Real World Data Analysis of Type 2 Diabetes Mellitus Treatment In An Integrated Health District

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VA L U E I N H E A LT H 2 0 ( 2 0 1 7 ) A 3 9 9 – A 8 1 1

PDB22 Availability of Health Economic Model Inputs In Japan: A Targeted Literature Review Langer J1, Nakanishi R1, Ball G2 Nordisk Pharma Ltd., Tokyo, Japan, 2QuintilesIMS, Tokyo, Japan

1Novo

Objectives: Cost-effectiveness analyses are playing an increasingly important role in Japan, as an integral part of the upcoming introduction to health technology assessment (HTA). However, current data availability to conduct such analyses may be limited. We conducted a targeted literature review to assess the availability of health economic (HE) model inputs for use in type 2 diabetes mellitus (T2DM) patients in Japan.  Methods: A comprehensive literature review was performed to identify studies published between 2010 and 2016 that reported costs and utility values associated with the management and complications of T2DM in Japan. PubMed, EMBASE and Ichushi Web databases were searched using medical headings and key terms in English and Japanese for macro – and microvascular complication costs and associated utility values. A manual search of Japanese sources related to medical societies, conferences, and diabetes networks was also conducted to enhance the search results. Articles that met the inclusion and exclusion criteria were screened at the title and abstract level followed by full-text screening by two reviewers.  Results: A total of 35 articles met the inclusion and exclusion criteria. Cost data were extracted from 27 articles while utility data were extracted from 17 articles. The identified articles included direct cost data pertaining to cardiovascular, eye, renal and acute diabetes-related complications as well as foot ulcer, neuropathy and amputation. Most health state utility values reported for T2DM and commonly occurring complications were based on the EQ-5D questionnaire.  Conclusions: While substantial HE model input cost data for T2DM patients in Japan was identified, data on utility values remains limited for some common T2DM complications. In addition, identified utility studies were often limited in terms of patient numbers or were outdated. Further research in this area is needed to establish standardized and strengthened HE modelling inputs for the rising HTA needs in Japan. PDB23 Growth of National Health Insurance Expenditure Related To Antidiabetics And Their Projections Up Until 2020 Aguade A, De Lagasnerie G, Fagot-Campagna A, Gastaldi-Menager C CNAMTS (National Health Insurance), Paris Cedex 20, France

Objectives: National health insurance expenditure related to diabetes represents € 10 billion, i.e. 8% of all expenditure. Mean expenditure per diabetic patient has stabilized since 2012, but the use of expensive new drugs could modify this curve.  Methods: This study was based on the population covered by the national health insurance general scheme that had received ≥ 1 reimbursement for antidiabetic drugs in 2012 and ≥ 1 reimbursement 3 years later. Treatment regimens were defined in the French health insurance system database (SNIIRAM) by reimbursements over a 4-month period to minimize the risk of wrongly attributing a modification of monotherapy to dual therapy. Projections were performed until 2020.  Results: Between 2012 and 2015, monotherapy and triple therapy rates remained stable (39% and 13% of patients), while the use of dual therapy decreased from 25% to 23% and the use of insulin therapy increased from 23% to 25%. Use of an insulin + other antidiabetic combination increased from 53% to 56%.The use of metformin, gliptins and GLP-1 agonists increased, while the use of sulphonylureas and other antidiabetics decreased.Expenditure related to antidiabetics increased from € 1.09 billion to € 1.2 billion. Half of the increased expenditure related to insulin therapy (€ 514 to € 614 million) was due to the increased use of insulin + GLP-1 agonist combinations (€ 62 to € 115 million, +€ 53M). Simple projection of the number of diabetic patients would result in an increase in the expenditure attributable to antidiabetics of +€ 178M between 2015 and 2020. According to various assumptions (treatment intensification, increasing use of certain molecules), this increase would be situated between +€ 208M and +€ 562M.  Conclusions: The financial impact related to modifications of the treatment modalities of diabetes constitutes a major challenge to a health system subject to budgetary constraints and in the presence of innovative treatments in fields such as oncology or hepatitis C. PDB24 Costs of Adding Sitagliptin or Sulphonylurea To Metformin: An Observational Study Using Administrative Database of Italy Sciattella P1, Russo A2, Caputi AP2, Mennini FS1 of Economics, Centre for Economic and International Studies (CEIS)-Economic Evaluation and HTA (EEHTA), University of Rome Tor Vergata, Rome, Italy, 2University of Messina, Messina, Italy 1Faculty

