scholarly journals Pharmacoeconomic aspects of the therapy for moderate and severe psoriatic arthritis

Author(s):  
A. V. Rudakova ◽  
D. G. Tolkacheva ◽  
V. D. Sokolova

Objective: to perform cost-effectiveness analysis of the treatment for adult patients with psoriatic arthritis (PsA) with a Russian interleukin- 17А inhibitor netakimab in comparison with other biologic disease-modifying antirheumatic drugs (bDMARDs) and targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs) and to evaluate the influence of the inclusion of netakimab in the therapy for PsA on the budget of the Russian healthcare system.Material and methods. The evaluation of cost-effectiveness was performed from the position of the Russian healthcare system for patients with moderate and severe PsA. The evaluation was performed based on the results of the network meta-analysis of the randomized clinical studies. The criterion of clinical effectiveness included the changes in the condition of the joints by the criteria of the American College of Rheumatology (ACR20, ACR50, and ACR70) and changes in skin symptoms by the index of the prevalence and severity of psoriasis (PASI 75 and PASI 90) with a recalculation into quality-adjusted life-year (QALY). The time horizon of the cost-effectiveness analysis was 2 years. The calculation was based on the registered prices and VAT. If there was an original drug and a biosimilar registered on the pharmaceutical market, the calculation was based on the median of the registered prices. The budget impact analysis of the influence of netakimab inclusion in the therapy for patients with PsA was performed considering the structure of the prescription of bDMARDs and tsDMARDs that was determined in the pharmaco-epidemiological study conducted in the Russian Federation in 2020. The analysis was performed for patients that received medication by the scheme of reimbursement. The time horizon of the study was 3 years old.Results. In the base-case analysis, the cost-effectiveness ratio for netakimab was 1.210 mln rub/QALY (by 66.2–88.5% lower than in cases when comparison drugs were used). The budget impact analysis showed that the inclusion of netakimab in the therapy for PsA could reduce the costs by 376.60 mln rub (21.1%). Considering budget saving, the number of additional patients that can be treated will increase by 26.7% within 3 years.Conclusion. Netakimab is characterized by higher cost-effectiveness in comparison with other bDMARDs (adalimumab, golimumab, guselkumab, ixekizumab, infliximab, secukinumab, ustekinumab, certolizumab pegol, etanercept) and tsDMARDs (apremilast, tofacitinib) prescribed in the Russian Federation for patients with PsA. The inclusion of netakimab in the therapy for PsA will reduce the financial burden on the healthcare system.

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e039057
Author(s):  
Lisa A de Jong ◽  
Annette W G van der Velden ◽  
Marinus van Hulst ◽  
Maarten J Postma

ObjectivesIn the ‘Comparison of an Oral Factor Xa Inhibitor With Low Molecular Weight Heparin in Patients With Cancer With Venous Thromboembolism’ (SELECT-D) trial, rivaroxaban showed relatively low venous thromboembolism (VTE) recurrence but higher bleeding compared with dalteparin in patients with cancer. We aim to calculate the cost-effectiveness and budget impact of rivaroxaban compared with dalteparin in patients with cancer at risk of recurrent VTE.SettingWe built a Markov model to calculate the cost-effectiveness from a societal perspective over a 5-year time horizon for the Dutch healthcare setting.ParticipantsA hypothetical cohort of 1000 cancer patients with VTE entered the model with baseline characteristics based on the SELECT-D trial.InterventionSix months of treatment with rivaroxaban (15 mg two times per day for first 3 weeks followed by 20 mg once daily) was compared with 6 months of treatment with dalteparin (200 IU/kg daily during month 1 followed by 150 IU/kg daily).Primary and secondary outcome measuresThe primary outcome of the cost-effectiveness analysis was the incremental cost-effectiveness ratio (ICER). The robustness of the model was evaluated in probabilistic and univariate sensitivity analyses. A budget impact analysis was performed to calculate the total annual financial consequences for a societal perspective in the Netherlands.ResultsIn the base case and all scenarios, rivaroxaban were cost-saving while also slightly improving the patient’s health, resulting in economically dominant ICERs. In the probabilistic sensitivity analysis, 77.8% and 98.7% of the simulations showed rivaroxaban to be cost-saving and more effective for a 5-year and 6-month time horizon, respectively. Rivaroxaban can save up to €11 326 763 (CI €5 164 254 to €17 363 231) in approximately 8000 cancer patients with VTE per year compared with dalteparin based on a 1-year time horizon.ConclusionsTreatment with rivaroxaban is economically dominant over dalteparin in patients with cancer at risk for recurrent VTE in the Netherlands. The use of rivaroxaban instead of dalteparin can save over €10 million per year, primarily driven by the difference in drug costs.


