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Cost-Effectiveness Analysis of Serelaxin in Treatment of Patients with Acute Decompensated Heart Failure
A652
VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 3 4 7 – A 7 6 6
event history with SI (Δ cost: € 38,482; Δ QALY: 1.16; ICER: € 33,191). Conclusions: Among patients with HeFH or CV event history without/with SI, evolocumab added to SOC may provide a CE option for lowering LDL-C, considering the commonly accepted thresholds in Spain of € 30,000-€ 45,000 per Δ QALY. PCV88 Cost-Effectiveness of Apixaban for The Treatment of Atrial Fibrillation Patients in The Kingdom of Saudi Arabia Osenenko KM1, Kherraf SA2, Samy IA3, Sambrook R1, Hersi A4 1ICON Epidemiology, Vancouver, BC, Canada, 2Pfizer, Dubai, United Arab Emirates, 3Pfizer, Jeddah, Saudi Arabia, 4College of Medicine, King Saud University, Riyadh, Saudi Arabia
Objectives: Atrial fibrillation (AF) is associated with considerable morbidity, mortality and healthcare costs. Apixaban, a novel oral anticoagulant, has improved efficacy and safety compared to warfarin on outcomes of stroke, systemic embolism, mortality, and reduced bleeding rates. The objective was to estimate the costeffectiveness of apixaban compared to other anticoagulants for AF treatment in the Kingdom of Saudi Arabia (KSA). Methods: A previously published lifetime Markov model (17 health states; 6-week cycles; United Kingdom [UK] setting) was adapted to the KSA Ministry of Health (MOH) perspective. The model enabled pairwise comparisons of apixaban against seven other anticoagulants. Apart from warfarin, treatment comparisons were indirect. Two subpopulations included vitamin K antagonist (VKA)-suitable and VKA-unsuitable patients. Unit costs for medications and physician visits were taken from published price lists. Due to scarcity of local cost data for clinical events, a cost ratio of 0.533, generated through comparison of UK and KSA physician visit costs, was applied to global model inputs to estimate local event costs. Background life expectancy was updated using KSA life tables, and utilities were from published sources. Costs and health benefits were discounted by 3.5% annually after the first year. Results: Apixaban was dominant versus warfarin (VKA-suitable) and rivaroxaban (VKA-suitable and VKA-unsuitable). Compared against dabigatran (110mg, 150 mg, 110/150mg blend), the incremental cost per quality-adjusted life-year (QALY) gained for apixaban was $5,166, $11,143, $10,849 (VKA-suitable) and $5,157, $14,424, $14,134 (VKA-unsuitable), respectively (2013 USD) . Cost/QALY for apixaban versus aspirin and aspirin+clopidogrel was $14,805 and $5,784 (VKA-suitable); and $10,564 and $44,203 (VKA-unsuitable), respectively. Conclusions: Apixaban may be cost-effective for AF treatment in the KSA, particularly compared to warfarin and rivaroxaban. Incremental costeffectiveness ratios for all comparisons were within conventional willingness-topay thresholds. Availability of robust local data inputs would enable refinement of apixaban cost-effectiveness estimates for AF treatment in the KSA. PCV89 Economic Evaluation of ASA 100mg, Simvastatin 40mg and Ramipril 5-10mg (POLYPILL) for Secondary Prevention of Cardiovascular Events in Mexico Kaskens L1, Gracia A1, Rodriguez Mendoza M2, Escobar Juárez Y2, Mendoza Medrano G3, Soto Molina H2 1Ferrer Internacional, Barcelona, Spain, 2HS Estudios Farmacoeconómicos S.A. de C.V., Mexico City, Mexico, 3Ferrer Mexico, México City, Mexico
Objectives: To assess the cost-effectiveness and cost-utility of AAS 100mg, simvastatin 40mg and ramipril 5-10mg (polypill), in comparison with its mono-components separately for secondary prevention of cardiovascular events with or without a recent history of MI, from the Mexican Health System perspective Methods: A cost-effectiveness and cost-utility analysis were developed through an economic Markov model, to evaluate the polypill in comparison with its mono-components separately. Effectiveness outcomes were expressed as life year’s gained and quality-adjusted life-years (QALY’s) associated with the benefits in adherence of the polypill. The study was conducted over a 20 years horizon, with a 5% discount rate. Costs were obtained from institutional