Omalizumab for the treatment of severe persistent allergic asthma: A systematic review and economic evaluation

Health Technology Assessment

Volumn 17, Issue 52, 2013, Pages

  Norman, G ^a   Faria, R ^a   Paton, F ^a   Llewellyn, A ^a   Fox, D ^a   Palmer, S ^a   Clifton, I ^b   Paton, J ^c   Woolacott, N ^a   McKenna, C ^a  

^a UNIVERSITY OF YORK   (United Kingdom)

^b ST JAMES S UNIVERSITY HOSPITAL   (United Kingdom)

^c UNIVERSITY OF GLASGOW   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

BETA ADRENERGIC RECEPTOR STIMULATING AGENT; CORTICOSTEROID; LONG ACTING DRUG; OMALIZUMAB; PLACEBO; ANTIASTHMATIC AGENT; ANTIIDIOTYPIC ANTIBODY; MONOCLONAL ANTIBODY;

ABDOMINAL PAIN; ADD ON THERAPY; ADOLESCENT; ADRENAL INSUFFICIENCY; ADULT; ALLERGIC ASTHMA; ANAPHYLAXIS; ARTERY THROMBOSIS; ARTICLE; BEHAVIOR DISORDER; BODY WEIGHT DISORDER; BRONCHITIS; CARDIOVASCULAR DISEASE; CATARACT; CEREBROVASCULAR ACCIDENT; CHILD; CLINICAL EFFECTIVENESS; COHORT ANALYSIS; CONTROLLED STUDY; COST EFFECTIVENESS ANALYSIS; DIABETES MELLITUS; DISEASE EXACERBATION; DRUG COST; DRUG EFFECT; DRUG FEVER; DRUG INDICATION; DRUG INDUCED HEADACHE; DRUG MEGADOSE; DRUG SAFETY; DRUG WITHDRAWAL; ECONOMIC EVALUATION; ENDOCRINE DISEASE; EVIDENCE BASED MEDICINE; EYE DISEASE; FEMUR FRACTURE; FRACTURE; FRAGILITY FRACTURE; GASTROINTESTINAL DISEASE; GLAUCOMA; HEALTH CARE UTILIZATION; HEART FAILURE; HEART INFARCTION; HIP FRACTURE; HOSPITALIZATION; HUMAN; HYPERGLYCEMIA; INCIDENCE; INJECTION SITE ERYTHEMA; INJECTION SITE PAIN; INJECTION SITE PRURITUS; INJECTION SITE REACTION; INJECTION SITE SWELLING; INTRAOCULAR HYPERTENSION; ISCHEMIC HEART DISEASE; LOW DRUG DOSE; LOWER RESPIRATORY TRACT INFECTION; MAINTENANCE THERAPY; MALIGNANT NEOPLASTIC DISEASE; METABOLIC DISORDER; MOOD DISORDER; MORTALITY; MUSCULOSKELETAL DISEASE; NATIONAL HEALTH SERVICE; NEUROLOGIC DISEASE; NONHODGKIN LYMPHOMA; OBSERVATIONAL STUDY; OUTCOME ASSESSMENT; PEPTIC ULCER; POPULATION RESEARCH; PRESCHOOL CHILD; PREVALENCE; PROGNOSIS; QUALITY ADJUSTED LIFE YEAR; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); RASH; SCHOOL CHILD; SEVERE PERSISTENT ALLERGIC ASTHMA; SEVERE PERSISTENT ASTHMA; SINUSITIS; SKIN DISEASE; SLEEP DISORDER; SPINE FRACTURE; SYMPTOM; SYSTEMATIC REVIEW; THROMBOSIS; UNITED KINGDOM; URTICARIA; WEIGHT GAIN; AGE; ASTHMA; COST BENEFIT ANALYSIS; DRUG UTILIZATION; ECONOMICS; HEALTH SERVICE; PROBABILITY; REVIEW; STATISTICAL MODEL; UTILIZATION REVIEW;

ADOLESCENT; ADRENAL CORTEX HORMONES; ADRENERGIC BETA-AGONISTS; ADULT; AGE FACTORS; ANTI-ASTHMATIC AGENTS; ANTIBODIES, ANTI-IDIOTYPIC; ANTIBODIES, MONOCLONAL, HUMANIZED; ASTHMA; CHILD; COST-BENEFIT ANALYSIS; DRUG UTILIZATION; GREAT BRITAIN; HEALTH SERVICES; HUMANS; MARKOV CHAINS; MODELS, ECONOMIC; QUALITY OF LIFE; STATE MEDICINE;

EID: 84888350899     PISSN: 13665278     EISSN: 20464924     Source Type: Journal    
DOI: 10.3310/hta17520     Document Type: Article

References (172)

1. Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention, 2010. URL: www.ginasthma.org/pdf/GINA_Report_2010.pdf
2. National Institute for Health and Clinical Excellence. NICE technology appraisal guidance 133: Omalizumab for severe persistent allergic asthma, 2007. URL: www.nice.org.uk/guidance/TA133
3. Pascual RM, Peters SP. Airway remodeling contributes to the progressive loss of lung function in asthma: An overview. J Allergy Clin Immunol 2005;116:477-86. http://dx.doi.org/10.1016/ j.jaci.2005.07.011
4. Baumel MJ, Du Buske L, Szefler SJ, Rosenwasser L, Nash DB. National guidelines for a novel therapy: Update on clinical trials and experience using consensus panel recommendations for incorporating omalizumab into asthma management. Pharm Ther 2006;31:276-82.