Author(s):  
Paolo Angelo Cortesi ◽  
Damiano Paolicelli ◽  
Marco Capobianco ◽  
Paolo Cozzolino ◽  
Lorenzo Giovanni Mantovani

INTRODUCTION: The availability of ocrelizumab for the relapsing forms of multiple sclerosis (MS) in the Italian markets raised some questions about its economic impact and value compared to the alternative treatment options available.AIM: To assess the cost-effectiveness and budget impact of ocrelizumab compared to the most used second line disease modifying therapies (DMTs) in Italy.METHODS: The study was divided in two phases: Phase 1 – based on the development of a decision analytical Markov model to assess the cost-effectiveness of ocrelizumab compared to natalizumab and fingolimod, and Phase 2 – based on the development of a budget impact model to assess the economic impact of ocrelizumab in Italy. Both models used the National Health System perspective; a lifetime horizon was applied in the cost-effectiveness analysis and a 3-year time horizon in the budget impact. The cost-effectiveness analysis results were reported as incremental cost-effectiveness ratio (ICER) expressed as € per Quality Adjusted Life Year (QALY) gained, the budget impact analysis results were reported as difference in the overall budget (€) between a scenario with and without ocrelizumab.RESULTS: The two analyses reported ocrelizumab as a cost-effective option compared to natalizumab and fingolimod with a positive impact on the overall NHS budget. In the base-case analysis, the ICER was € 2,023 for ocrelizumab compared to fingolimod; while ocrelizumab resulted cost-saving compared to natalizumab. The sensitivity analysis confirmed the base-case analysis results. Further, the use of ocrelizumab was associated to a budget decrease of € 21 million (-2.6%) in a 3-year time horizon.CONCLUSION: The results of our cost-effectiveness and budget impact models reported ocrelizumab as an effective and efficient treatment in patients with relapsing forms of MS who failed a first line DMTs from the Italian NHS perspective.


Author(s):  
I. A. Vilyum ◽  
B. V. Andreev ◽  
M. A. Proskurin ◽  
Yu. E. Balykina

The aim: to provide a comprehensive pharmacoeconomic evaluation of the maintenance therapy with antipsychotics in outpatients diagnosed with schizophrenia.Materials and methods. The analysis was conducted by two mutually complementary steps: an epidemiological study on outpatients with schizophrenia, and a subsequent pharmacoeconomic modeling. Two medical technologies were evaluated and compared: treatment with classical antipsychotics (kA) and treatment with atypical antipsychotics (AA). For the clinical and economic analysis of these treatments, we used a number of indices derived from our retrospective study of patients’ medical records. The cost-effectiveness analysis, incremental analysis, and «budget impact» analysis were performed taking into account the direct and indirect costs of the treatments.Results. We determined the costs of managing outpatients with schizophrenia from the perspective of the healthcare budget and the social burdens; we also looked into the relevance and effectiveness of the current costs at various time intervals – 6, 12 and 24 months. As shown, the treatment strategies involving AA were more budget-consumptive than the kA treatments. even if the treatments were switched to the reproduced AA (up to 100% replacement), the costs would remain to be higher than those for the kA. The «cost-effectiveness» analysis related to «the proportion of stable patients» for the horizons of 6 and 12 months indicated that the reproduced AA would be more economically effective than the kA. However, when the observation period was increased to 24 months, this economic advantage of AA diminished, and the kA drugs had a lower CeR instead. For the «number of hospitalization-free days per year», the use of AA was more cost-effective only versus the 100% use of reproduced AA at the simulated horizon of 12 months. When the use of 100% reference AA or the combined use of reference + reproduced AA was simulated, the treatment with kA remained more economically effective, regardless of the simulated period.Conclusion. The pharmacoeconomic simulation of the antipsychotic therapy in outpatients with schizophrenia suggests the ways to optimize the treatment. Among them, (a) using AA for the treatment of at least 15.6% of patients (those who are employed); keeping the ≥60% use of kA to ensure the optimal resource-saving effect of the treatment; (b) using reproduced AA at the level of ≥70% (instead of the reference AA similar in efficacy and safety) to keep the treatment economically feasible. 


