Health Economic Evaluation of HDM Slit-Tablet For Allergen Immunotherapy In House Dust Mite Induced Allergic Rhinitis with or Without Allergic Asthma In An Italian Setting

Health Economic Evaluation of HDM Slit-Tablet For Allergen Immunotherapy In House Dust Mite Induced Allergic Rhinitis with or Without Allergic Asthma In An Italian Setting

A550 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 contained about 500,000 patients. During 2009-2013 the number of patients with a re...

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A550

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

contained about 500,000 patients. During 2009-2013 the number of patients with a recorded diagnosis of asthma increased from 2% up to 5%. Among asthma patients, no real trend over time was observed for the prevalence of severe and poorly controlled severe asthma. The proportion of patients with severe asthma fluctuated between 8% and 10% and the proportion with poorly controlled severe asthma fluctuated between 2.5% and 3.5%. These prevalences were higher among females than males.  Conclusions: Results regarding the prevalence of asthma are in line with known literature. Prevalences of (poorly controlled) severe asthma were subject to fluctuations within a single year, but remained stable during 2009-2013. Determining prevalences of (poorly controlled) severe asthma by using healthcare databases only requires multiple proxies. Therefore, the question is whether the observed prevalences correctly reflect the actual prevalences. Using patient reported outcomes might support studies regarding severe asthma and/or poorly controlled severe asthma.

RESPIRATORY-RELATED DISORDERS – Cost Studies PRS9 Budget Impact Model Of Indacaterol/Glycopyrronium In The Treatment Of Copd In Italy Based On Flame Study Pitotti C1, Burke C2 1Novartis Farma, Origgio, Italy, 2Product Lifecycle Services - Novartis Business Services, Dublin, Ireland

Objectives: A 3-year budget-impact model (BIM) using data from the FLAME study was developed to estimate the economic impact on the Italian health care budget of switching COPD patients treated with salmeterol/fluticasone to indacaterol/glycopyrronium.  Methods: The model considered patients with moderate, severe and very severe COPD who are diagnosed and treated only with salmeterol/fluticasone or indacaterol/glycopyrronium in the Italian setting. The BIM was developed from the perspective of the National Healthcare Service (NHS). Only direct medical costs were considered: drug costs (salmeterol/fluticasone and indacaterol/ glycopyrronium ), adverse events costs (pneumonia, tuberculosis and influenza) and disease-related costs (exacerbations management costs, emergency department and hospitalisation). The model assumes an uptake of patients treated with indacaterol/glycopyrronium of 50% in the first year, 30% in the second year and 30% in the third year deriving from salmeterol/fluticasone. Public net prices and National Tariffs were considered to estimate cost of drugs and medical resources used, respectively. Costs were assessed in Euros (2015).  Results: The total number of patients considered in the model was 195.518 (Year 1), 4.100 of which treated with indacaterol/glycopyrronium. After switching, the number of patient treated with indacaterol/glycopyrronium was estimated to be 151.865 (at Year 3). The reduction of exacerbation events (moderate, severe and very severe) was estimated to be 28.852. Considering all costs, as listed, the budget impact of switching patients from salmeterol/fluticasone to indacaterol/glycopyrronium was estimated to generate a saving of 10 million Euros over 3 years for the NHS. Considering only drugs costs, it was estimated saving would be 3,7 million Euros over 3 years.  Conclusions: Indacaterol/glycopyrronium compared to salmeterol/fluticasone used to treat moderate, severe and very severe COPD patients was estimated to be cost saving for the Italian NHS. Greater savings are predicted if a higher number of patients switch to indacaterol/glycopyrronium.