Objectives: To compare health-care costs of diabetic patients who start treatment with Sitagliptin (SITA) or Sulphonylurea (SUL), using Health Information Systems (HIS) of the Marche region.  Methods: From HIS, which collects information related to hospitalizations, drugs prescriptions and outpatient visits, we identified all diabetic patients who started treatment with SITA or SUL in addition to MET, during the period 2009-2011. To identify the cohort of interest, we applied the following inclusion criteria: first prescription (index-prescription) of SITA (ATC A10BH01, A10BD07) or SUL (ATC A10BB, A10BD02); adherence to SITA or SUL treatment, measured by Medication Possession Ratio (MPR), ≥ 80%. adherence to MET (ATC A10BA02) treatment, MPR≥ 80%, during the year before the indexprescripton. Selected patients were stratifyed in SITA or SUL users, according to the index-prescription; demographics and clinical characteristics were assessed at baseline and a propensity score-matching analysis (PSM) was used to balance the two groups. Health-care costs for drugs, outpatient visits and hospitalizations were calculated for the 3 years following the index-prescription.  Results: 411 new users were selected: 220 (53.5%) with a first SUL prescription, 191 (46.5%) with a first SITA prescription. Applying the PSM, 340 patients (82.7% of total patients) were paired, for which no statistically significant differences were observed for

variables considered at baseline. The analysis showed a higher cost for the first year of treatment for patients treated with SITA (€ 1,471) compared to those treated with SUL (€ 1,018). From the second year of treatment the cost of patients treated with SITA was systematically lower: € 1,235 vs € 1,315 in the second year and € 1,414 vs. € 1,710 in the third year.  Conclusions: The study, based on italian administrative databases, allowed to estimate the health-care costs of patients treated with SITA or SUL, highlighting a progressive reduction in costs for SITA treated patients starting from the second year of treatment. PDB25 Real World Data Analysis of Type 2 Diabetes Mellitus Treatment In An Integrated Health District Trillo Mata JL1, Usó Talamantes R1, Sanmartín Almenar A1, Matoses Nacher D1, Bastardes Climent B2, Illescas Noe C2, Caballer Tarazona V2, Navarro J1 1Hospital Clínico Universitario de Valencia, Valencia, Spain, 2Universitat Politècnica de València, Valencia, Spain

Objectives: The main objective of this study is to analyse the treatment of patients with type 2 Diabetes Mellitus (DM2) in an integrated health district using real world data. The relation between cost and glycaemic level control was analysed.  Methods: We conducted a cross section retrospective study of the population (n= 343.443 inhabitants) of an integrated health district in Valencia (Spain) from 2014 to 2016. A database with sociodemographic, clinic and economic variables was constructed from diverse sources of electronic health information systems available in the health district. A statistical descriptive analysis was performed. The treatment effectiveness was analysed as a controlled patient ratio according to the target for glucose control, as reflected by glycated hemoglobin HbA1c. The efficiency was measured as cost by controlled patients and non-controlled patients by year.  Results: The prevalence of DM2 in this district was 7.91% in 2016. The cost of oral glucose-lowering agents was 12 million euros while the cost of insulin was 3 million euros. Furthermore the cost of oral glucose-lowering agents had increased proportionally more than the cost of insulin in the period 2014-2016. The group of prolonged action insulins were primarily used in the case of insulins. While the combination of oral glucose-lowering agents (ATC A10BD) and gliptins (A10BH) generated the highest cost.Regarding the effectiveness, the percentage for controlled patients was higher than for non-controlled patients.The cost of noncontrolled patients increased during 2016, while the cost of controlled patients slightly decreased.  Conclusions: The cost of oral glucose-lowering agents against insulin is higher. What is more, it has produced an increment of DDD during the period 2014-2016 in this district. Therefore, as the increase in the cost of newer medications continues, patient resources should be taken into account by practitioners and generic, less costly alternatives should be taken into consideration more frequently. PDB26 Cost-Effectiveness of Empagliflozin In Patients With Type 2 Diabetes Mellitus At High Cardiovascular Risk In Poland Pawlik D1, Wójcik R1, Zawodnik A2, Kaczor MP3 1Aestimo s.c., Kraków, Poland, 2Boehringer Ingelheim Poland, Warsaw, Poland, 3Jagiellonian University Medical College, Kraków, Poland

