Cost-Effectiveness Evaluation of Acarizax® In Patients with House Dust Mites Induced Allergic Asthma And Allergic Rhinitis In Slovakia

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plus BR (BBR) versus BR alone in the treatment of MDR-TB and XDR-TB, over a 10-year time horizon. The costs and effectiveness (life years gained [LYG]) of treatment were evaluated in the base case from both a National Health Service (NHS) and societal perspective. Clinical data were sourced from clinical trials. Resource utilisation data were obtained from interviewing a panel of clinicians. The study considered NHS tariffs for inpatient and outpatient resources and an average hospital stay, with active disease, of 63 days for MDR_TB patients and 76 days for XDR_TB patients according to expert opinion. Drug costs were provided by reference centres for the treatment of tuberculosis. A 3% annual discount rate was applied to costs and effectiveness. Sensitivity analyses were conducted to test the robustness of the results.  Results: Over a 10-year period, the ICERs for BBR versus BR alone were € 16,639/LYG and € 4,081/LYG for the NHS and societal perspectives, respectively. Similar results were observed across the deterministic sensitivity analysis. BBR dominated BR alone when considering a societal perspective, a 20% price decrease for bedaquiline and a mean hospital stay of 6 months. In the PSA, BBR was cost-effective in 88% - 96% of simulations, at thresholds of € 40,000 and € 60,000 (NHS perspective). From a societal perspective, BBR was dominant in 19% of simulations, and considered cost-effective in 94%-97% of simulations.  Conclusions: In Italy, BBR is cost-effective vs BR alone in the treatment of MDR-TB and XDR-TB under a range of scenarios. PRS32 Cost Effectiveness Analysis of Rivaroxaban For Treatment of Deep Vein Thrombosis And Pulmonary Embolism In Greece Gourzoulidis G1, Kourlaba G2, Kakisis J3, Matsagkas M4, Giannakoulas G5, Gourgoulianis K6, Vassilakopoulos T7, Arzoumanidou D8, Maniadakis N1 1National School of Public Health, Athens, Greece, 2EVROSTON LP, Athens, Greece, 3Athens University Medical School, Attikon Hospital, Athens, Greece, 4University of Ioannina, Ioannina, Greece, 5AHEPA Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece, 6University Hospital of Larissa, University of Thessaly, Larissa, Greece, 7University of Athens Medical School, Evangelismos Hospital, Athens, Greece, 8Bayer Hellas AG, Athens, Greece

Objectives: To evaluate the cost-effectiveness of rivaroxaban compared to standard of care(SoC) with enoxaparin followed by dose-adjusted vitamin-K-antagonists for the treatment of Deep Vein Thrombosis(DVT) and Pulmonary Embolism(PE) in Greece.  Methods: An existing Markov model was locally adapted by a third-party payer perspective to reflect the management and complications of DVT and PE in the course of three-month cycles, up to death. The clinical inputs and utility values were extracted from published studies. Direct medical costs, obtained from local resources, were incorporated in the model and refer to year 2015. Both costs and outcomes were discounted at 3.5%. The incremental cost effectiveness ratio(ICER) per quality-adjusted-life year(QALY) gained was calculated. Probabilistic sensitivity analysis(PSA) was undertaken to deal with uncertainty.  Results: The base case analysis showed that rivaroxaban in 3- and 6-month treatment duration for DVT and PE, respectively, as this is the common clinical practice in Greece, was associated with a 0.02 and 0.01 increment in QALYs compared to SoC, respectively. Rivaroxaban was associated with additional drug acquisition cost (€ 145 for DVT and € 305 for PE), but reduced monitoring cost (-€ 47 for DVT and -€ 64 for PE) and events costs (-€ 152 for DVT and -€ 133 for PE). Therefore, rivaroxaban was a dominant (less costly, more effective) and cost-effective (ICER: € 4,555) alternative over SoC for the management of DVT and PE, respectively. PSA revealed that the probability of rivaroxaban being cost-effective at a threshold of € 34,000/QALY were 100% and 78% for DVT and PE, respectively. Rivaroxaban was found to be a cost-effective option compared to SoC when other treatment durations (6, 12 and 3, 12 months for patients with DVT and PE, respectively) were considered.  Conclusions: Rivaroxaban may represent a cost–effective option relative to SoC for the management of DVT and PE in Greece, regardless of the required treatment duration.