PRS10 Budget Impact of Bronchial Thermoplasty In Patients with Uncontrolled Severe Asthma

Objectives: Despite clinical and National Institute for Health and Care Excellence (NICE) guidelines for managing cow’s milk protein allergy (CMPA), amino acid formulas (AAFs) are often used first-line in place of recommended extensively hydrolysed formulas (eHFs). We evaluated potential cost savings to be made through improving prescribing practice in line with guidelines.  Methods: An Excel-based budget impact model (BIM) was developed for management of infants under 2 years old diagnosed with CMPA (UK national health service [NHS] perspective [2015]: Clinical Commissioning Group [CCG] prescribing data: live UK birth data, CMPA product acquisition costs [£] and specialist visit costs). Three base case scenarios were considered: mean eHF/AAF prescribing values with current CMPA product distribution; recommended eHF/AAF prescribing values (90% eHF / 10% AAF) with current CMPA product distribution; recommended eHF/AAF prescribing values with increased use of the Nestlé Health Science (NHSc) CMPA portfolio (Althera [eHF] and Alfamino [AAF]). Univariate sensitivity analyses evaluated the impact on cost savings of prescribing practices across CCGs, product costs and physician visits.  Results: Mean eHF:AAF prescribing was 41%:59%, ranging from 19%:81% to 84%:16%. Based on current product acquisition prices, possible annual savings exceeding £10 million are possible for the UK NHS through improving prescribing practices. Annual cost savings were observed across all CCGs, from £1 million (84% eHF) to over £14 million (19% eHF). More can be saved by increasing prescription of the NHSc product portfolio (£400,000 additional savings over 5 years by reaching 15%). The proportion of AAF was the main driver of costs, whereas physician visits was not.  Conclusions: Prescribing eHFs/AAFs according to guidelines can produce substantial cost savings for the UK NHS. Further savings can be made by increased use of the NHSc CMPA product portfolio. Thus, there is an opportunity to reduce CMPA cost burden in the UK through optimised prescribing. PRS12 Budget Impact Analysis of Aclidinium Bromide In The Treatment of Chronic Obstructive Pulmonary Disease Yagudina R, Kulikov A, Makarova E I.M. Sechenov First Moscow State Medical University, Moscow, Russia

Objectives: To assess the budget impact of switching adult patients with chronic obstructive pulmonary disease (COPD) from Glycopyrronium bromide and Tiotropium bromide to Aclidinium bromide in the Russian Federation.  Methods: Information search was conducted in the public domain. Pharmacoeconomic analysis method - budget impact analysis and direct cost analysis were performed. For reference, we accepted the exchange rate was 1 EUR =  74, 70 RUB.  Results: This study was designed for two possible scenarios. The first scenario was included direct comparison COPD treatment with Aclidinium bromide and Tiotropium bromide. The second scenario was based on meta-analyses of Aclidinium bromide, Glycopyrronium bromide and Tiotropium bromide. We started with the calculation of direct cost of the various medications per patient for two scenarios. Cost analysis was conducted on the cost of basic pharmacotherapy, compensation costs for treatment of exacerbations, compensation costs for side effects and adverse reactions for each scenario. The study had a time frame of one year. The total cost per one patient with COPD amounted to 483 EUR (60 doses) and 500 EUR (30 doses) for the Aclidinium group and 585 EUR for the Tiotropium group for the first scenario and 335 EUR (60 doses) and 352 EUR (30 doses) for the Aclidinium group, 412 EUR and 436 EUR for the Tiotropium group and Glycopyrronium group respectively for the second scenario. Further in the present study, based on the results of the “cost analysis” it was revealed that the switching 100 patients to Aclidinium bromide saved 9 379 EUR for the first scenario and 7 667 EUR for the second scenario.  Conclusions: The budget impact analysis results obtained in this Aclidinium bromide versus others long-acting muscarinic antagonists comparative study demonstrated that Aclidinium therapy resulted in budget saving.