sources. The direct medical costs considered were: pharmacological costs, acute adverse events and hospitalizations. Univariate and probabilistic sensitivity analyses were performed. The results were expressed as cost per life years gained and QALY’s, also incremental cost-effectiveness ratio (ICER) was calculated Results: The polypill presents 5.76175 life years gained and 4.78911 QALY’s, in comparison the life years gained with mono-components separately were 5.74624 and 4.77445 QALY’s. The polypill has a greater effectiveness compared with its mono-components with an incremental of 0.01551 life years gained and 0.01466 QALY’s. The average total cost per patient was € 11,263.55 using polypill and € 11,136.43 for mono-components, with an incremental cost of € 126.98. The ICER estimated was € 8,187.95 per life years gained and € 8,662.68 per QALY’s. Conclusions: Therefore, the polypill is a cost-effective option compared with its mono-components in the secondary prevention of cardiovascular events in adult patients with or without a recent history of MI in Mexico PCV90 Cost-Effectiveness of Rivaroxaban Within Subgroups for Atrial Fibrillation and Venous Thromboembolism in The Netherlands Gout-Zwart J1, Sediq A1, van den Bosch M2, Postma MJ1 1University of Groningen, Groningen, The Netherlands, 2Bayer BV, Mijdrecht, The Netherlands
Objectives: The discovery of novel oral anticoagulants, such as rivaroxaban, has brought new treatment options for prevention of stroke in non-valvular atrial fibrillation (NVAF) patients and treatment of (recurrent) venous thromboembolism ((r)VTE). We explored if the benefits of rivaroxaban treatment could outweigh costs, compared to current standard therapy with vitamin K antagonists (VKAs) within specific subgroups in the Netherlands. Methods: For NVAF and VTE a decision-tree was created, respectively based on the ROCKET AF and EINSTEIN pooled-analysis studies. The study was performed for a time-horizon of one year and from a healthcare payers’ perspective. For NVAF a VKA alone was used as comparator. For VTE the combination enoxaparin with acenocoumarol (23% of patients) or phenprocoumon (77% of patients) was used as comparative treatment. Both comparative treatments are guided by Dutch thrombotic services. Efficacy and safety of different drug therapies
were taken into account, together with resulting costs and (dis)utilities. Results were specified for subgroups in scenario analyses: NVAF + VTE patients (base case); NVAF and VTE patients separately; unstable NVAF patients with TTR (time in therapeutic range) < 60%. A probabilistic sensitivity analysis (PSA) was performed to investigate the influence of parameter uncertainty on the incremental cost-effectiveness ratio (ICER). Results: For the analyzed subgroups the use of rivaroxaban was cost saving and provided health gains compared to treatment with VKAs. Cost savings were highest for VTE patients, followed by unstable NVAF patients. Health gains were approximately the same for each subgroup at 0.023-0.026 quality adjusted life-years (QALY) per patient. Conclusions: From a healthcare payers perspective in the Dutch setting, rivaroxaban treatment is likely to be dominant over current standard therapy with VKAs, for the prevention of stroke in patients with (unstable) NVAF and treatment of (r)VTE. PCV91 Cost-Effectiveness of Sacubitril/ Valsartan in Chronic Heart Failure with Reduced Ejection Fraction in The Czech Republic: Analysis Based on Patient Characteristics From Randomized Clinical Trial and Local Registries Spinar J1, Klimes J2, Vesela V2, Deschaseaux C3, Haroun R3, Dostal F2, Depta J3 1University Hospital Brno, Brno, Czech Republic, 2Novartis, s.r.o., Prague, Czech Republic, 3Novartis Pharma AG, Basel, Switzerland
