ML) IN Patients With Type 2 Diabetes Mellitus In Serbia

VA L U E I N H E A LT H

PDB38 Cost-Effectiveness Analysis Of Insulin Degludec Versus Insulin Glargine U100 In Type 1 And Type 2 Diabetes Patients From The Portuguese National Healthcare System Perspective: Evidence From The Switch 1&2 Trials Ramirez de Arellano Serna A1, Darba J2, Tikkanen C3, Conde V4 1Novo Nordisk, Madrid, Spain, 2Universitat de Barcelona, Barcelona, Spain, 3Novo Nordisk Healthcare AG, Copenhagen, Denmark, 4Novo Nordisk, Paco de Arcos, Portugal

Objectives: SWITCH 1&2 randomised, double-blind, two-period, crossover trials in patients with Type 1 and Type 2 diabetes showed fewer hypoglycemic events with insulin degludec (IDeg) vs insulin glargine U100 (IGlar U100). The current study assessed the cost-effectiveness of IDeg vs IGlar U100 from a Portuguese healthcare perspective, using data from the SWITCH 1&2 trials.  Methods: A short-term costeffectiveness model was elaborated to calculate effectiveness results for IDeg vs IGlar U100. Hypoglycaemia and insulin dose data from SWITCH 1&2, the costs of insulin, needles, blood glucose tests and hypoglycaemic events in Portugal, and disutilities for different types of hypoglycaemic events have been used to populate the model. Benefits were measured in QALYs.  Results: In both trials non-severe nocturnal and severe hypoglycaemic events were significantly lower in favour of IDeg. Non-severe daytime hypoglycemic events did not show any difference in SWITCH 1 trial while in SWITCH 2 trial there were a significant lower number of events in favour of IDeg. End-of-trial basal insulin dose was significantly lower with IDeg vs IGlar U100 while bolus doses in T1DM were similar. IDeg proved to be a cost-effective therapy for T1DM and T2DM showing an incremental cost-effectiveness ratio (ICER) of 7,349.19€ /QALY and 21,930.20€ /QALY, respectively. Both ICERs were lower than the willingness to pay threshold of 30,000€ /QALY. Sensitivity analyses confirmed the robustness of results.  Conclusions: This cost-effectiveness study demonstrates that IDeg is a cost-effective therapy over IGlar U100 for T1DM and T2DM patients from the perspective of the Portuguese healthcare system. PDB39 Cost-Utility Evaluation Of Insulin Glargine (300 U/ML) Versus Insulin Glargine (100 U/ML) And Insulin Degludec (100 U/ML) In Patients With Type 2 Diabetes Mellitus In Slovenia Bogdanovic M1, Rados Krnel S2, Fournier M3 d.o.o., Belgrade, Serbia, 2Pharmec, Ljubljana, Slovenia, 3Sanofi, Chilly-Mazarin, France 1sanofi-aventis

Objectives: The study aims to assess the cost-utility of insulin glargine 300U/ ml (GLA-300) compared to a biosimilar of insulin glargine 100U/ml (GLA-100) and insulin degludec 100U/ml (DEG-100) in patients with type 2 diabetes mellitus in Slovenia.  Methods: A cost-utility model was developed to estimate differences in costs and clinical outcomes. The perspective of the analysis was that of a healthcare payer in Slovenia within one year time horizon. Main outcome was incremental cost-effectiveness ratio (ICER) expressed in Euros (EUR) per quality adjusted life years (QALYs). Costs considered were drug costs, resource consumption costs and costs of treating hypoglycaemia. Insulin dosages used per each of the comparators relied on pooled analysis of EDITION 1-2-3 clinical trials. Efficacy in the model was analysed based on comparators’ impact on: incidence of hypoglycaemic events, body mass index and dosage flexibility. Changes of these parameters were cited from EDITION 1-2-3 for comparison with GLA-100, and from network meta-analysis for comparison with DEG-100. Probabilistic sensitivity analysis (PSA) was conducted to test the model robustness.  Results: In the base case analysis, GLA-300 was associated with incremental QALYs compared to GLA-100 and DEG-100 estimated at 0.0082 and 0.0112, respectively. Total costs associated with GLA-300 were higher than those of GLA-100 (+€ 171.7) and lower than those of DEG-100 (-€ 624.4). In comparison with GLA-100, the estimated ICER was € 20,911/ QALY, while in comparison with DEG-100, GLA-300 was pharmacoeconomically dominant as it obtains additional health gains with associated cost savings. At the € 25,000 cost-effectiveness threshold, PSA estimated a probability of 54% and 99% for GLA-300 being cost-effective in comparison with GLA-100 and DEG-100, respectively.  Conclusions: Based on a reduced incidence of hypoglycaemia and possibility for dose flexibility, GLA-300 is likely to be cost effective in economic and clinical conditions of Slovenia in comparison to GLA-100 and pharmacoeconomically dominant in comparison to DEG-100. PDB40 Cost-Utility Evaluation Of Insulin Glargine (300 U/ML) Versus Insulin Glargine (100 U/ML) And Insulin Degludec (100 U/ML) IN Patients With Type 2 Diabetes Mellitus In Serbia Mihajlović J1, Bogdanovic M2, Fournier M3 Sad, Serbia, 2sanofi-aventis d.o.o., Belgrade, Serbia, 3Sanofi, Chilly-Mazarin, France

