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Jürgen Stein,1,2 Jennifer Scarlet Haas,3 Siew Hwa Ong,4 Kathrin Borchert,3 Thomas Hardt,5 Elmira Lechat,4 Kerry Nip,5 Douglas Foerster,4 Sebastian Braun,3 Daniel C Baumgart6 1Interdisciplinary Crohn Colitis Center Rhein-Main, Frankfurt/Main, Germany; 2Department of Gastroenterology and Clinical Nutrition, DGD Clinics Sachsenhausen, Teaching Hospital of the J.W. Goethe University, Frankfurt/Main, Germany; 3Xcenda GmbH, Hannover, Germany; 4Vifor Pharma Ltd., Glattbrugg, Switzerland; 5Vifor Pharma Deutschland GmbH, Munich, Germany; 6Division of Gastroenterology, University of Alberta, Edmonton, AB, Canada Background: Iron-deficiency anemia and iron deficiency are common comorbidities associated with inflammatory bowel disease (IBD) resulting in impaired quality of life and high health care costs. Intravenous iron has shown clinical benefit compared to oral iron therapy. Aim: This study aimed to compare health care outcomes and costs after oral vs intravenous iron treatment for IBD patients with iron deficiency or iron deficiency anemia (ID/A) in Germany. Methods: IBD patients with ID/A were identified by ICD-10-GM codes and newly commenced iron treatment via ATC codes in 2013 within the InGef (formerly Health Risk Institute) research claims database. Propensity score matching was performed to balance both treatment groups. Non-observable covariates were adjusted by applying the difference-in-differences (DID) approach. Results: In 2013, 589 IBD patients with ID/A began oral and 442 intravenous iron treatment. After matching, 380 patients in each treatment group were analyzed. The intravenous group had fewer all-cause hospitalizations (37% vs 48%) and ID/A-related hospitalizations (5% vs 14%) than the oral iron group. The 1-year preobservation period comparison revealed significant health care cost differences between both groups. After adjusting for cost differences by DID method, total health care cost savings in the intravenous iron group were calculated to be €367. While higher expenditure for medication (€1,876) was observed in the intravenous iron group, the inpatient setting achieved most cost savings (€1,887). Conclusion: IBD patients receiving intravenous iron were less frequently hospitalized and incurred lower total health care costs compared to patients receiving oral iron. Higher expenditures for pharmaceuticals were compensated by cost savings in other domains. Keywords: inflammatory bowel disease, iron-deficiency anemia, claims data, iron treatment, health care cost, Germany

Economic evaluation is established within health-technology assessment but is challenged by those wanting to use economic evaluation to inform pricing and/or incorporate nontraditional sources of value and the views of diverse stakeholders. The changing role of economic evaluation in (formally or informally) assessing prices/values in four jurisdictions (UK, Australia, Germany and USA) is detailed and the authors propose a taxonomy of factors impacting the value of medical technology spanning clinical utility (effectiveness, safety/tolerability and quality of evidence), consumer demand (consumer preferences, process utility and unmet need), economic incentives (innovation, option value and market competition) and the societal perspective (social justice, social values and national interest). The authors suggest that multicriteria decision analysis methods grounded in hedonic-pricing theory can facilitate the valuing/pricing of medical technologies. The use of such an approach is hindered by a paucity of relevant educational opportunities, vested interests and aversion to placing prices/values on health.

Background The safety and efficacy of racecadotril to treat acute watery diarrhea (AWD) in children is well established, however its cost effectiveness for infants and children in Europe has not yet been determined. Objective To evaluate the cost utility of racecadotril adjuvant with oral rehydration solution (ORS) compared to ORS alone for the treatment of AWD in children younger than 5 years old. The analysis is performed from a United Kingdom National Health Service (NHS) perspective. Methods A decision tree model has been developed in Microsoft(®) Excel. The model is populated with the best available evidence. Deterministic and probabilistic sensitivity analyses (PSA) have been performed. Health effects are measured as quality-adjusted life years (QALYs) and the model output is cost (2011 GBP) per QALY. The uncertainty in the primary outcome is explored by probabilistic analysis using 1000 iterations of a Monte Carlo simulation. Results Deterministic analysis results in a total incremental cost of -£379 in favor of racecadotril and a total incremental QALY gain in favor of racecadotril of +0.0008. The observed cost savings with racecadotril arise from the reduction in primary care reconsultation and secondary referral. The difference in QALYs is largely attributable to the timely resolution of symptoms in the racecadotril arm. Racecadotril remains dominant when base case parameters are varied. Monte Carlo simulation and PSA confirm that racecadotril is the dominant treatment strategy and is almost certainly cost effective, under the central assumptions of the model, at a commonly used willingness to pay proxy threshold range of £20,000-£30,000 per QALY. Conclusion Racecadotril as adjuvant therapy is more effective and less costly compared to ORS alone, from a UK payer perspective, for the treatment of children with acute diarrhea.

OBJECTIVE: Exocrine pancreatic insufficiency (EPI) is frequent in patients with chronic pancreatitis (CP). This 1-year, prospective, multicenter, observational, disease management study aimed to assess symptom improvement and quality of life in patients with CP with EPI who were receiving pancreatic enzyme replacement. METHODS: Patients with CP and chronic EPI were either assigned to cohort 1 that consisted of patients already taking pancreatin (Kreon; Abbott Arzneimittel GmbH, Hannover, Germany) or cohort 2 that consisted of patients with newly diagnosed EPI without prior pancreatic enzyme treatment. Symptoms were documented, and quality of life was assessed using the gastrointestinal quality of life index (GIQLI) at baseline, 6 months, and 1 year. RESULTS: A total of 294 patients were evaluated (cohort 1, n = 206; cohort 2, n = 88). The proportion of patients experiencing gastrointestinal symptoms and recurrent pain after 1 year was significantly reduced in both cohorts (P < 0.001). The alleviation of symptoms was reflected in GIQLI score improvements at 1 year in both cohorts (P < 0.001), independent of CP severity and etiology. Improvements in GIQLI score were more pronounced in cohort 2 (P < 0.001). CONCLUSIONS: Pancreatin demonstrated symptom relief and improvement in quality of life in patients with CP-related EPI in this disease management study.