Objectives: Chronic heart failure (CHF) represents substantial health and economic burden to society. Fixed combination of sacubitril-valsartan; S/V for CHF with reduced ejection fraction (HF-rEF) has been approved in EU (November 2015). In the Czech Republic, HTA process for this intervention that significantly reduced patients’ mortality, morbidity and improves QoL compared to standard of care ACEi, is ongoing. We estimated cost-effectiveness of S/V vs. ACEi (+background therapy) from Czech health care system perspective. Methods: A two stage Markov cohort model (health states alive, dead), with regression models used to predict events was used. Cardio-vascular (CV) mortality from key clinical trial; PARADIGM-HF (head-tohead S/V vs. ACEi; enalapril) is estimated using parametric survival curves. Non-CV mortality is estimated using national life tables with CV-mortality removed, the hospitalisation rate using a negative binomial regression. Utility based on EQ-5D is estimated using a mixed model from PARADIGM-HF. Life-time horizon, 1-month cycle-length, 3% discount rates for cost and outcomes (QALYs) was applied. Base-line patient characteristics came from the 1) PARADIGM-HF, or local HF registries, i.e. 2) ESC-HF (Czech sub-group) and 3) AHEAD (registry of acute HF patients; sub-group of CHF). Unit costs come from local lists of reimbursed medicines, procedures and DRG codes. The cost of S/V and hospitalisation was calculated as € 5.3/day, € 2,625/ event. Results: In life-time horizon, incremental (discounted) costs, QALYs and ICERs for S/V vs. ACEi were 1) € 8.8k, 0.36 QALYs and € 24.3k; 2) € 9.1k, 0.35 QALYs and € 26.2k; and 3) € 7.6k, 0.26 QALYs and € 29.1k. According to probabilistic sensitivity analysis, there is 1) 100%; 2) 97%; 3) 95% probability that S/V ICERs is below locally applied WTP threshold (€ 45,000) compared to ACEi. Conclusions: S/V is costeffective therapy for HF-rEF compared to current standard of care (ACEi), based on various patients characteristics coming from both RCT and local registries in the Czech Republic. PCV92 Cost-Effectiveness Analysis of Serelaxin in Treatment of Patients with Acute Decompensated Heart Failure Tolordava G, Arinina E, Yagudina R, Kulikov A I.M. Sechenov First Moscow State Medical University, Moscow, Russia
Objectives: Comparative cost-effectiveness analysis of two treatment schemes for patients with acute decompensated heart failure: standard care and standard care plus serelaxin. Methods: Cost analysis was carried out on the basis of existing standards for the provision of emergency and specialized medical care to patients with heart failure in Russia. Direct costs including readmission of patients with acute decompensated heart failure within a year were calculated. The survey of Russian cardiology experts with experience in the use of serelaxin was conducted. The criterion of effectiveness in the pharmacoeconomic study was life-years gained (LYG) calculated by modelling on the basis of data on mortality and survival. This data were based on randomized clinical trials results and retrospective data analyses confirmed by the experts. For reference, the exchange rate was 1 EUR= 75 RUB. Results: Serelaxin is a new medicinal drug for acute decompensated heart failure - a recombinant form of the human hormone relaxin-2 administered intravenously during 48 hours. According to the expert opinion only 7% of patients with acute decompensated heart failure are required to administer serelaxin in real clinical practice. Total costs for 100 patients in standard therapy group with serelaxin administered in 7% of patients equal 177,000 € for 12 months and in standard group only equal 166,507 € . LYG is 70,5 and 69,7 respectively. Conducted pharmacoeconomic analysis revealed that cost-effectiveness ratio (CER) serelaxin group was 2,510 € , and in standard therapy group CER was 2 390 € . Incremental cost-effectiveness ratio in serelaxin group was 12,461 € . That is 1,5 times lower than willingness-to-pay threshold in Russia. Conclusions: Treatment with serelaxin is cost-effective in comparison with standard care in patients with acute decompensated heart failure in the Russian Federation healthcare conditions. PCV93 Cost-Effectiveness Analysis of On-Pump and Off-Pump Stable Multivessel Coronary Artery Bypass Grafting†“mass iii 5-Year Follow-Up Scudeler TL1, Hueb W1, de Soárez PC2, Campolina AG3, Hueb AC1, Rezende PC1, Lima EG1, Garzillo CL1, Costa LM1, Oikawa FT1, Ramires JA1, Kalil Filho R1 1Heart Institute (InCor) University of Sao Paulo, Sao Paulo, Brazil, 2University of Sao Paulo, Sao Paulo, Brazil, 3Cancer Institute of the State of São Paulo, Sao Paulo, Brazil