1Mihajlović  Health Analytics, Novi

Objectives: The study aims to assess the cost-utility of insulin glargine 300 units/ml (GLA-300) compared to insulin glargine 100 units/ml (GLA-100) and insulin degludec 100 units/ml (DEG-100) in patients with type 2 diabetes mellitus in Serbia.  Methods: A cost-utility model was developed to estimate differences in costs and clinical outcomes. The perspective of the analysis was that of a healthcare payer in Serbia within one year time horizon. Main outcome was incremental cost-effectiveness ratio (ICER) expressed in dinars (RSD) per quality adjusted life years (QALYs). Costs considered were drug costs and costs of treating hypoglycaemia. Insulin dosages used per each of the comparators relied on pooled analysis of EDITION 1-2-3 clinical trials. Efficacy in the model was analysed based on comparators’ impact on: incidence of hypoglycaemic events, body mass index and dosage flexibility. Changes of these parameters were cited from EDITION 1-2-3 for comparison with GLA-100, and from network meta-analysis for comparison with DEG-100. Probabilistic sensitivity analysis (PSA) was conducted to test the model robustness.  Results: In the base case analysis, GLA-300 was associated with incremental QALYs compared to GLA-100 and DEG-100 estimated at 0.0082 and 0.0112, respectively. Total costs associated with GLA-300 were higher than those of

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GLA-100 (+RSD3,714.9) and lower than those of DEG-100 (-RSD35,560.7). In comparison with GLA-100, the estimated ICER was RSD 452,536/QALY, while in comparison with DEG-100, GLA-300 was pharmacoeconomically dominant as it obtains additional health gains with associated cost savings. At the 3xGDP/capita cost-effectiveness threshold, PSA estimated a probability of 66% and 93% for GLA-300 being cost-effective in comparison with GLA-100 and DEG-100, respectively.  Conclusions: Based on a reduced incidence of hypoglycaemia and possibility for dose flexibility, GLA-300 is likely to be highly cost effective in economic and clinical conditions of Serbia in comparison to GLA-100 and pharmacoeconomically dominant in comparison to DEG-100. PDB41 Impact of Comorbid Critical Limb Ischemia And Diabetes on Healthcare Resource Use And Costs Ting W1, Haskell L2, Lurie F3, Berger JS4, Eapen Z5, Valko M6, Rich K6, Crivera C2, Schein JR2, Alas V6 1Mount Sinai Hospital, New York, NY, USA, 2Janssen Scientific Affairs, LLC, Raritan, NJ, USA, 3ProMedica, Toledo, OH, USA, 4New York University School of Medicine, New York, NY, USA, 5Duke University, Durham, NC, USA, 6GNS Healthcare, Cambridge, MA, USA