5. Gibeon DS, Campbell DA, Menzies-Gow AN. The systematic assessment of difficult-to-treat asthma: Why do it? Clin Pulm Med 2010;17:255-9. http://dx.doi.org/10.1097/ CPM.0b013e3181f9d80c
6. Robinson DS, Campbell DA, Durham SR, Pfeffer J, Barnes PJ, Chung KF, et al. Systematic assessment of difficult-to-treat asthma. Eur Respir J 2003;22:478-83. http://dx.doi.org/10.1183/ 09031936.03.00017003
7. Heaney LG, Robinson DS. Severe asthma treatment: need for characterising patients. Lancet 2005;365:974-6. http://dx.doi.org/10.1016/S0140-6736(05)71087-4
8. NHS Information Centre for Health and Social Care. Quality and Outcomes Framework 2008/2009 Prevalence Data Tables. URL: http://data.gov.uk/dataset/quality-and-outcomes-framework-2008-2009-prevalence-data-tables. Cited 23 August 2012.
9. Asthma UK. 'Facts for journalists' webpage. URL: www.asthma.org.uk/news-centre/facts-forjournalists/. Cited 23 August 2012.
10. Department of Health. An outcomes strategy for chronic obstructive pulmonary disease (COPD) and asthma in England. 2011. URL: www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/ documents/digitalasset/dh_128428.pdf
11. National Asthma Education Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. [Erratum appears in J Allergy Clin Immunol 2008 Jun;121:1330.] J Allergy Clin Immunol 2007;120:S94-138. http://dx.doi.org/ 10.1016/j.jaci.2007.09.029
12. Kelly HW. Rationale for the major changes in the pharmacotherapy section of the National Asthma Education and Prevention Program guidelines. J Allergy Clin Immunol 2007;120:989-94. http://dx.doi.org/10.1016/j.jaci.2007.01.035
13. British Thoracic Society, Scottish Intercollegiate Guidelines Network. British guideline on the management of asthma: a national clinical guideline. 2012. URL: www.sign.ac.uk/pdf/sign101.pdf
14. National Institute for Health and Clinical Excellence. NICE technology appraisal guidance 201: Omalizumab for severe persistent allergic asthma in children aged 6 to 11 years. 2010. URL: www.nice.org.uk/guidance/TA201
15. Manufacturer Submission of Evidence to the National Institute of Health and Clinical Excellence: Multiple Technology Appraisal (MTA) Xolair (omalizumab) for the Treatment of Severe Persistent Allergic Asthma (review of TA133 and TA201) Camberley: Novartis Pharmaceuticals UK Ltd; 2012.
16. NHS reference costs 2009-2010. URL: www.dh.gov.uk/en/Publicationsandstatistics/Publications/ PublicationsPolicyAndGuidance/DH_123459. Cited 24 April 2012.
17. NHS collaboration of the United Kingdom Medicines Information Pharmacists' Group and The National Prescribing Centre. New drugs in clinical development: Omalizumab. 2001. URL: www.ukmi.nhs.uk/Newmaterial/html/docs/OMALIZUMAB%20FINAL.pdf
18. European Medicines Agency. Summary of product characteristics (Xolair). 2011. URL: www.ema. europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000606/ WC500057298.pdf
19. Humbert M, Beasley R, Ayres J, Slavin R, Hebert J, Bousquet J, et al. Benefits of omalizumab as add-on therapy in patients with severe persistent asthma who are inadequately controlled despite best available therapy (GINA 2002 step 4 treatment): INNOVATE. Allergy 2005;60:309-16. http://dx.doi.org/10.1111/j.1398-9995.2004.00772.x
20. Lanier B, Bridges T, Kulus M, Taylor AF, Berhane I, Vidaurre CF. Omalizumab for the treatment of exacerbations in children with inadequately controlled allergic (IgE-mediated) asthma. J Allergy Clin Immunol 2009;124:1210-16. http://dx.doi.org/10.1016/j.jaci.2009.09.021
21. Scottish Medicines Consortium. Product Update: Omalizumab (Xolair®) 75mg, 150mg solution for injection as prefilled syringe (No: 708/11). 2011. URL: www.scottishmedicines.org.uk/files/advice/ omalizumab_Xolair_ABBREVIATE_FINAL_May_2011_for_website.pdf
22. British Medical Association and Royal Pharmaceutical Society of Great Britain. British National Formulary. No. 63, March 2012. URL: www.medicinescomplete.com/mc/bnf/current/129493. htm#_129493
23. Centre for Reviews and Dissemination. Systematic reviews: CRD's guidance for undertaking reviews in healthcare. 3rd ed. 2009. URL: www.york.ac.uk/inst/crd/SysRev/!SSL!/WebHelp/SysRev3.htm
24. Moher D, Liberati A, Tetzlaff J, Altman D, The PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: The PRISMA statement. PLoS Med 2009;6:e1000097. doi:10.1371/journal.pmed.97.
25. Higgins J, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration. URL: www.cochrane-handbook.org/
26. Novartis Pharmaceuticals UK Ltd. Summary of Product Characteristics (SPC) for Xolair® (omalizumab). electronic Medicines Compendium (eMC). 2011. URL: www.medicines.org.uk/EMC/ medicine/24912/SPC/Xolair+Solution+for+Injection/. Cited 28 December 2011.