Objectives: In this ancillary study from MASS III trial, costs and effectiveness were compared between on-pump versus off-pump coronary artery bypass graft surgery
VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 3 4 7 – A 7 6 6
event history with SI (Δ cost: € 38,482; Δ QALY: 1.16; ICER: € 33,191). Conclusions: Among patients with HeFH or CV event history without/with SI, evolocumab added to SOC may provide a CE option for lowering LDL-C, considering the commonly accepted thresholds in Spain of € 30,000-€ 45,000 per Δ QALY. PCV88 Cost-Effectiveness of Apixaban for The Treatment of Atrial Fibrillation Patients in The Kingdom of Saudi Arabia Osenenko KM1, Kherraf SA2, Samy IA3, Sambrook R1, Hersi A4 1ICON Epidemiology, Vancouver, BC, Canada, 2Pfizer, Dubai, United Arab Emirates, 3Pfizer, Jeddah, Saudi Arabia, 4College of Medicine, King Saud University, Riyadh, Saudi Arabia
Objectives: Atrial fibrillation (AF) is associated with considerable morbidity, mortality and healthcare costs. Apixaban, a novel oral anticoagulant, has improved efficacy and safety compared to warfarin on outcomes of stroke, systemic embolism, mortality, and reduced bleeding rates. The objective was to estimate the costeffectiveness of apixaban compared to other anticoagulants for AF treatment in the Kingdom of Saudi Arabia (KSA). Methods: A previously published lifetime Markov model (17 health states; 6-week cycles; United Kingdom [UK] setting) was adapted to the KSA Ministry of Health (MOH) perspective. The model enabled pairwise comparisons of apixaban against seven other anticoagulants. Apart from warfarin, treatment comparisons were indirect. Two subpopulations included vitamin K antagonist (VKA)-suitable and VKA-unsuitable patients. Unit costs for medications and physician visits were taken from published price lists. Due to scarcity of local cost data for clinical events, a cost ratio of 0.533, generated through comparison of UK and KSA physician visit costs, was applied to global model inputs to estimate local event costs. Background life expectancy was updated using KSA life tables, and utilities were from published sources. Costs and health benefits were discounted by 3.5% annually after the first year. Results: Apixaban was dominant versus warfarin (VKA-suitable) and rivaroxaban (VKA-suitable and VKA-unsuitable). Compared against dabigatran (110mg, 150 mg, 110/150mg blend), the incremental cost per quality-adjusted life-year (QALY) gained for apixaban was $5,166, $11,143, $10,849 (VKA-suitable) and $5,157, $14,424, $14,134 (VKA-unsuitable), respectively (2013 USD) . Cost/QALY for apixaban versus aspirin and aspirin+clopidogrel was $14,805 and $5,784 (VKA-suitable); and $10,564 and $44,203 (VKA-unsuitable), respectively. Conclusions: Apixaban may be cost-effective for AF treatment in the KSA, particularly compared to warfarin and rivaroxaban. Incremental costeffectiveness ratios for all comparisons were within conventional willingness-topay thresholds. Availability of robust local data inputs would enable refinement of apixaban cost-effectiveness estimates for AF treatment in the KSA. PCV89 Economic Evaluation of ASA 100mg, Simvastatin 40mg and Ramipril 5-10mg (POLYPILL) for Secondary Prevention of Cardiovascular Events in Mexico Kaskens L1, Gracia A1, Rodriguez Mendoza M2, Escobar Juárez Y2, Mendoza Medrano G3, Soto Molina H2 1Ferrer Internacional, Barcelona, Spain, 2HS Estudios Farmacoeconómicos S.A. de C.V., Mexico City, Mexico, 3Ferrer Mexico, México City, Mexico
Objectives: To assess the cost-effectiveness and cost-utility of AAS 100mg, simvastatin 40mg and ramipril 5-10mg (polypill), in comparison with its mono-components separately for secondary prevention of cardiovascular events with or without a recent history of MI, from the Mexican Health System perspective Methods: A cost-effectiveness and cost-utility analysis were developed through an economic Markov model, to evaluate the polypill in comparison with its mono-components separately. Effectiveness outcomes were expressed as life year’s gained and quality-adjusted life-years (QALY’s) associated with the benefits in adherence of the polypill. The study was conducted over a 20 years horizon, with a 5% discount rate. Costs were obtained from institutional sources. The direct medical costs considered were: pharmacological costs, acute