Chanez P1, Marty R2, Croisille A2, Benet C3, Saidani N3, Aubier M4 University, Marseille, France, 2HEVA-HEOR, Lyon, France, 3Boston Scientific, Voisins-le-Bretonneux, France, 4Hospital Bichat APHP and INSERM U1152 Diderot University, Paris, France

PRS13 Health Economic Evaluation of HDM Slit-Tablet For Allergen Immunotherapy In House Dust Mite Induced Allergic Rhinitis with or Without Allergic Asthma In An Italian Setting

Objectives: To investigate the budget impact in France of bronchial thermoplasty (BT) as add-on to standard care (BT-SC) compared to omalizumab as add-on to standard care (O-SC) and to standard care (SC) alone in the treatment of patients with severe asthma who fail intense pharmacological treatment. Methods: Clinical outcomes were modelled (Markov model) in a cohort of uncontrolled, severe asthma patients over 5 years. BT is given as a course of 3 sessions during the 1st year. Costs were allocated on the basis of French standard health costs. Four cost scenarios were examined, varying the cost of BT, the burden of hospital stays and the extent of healthcare consumption.  Results: In the scenario with lowest total cost of BT and lowest healthcare consumption, per capita costs over the 1st year in BT-SC were €  14,016 higher than in SC, but €  3,356 lower than in O-SC. From the 2nd year onward, BT-SC would generate an annual per capita saving of €  208 compared to SC and of €  17,771 compared to O-SC. In the scenario with highest total cost of BT and highest healthcare resource utilization, the excess cost associated with BT-SC during the 1st year was €  17,273 and the cost saving for years 2-5 compared to SC was €  735/year. When extrapolated to all adult patients with uncontrolled severe asthma in France (16,651 individuals; 10% treated by BT-SC, 2.5% by O-SC and 87.5% with SC), the budget impact of introduction of BT would be savings of €  9,758,566 to €   16,390,259, depending on the cost scenario.  Conclusions: Introduction of BT for patients with severe uncontrolled asthma would generate cost savings in the French setting.

Cadario G1, Maspoli M2, Di Matteo S3, Valentino MC3, Oselin M3, Bruno GM3, Colombo GL4 1Città della Salute Hospital, Turin, Italy, 2Piedmont Region-Regional Healthcare System, Turin, Italy, 3S.A.V.E. Studi - Health Economics & Outcomes Research, Milan, Italy, 4University of Pavia, Milan, Italy

1Aix-Marseille

PRS11 The Health Economic Impact of Managing CMPA According To Guidelines: Challenging Current Treatment Practise In The UK Wright A1, Yi Y1, Delaney M2, Dive-Pouletty C3 1PHMR Ltd, London, UK, 2Nestle Health Science, Gatwick, UK, 3Nestle Health Science, Lausanne, Switzerland

Objectives: We conducted a health economic evaluation of allergen immunotherapy with HDM SLIT-tablet for patients with house dust mite induced allergic rhinitis (AR) and for patients with allergic rhinitis plus allergic asthma (RA+AA) in an Italian setting.  Methods: Analysis included patients and data taken from Regional Allergy Network of the Piedmont Region (RRA). We built a cost utility model with the aim to capture the costs and health consequences of treatment for HDM AR and AA plus AR patients. The following parameters were included: effectiveness of available treatment options; acquisition costs of treatment; symptomatic pharmacotherapy use and other healthcare resource use associated with the considered conditions; quality of life experienced by patients. A budget impact analysis was carried out to assess the annual cost of treatment per patient with HDM SLITTABLET as compared to patients receiving symptomatic pharmacotherapy only. The analysis estimated the total costs and QALYs for one hypothetical adult patient receiving HDM SLIT-TABLET in addition to symptomatic pharmacotherapy and one hypothetical adult patient receiving symptomatic pharmacotherapy only, over a ten-year period.  Results: Regarding the cost-utility analysis, ICER values were found to be equal to €  73,254 for the first year, €  7,797 for the fifth year and €  3,456 for the tenth year for AR patients. The ICER values for AR plus AA were €  31,095 for the first year, €  6,254 for the fifth year and €  3,153 for the tenth year. The first year was the most critical one, due to the drug cost; starting from the first year for AR patient and from the second year for AA plus AR patients an acceptable ICER value was achieved, due to the improved quality of life.  Conclusions: Patients receiving HDM SLIT-TABLET in addition to symptomatic pharmacotherapy were cost effective as compared to patient receiving symptomatic pharmacotherapy only.