27. Golder S, Loke Y, McIntosh HM. Poor reporting and inadequate searches were apparent in systematic reviews of adverse effects. J Clin Epidemiol 2008;61:440-8. http://dx.doi.org/10.1016/ j.jclinepi.2007.06.005
28. Busse WW, Morgan WJ, Gergen PJ, Mitchell HE, Gern JE, Liu AH, et al. Randomized trial of omalizumab (anti-IgE) for asthma in inner-city children. N Engl J Med 2011;364:1005-15. http://dx.doi.org/10.1056/NEJMoa1009705
29. Chanez P, Contin-Bordes C, Garcia G, Verkindre C, Didier A, De Blay F, et al. Omalizumab-induced decrease of FcRI expression in patients with severe allergic asthma. Respir Med 2010;104:1608-17. http://dx.doi.org/10.1016/j.rmed.2010.07.011
30. Ayres JG, Higgins B, Chilvers ER, Ayre G, Blogg M, Fox H. Efficacy and tolerability of antiimmunoglobulin E therapy with omalizumab in patients with poorly controlled (moderate-to-severe) allergic asthma. Allergy 2004;59:701-8. http://dx.doi.org/10.1111/j.1398-9995.2004.00533.x
31. Bousquet J, Siergiejko Z, Swiebocka E, Humbert M, Rabe KF, Smith N, et al. Persistency of response to omalizumab therapy in severe allergic (IgE-mediated) asthma. Allergy 2011;66:671-8. http://dx.doi.org/10.1111/j.1398-9995.2010.02522.x
32. Bardelas J, Figliomeni M, Kianifard F, Meng X. A 26-week, randomized, double-blind placebocontrolled, multicenter study to evaluate the effect of omalizumab on asthma control in patients with persistent allergic asthma. J Asthma 2012;49:144-52. http://dx.doi.org/10.3109/ 02770903.2011.648296
33. Hanania NA, Alpan O, Hamilos DL, Condemi JJ, Reyes-Rivera I, Zhu J, et al. Omalizumab in severe allergic asthma inadequately controlled with standard therapy: a randomized trial. Ann Intern Med 2011;154:573-82.
34. Hoshino M, Ohtawa J. Effects of adding omalizumab, an anti-immunoglobulin E antibody, on airway wall thickening in asthma. Respiration 2012;83:520-8. http://dx.doi.org/10.1159/ 000334701
35. Ohta K, Miyamoto T, Amagasaki T, Yamamoto M. Efficacy and safety of omalizumab in an Asian population with moderate-to-severe persistent asthma. Respirology 2009;14:1156-65. http://dx.doi.org/10.1111/j.1440-1843.2009.01633.x
36. Vignola AM, Humbert M, Bousquet J, Boulet LP, Hedgecock S, Blogg M, et al. Efficacy and tolerability of anti-immunoglobulin E therapy with omalizumab in patients with concomitant allergic asthma and persistent allergic rhinitis: SOLAR. Allergy 2004;59:709-17. http://dx.doi.org/ 10.1111/j.1398-9995.2004.00550.x
37. Barnes N, Menzies-Gow A, Mansur A, Spencer D, Percival F, Niven R, et al. Effectiveness of omalizumab in severe allergic asthma: a retrospective real world study in 10 UK centres. J Asthma 2013;50:529-36.
38. Braunstahl G-J, Leo J, Chien-Wei C, Maykut R, Panayiotis G, Peachey G. The eXpeRience registry: monitoring the 'real-world' effectiveness of omalizumab in allergic asthma. European Respiratory Society Annual Congress. Amsterdam, 2011. p. 719s (Poster P3953). URL: www.ers-education.org/ ersMade/abstract_print_11/search/3284.htm
39. Brusselle G, Michils A, Louis R, Dupont L, Van de Maele B, Delobbe A, et al. "Real-life" effectiveness of omalizumab in patients with severe persistent allergic asthma: The PERSIST study. Respir Med 2009;103:1633-42. http://dx.doi.org/10.1016/j.rmed.2009.06.014
40. Cazzola M, Camiciottoli G, Bonavia M, Gulotta C, Ravazzi A, Alessandrini A, et al. Italian real-life experience of omalizumab. Respir Med 2010;104:1410-16. http://dx.doi.org/10.1016/ j.rmed.2010.04.013
41. Costello RW, Long DA, Gaine S, McDonnell T, Gilmartin JJ, Lane SJ. Therapy with omalizumab for patients with severe allergic asthma improves asthma control and reduces overall healthcare costs. Ir J Med Sci 2011;180:637-41. http://dx.doi.org/10.1007/s11845-011-0716-2
42. Deschildre A, Just J, Marguet C, Rittie JL, Derelle J, Pin I, et al. Short term improvement of asthma control by omalizumab in difficult-to-treat asthmatic children: A French national survey. European Respiratory Society 20th Annual Congress. Barcelona, 2010. p. Poster P2636. URL: www.ersnet. org/learning_resources_player/abstract_print_10/main_frameset.htm
43. Brodlie M. Effect of omalizumab on oral corticosteroid requirements of young children with severe asthma; data relating to North East England. Personal communication with Alexis Llewellyn.