2020 ◽  
Vol 15 (1) ◽  
pp. 73-82
Author(s):  
A. V. Rudakova ◽  
E. A. Stadnik

Background. Currently, treatment of recurrent / refractory chronic lymphocytic leukemia (CLL) involves the appointment of regimens with innovative drugs, which include ibrutinib and a combination of venetoclax and rituximab. Wherein said combination provides continuing over time high frequency eradication of minimal residual disease. Thereby, this regimen can be canceled if patients do not progress after 2 years from therapy start.The objective of the study was to assess the pharmacoeconomic aspects of therapy with venetoclax and rituximab combination in patients with recurrent / refractory CLL compared with ibrutinib monotherapy.Materials and methods. Analysis was performed by a simulation method from a position of the health care system. In accordance with network meta-analysis results of clinical studies in the recurrent / refractory CLL treatment (MURANO for venetoclax + rituximab combination and RESONATE and HELIOS for ibrutinib), which showed the absence of statistically significant differences in progression-free and overall survival between these treatment options, the cost-minimization method was used in the analysis. In the basic version, the model time horizon is 4 years. The price of venetoclax, rituximab and ibrutinib in the calculation corresponded to that registered (for rituximab – the median of the registered prices) with the value-added tax and the weighted average wholesale allowance taking into account the population in Russia.When analyzing the healthcare system budget impact, the time horizon of the study was 4 years. Therapy with combination of venetoclax + rituximab starting from the first year was suggested in 100 % of newly identified recurrent / refractory CLL patients. In the base case, it was estimated that 100 patients would need therapy every year.In the basic version of analysis, the cost of therapy after progression was not taken into account. In sensitivity analysis, an option taking into account therapy cost after progression, suggesting the appointment of venetoclax in the ibrutinib group and ibrutinib in the venetoclax + rituximab group, was also evaluated. In addition, variants with disease progression were additionally evaluated in 15 % of patients per year in the venetoclax therapy group at the end of the 2-year treatment course, as well as with an increase and decrease in the disease progression rate by 15 % in both comparison groups.As part of the sensitivity analysis, an assessment is made of a 15 % decrease and increase in Venetoclax price, a 30 % decrease in Ibrutinib price compared to registered price and the option with a 3-year study time horizon. When analyzing the budget impact, options with an increase in the number of patients annually identified and requiring treatment by 10, 20, 30 and 50 % were evaluated. Clinical and economic analysis was carried out with a discount rate of 3.5 % per year. A budget impact analysis was performed without discounting.Results. According to the results of cost-effectiveness analysis in the basic version, a regimen including venetoclax can reduce costs by 46.3 % compared with ibrutinib (cost for 4 years per patient is 10.422 and 19.413 million rubles, respectively). Therapy with combination of venetoclax + rituximab in 100 newly identified recurrent / refractory CLL patients annually instead of ibrutinib monotherapy will result in a reduction in therapy costs by 29.0 %, or by 1.579 billion rubles for 4 years per 100 patients starting therapy annually. The sensitivity analysis demonstrated the high reliability of the results. Conclusion. The treatment of recurrent / refractory CLL with a combination of venetoclax and rituximab is comparable in clinical efficacy with ibrutinib monotherapy and can significantly reduce the cost of the healthcare system, and therefore increase the availability of innovative therapy for this group of patients.