adverse events and hospitalizations. Univariate and probabilistic sensitivity analyses were performed. The results were expressed as cost per life years gained and QALY’s, also incremental cost-effectiveness ratio (ICER) was calculated Results: The polypill presents 5.76175 life years gained and 4.78911 QALY’s, in comparison the life years gained with mono-components separately were 5.74624 and 4.77445 QALY’s. The polypill has a greater effectiveness compared with its mono-components with an incremental of 0.01551 life years gained and 0.01466 QALY’s. The average total cost per patient was € 11,263.55 using polypill and € 11,136.43 for mono-components, with an incremental cost of € 126.98. The ICER estimated was € 8,187.95 per life years gained and € 8,662.68 per QALY’s. Conclusions: Therefore, the polypill is a cost-effective option compared with its mono-components in the secondary prevention of cardiovascular events in adult patients with or without a recent history of MI in Mexico PCV90 Cost-Effectiveness of Rivaroxaban Within Subgroups for Atrial Fibrillation and Venous Thromboembolism in The Netherlands Gout-Zwart J1, Sediq A1, van den Bosch M2, Postma MJ1 1University of Groningen, Groningen, The Netherlands, 2Bayer BV, Mijdrecht, The Netherlands
Objectives: The discovery of novel oral anticoagulants, such as rivaroxaban, has brought new treatment options for prevention of stroke in non-valvular atrial fibrillation (NVAF) patients and treatment of (recurrent) venous thromboembolism ((r)VTE). We explored if the benefits of rivaroxaban treatment could outweigh costs, compared to current standard therapy with vitamin K antagonists (VKAs) within specific subgroups in the Netherlands. Methods: For NVAF and VTE a decision-tree was created, respectively based on the ROCKET AF and EINSTEIN pooled-analysis studies. The study was performed for a time-horizon of one year and from a healthcare payers’ perspective. For NVAF a VKA alone was used as comparator. For VTE the combination enoxaparin with acenocoumarol (23% of patients) or phenprocoumon (77% of patients) was used as comparative treatment. Both comparative treatments are guided by Dutch thrombotic services. Efficacy and safety of different drug therapies
were taken into account, together with resulting costs and (dis)utilities. Results were specified for subgroups in scenario analyses: NVAF + VTE patients (base case); NVAF and VTE patients separately; unstable NVAF patients with TTR (time in therapeutic range) < 60%. A probabilistic sensitivity analysis (PSA) was performed to investigate the influence of parameter uncertainty on the incremental cost-effectiveness ratio (ICER). Results: For the analyzed subgroups the use of rivaroxaban was cost saving and provided health gains compared to treatment with VKAs. Cost savings were highest for VTE patients, followed by unstable NVAF patients. Health gains were approximately the same for each subgroup at 0.023-0.026 quality adjusted life-years (QALY) per patient. Conclusions: From a healthcare payers perspective in the Dutch setting, rivaroxaban treatment is likely to be dominant over current standard therapy with VKAs, for the prevention of stroke in patients with (unstable) NVAF and treatment of (r)VTE. PCV91 Cost-Effectiveness of Sacubitril/ Valsartan in Chronic Heart Failure with Reduced Ejection Fraction in The Czech Republic: Analysis Based on Patient Characteristics From Randomized Clinical Trial and Local Registries Spinar J1, Klimes J2, Vesela V2, Deschaseaux C3, Haroun R3, Dostal F2, Depta J3 1University Hospital Brno, Brno, Czech Republic, 2Novartis, s.r.o., Prague, Czech Republic, 3Novartis Pharma AG, Basel, Switzerland