44. Korn S, Thielen A, Seyfried S, Taube C, Kornmann O, Buhl R. Omalizumab in patients with severe persistent allergic asthma in a real-life setting in Germany. Respir Med 2009;103:1725-31. http://dx.doi.org/10.1016/j.rmed.2009.05.002
45. Molimard M, de Blay F, Didier A, Le Gros V. Effectiveness of omalizumab (Xolair) in the first patients treated in real-life practice in France. Respir Med 2008;102:71-6. http://dx.doi.org/10.1016/j. rmed.2007.08.006
46. Ohta K, Yamamoto M, Sato N, Ikeda K, Miyamoto T. One year treatment with omalizumab is effective and well tolerated in Japanese patients with moderate-to-severe persistent asthma. Allergol Int 2010;59:167-74. http://dx.doi.org/10.2332/allergolint.09-OA-0137
47. Zureik M, Molimard M, Aubier M, Levy J, Humbert M, Grimaldi-Bensouda L. Effect of omalizumab on the risk of hospitalisation in patients with uncontrolled severe asthma in real life. The PAX-LASER cohort. European Respiratory Society 20th Annual Congress. Barcelona, 2010. p. Poster E5483. URL: www.ers-education.org/media/2010/ePosters/150305.html
48. Busse W, Corren J, Lanier BQ, McAlary M, Fowler-Taylor A, Cioppa GD, et al. Omalizumab, anti-IgE recombinant humanized monoclonal antibody, for the treatment of severe allergic asthma. J Allergy Clin Immunol 2001;108:184-90. http://dx.doi.org/10.1067/mai.2001.117880
49. Buhl R, Hanf G, Solèr M, Bensch G, Wolfe J, Everhard F, et al. The anti-IgE antibody omalizumab improves asthma-related quality of life in patients with allergic asthma. Eur Respir J 2002;20: 1088-94. http://dx.doi.org/10.1183/09031936.02.00016502
50. Holgate ST, Chuchalin AG, Hébert J, Lötvall J, Persson GB, Chung KF, et al. Efficacy and safety of a recombinant anti-immunoglobulin E antibody (omalizumab) in severe allergic asthma. Clin Exp Allergy 2004;34:632-8. http://dx.doi.org/10.1111/j.1365-2222.2004.1916.x
51. Niven R, Chung KF, Panahloo Z, Blogg M, Ayre G. Efficacy of omalizumab in patients with inadequately controlled severe persistent allergic (IgE-mediated) asthma: a subgroup analysis of an open label trial. American Thoracic Society International Conference, 18-23 May 2007, San Francisco, CA, USA, Poster #414.
52. Buhl R, Soler M, Fox H, Ashby M, McAlary M, Cooper J, et al. Omalizumab (Xolair®, rhumab-e25) decreases hospitalization due to serious asthma exacerbations. Am J Respir Crit Care Med 2001;163:A858.
53. Braunstahl G-J, Leo J, Thirlwell J, Peachey G, Maykut R. Uncontrolled persistent allergic asthma in practice: eXpeRience registry baseline characteristics. Curr Med Res Opin 2011;27:761-7. http://dx.doi.org/10.1185/03007995.2011.557717
54. Brodlie M, McKean MM, Moss S, Spencer DA. The oral corticosteroid-sparing effect of omalizumab in children with severe asthma. Arch Dis Child 2012;97:604-9. http://dx.doi.org/10.1136/ archdischild-2011-301570
55. Kirk A, Spencer D, Radwan A. Effect of omalizumab on oral corticosteroid requirements of young children with severe asthma; results of a UK survey. Thorax 2010;65:A86 P23.
56. Domingo C, Moreno A, Jose Amengual M, Monton C, Suarez D, Pomares X. Omalizumab in the management of oral corticosteroid-dependent IGE-mediated asthma patients. Curr Med Res Opin 2011;27:45-53. http://dx.doi.org/10.1185/03007995.2010.536208
57. Gutierrez B. Persistence and compliance with omalizumab in a managed-care population. J Allergy Clin Immunol 2007;119:S160. http://dx.doi.org/10.1016/j.jaci.2006.11.565
58. Randolph CC, Kearney D. Omalizumab therapy for moderate to severe asthma in private allergy practice: A six year experience. J Allergy Clin Immunol 2010;125:AB199(780).
59. Stukus DR, Lang DM. A retrospective evaluation of outcomes in asthmatic patients receiving omalizumab, including patients with IgE levels >700 IU/L. AAAAI 64th Annual Meeting. Philadelphia, 2008. Poster #157.
60. Michils A, Vandenplas O, Brusselle G, Lee C, Van Schoor J, Gurdain S, et al. Real-life persistence beyond the first year of omalizumab treatment in patients with severe allergic asthma: The R-Pixel study. European Respiratory Society Annual Conference. Amsterdam, 2011. p. Session 413 P3959. URL: www.ers-education.org/ersMade/abstract_print_11/search/3290.htm
61. Britton M, Howes T, Boland A, Saralaya D, Hepburn D, Nordstrom M, et al. Real-life effectiveness of omalizumab in patients with severe persistent allergic (IgE-mediated) asthma: Pooled data from 3 UK centres. European Respiratory Society Annual Conference. Amsterdam, 2011. p. Session 51 P273. URL: www.ers-education.org/ersMade/abstract_print_11/search/0108.htm
62. Tzortzaki EG, Georgiou A, Kampas D, Lemessios M, Markatos M, Adamidi T, et al. Long-term omalizumab treatment in severe allergic asthma: The South-Eastern Mediterranean "real-life" experience. Pulm Pharmacol Ther 2012;25:77-82. http://dx.doi.org/10.1016/j.pupt.2011.11.004
63. Chung K, Ankerst J, Rolli M, Gao J, Reisner C. Long-term asthma control with omalizumab, an anti-IgE monoclonal antibody, in patients with severe allergic asthma. European Respiratory Society. Copenhagen, 2005. Poster 417 Thematic Poster Session: Treatment options for moderate and severe asthma. URL: https://www.ersnetsecure.org/public/prg_congres.abstract? ww_i_presentation=18266
64. Storms W, Bowdish MS, Farrar JR. Omalizumab and asthma control in patients with moderate-tosevere allergic asthma: A 6-year pragmatic data review. Allergy Asthma Proc 2012;33:172-7. http://dx.doi.org/10.2500/aap.2012.33.3527
65. Barnes N, Radwan A. The APEX study: Retrospective review of oral corticosteroid use in omalizumab-treated severe allergic asthma patients in UK clinical practice. European Respiratory Society Annual Conference. Amsterdam, 2011. Session 51 P269. URL: www.ers-education.org/ ersMade/abstract_print_11/search/0104.htm (last accessed 30 March 2012).
