Hereditary angioedema (HAE) is a rare and potentially life-threatening condition. The efficacy of acute HAE treatments has not been assessed in head-to-head comparative studies. This study aimed to establish the relative efficacy of icatibant [Shire HGT] versus C1-esterase inhibitor concentrate (C1-INH) [CSL Behring], C1-INH [ViroPharma], rh-C1-INH [Pharming], and ecallantide [Dyax]. A systematic literature review identified nine relevant randomised clinical trials. Indirect comparison (IC) hazard ratios (HR) between treatments were calculated using the methods of Bucher et al (1997) and Song et al (2003). To account for trial heterogeneity, five sets of icatibant data were considered separately; three clinical endpoint definitions (time to onset of primary symptom relief, time to initial symptom improvement [subject-assessed], and time to onset of symptom relief based on composite VAS score); and three rescue medication (RM) censoring methods (no censoring [RMs ignored], censoring subjects who took RMs prior to onset of symptom relief, and resetting time to onset of symptom relief to 24 h for censored subjects) were considered separately in the ICs. The IC considered each of the 45 icatibant data/endpoint definition/RM censoring combinations. HR estimates favoured (HR ≥1) 37/45 icatibant combinations versus C1-INH [CSL Behring] 20 IU/kg (Median HR = 1.39 [minimum 0.72, maximum 2.10]), 45/45 (29 statistically significant) versus C1-INH [CSL Behring] 10 IU/kg (Median HR = 2.19 [minimum 1.07, maximum 3.39]), 32/45 versus C1-INH [ViroPharma] (Median HR = 1.36 [minimum 0.63, maximum 2.22]), 24/45 versus rh-C1-INH 50 IU/kg (Median HR = 1.04 [minimum 0.48, maximum 1.70]), and 43/45 versus ecallantide (Median HR = 1.67 [minimum 0.75, maximum 2.66]). Icatibant showed improved time to symptom relief when compared with C1-INH [CSL Behring] 10 IU/kg. No clear differences were evident versus either C1-INH [CSL Behring] 20 IU/kg (SmPC dosing) or the three other HAE treatments.

To evaluate the cost-effectiveness of icatibant [Shire HGT] 30 mg subcutaneous versus C1-esterase inhibitor concentrate (C1-INH) [CSL-Behring] 20 IU/kg intravenous for moderate to severe attacks of hereditary angioedema (HAE) types I and II in the UK setting. A probabilistic cost-utility model was developed over a time horizon of 96 h (the duration of a single acute attack). Comparisons were made for therapy administered at home and in hospital. Quality-adjusted life years (QALYs) were estimated by combining the time to onset of symptom relief with utility weights for the health states before and after onset of symptom relief. Clinical evidence and other model parameters were identified by systematic review. An indirect comparison using previously published methods was conducted. Costs relating to drug acquisition; administration; repeat injections; monitoring and supportive care; hepatitis A and B vaccinations for C1-INH; self-administration training; and adverse events were considered. Probabilistic and univariate sensitivity analyses were conducted. The indirect analysis suggested a non-significant trend towards a reduced time to symptom relief for icatibant when compared with C1-INH. In the economic analysis, there was a non-significant inter-treatment difference in estimated QALYs per attack, equivalent to ∼0.75 quality-adjusted life hours in icatibant's favour. In the base-case analysis (SmPC dosing and NHS list price), total costs per attack were estimated as £1,577 for icatibant and £2,169 for C1-INH; a saving of £592 (95%CI: £394–£715) per attack with icatibant. This is one of the first comparative health economic models presented for HAE. The systematic approach to data identification and analysis led to successful submissions to SMC and AWMSG in this orphan indication. The analysis demonstrated that icatibant reduces costs versus C1-INH (20 IU/kg at SmPC dosing) when treating acute HAE attacks in the UK setting.

OBJECTIVETo evaluate the quality of life and economic impact of switching therapy from infliximab to adalimumab in patients with rheumatoid arthritis (RA).METHODSIn this open-label study, patients demonstrating a clinical response to infliximab were switched to treatment with adalimumab and followed for 16 weeks. Both generic (Health Assessment Questionnaire and Short Form 36 Physical Component Summary and Mental Component Summary) and specific (Rheumatoid Arthritis Quality of Life questionnaire) assessment instruments of physical function and of quality of life were employed. An economic analysis of treatment-related costs was also performed. Disease activity was assessed by the composite 28-joint count Disease Activity Score (DAS28). C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) were measured as acute phase markers.RESULTSNineteen patients were enrolled and completed the study. No changes in functional and quality-of-life measures were observed. One-year extrapolation data showed potential reductions in costs following switching to adalimumab that could be attributed primarily to reductions in patient- and staff-related costs. Safety and tolerability were similar for both treatments. Although there was a significant reduction in DAS28 (P < 0.005) and CRP (P < 0.001) after switching to adalimumab, there were no significant changes in individual DAS28 components, including swollen and tender joint counts and ESR.CONCLUSIONSA switch from infliximab to adalimumab in patients with RA who have responded to infliximab is a feasible, well-tolerated treatment option, with the potential for direct and indirect economic advantages.