Objectives: Chronic heart failure (CHF) represents substantial health and economic burden to society. Fixed combination of sacubitril-valsartan; S/V for CHF with reduced ejection fraction (HF-rEF) has been approved in EU (November 2015). In the Czech Republic, HTA process for this intervention that significantly reduced patients’ mortality, morbidity and improves QoL compared to standard of care ACEi, is ongoing. We estimated cost-effectiveness of S/V vs. ACEi (+background therapy) from Czech health care system perspective. Methods: A two stage Markov cohort model (health states alive, dead), with regression models used to predict events was used. Cardio-vascular (CV) mortality from key clinical trial; PARADIGM-HF (head-tohead S/V vs. ACEi; enalapril) is estimated using parametric survival curves. Non-CV mortality is estimated using national life tables with CV-mortality removed, the hospitalisation rate using a negative binomial regression. Utility based on EQ-5D is estimated using a mixed model from PARADIGM-HF. Life-time horizon, 1-month cycle-length, 3% discount rates for cost and outcomes (QALYs) was applied. Base-line patient characteristics came from the 1) PARADIGM-HF, or local HF registries, i.e. 2) ESC-HF (Czech sub-group) and 3) AHEAD (registry of acute HF patients; sub-group of CHF). Unit costs come from local lists of reimbursed medicines, procedures and DRG codes. The cost of S/V and hospitalisation was calculated as € 5.3/day, € 2,625/ event. Results: In life-time horizon, incremental (discounted) costs, QALYs and ICERs for S/V vs. ACEi were 1) € 8.8k, 0.36 QALYs and € 24.3k; 2) € 9.1k, 0.35 QALYs and € 26.2k; and 3) € 7.6k, 0.26 QALYs and € 29.1k. According to probabilistic sensitivity analysis, there is 1) 100%; 2) 97%; 3) 95% probability that S/V ICERs is below locally applied WTP threshold (€ 45,000) compared to ACEi. Conclusions: S/V is costeffective therapy for HF-rEF compared to current standard of care (ACEi), based on various patients characteristics coming from both RCT and local registries in the Czech Republic. PCV92 Cost-Effectiveness Analysis of Serelaxin in Treatment of Patients with Acute Decompensated Heart Failure Tolordava G, Arinina E, Yagudina R, Kulikov A I.M. Sechenov First Moscow State Medical University, Moscow, Russia
Objectives: Comparative cost-effectiveness analysis of two treatment schemes for patients with acute decompensated heart failure: standard care and standard care plus serelaxin. Methods: Cost analysis was carried out on the basis of existing standards for the provision of emergency and specialized medical care to patients with heart failure in Russia. Direct costs including readmission of patients with acute decompensated heart failure within a year were calculated. The survey of Russian cardiology experts with experience in the use of serelaxin was conducted. The criterion of effectiveness in the pharmacoeconomic study was life-years gained (LYG) calculated by modelling on the basis of data on mortality and survival. This data were based on randomized clinical trials results and retrospective data analyses confirmed by the experts. For reference, the exchange rate was 1 EUR= 75 RUB. Results: Serelaxin is a new medicinal drug for acute decompensated heart failure - a recombinant form of the human hormone relaxin-2 administered intravenously during 48 hours. According to the expert opinion only 7% of patients with acute decompensated heart failure are required to administer serelaxin in real clinical practice. Total costs for 100 patients in standard therapy group with serelaxin administered in 7% of patients equal 177,000 € for 12 months and in standard group only equal 166,507 € . LYG is 70,5 and 69,7 respectively. Conducted pharmacoeconomic analysis revealed that cost-effectiveness ratio (CER) serelaxin group was 2,510 € , and in standard therapy group CER was 2 390 € . Incremental cost-effectiveness ratio in serelaxin group was 12,461 € . That is 1,5 times lower than willingness-to-pay threshold in Russia. Conclusions: Treatment with serelaxin is cost-effective in comparison with standard care in patients with acute decompensated heart failure in the Russian Federation healthcare conditions. PCV93 Cost-Effectiveness Analysis of On-Pump and Off-Pump Stable Multivessel Coronary Artery Bypass Grafting†“mass iii 5-Year Follow-Up Scudeler TL1, Hueb W1, de Soárez PC2, Campolina AG3, Hueb AC1, Rezende PC1, Lima EG1, Garzillo CL1, Costa LM1, Oikawa FT1, Ramires JA1, Kalil Filho R1 1Heart Institute (InCor) University of Sao Paulo, Sao Paulo, Brazil, 2University of Sao Paulo, Sao Paulo, Brazil, 3Cancer Institute of the State of São Paulo, Sao Paulo, Brazil
Objectives: In this ancillary study from MASS III trial, costs and effectiveness were compared between on-pump versus off-pump coronary artery bypass graft surgery