PRS33 Cost-Effectiveness of Roflumilast As Add-On To Triple Inhaled Therapy Vs Triple Inhaled Therapy In Patients with Severe And Very Severe COPD Associated with Chronic Bronchitis In Sweden Engström A1, Varol N2 Pharma AB, Solna, Sweden, 2AstraZeneca, Cambridge, UK

1Takeda

Objectives: Roflumilast (ROF) is an oral phosphodiesterase-4 inhibitor indicated for maintenance treatment of severe COPD associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment. The REACT study (NCT01329029) showed that ROF reduces exacerbations and hospital admissions when added to triple therapy of inhaled glucocorticosteroid (ICS), long-acting β 2-agonist (LABA), and long-acting muscarinic antagonist (LAMA). The objective of this analysis was to estimate the cost-effectiveness of ROF+ICS+LABA+LAMA vs ICS+LABA+LAMA in managing severe and very severe COPD patients in a Swedish healthcare setting incorporating efficacy outcomes from REACT.  Methods: A Markov model developed in TreeAge 2009 with an Excel interface was used to simulate life-long costs and outcomes (QALYs). The model had monthly cycles and three health states: severe COPD, very severe COPD and death, with irreversible transitions to very severe COPD. All input parameters on costs and epidemiology were obtained from Swedish sources. Clinical effectiveness was based on results from clinical trials. Analyses adopted a societal perspective and included lost productivity using a human capital approach. Transition probabilities, state utilities, exacerbation disutilities and hospital mortality were based on published literature. Background mortality was determined through risk of death in the general population and standardised mortality ratios from the literature. Costs and outcomes were discounted at 3%. Uncertainty was investigated through one-way and probabilistic sensitivity analyses.  Results: Treatment with ROF+ICS+LABA+LAMA vs ICS+LABA+LAMA is associated with an incremental QALY gain of 0.421 and an incremental cost of SEK 68,517 (€ 7,392) resulting in incremental cost per QALY of SEK 162,566 (€ 17,540) from a societal perspective (SEK1= € 0.1079, ECB exchange rate

on 27/5/2016).  Conclusions: Roflumilast as add-on to ICS+LABA+LAMA is a costeffective treatment for severe and very severe COPD in Sweden. This conclusion is robust under different sensitivity analyses that explore the impact of uncertainties on cost-effectiveness. PRS34 Economic Evaluation of Tiotropium/Olodaterol Administrated Through The Respimat Inhaler As Maintenance Treatment of Patients With Chronic Obstructive Pulmonary Disease (COPD) In Poland Pawlik M1, Karwala P1, Zyla A1, Parkitny M1, Walczak J1, Pieniazek I1, Augustynska J1, Zawodnik A2 1Arcana Institute Ltd, Krakow, Poland, 2Boehringer Ingelheim Poland, Warsaw, Poland