66. King S, Patterson J, West S, McCool R, Duffy S, Glanville J, et al. A report on asthma-related mortality rates from severe exacerbations. York: York Health Economics Consortium (YHEC) for Novartis AG; 2011.
67. Sweeney J, Brightling CE, Menzies-Gow A, Niven RM, Patterson CC, Heaney LG, et al. Clinical management and outcome of refractory asthma in the UK from the British Thoracic Society Difficult Asthma Registry. Thorax 2012;67:754-6. http://dx.doi.org/10.1136/thoraxjnl-2012-201869
68. Siergiejko Z, Świebocka E, Smith N, Peckitt C, Leo J, Peachey G, et al. Oral corticosteroid sparing with omalizumab in severe allergic (IgE-mediated) asthma patients. Curr Med Res Opin 2011;27: 1-6. http://dx.doi.org/10.1185/03007995.2011.620950
69. Kaiser J. Medical Officer's Efficacy Review, Genentech, Omalizumab BLA STN 103976/0. Food and Drug Administration (FDA). 2003. URL: www.fda.gov/downloads/Drugs/ DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/ TherapeuticBiologicApplications/ucm113459.pdf (last accessed 30 March 2012).
70. Molimard M, Buhl R, Niven R, Le Gros V, Thielen A, Thirlwell J, et al. Omalizumab reduces oral corticosteroid use in patients with severe allergic asthma: real-life data. Respir Med 2010;104:1381-5. http://dx.doi.org/10.1016/j.rmed.2010.06.001
71. Eisner M, Miller M, Chou W, Rahmaoui A, Bradley M. Omalizumab and malignancy: Interim results from the EXCELS study. European Respiratory Society Annual Conference. Amsterdam, 2011. Session 413 P3954. URL: www.ers-education.org/ersMade/abstract_print_11/search/3285.htm (last accessed 30 March 2012).
72. Starke P. FDA Clinical Review: BLA STN 103976/5149: Xolair® (omalizumab): Pediatric supplement for 6-11 years of age. Food and Drug Administration (FDA). 2009. URL: www.fda.gov/downloads/ Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM202179.pdf (last accessed 30 March 2012).
73. European Medicines Agency (EMA). Xolair: EPAR-Scientific Discussion. 2005. URL: www.ema. europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Discussion/human/000606/ WC500057295.pdf (last accessed 30 March 2012).
74. European Medicines Agency (EMA). Xolair-H-C-606-II-18: EPAR-Assessment Report-Variation. 2009. URL: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/000606/WC500057307.pdf (last accessed 30 March 2012).
75. Medicines and Healthcare Products Regulatory Agency (MHRA). Omalizumab: potential risk of arterial thrombotic events. Drug Safety Update 2011;4:A4. URL: www.mhra.gov.uk/ Safetyinformation/DrugSafetyUpdate/CON108685 (last accessed 30 March 2012).
76. Buhl R, Fernandez Vidaurre C, Blogg M, Zhu J, Eisner MD, Canvin J, et al. No difference observed in the risk of malignancy in patients exposed to omalizumab compared with controls. European Respiratory Society Annual Conference. Amsterdam, 2011. Session 415 P4004. URL: www.erseducation. org/ersMade/abstract_print_11/search/3335.htm (last accessed 30 March 2012).
77. Corren J, Casale TB, Lanier B, Buhl R, Holgate S, Jimenez P. Safety and tolerability of omalizumab. Clin Exp Allergy 2009;39:788-97. http://dx.doi.org/10.1111/j.1365-2222.2009.03214.x
78. Rodrigo GJ, Neffen H, Castro-Rodriguez JA. Efficacy and safety of subcutaneous omalizumab vs. placebo as add-on therapy to corticosteroids for children and adults with asthma: a systematic review. Chest 2011;139:28-35. http://dx.doi.org/10.1378/chest.10-1194
79. Limb SL, Starke PR, Lee CE, Chowdhury BA. Delayed onset and protracted progression of anaphylaxis after omalizumab administration in patients with asthma. J Allergy Clin Immunol 2007;120:1378-81. http://dx.doi.org/10.1016/j.jaci.2007.09.022
80. Tan RA, Corren J. Safety of omalizumab in asthma. Expert Opin Drug Saf 2011;10:463-71. http://dx.doi.org/10.1517/14740338.2011.563840
81. Busse W, Buhl R, Vidaurre CF, Blogg M, Zhu J, Eisner MD, Canvin J. Omalizumab and the risk of malignancy: results from a pooled analysis. J Allergy Clin Immunol 2012;129:983-9
82. Hoes JN, Jacobs JWG, Verstappen SMM, Bijlsma JWJ, Van der Heijden GJMG. Adverse events of low-to medium-dose oral glucocorticoids in inflammatory diseases: a meta-analysis. Ann Rheum Dis 2009;68:1833-8. http://dx.doi.org/10.1136/ard.2008.100008
83. Sarnes E, Crofford L, Watson M, Dennis G, Kan H, Bass D. Incidence and US Costs of Corticosteroid-Associated Adverse Events: A Systematic Literature Review. Clin Ther 2011;33:1413-32. http://dx. doi.org/10.1016/j.clinthera.2011.09.009
84. Manson SC, Brown RE, Cerulli A, Vidaurre CF. The cumulative burden of oral corticosteroid side effects and the economic implications of steroid use. Respir Med 2009;103:975-94. http://dx.doi. org/10.1016/j.rmed.2009.01.003
85. Allen DB, Mullen M, Mullen B. A meta-analysis of the effect of oral and inhaled corticosteroids on growth. J Allergy Clin Immunol 1994;93:967-76. http://dx.doi.org/10.1016/S0091-6749(94) 70043-5
86. Drummond MF, Jefferson TO. Guidelines for authors and peer reviewers of economic submissions to the BMJ. BMJ 1996;313:275-83. http://dx.doi.org/10.1136/bmj.313.7052.275
87. Philips Z, Ginnelly L, Sculpher M, Claxton K, Golder S, Riemsma R, et al. Review of guidelines for good practice in decision-analytic modelling in health technology assessment. Health Technol Assess 2004;8:1-158.