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

A551

PRS14 Adherence To Gold Criteria Strategy In Treatment of Chronic Obstructive Pulmonary Disease (COPD) Patients: Cost Implications In Turkey

savings for the French NHI by increasing the compliance of GPs prescriptions with the COPD guidelines.

Tatar M1, Tuna E2, Senturk A2, Sarioz F3, Konya A4 University, Ankara, Turkey, 2Polar Health Economics and Policy Consultancy, Ankara, Turkey, 3Novartis, İstanbul, Turkey, 4Novartis, Istanbul, Turkey

PRS17 Burden of Non-Tuberculous Mycobacterial Pulmonary Disease In Germany Based on Sick Fund Data Analysis

Objectives: COPD, a major cause of mortality and morbidity globally and in Turkey, is a progressive respiratory disease predominantly caused by smoking. The Global Initiative for Chronic Lung Disease (GOLD) strategy provides an evidence based approach to treatment and prevention of COPD. This study had two main aims as to compare the clinical practice and GOLD recommendations and to assess the cost implications of adherence or non-adherence.  Methods: A two-staged methodology was adopted for the study. First, treatment strategies of 1,610 patients were compared to the recommendations of GOLD 2013 and adherence to the GOLD recommendations were assessed. Second, the costs of treatment with GOLD recommendations and clinical practice were calculated by using the Turkish Social Security Institute’s (SSI) price tariff.  Results: There were major differences in GOLD recommendations and clinical practice. Although LABA+LAMA+ICS treatment is not recommended for GOLD A, B and C patients, this combination was the most widely prescribed treatment (49.5%, 61.2% and 70.3% of patients respectively). In all GOLD groups, except GOLD A category, the annual cost of treatment was higher in clinical practice compared to GOLD recommendations. Although the annual treatment cost per patient by GOLD recommendations was 540.16TL (164€ ) for GOLD B, in actual practice the cost per patient was 981.53 TL (298€ ). Additionally, costs were 763.82 TL (232€ ) vs. 1,063.50 TL (322€ ) for GOLD C and 944.55 TL (286€ ) vs. 1,085.07 TL (329€ ) for GOLD D.  Conclusions: Although GOLD is widely referred to as a gold standard of care, adherence to its recommendations may not always be the case. The results of our study demonstrate that when clinicians do not follow GOLD recommendations, this non-adherence has negative cost implications for the reimbursement agency.

Diel R1, Obradovic M2, Jacob J3 1University Hospital Schleswig-Holstein, Kiel, Germany, 2Insmed GmbH, Frankfurt am Main, Germany, 3Health Risk Institute GmbH, Berlin, Germany

1Hacettepe

PRS15 A 12-Week Cost Analysis to Compare Fluticasone Furoate/ Vilanterol And Beclomethasone Dipropionate/Formoterol In The Treatment of Mild-To-Moderate Asthma

Objectives: Non-tuberculous mycobacterial pulmonary disease (NTMPD) is rare and may in some patients cause severe and irreversible lung damage. Current treatment requires lengthy multi-drug antibiotic regimen that can be poorly tolerated and have limited efficacy. Robust epidemiological data and data on healthcare resource use associated with NTMPD are scarce. This research aims to evaluate incidence, mortality and costs related to NTMPD in Germany.  Methods: A representative sample of statutory health insurance data in Germany was used to identify subjects with NTMPD based on ICD-10 code. Newly diagnosed NTMPD patients in year 2010 and 2011 (N= 125 in total) were followed for a period of three years. A control group (N= 1,250) was constructed matched by age, gender and Charlson co-morbidity index. Incidence of NTMPD was explored. Mortality and resource use were compared between the NTMPD group and matched control group.  Results: Annual incidence rate for NTMPD was 2.3/100.000. In the period between the index quarter and the 3-year follow-up, 22% and 6% of patients died in the NTM and control group, respectively (p< 0.001). Total cost for NTMPD patient in the first year following diagnosis was more than four times higher in NTMPD group vs. control group (€ 14,166 vs. € 3,070, p< .0001). Total cost in NTMPD group however decreased in year 2 and 3 to €  10,921 and €  8,652, respectively, mainly due to less hospitalizations. Majority of costs in NTMPD group were attributable to inpatient stay (49%) and overall medication (29%).  Conclusions: In Germany, patients with NTMPD were associated with high mortality rates and substantial healthcare resource use. With increasing prevalence of this disease in Germany, the burden of caring for these patients could become increasingly taxing on the healthcare system, calling for more effective management and therapies.