Objectives: The objective of this study was to carry out an economic evaluation of a combination of tiotropium/olodaterol administrated through the Respimat inhaler as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD) from both the public payer’s (National Health Fund-NHF) and common (patients and NHF) perspectives in Poland. Methods: Five comparators were included: tiotropium/olodaterol was compared with tiotropium and fluticasone/salmeterol combination therapy in a cost-utility analysis and with three LAMA+LABA combination therapies (tiotropium+formoterol, tiotropium+indacaterol, tiotropium+salmeterol) a costminimization analysis as they have similar efficacy and comparable safety profile to tiotropium/olodaterol. A patient level Markov model with life-time horizon included four health states defined by GOLD stages and death. Drug cost, disease management, cost of rescue medication and exacerbations were estimated in 2015. Clinical data were obtained from the performed network meta-analyses.  Results: Quality adjusted life years related with tiotropium/olodaterol and tiotropium generated 8.150 QALY and 7.977 QALY, respectively. The difference is caused by alternative sources of clinical data. The incremental cost-utility ratio (ICUR) of tiotropium/ olodaterol vs tiotropium was estimated to be € 8,828/QALY from NHF and € 11,982/ QALY from common perspective. QALY associated with tiotropium/olodaterol arm and fluticasone/salmeterol arm resulted in 8.091 QALY and 7.818 QALY, respectively. The ICUR of tiotropium/olodaterol vs fluticasone/salmeterol amounted to be € 5,165/QALY from NHF and € 10,029/QALY from common perspective. The results of CUA were below the threshold accepted for Poland (€ 28,586/QALY). The incremental cost for the comparisons of tiotropium/olodaterol vs: tiotropium+formoterol, tiotropium+indacaterol and  tiotropium+salmeterol was estimated to be -€ 592, -€ 216, -€ 592, respectively from NHF perspective and € 583, -€ 841, € 534, respectively from common perspective.  Conclusions: Use of tiotropium/olodaterol in a maintenance treatment of patients with COPD is a cost-effective strategy in comparison to tiotropium and fluticasone/salmeterol. Furthermore the assessed technology is less expensive than LAMA+LABA combination therapies from NHF perspective. PRS35 Cost-Effectiveness Analysis of Sq® Hdm Slit-Tablet For House Dust Mite Respiratory Allergic Disease In Czech Republic Mazalova M1, Babela R2, Hahn-Pedersen J3, Dolezal T1 OUTCOMES, Prague, Czech Republic, 2ALK Slovakia(1), St. Elizabeth University (2), BRATISLAVA, Slovakia, 3ALK, Hørsholm, Denmark

1VALUE

Objectives: Recently, a house dust mite (HDM) sublingually administered allergy immunotherapy tablet (SQ® HDM SLIT-tablet; ACARIZAX®) has been developed for at-home treatment. The objective was to assess the cost-effectiveness of ACARIZAX® for the treatment of patients with allergic rhinitis (AR) and/or allergic asthma (AA) in comparison to standard of care (pharmacotherapy) in the Czech Republic.  Methods: Decision tree models were developed based on the pivotal clinical trials MT-04 (AA) and MT-06 (AR) with a 5-year time-horizon. The choice of comparator was in line with the clinical trials, i.e. standard pharmacotherapy in addition to either ACARIZAX® SLIT-tablet or placebo SLIT-tablet. Utility values and healthcare utilisation values used in the models were taken from the pivotal clinical trials. The direct costs were adopted for Czech settings.  Results: A HDM AR patient treated with ACARIZAX® for three years as add-on to pharmacotherapy generates costs of 95 953 CZK in the five year time horizon in comparison to 4 296 CZK generated by a patient treated with pharmacotherapy only. An ACARIZAX® patient on the other hand gains 4.33 quality-adjusted life-years (QALYs); a pharmacotherapy patient gains only 4.19 QALY in the same time horizon. HDM AA ACARIZAX® patient generates costs of 119 217 CZK and gains 3.59 QALY in 5 years. HDM AA patient treated only with pharmacotherapy costs the payers 16 199 CZK and generates 3.40 QALY in the same time horizon. Final incremental cost-effectiveness ratio for a HDM AA patient is 0.54 mil CZK/QALY and for HDM AR patient 0.68 mil CZK/ QALY.  Conclusions: Considering the willingness to pay threshold of 1,27 mil. CZK (3xGDP per capita in year 2015), ACARIZAX® shows to be cost-effective treatment for the target population in comparison to pharmacotherapy.