BACKGROUND:We sought to review the economics literature on enteral nutrition (EN) and oral nutrition supplements (ONS) against the background of an ongoing clinical guideline development. METHODS:We searched the Health Economic Evaluations Database, the NHS Economic Evaluation Database, and the Cochrane Database of Systematic Reviews. RESULTS:Enteral vs parenteral nutrition was found to be the most common comparison undertaken. The randomized trial evidence suggests that, in some groups of patients, EN is better in terms of clinical endpoints and/or length of hospital stay. This should translate into a lower mean cost for EN, given the reduced daily cost. These studies should be treated with caution because of their small sample size and poor quality. Costing was often crude and poorly reported, tending to focus on the narrow costs of the nutrition supplements. Only 1 study of a nutrition supplement in the community setting was found. CONCLUSIONS:There is some evidence to indicate economic advantages of enteral over parenteral nutrition and of immune-enhancing supplements relative to control diet. There is a lack of well-designed studies taking a broad view of relevant comparators, costs, and outcomes. The cost-effectiveness of different forms of nutrition in different patient groups remains to be established.

PHP34 ENTERAL FEEDING IN THE COMMUNITY: A STUDY OF HEALTH ECONOMIC OUTCOMES USING THE GENERAL PRACTICE RESEARCH DATABASE (GPRD) Pang F, Girod I, Saleh A, Knight H, Glencorse C, Edington J Abbott Laboratories UK, Maidenhead, Berkshire, UK; MAPI Values UK, Macclesfield, Cheshire, UK; Orion Technology, Gerrards Cross, Buckinghamshire OBJECTIVE: NICE is currently developing clinical guidelines on nutritional support in adults. The objective of this study was to determine which patients in primary care in the UK were prescribed enteral nutrition (sip & tube feeds) and to examine the associated economic outcomes. METHODS: Patients prescribed enteral nutrition during 2000/2001 were identified from the General Practice Research Database (GPRD). The results were analysed according to pre-determined BMI categories and diagnostic categories (cancer, dysphagia, stroke, GI, neurological, respiratory disorders, cystic fibrosis, renal disease, feeding difficulties). Results for the two largest diagnostic groups (GI disorders and cancer) are presented. RESULTS: In all, 2.34 million patients were registered on GPRD. 13,153 patients (0.6%) received >1 prescriptions for enteral nutrition, of whom 1332 had a recorded height and weight measurement. In all, 83% of patients with GI disorders and 69% with cancer had a BMI below 25. The number of nutritional prescriptions as a percentage of the total prescriptions by primary diagnosis category (cancer and GI disorders respectively) were as follows: BMI 15–<20 (1.1%, 3.0%), 21–<25 (3.2%, 2.1%), 26–<30 (1.2%, 0.3%) and 31–<40 (0.5%, 0.4%). GP visits were frequent in both diagnostic groups in all BMI categories (mean range 27–36 for GI disorders; 38–59 for cancer). Hospitalisations were also frequent with means ranging from 2.5–3.0 for GI disorders; 1.9–4.6 for cancer, possibly reflecting severity of disease. CONCLUSIONS: It is expected that patients with a lower BMI would have a higher percentage of nutritional prescriptions. Whilst this was found to be the case for patients with GI disorders, the study results showed that patients with cancer and a low BMI had fewer nutritional prescriptions. This suggests that some patients in the community who could benefit from enteral nutrition may not be receiving it.

Background Et aims: Malnutrition is common in sick elderly people on admission to hospital and in the community. We conducted a randomised controlled trial to determine if nutritional supplementation after discharge from hospital improved nutritional status and functional outcomes, or reduced health-care costs.Methods: Elderly malnourished subjects were randomised to 8 weeks of supplementation or no supplementation post discharge, and followed up for 24 weeks. Weight, body mass index, anthropometrics, handgrip strength, quality of life and requirements for health-care professionals' services and social services were measured throughout the study.Results: Nutritional status improved significantly from baseline to week 24 in the intervention group (P<0.05), but not in the control group. There was no significant difference in nutritional status between groups at week 24. Handgrip strength improved significantly in the intervention group during supplementation, and was significantly different from that of the control group at week 8, but decreased thereafter. There was no significant difference in quality of life or health economic outcomes between groups at week 24.Conclusions: In already malnourished elderly subjects, it may be too late to expect to improve function or quality of life or to reduce health-care costs simply by providing nutritional supplements after hospitalisation. Prevention is key. All. elderly patients should be nutritionally assessed as part of their routine care, and appropriate intervention initiated early. (C) 2003 Elsevier Ltd. All rights reserved.