Dal Negro RW1, Distante C2, Bonadiman L3, Turco P3, Iannazzo S2 Center for Respiratory Pharmacoeconomics & Pharmacoepidemiology, Verona, Italy, 2SIHS SRL, Torino, Italy, 3Research & Clinical Governance, Verona, Italy

PRS18 Costs of Perennial Allergic Rhinitis And Asthma Increase with Level of Severity And Level of Disease Control

Objectives: The present study was an observational, retrospective analysis to compare the treatment costs of mild-to-moderate asthmatic patients assuming Fluticasone furoate/Vilanterol (F/V) 92/22 µg delivered via the Ellipta device once a day or Beclomethasone dipropionate/Formoterol (B/F) 100/6 µg delivered via the Nexthaler device twice a day, over a 12-week period.  Methods: Clinical data and consumption of healthcare resources were derived from the database of the Lung Unit of the Specialist Medical Centre (CEMS), Verona, Italy. The perspective was the Italian NHS. The propensity score (PS) method designed as matching on baseline covariates, as gender, age, forced expiratory volume in 1 second (FEV1) and presence of comorbidities, was applied.  Results: 77 patients treated with B/F in the period February-September 2015, and 40 patients treated with F/V were identified. The PS-matching process returned a cohort of 40 B/F patients matched with 40 F/V patients. The mean (±SE) number of relapses per patient during the follow-up was 0.53 (±0.12) in B/F and 0.28 (±0.07) in F/V patients. The average number of hospitalizations was 0.15 (±0.06) in B/F, and 0.08 (±0.04) in F/V patients. The difference between the two groups in terms of FEV1(L) improvement vs baseline was 0.11 in favour of F/V group (p =  0.007). The mean total cost during the study period, calculated as hospitalization, GP and specialist visits, rescue medications and treatment cost, was €  443.97 per patient treated with B/F, and €  281.11 per patient treated with F/V.  Conclusions: F/V showed the potential for enhanced clinical outcomes and reduced costs when compared to B/F.

Belhassen M1, Demoly P2, Bloch-Morot E3, de Pouvourville G4, Ginoux M1, Chartier A5, Laforest L1, Serup-Hansen N6, Toussi M7, van Ganse E1 1PharmacoEpidemiology Lyon, LYON, France, 2Department of Pulmonology, Montpellier, France, 3French Association for Continual Medical Education of Allergists, Reims, France, 4ESSEC Business School, Cergy-Pontoise, France, 5ALk Abello, Courbevoie, France, 6ALK, Hørsholm, Denmark, 7IMS Health, Paris La Défense, France

1National

PRS16 Positive Impact of Indacaterol Launch on Guidelines Compliance And Consequences on COPD Daily Treatment Cost In France Thonnelier C1, Duco J2, Benjamin K2, Bloino C3 Pharma SAS, Rueil-Malmaison, France, 2Novartis Pharma, Rueil-Malmaison, France, 3Novartis, Rueil-Malmaison, France