PRS36 Cost-Effectiveness Evaluation of Acarizax® In Patients with House Dust Mites Induced Allergic Asthma And Allergic Rhinitis In Slovakia Babela R1, Hahn-Pedersen J2, Pruzinec P3, Uraz V1 Slovakia(1), St. Elizabeth University (2), BRATISLAVA, Slovakia, 2ALK, Hørsholm, Denmark, 3Slovak Medical University, BRATISLAVA, Slovakia

1ALK

Objectives: Allergic asthma (AA) and allergic rhinitis (AR) are chronic global health problems that can have a significantly detrimental effect on quality of life and healthcare costs. The prevalence of AR in EU is between 17.8% and 26%. ACARIZAX® economic models attempt to capture the costs and health consequences of treatment for house dust mite (HDM) AR and HDM AA patients.  Methods: Both models



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followed a decision tree structure. The analyses estimate the total costs and qualityadjusted life-years (QALYs) for the adult patient receiving ACARIZAX® in addition to pharmacotherapy and placebo plus pharmacotherapy (based on MITRA/MERIT trials) over a conservative five year period. The effect obtained in both groups in the trials was assumed to be sustained throughout the 5 years. An annual discount rate of 5% was applied for both costs and QALYs. Costs were estimated by taking healthcare utilisation values from MERIT and MITRA trials. The effectiveness of ACARIZAX® and pharmacotherapy was determined by the utility scores. One-way deterministic sensitivity analyses (DSA) were undertaken.  Results: Both base case scenarios indicated cost effectiveness of ACARIZAX® in Slovakia. For the adult patients with persistent moderate to severe HDM AR the ICER was 9,969 EUR. For the adult patients with HDM AA not well controlled by inhaled corticosteroids and associated with mild to severe HDM AR the ICER was 9,689 EUR.  Conclusions: Results indicate that according to current Slovak 2016 threshold (20,592 EUR), ACARIZAX® is cost effective in patients with persistent moderate to severe HDM AR despite use of symptom-relieving medication, and also in HDM AA patients not well controlled by inhaled corticosteroids and associated with mild to severe HDM AR. When the unit price of ACARIZAX® and resources used were altered, the results of the analysis did not change significantly, and the treatment remained cost effective in both ranges tested.

PRS37 Pharmacoeconomic Analysis of Treatment of Children with Severe Uncontrolled Asthma with Omalizumab In Russia Kolbin A1, Namazova-Baranova L2, Vishneva E2, Frolov M3, Galankin T1, Alekseeva A2, Dobrynina E2 1First Pavlov State Medical University of St. Petersburg, Saint Petersburg, Russia, 2Scientific Centre of Children Health, Moscow, Russia, 3Volgograd State Medical University, Volgograd, Russian Federation

Objectives: Omalizumab is the first and yet the only highly effective biological drug that was introduced in 2002 to treat pharmacologically resistant asthma. It was approved in Russia in 2007. This is the first pharmacoeconomic evaluation of omalizumab use in addition to a maintenance therapy in 6-17 years old children with severe uncontrolled atopic asthma in Russia.  Methods: Thorough literature search was conducted, two randomized clinical trials of omalizumab in children were retrieved. The data of real clinical practice in children with severe asthma were obtained from experts. The disease was modeled as a discrete-time Markov chain with one-week cycle with 7 states: controlled asthma, partially controlled asthma, uncontrolled asthma, non-severe exacerbation, severe exacerbation without hospitalization, severe exacerbation with hospitalization, and death. Direct (medication, laboratory tests, general practitioner visits, asthma-related hospitalization, glucocorticoid-related side effects) and indirect costs (losses of gross domestic product and social security fund payments due to temporary incapacity) were included into the model. Cost-utility and cost-effectiveness analyses were implemented based on Markov chains. Model horizons were 2 and 5 years.  Results: Cost-utility analisis showed that “omalizumab plus standard therapy” strategy is economically feasible in 6-17 years old children with an increased rate of annual hospitalization (≥ 9) who require an average dose of omalizumab 558 mg/month (incremental costutility ratio is 1,259,185 rubles/QALY for 5 year horizon, which is less then societal willingness-to-pay threshold that is 1,341,308 rubles). Cost-effectiveness analysis of decrease in hospitalization rate found that additional 39,820 rubles should be spent to prevent one hospitalization in 5 years (the cost of one hospitalization is estimated to be 43,140 rubles in average).  Conclusions: Omalizumab is pharmacoeconomically useful in children with severe uncontrolled asthma (≥ 9 annual hospitalizations in average). PRS38 Pharmacoeconomic Analysis of Treatment of Adult Patients with Severe Uncontrolled Asthma with Omalizumab In Russia Kolbin A1, Frolov M2, Galankin T1 1First Pavlov State Medical University of St. Petersburg, Saint Petersburg, Russia, 2Volgograd State Medical University, Volgograd, Russian Federation