Objectives: Prevalence of diabetes in peripheral artery disease patients is high and these patients are at increased risk for major cardiovascular events. This study’s aim was to use a retrospective cohort to assess healthcare resource use (HRU) and costs among critical limb ischemia (CLI) patients with diabetes.  Methods: Using a major US database comprised of integrated administrative claims and electronic health records (2007-15), we estimated annual all-cause HRU and total healthcare costs for a sample of 3,189 CLI adults ≥ 50 years. CLI was characterized by rest pain, ulceration or gangrene. HRU and costs were calculated from medical and pharmacy claims for 1 year following first diagnosis of CLI (index date). Patients who died in the post-index period were included. We stratified patients into 2 cohorts: with and without pre-index diabetes diagnosis. Reverse Engineering and Forward Simulation (REFSTM), a hypothesis free machine learning platform that uses Bayesian network inference, was used to build an ensemble of prediction models for hospitalization and annual total healthcare costs of CLI patients.  Results: Nearly 50% of CLI patients had comorbid diabetes. Diabetics had more hospitalizations (mean [SD]: 1.5 [2.0] vs 1.1 [1.6], p< 0.001) and higher costs ($70,808 [$102,568] vs $43,319 [$76,751], p< 0.001) compared to non-diabetics. REFSTM selected factors with the highest frequency in both models. Those predictive of hospitalization were (OR, SD): cellulitis and abscess (2.1, 0.04), beta blockers non-selective (2.1, 1.3), and other aftercare (1.6, 0.1). Predictors of increased costs were (% change in cost, SD): south region (1.2, 0.03), chronic skin ulcers (2.0, 0.1), and chronic kidney disease (1.9, 0.2).  Conclusions: HRU and costs were higher for CLI patients with comorbid diabetes. Factors driving these increases in the overall CLI population may be related to the increased complexity of comorbid diabetes and may provide an opportunity for cost savings via timely care decisions in diabetes and CLI. PDB42 The Real-World Impact Of Mild To Moderate Hypoglycemic Events In Portugal – Results From The Hipos-Pharma Study Laires PA1, Conceição J1, Alão S1, Guerreiro JP2, Romano S2, Longo P2, Miranda A2, Torre C2 Sharp & Dohme, Porto Salvo, Portugal, 2Center for Health Evaluation & Research, Lisbon, Portugal

1Merck

Objectives: We measured the impact of mild to moderate hypoglycemic events occurring in ambulatory Type 2 Diabetes Mellitus (T2DM) patients, including healthcare consumption, productivity losses and disease management. Methods: HIPOS-PHARMA was a nationwide observational, cross-sectional, multicenter study performed from 4 April until 20 May 2016 in community pharmacies of Portugal, which surveyed T2DM patients under treatment for at least 3 months. A structured questionnaire was managed by pharmacists, including questions about awareness, prevalence and the impact of hypoglycemic episodes.  Results: Among those T2DM patients experiencing a mild to moderate hypoglycemic episode in the previous 3 months (17.8% out of 1890 surveyed T2DM patients) 9.1% required non-scheduled medical/nursing consultations and 9.4% reported absenteeism from work (mean loss of 1.5 working days) as a consequence of such events. In addition, almost a fifth (18.3%) not only required therapeutic modification, mainly dosage modification (68.9%), but also drug switch (18.0%) and temporary treatment interruption (8.2%). The recorded hypoglycemic events also led to a modification of self-monitoring of blood glucose levels in over a third of patients (38.3%; with a mean additional consumption of 2.7 blood glucose test strips). Furthermore, in our study, T2DM patients didn’t fully acknowledge when they were having a hypoglycemic episode (Always: 53.0%; Almost always: 27.1%; Sometimes: 11.1%; Rarely: 5.0%; Never: 3.8%) and that underreporting of these relevant events occurred with only 46.4% of patients reporting it to an healthcare professional (Physician: 80.7%; Pharmacist: 18.7%; Nurse: 17.4%; Other 1.9%).  Conclusions: In this nationwide study we observed that mild to moderate hypoglycemic episodes are associated with healthcare consumption, productivity losses and changes in management of Diabetes. Furthermore, we also confirmed that there is a need for improvement in the communication between patients and healthcare professionals in order to increase patient awareness and reporting of diabetes-related hypoglycemic events. PDB43 Pump-Downloaded Insulin Usage For The First 12 Months In A Cohort of Children Newly-Diagnosed With Type 1 Diabetes (T1D) Ridyard CH1, Blair J2, Hughes DA1, On behalf of the SCIPI Trial Investigators3 University, Bangor, UK, 2Alder Hey Children’s NHS Foundation Trust, Liverpool, UK, 3Clinical Trials Research Centre, Liverpool, UK

1Bangor

Objectives: Continuous subcutaneous insulin infusions (CSII) are an alternative to multiple daily injections (MDI) for glycaemic control and reducing risks of developing long term microvascular and macrovascular complications in type 1 diabetes (T1D). As part of a randomised clinical trial (SCIPI, ISRCTN29255275), we compared insulin