88. Novartis Pharmaceuticals UK Ltd. Xolair® (omalizumab). Single Technology Appraisal (STA). Manufacturer submission of evidence. 2007. URL: www.nice.org.uk/nicemedia/live/11686/37589/ 37589.pdf (last accessed 30 March 2012).
89. Novartis Pharmaceuticals UK Ltd. Xolair® (omalizumab) for severe persistent allergic asthma in children aged 6-<12 years. Single Technology Appraisal (STA). Manufacturer submission of evidence. 2007. URL: www.nice.org.uk/nicemedia/live/12266/48874/48874.pdf (last accessed 30 March 2012).
90. Oba Y, Salzman GA. Cost-effectiveness analysis of omalizumab in adults and adolescents with moderate-to-severe allergic asthma. J Allergy Clin Immunol 2004;114:265-9. http://dx.doi.org/ 10.1016/j.jaci.2004.05.049
91. Wu AC, Paltiel AD, Kuntz KM, Weiss ST, Fuhlbrigge AL. Cost-effectiveness of omalizumab in adults with severe asthma: results from the Asthma Policy Model. J Allergy Clin Immunol 2007;120: 1146-52. http://dx.doi.org/10.1016/j.jaci.2007.07.055
92. Campbell JD, Spackman DE, Sullivan SD. The costs and consequences of omalizumab in uncontrolled asthma from a USA payer perspective. Allergy 2010;65:1141-8.
93. Dewilde S, Turk F, Tambour M, Sandstrom T. The economic value of anti-IgE in severe persistent, IgE-mediated (allergic) asthma patients: adaptation of INNOVATE to Sweden. Curr Med Res Opin 2006;22:1765-76. http://dx.doi.org/10.1185/030079906X132389
94. Brown R, Turk F, Dale P, Bousquet J. Cost-effectiveness of omalizumab in patients with severe persistent allergic asthma. Allergy 2007;62:149-53. http://dx.doi.org/10.1111/j.1398-9995. 2006.01310.x
95. Dal Negro RW, Guerriero M, Micheletto C, Tognella S, Visconti M. Changes in total IgE plasma concentration measured at the third month during anti-IgE treatment predict future exacerbation rates in difficult-to-treat atopic asthma: a pilot study. J Asthma 2011;48:437-41. http://dx.doi.org/ 10.3109/02770903.2011.578316
96. Dal Negro RW, Pradelli L, Tognella S, Micheletto C, Iannazzo S. Cost-utility of add-on omalizumab in difficult-to-treat allergic asthma in Italy. Eur Ann Allergy Clin Immunol 2011;43:45-53.
97. Soler M. Omalizumab, a monoclonal antibody against IgE for the treatment of allergic diseases. Int J Clin Pract 2001;55:480-3.
98. Bousquet J, Cabrera P, Berkman N, Buhl R, Holgate S, Wenzel S, et al. The effect of treatment with omalizumab, an anti-IgE antibody, on asthma exacerbations and emergency medical visits in patients with severe persistent asthma. Allergy 2005;60:302-8. http://dx.doi.org/10.1111/ j.1398-9995.2004.00770.x
99. Lowhagen O, Ekstrom L, Holmberg S, Wennerblom B, Rosenfeldt M. Experience of an emergency mobile asthma treatment programme. Resuscitation 1997;35:243-7. http://dx.doi.org/10.1016/ S0300-9572(97)00059-2
100. Sullivan S, Eisner MCJD, Omachi T. Risk of mortality associated with asthma exacerbation. American Thoracic Society. San Diego, CA, 2009. URL: http://ajrccm.atsjournals.org/cgi/reprint/179/ 1_MeetingAbstracts/A4770 (last accessed 30 March 2012).
101. Lecomte P, Lee CS, Van Nooten FE, Thompson CL. Cost-effectiveness analysis of xolair under real life conditions in Belgian patients with severe allergic asthma. Value Health 2009;12:A302(PRS21).
102. Jones J, Shepherd J, Hartwell D, Harris P, Cooper K, Takeda A, et al. Omalizumab for the treatment of severe persistent allergic asthma. Health Technol Assess 2009;13:31-9.
103. Tsuchiya A, Brazier J, McColl E, Parkin D. Deriving preference-based single indices from nonpreference-based condition-specific instruments: Converting AQLQ into EQ-5D indices. Sheffield: ScHARR; 2002. URL: http://eprints.whiterose.ac.uk/10952/
104. Lloyd A, Price D, Brown R. The impact of asthma exacerbations on health-related quality of life in moderate to severe asthma patients in the UK. Prim Care Respir J 2007;16:22-7. http://dx.doi.org/ 10.3132/pcrj.2007.00002
105. National Institute for Health and Clinical Evidence. Guide to the methods of technology appraisal. London: NICE; 2008. URL: www.nice.org.uk/media/B52/A7/TAMethodsGuideUpdatedJune2008.pdf (last accessed 30 March 2012).