Objectives: Omalizumab is the first and yet the only highly effective biological drug that was introduced in 2002 to treat pharmacologically resistant asthma. It was approved in Russia in 2007. This is the first pharmacoeconomic evaluation of omalizumab use in addition to a maintenance therapy in patients with severe uncontrolled atopic asthma in Russia.  Methods: Thorough literature search was conducted, eleven randomized clinical trials of omalizumab were retrieved. The disease was modeled as a discrete-time Markov chain with one-week cycle with 7 states: controlled asthma, partially controlled asthma, uncontrolled asthma, nonsevere exacerbation, severe exacerbation without hospitalization, severe exacerbation with hospitalization, and death. Direct (medication, laboratory tests, general practitioner visits, asthma-related hospitalization, glucocorticoid-related side effects) and indirect costs (losses of gross domestic product and social security fund payments due to temporary incapacity) were included into the model. Costutility and cost-effectiveness analyses were implemented based on Markov chains. Model horizons were 2 and 5 years.  Results: Cost-utility analisis showed that “omalizumab plus standard therapy” strategy is economically feasible in patients 18 years old and older with an increased rate of annual hospitalization (≥ 4) who require oral corticosteroid maintenance and an average dose of omalizumab 300 mg/month (incremental cost-utility ratio is 1,139,767 rubles/QALY for 5 year horizon, which is less then societal willingness-to-pay threshold that is 1,341,308 rubles). Cost-effectiveness analysis of decrease in hospitalization rate found that additional 57,287 rubles should be spent to prevent one hospitalization in 5 years (the cost of one hospitalization is estimated to be 31,059 rubles in average).  Conclusions: Although being clinically highly effective, omalizumab has high cost that limits its pharmacoeconomical usefulness to severe patients with an increased rate of annual

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hospitalization (≥ 4) who require no more than 300 mg/month of omalizumab in average. Price reduction might significantly increase the proportion of economically eligible patients. PRS39 Cost-utility of nintedanib vs. Pirferidone in the treatment of idiopathic pulmonary fibrosis in spain Soulard S1, Crespo C2 Ingelheim Spain, Sant Cugat del Valles, Spain, 2Boehringer Ingelheim, Sant Cugat del Vallès (Barcelona), Spain

1Boehringer

Objectives: Idiopathic Pulmonary Fibrosis (IPF) is a rare, progressive disease of unknown aetiology with a dismal median survival of 3 years. To date, two antifibrotic agents are commercialised in Spain to treat IPF: nintedanib and pirfenidone. The aim of this study is to compare their relative cost-effectiveness from the Spanish setting.  Methods: A previously developed Markov model simulating a hypothetical cohort of patients with IPF followed up for their lifetime was adapted to the Spanish National Health System perspective. Relative effectiveness was calculated from a network meta-analysis using data from each pivotal trial. Mortality, loss of lung function and acute exacerbations were included to measure efficacy outcomes while toxicity (serious adverse events) and tolerability (overall discontinuation) were included to measure safety. The baseline risk of each event was estimated using data from the control arm of nintedanib clinical trials (TOMORROW, INPULSIS-1, INPULSIS-2). An annual discount rate of 3% was set for both costs and health benefits. Sensitivity analyses (deterministic and probabilistic) tested the impact of alternate efficacy and safety outcomes, costs, time horizons and utility values, as well as differential rates of discontinuation. The cost inputs came from Spanish sources, reported in 2016 euros.  Results: Nintedanib yielded higher quality-adjusted life years (QALY) than pirfenidone (3.66 QALY vs. 3.62 QALY, respectively) and was associated with lower total costs (€ 6,854 less) mainly due to fewer acute exacerbations. Consequently, nintedanib dominated pirfenidone due to better effectiveness and lower costs. One-way deterministic and probability sensitivity analyses showed that the model was robust to most variations. If pirfenidone price was 25% lower, nintedanib would still dominate pirfenidone.  Conclusions: In the Spanish setting, nintedanib was found to be economically dominant (less costly and more effective) over pirfenidone, mainly due to fewer acute exacerbations. PRS40 Cost-Effectiveness of Tiotropium Versus Glycopyrronium In Moderate To Very Severe COPD In France Eklund O1, Borgstrom F2, Lindh M1, Detournay B3, Setton M4, Le Lay K4 Research, Stockholm, Sweden, 2Karolinska Institutet, Stockholm, Sweden, 3Cemka-Eval, Bourg-la-Reine, France, 4Boehringer Ingelheim France, Paris, France