1Novartis

Objectives: Indacaterol is a Long Acting Beta-2 Agonist (LABA) which was launched in 2011 for chronic obstructive pulmonary disease (COPD). The current guidelines in France - from the Global Initiative for Chronic Obstructive Lung Disease (GOLD) in 2011 - recommend a bronchodilatator as a first line treatment. But the most prescribed therapy is a fixed dose combination (FDC) of a LABA with a corticosteroid (ICS), normally dedicated from severe to very severe COPD patients with an history of repeated exacerbations. The aim of this study was to demonstrate the positive impact of Indacaterol launch on treatment guidelines compliance and on daily treatment cost (DTC).  Methods: Data from the IMS Disease Analyzer panel - 1200 General Practitioners (GPs) who provides anonymized information about their prescriptions- were used. Data about COPD therapeutic schemes were screened from 2009 to 2015. Market shares of every therapeutic schemes were also extrapolated to the situation where Indacaterol would not be launched. Costs of scheme were extracted from the National Health Insurance (NHI) database. The DTC per patient was then compared between both situations, with or without Indacaterol.  Results: The COPD DTC was stable between 2009 and 2011 as about 1.59€  per patient. Since then the DTC has decreased with or without Indacaterol launch thanks to price decreases of several products. Four years after Indacaterol launch, the market share of LABA+ICS FDC lost about seventeen points. The DTC decreased to 1.32€  per patient with Indacaterol versus 1.36€  per patient without Indacaterol launch and generated a total economy of about 46 million euros.  Conclusions: This analysis demonstrated that the Indacaterol launch was able to generate remarkable

Objectives: Allergic rhinoconjunctivitis (ARC) is a common disorder, with a prevalence of 17-29% in European adults. Asthma affects around 6% of the French population with considerable Medical Resource Utilization (MRU). Our study aimed to detail MRU and related direct cost in Perennial Allergic Rhinitis (PAR), with or without concomitant allergic asthma (AA) in France. Methods: Using French Electronic Health Records (EHRs), we identified in 2010 two cohorts of patients, based on General Practitioners’ diagnoses, prescribing and clinical data. The first cohort included patients with PAR but no AA, while the second cohort included patients with PAR and concomitant AA. For each patient, the medical record was linked to corresponding claims data with reimbursed MRU and costs between 2011 and 2013. In each cohort, sub-groups analyses were performed according to severity of rhinitis and level of asthma control.  Results: The mean total annual cost for a patient with PAR and no AA was 247€  in 2013. This varied from 202€  to 298€  depending on rhinitis severity. Medical consultations made up almost 50% of these costs, while allergy drug made up 10%. For patients with PAR and concomitant AA, the mean annual cost varied between 403€  and 550€ , depending on the level of asthma control. Asthma drugs accounted for 20% and medical consultations for 35% of the costs.  Conclusions: This innovative study linking diagnoses from EHRs to claims data (MRU) was one of the first of its kind to be conducted in France, certainly in allergy. It collected valid data on PAR management, with or without concomitant AA, and on related costs. There was a clear relationship between MRU or associated costs, and severity of PAR and control of AA. Improved disease control for patients with PAR and AA would decrease the burden of disease. PRS19 The Cost of Asthma In Italy Dal Negro RW1, Distante C2, Bonadiman L3, Turco P3, Iannazzo S2 Center for Respiratory Pharmacoeconomics & Pharmacoepidemiology, Verona, Italy, 2SIHS SRL, Torino, Italy, 3Research & Clinical Governance, Verona, Italy

1National

Objectives: Asthma is a common chronic disease of the airways with a significant burden on patients’ quality of life and on the society. The SIRIO study estimated in 2007 an average direct cost of 1,075 €  per patient/year in Italy. The objective of this study was to update this information.  Methods: An observational retrospective analysis was conducted in 817 patients from the Lung Unit of the Specialist Medical Centre (CEMS), Verona (Italy), over the period June 2012-December 2015. Clinical and economic data were obtained for the 12±2 months prior the assignation at the specialist centre (pre-study) and recorded during 36 months of follow-up. The cost prospective was the Italian National Health Service. Clinical data were measured in terms of forced expiratory volume in 1 second (FEV1%) and number of relapses. Healthcare resources as number of hospitalization, visits, and treatments were recorded.  Results: The cohort had 42.96% male prevalence, mean (±SE) age of 49.06 (±0.64) years, and FEV1 87.47% (±0.81%). Comorbidities were present in 69.16% of the cohort. Relapses in pre-study were 0.91 (±0.09) per patient/year. The average FEV1 significantly improved in the follow-up (delta= 7.23%, p<  0.001) and a trend towards