106. Watson L, Turk F, James P, Holgate ST. Factors associated with mortality after an asthma admission: a national United Kingdom database analysis. Respir Med 2007;101:1659-64. http://dx.doi.org/ 10.1016/j.rmed.2007.03.006
107. Walker S, Burch J, McKenna C, Wright K, Griffin S, Woolacott N. Omalizumab for the treatment of severe persistent allergic asthma in children aged 6-11 years. Health Technol Assess 2011; 15(Suppl. 1):13-21.
108. Miller MK, Lee JH, Miller DP, Wenzel SE, Tenor Study G. Recent asthma exacerbations: A key predictor of future exacerbations. Respir Med 2007;101:481-9. http://dx.doi.org/10.1016/ j.rmed.2006.07.005
109. Sullivan SD, Wenzel SE, Bresnahan BW, Zheng B, Lee JH, Pritchard M, et al. Association of control and risk of severe asthma-related events in severe or difficult-to-treat asthma patients. Allergy 2007;62:655-60. http://dx.doi.org/10.1111/j.1398-9995.2007.01383.x
110. Haselkorn T, Fish JE, Zeiger RS, Szefler SJ, Miller DP, Chipps BE, et al. Consistently very poorly controlled asthma, as defined by the impairment domain of the Expert Panel Report 3 guidelines, increases risk for future severe asthma exacerbations in The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens (TENOR) study. J Allergy Clin Immunol 2009;124: 895-902. http://dx.doi.org/10.1016/j.jaci.2009.07.035
111. Seddon PC, Heaf DP. Long term outcome of ventilated asthmatics. Arch Dis Child 1990;65:1324-7; discussion 27-8. http://dx.doi.org/10.1136/adc.65.12.1324
112. Kearney SE, Graham DR, Atherton ST. Acute severe asthma treated by mechanical ventilation: a comparison of the changing characteristics over a 17 yr period. Respir Med 1998;92:716-21. http://dx.doi.org/10.1016/S0954-6111(98)90001-4
113. Gupta D, Keogh B, Chung KF, Ayres JG, Harrison DA, Goldfrad C, et al. Characteristics and outcome for admissions to adult, general critical care units with acute severe asthma: a secondary analysis of the ICNARC Case Mix Programme Database. Crit Care 2004;8:R112-21. http://dx.doi. org/10.1186/cc2835 PMid:15025785
114. Wildman MJ, Sanderson CFB, Groves J, Reeves BC, Ayres JG, Harrison D, et al. Survival and quality of life for patients with COPD or asthma admitted to intensive care in a UK multicentre cohort: the COPD and Asthma Outcome Study (CAOS). Thorax 2009;64:128-32. http://dx.doi.org/10.1136/ thx.2007.091249
115. United Kingdom, Interim Life Tables, 1980-82 to 2008-10 (EXCEL sheet 858Kb). Office for National Statistics; 2011. URL: www.ons.gov.uk/ons/rel/lifetables/interim-life-tables/2008-2010/sum-ilt-2008-10.html (last accessed 26 April 2012).
116. Curtis L. Unit Costs of Health and Social Care 2010. Personal Social Services Research Unit (PSSRU); 2010. URL: www.pssru.ac.uk/uc/uc2010contents.htm (last assessed 12 December 2011).
117. Gurwitz JH, Bohn RL, Glynn RJ, Monane M, Mogun H, Avorn J. Glucocorticoids and the risk for initiation of hypoglycemic therapy. Arch Intern Med 1994;154:97-101. http://dx.doi.org/10.1001/ archinte.1994.00420010131015
118. Blackburn D, Hux J, Mamdani M. Quantification of the risk of corticosteroid-induced diabetes mellitus among the elderly. J Gen Intern Med 2002;17:717-20. http://dx.doi.org/10.1046/j.1525-1497.2002.10649.x
119. Walsh LJ, Wong CA, Oborne J, Cooper S, Lewis SA, Pringle M, et al. Adverse effects of oral corticosteroids in relation to dose in patients with lung disease. Thorax 2001;56:279-84. http://dx.doi.org/10.1136/thorax.56.4.279
120. Varas-Lorenzo C, Alberto Garcia Rodriguez L, Maguire A, Castellsague J, Perez-Gutthann S. Use of oral corticosteroids and the risk of acute myocardial infarction. Atherosclerosis 2007;192:376-83. http://dx.doi.org/10.1016/j.atherosclerosis.2006.05.019
121. Huiart L, Ernst P, Ranouil X, Suissa S. Oral corticosteroid use and the risk of acute myocardial infarction in chronic obstructive pulmonary disease. Can Respir J 2006;13:134-8.
122. van Staa TP, Geusens P, Pols HAP, de Laet C, Leufkens HGM, Cooper C. A simple score for estimating the long-term risk of fracture in patients using oral glucocorticoids. QJM 2005;98: 191-8. http://dx.doi.org/10.1093/qjmed/hci029
123. Donnan PT, Libby G, Boyter AC, Thompson P. The population risk of fractures attributable to oral corticosteroids. Pharmacoepidemiol Drug Saf 2005;14:177-86. http://dx.doi.org/10.1002/pds.1075
124. Steinbuch M, Youket TE, Cohen S. Oral glucocorticoid use is associated with an increased risk of fracture. Osteoporos Int 2004;15:323-8. http://dx.doi.org/10.1007/s00198-003-1548-3
125. Garbe E, LeLorier J, Boivin JF, Suissa S. Risk of ocular hypertension or open-angle glaucoma in elderly patients on oral glucocorticoids. Lancet 1997;350:979-82. http://dx.doi.org/10.1016/ S0140-6736(97)03392-8
126. Piper JM, Ray WA, Daugherty JR, Griffin MR. Corticosteroid use and peptic ulcer disease: Role of nonsteroidal anti-inflammatory drugs. Ann Intern Med 1991;114:735-40.