1Quantify

Objectives: Exacerbations are important drivers of COPD-related costs and have been shown to increase mortality, as well as decrease health-related quality of life in COPD-patients. Tiotropium (TIO) is a long-acting anticholinergic (LAMA) and a well-established bronchodilator for the treatment of moderate to very severe COPD. Evidence from a recent head-to-head trial, SPARK, suggests that TIO is superior to glycopyrronium (GLY) in preventing severe exacerbations. This study assessed the cost-effectiveness of TIO versus GLY for France making use of this new clinical evidence.  Methods: Treatment efficacy was modelled in a Markov cohort model as improvements in lung function, quality-adjusted life years and as a lowering of the risk of exacerbations (rate of exacerbations), by using best available clinical data for moderate to very severe (GOLD II – IV) COPD from the UPLIFT and SPARK trials. Mortality and cost inputs were obtained from relevant sources in France. Health and cost outcomes (€  2011) were simulated over an approximate life time horizon, starting from an age of 65 years and considering a societal perspective without indirect costs. Robustness of results was validated in deterministic sensitivity analyses.  Results: Over a life time horizon, TIO resulted in an incremental cost of € 2,138 and generated a better health outcome of 0.18 in incremental QALYs compared to GLY for the average COPD patient. The cost per QALY gained (ICER) was € 11,880. The main driver of results was the relative risk of severe exacerbations found in SPARK (RR GLY/TIO: 1.43 CI 1.05-1.97, P =  0.025).  Conclusions: The results from this study show that TIO may be considered as a cost-effective treatment in moderate to very severe COPD in France. The findings were to a large extent driven by TIO being relatively efficacious in preventing severe exacerbations, based on the outcomes in the SPARK trial.

PRS41 Estimating The Impact Associated To The Use Omalizumab In The Treatment of Severe Persistent Allergic Asthma In Portugal – Evaluating Outcomes And Treatment Costs Using Real World Data From Portuguese Patients Moital I1, Carrasco J1, Cardoso I2, Mesquita D1, Felix J3, Vandewalle B4 1Novartis Farma Portugal, Porto Salvo, Portugal, 2Novartis Farma – Produtos Farmacêuticos S.A., Porto Salvo, Portugal, 3Exigo Consultores, Alhos Vedros, Portugal, 4Exigo Consultores, Lisboa, Portugal

Objectives: The eXpeRience registry collected real world data on patients receiving omalizumab for severe uncontrolled persistent allergic asthma (SAA). Quantify the clinical benefits, health resource utilization and estimate cost-effectiveness of omalizumab compared to standard of care in the treatment of Portuguese patients with SAA.  Methods: A cost-effectiveness model was developed to estimate the health outcomes and costs of omalizumab compared to standard-of-care. The eXperience data was used to characterize effectiveness, real world outcomes and resource utilization. Outcomes of interest were exacerbations, hospitalizations, emergency room (ER) visits, consultations and work and school absenteeism.  Results: The analysis of the 62 patients demonstrated that use of omalizumab resulted in fewer