2021 ◽  
pp. 28-35
Author(s):  
E. G. Fedina ◽  
K. A. Perova ◽  
T. S. Teptsova ◽  
D. S. Shchurov

The study aims to estimate the MitraClip system’s cost-effectiveness compared with optimal medical therapy in adult patients with inoperable mitral regurgitation and assess its impact on the budget of the Russian Federation health system.Materials and methods. The cost-effectiveness analysis of the MitraClip system was carried out using the Markov model. The time horizon was three & five years. The budget impact analysis (BIA) model compared the costs of treating patients distributed across different management practices. Standard management practice included only optimal medical therapy. Expected management practice included different patient allocation between the MitraClip system and optimal medical therapy. The time horizon for the budget impact analysis was five years. Results. The incremental cost-effectiveness ratio (ICER) per additional quality-adjusted life-year (QALY) gained of the MitraClip system in comparison with optimal medical therapy was 6,271,657 rubles in three years and 3,451,342 rubles in five years. Based on the BIA results of the MitraClip system, its use would lead to an increase in costs by 12.6 billion rubles (+6.09%, minimal scenario), by 37.8 billion rubles (+18.28%, optimal scenario) or by 63 billion rubles (+30.47%, maximum scenario).Conclusion. As a result of the analysis performed, it was found that economic efficiency is noted with an increasing time horizon of up to five years. The obtained ICER values are comparable with the average values obtained in other foreign cost-effectiveness studies. The use of this technology will lead to an increase in direct medical costs by 6.09% over five years compared to the current management practice. In more comprehensive MitraClip system implementation (maximum scenario), direct medical costs will increase by 30.47% compared to the current management practice.


2021 ◽  
Vol 9 (E) ◽  
pp. 1182-1189
Author(s):  
Olga Krylova ◽  
Anatoliy Krasheninnikov ◽  
Elza Mamontova ◽  
Galina Tananakina ◽  
D. Belyakova

BACKGROUND: In March 2020, the coronavirus disease (COVID-19) infection was assigned the status of a pandemic. As of the beginning of 2021, the Russian Federation ranks fourth in terms of the prevalence of coronavirus infection. Over the period from March 2020 to February 2021, more than 84,000 fatal cases of the disease were recorded in Russia. AIM: However, at the moment, there are no medications with proven effectiveness and safety against the novel coronavirus infection. In this regard, the purpose of our study was to conduct a pharmacoeconomic analysis of medications for etiotropic therapy of all forms of COVID-19 recommended by the Ministry of Health of the Russian Federation (clinical guidelines, version 10 dated February 8, 2021) to identify the best treatment option. MATERIALS AND METHODS: In the course of the study, the “cost of illness” was determined for all forms of the disease in an outpatient and inpatient setting. The authors took into account the direct medical costs of medication therapy and diagnostic and treatment procedures. In terms of direct non-medical costs, they calculated the cost of a bed-day excluding medication treatment, and indirect costs included payments for temporary disability sheets. Costs for medications were calculated based on the active ingredient (AI) and the packages for treatment on an outpatient basis and in the case of the hospital setting based on the AI only. The cost of medical and diagnostic procedures was determined based on the Tariff Agreement for 2020 dated December 30, 2019. Next, a cost-effectiveness analysis was performed. Effectiveness criteria were selected based on published clinical trial results for the medications in question. Then, they performed a calculation of the cost-effectiveness coefficients and an incremental analysis. RESULTS: Thus, in the course of the analysis of the cost of illness, the most economically profitable treatment regimens were the ones with hydroxychloroquine both for outpatient treatment (13,150.31 rubles: Mild form, 22,326.44 rubles: Moderate form excluding antibiotic therapy, and 21,513.76 rubles: Moderate form, taking into account antibacterial therapy) and for inpatient treatment (34,441.53 rubles). CONCLUSION: As a result of the cost-effectiveness analysis, the use of favipiravir can be considered optimal (comparative effectiveness research = 17,607.14 rubles), and for the mild form, the optimal medication is umifenovir, since during the incremental analysis, it was found that for therapy with favipiravir, 100 people would need an additional allocation of 96.291 rubles, which, given the form of the disease, is not entirely appropriate.


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