the AMPLE trial patient population, which was a direct headto-head comparison of subcutaneous abatacept and adalimumab in RA. The time horizon was set at 2 years, which corresponds with the length of the AMPLE study. Direct medical costs included pharmaceutical costs based on the registered maximum selling prices, cost of adverse event treatment, outpatient and inpatient treatment, and diagnostic and laboratory monitoring costs (Rubles, 2015). Results showed that the total 2-year costs of treating 100 patients were 143,750,205.87 rubles for abatacept compared with 165,749,479.26 rubles for adalimumab, at a total cost-savings of treating an entire cohort with abatacept equal to 21,999,273.38 rubles or 219,992.73 rubles per patient. The cost-effectiveness ratios across all disease activity measures (ACR 20, 50, 70, 90; DAS-28; HAQ-DI; CDAI; SDAI) demonstrated that abatacept compared to adalimumab had a lower cost per health outcome. Therefore, from a pharmacoeconomic point of view, subcutaneous abatacept is most likely a preferable alternative compared with adalimumab for the treatment of RA patients in the Russian Federation.
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease, which, in the cases of high activity, results in extensive damage to various tissues and organs, as well as promotes early patient disability. Most drugs used for the treatment of SLE are currently prescribed off-label, since this specific indication is not reflected in their prescribing information. At the same time, the advent of belimumab (Benlysta®), an innovative biological product for the treatment of SLE, which represents the most severe connective tissue disorder, provided patients with an access to a highly effective targeted therapy, which specifically impacts one of the main mechanisms of the disease. The innovative and proprietary product, Belimumab, has a relatively high cost, which, as the healthcare budget is restricted, requires that a pharmacoeconomic evaluation be completed of combined use of belimumab with standard of care (SoC) versus SoC alone. The present study showed that the use of belimumab combined with SoC in patients with SLE was, clearly, associated with additional costs compared to SoC alone. However, given low incidence of the condition, the overall increase in costs is unlikely to be significant. On the other hand, it was noted that the high belimumab efficacy resulted in lower direct costs of treating the SLE (cardiovascular, cutaneous, and pulmonary) complications, as well as the costs of hospital care. A comparative analysis has demonstrated that the annual cost of treatment with belimumab was similar to the cost of other genetically engineered biological products, which have already been included into the List of Vital and Essential Drugs used for rheumatic diseases, particularly rheumatoid arthritis. In this view, the use of belimumab, which represents the only targeted drug for SLE, could be considered during the review of policy for subsidised drug provision to patients with this condition.
Pharmacoeconomic evaluation of patients with BRAF mutation-positive melanoma treatment with dabrafenib and vemurafenib was conducted in the present study. When analyzing the costs required per one year of the therapy with the drugs being compared, it was established that treatment with dabrafenib was 28% less expensive in comparison with vemurafenib, and the differences in the cost per patient per year was 1,633,622 RUB. The budget impact analysis has shown that dabrafenib comparing to vemurafenib treatment to may reduce budget costs by 1,268,108 RUB per patient within first one year. The results based on data from previous clinical studies have shown that treatment with dabrafenib reduces costs by 35% as compared to the therapy with vemurafenib. Analysis demonstrated that throughout the projected cohort of patients (1245 patients), requiring BRAF-kinase inhibitors treatment, dabrafenib treatment allows to treat additional 680 patients in comparison with vemurafenib within the period before the beginning of progression. Therefore, dabrafenib therapy is preferred treatment option for patients with BRAF mutation-positive advanced and unresectable melanoma in Russian Federation.
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
Basal cell carcinoma (BCC) is the most common non-melanocytic skin cancer and is a tumor of the basal layer of the epidermis and hair follicles. Patients with a history of locally advanced or metastatic forms of BPC, undergo surgical treatment or radiation therapy. Until now, in the absence of the effectiveness of these methods, palliative medical care was provided to the patient with CCB. The emergence of a molecular-directed drug, vismodegib (Erivedge ™), opens up new prospects for the treatment of these forms of BPC and requires justification of its use in BPC patients with the help of health technology assessment (HTA). In the decision-making process regarding the implementation of this treatment method for patients with locally advanced and metastatic BPC, it is necessary to take into account both economic, clinical components and social significance, since the use of vismodehyb represents the only possibility of treating patients with these forms of BPC, surgical method and radiation therapy is not applicable.