Objectives: To assess the cost-effectiveness of empagliflozin 10mg as an addon to standard care (SoC) in Polish patients with Type 2 Diabetes (T2D) at high risk for cardiovascular events (CV).  Methods: An existing health economic, stochastic model was used to simulate individual profiles of patients treated with empagliflozin 10mg added to SoC versus patients treated with SoC only, over a lifetime horizon. Modelling of diabetes-related events was implemented using a risk equations derived from the EMPA-REG OUTCOME™ study patient-level data for 10 cardiovascular and renal events by fitting parametric survival functions. Model outcomes included annual and cumulative event rates, life years (LY) and qualityadjusted life-years (QALYs). Two perspectives were adopted using cost data from Polish sources: the public healthcare payer (PP) and the public payer plus patient (PP+P) perspective. Simulated costs and outcomes were discounted at a 5.0% and 3.5% annual rate, respectively. Probabilistic (PSA) and deterministic (DSA) sensitivity analyses were conducted to address uncertainty and test the robustness of the model results.  Results: Adding empagliflozin 10mg to SoC resulted in longer survival (9.8 LY vs. 8.7 LY with SoC) and a QALY gain of 0.81 at an additional cost of PLN10895 (€ 2,522) (PP) and PLN17184 (€ 3,978) (PP+P) versus SoC only. The basecase incremental cost-utility ratio (ICUR) was PLN13440 (€ 3,111) per QALY from the healthcare payer perspective and PLN21198 (€ 4,907) per QALY from the payer plus patient perspective, which is well below the cost-effectiveness threshold in Poland (PLN130002(€ 30093)/QALY). Irrespective of the cost perspective chosen, empagliflozin was estimated to have a 100% probability of being cost-effective. Base-case results were shown to be robust across a range of model parameters, with empagliflozin remaining cost-effective in all DSA scenarios investigated.  Conclusions: Empagliflozin 10mg represents a highly cost effective option for the treatment of T2D patients with high risk of CV events in Poland. PDB27 Cost-Effectiveness of Switching To Insulin Degludec (IDEG) In RealWorld Clinical Practice In Italy Haldrup S1, Lapolla A2, Gundgaard J1, Wolden ML1 1Novo Nordisk A/S, Søborg, Denmark, 2Padova University, Padova, Italy

Objectives: To evaluate the cost-effectiveness of switching to IDeg from another basal insulin in type 1 (T1D) or type 2 (T2D) diabetes in routine care.  Methods: Data were drawn from an Italian subpopulation of EU-TREAT, a multicentre, retrospective chart review study, which investigated switching from any basal insulin (± prandial insulin [± oral antidiabetic drugs in T2D]) to IDeg. Parameters in the basecase model were change in hypoglycaemia rates, basal and prandial insulin dose and body weight at 6 months post-switch and cost of treatment and complications. A 1-year, cost-effectiveness model evaluated the Incremental Cost-Effectiveness