127. Curtis JR, Westfall AO, Allison J, Bijlsma JW, Freeman A, George V, et al. Population-based assessment of adverse events associated with long-term glucocorticoid use. Arthritis Rheum 2006;55:420-6. http://dx.doi.org/10.1002/art.21984
128. Wang JJ, Rochtchina E, Tan AG, Cumming RG, Leeder SR, Mitchell P. Use of inhaled and oral corticosteroids and the long-term risk of cataract. Ophthalmology 2009;116:652-7. http://dx.doi. org/10.1016/j.ophtha.2008.12.001
129. Zonana-Nacach A, Barr SG, Magder LS, Petri M. Damage in systemic lupus erythematosus and its association with corticosteroids. Arthritis Rheum 2000;43:1801-8. http://dx.doi.org/10.1002/1529-0131(200008)43:8<1801::AID-ANR16>3.0.CO;2-O
130. Suissa S. Relative excess risk: An alternative measure of comparative risk. Am J Epidemiol 1999;150:279-82. http://dx.doi.org/10.1093/oxfordjournals.aje.a009999
131. WHO Disease and Injury Country Estimates; Burden of Disease; Table 2. Estimated DALYs per 100,000 population by cause, and Member State, United Kingdom. World Health Organization; 2004. URL: www.who.int/healthinfo/global_burden_disease/gbddeathdalycountryestimates2004. xls. (Last accessed 28 December 2011).
132. Murray CJL, Acharya AK. Understanding DALYs. J Health Econ 1997;16:703-30. http://dx.doi.org/ 10.1016/S0167-6296(97)00004-0
133. Williams A. Calculating the global burden of disease: Time for a strategic reappraisal? Health Econ 1999;8:1-8. http://dx.doi.org/10.1002/(SICI)1099-1050(199902)8:1<1::AID-HEC399>3.0.CO;2-B
134. Sassi F. Calculating QALYs, comparing QALY and DALY calculations. Health Policy Plan 2006;21: 402-08. http://dx.doi.org/10.1093/heapol/czl018
135. National Institute for Health and Clinical Excellence (NICE). Human growth hormone (somatropin) for the treatment of growth failure in children. 2010. URL: www.nice.org.uk/guidance/TA188 (last accessed 30 March 2012).
136. Heaney LG. The effect of the Omalizumab dosing table expansion on the size of the population of severe persistent allergic asthma patients potentially eligible for omalizumab therapy: analysis of data from the BTS Difficult Asthma Registry: Centre for Infection and Immunity, Queen's University of Belfast, on behalf of the British Thoracic Society Difficult Asthma Network. URL: www.ers-education.org/Media/Media.aspx?idMedia=210149
137. Heaney LG, Brightling CE, Menzies-Gow A, Stevenson M, Niven RM, British Thoracic Society Difficult Asthma Network. Refractory asthma in the UK: cross-sectional findings from a UK multicentre registry. Thorax 2010;65:787-94. http://dx.doi.org/10.1136/thx.2010.137414
138. de Vries F, Setakis E, Zhang B, van Staa TP. Long-acting beta2-agonists in adult asthma and the pattern of risk of death and severe asthma outcomes: a study using the GPRD. Eur Respir J 2010;36:494-502. http://dx.doi.org/10.1183/09031936.00124209
139. Aburuz S, Gamble J, Heaney LG. Assessment of impairment in health-related quality of life in patients with difficult asthma: psychometric performance of the Asthma Quality of Life Questionnaire. Respirology 2007;12:227-33. http://dx.doi.org/10.1111/j.1440-1843.2006.01020.x
140. Steuten L, Palmer S, Vrijhoef B, van Merode F, Spreeuwenberg C, Severens H. Cost-utility of a disease management program for patients with asthma. Int J Technol Assess Health Care 2007;23:184-91. http://dx.doi.org/10.1017/S0266462307070298
141. Fuhlbrigge AL, Bae SJ, Weiss ST, Kuntz KM, Paltiel AD. Cost-effectiveness of inhaled steroids in asthma: impact of effect on bone mineral density J Allergy Clin Immunol 2006;117:359-66. http://dx.doi.org/10.1016/j.jaci.2005.10.036
142. Johannesson M, Weinstein S. On the decision rules of cost-effectiveness analysis. J Health Econ 1993;12:459-67. http://dx.doi.org/10.1016/0167-6296(93)90005-Y
143. Briggs A, Claxton K, Sculpher M, editors. Decision Modelling for Health Economic Evaluation. Oxford: Oxford University Press, 2005.
144. World Health Organization. Global Burden of Disease 2004 Summary Tables. URL: www.google.co. uk/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=0CEsQFjAA&url=http%3A%2F%2Fwww. who.int%2Fentity%2Fhealthinfo%2Fglobal_burden_disease%2FDALYMDG_00_2004. xls&ei=zVnkT5nCIuag0QWLp8n0CA&usg=AFQjCNH2XdlwuILXVa2qemtubIl-J_qovw (last accessed 6 March 2012).
145. World Health Organization. Global burden of disease 2004 update: disability weights for diseases and conditions. 2004. URL: www.who.int/healthinfo/global_burden_disease/ GBD2004_DisabilityWeights.pdf (last accessed 30 March 2012).
146. Sullivan PW, Slejko JF, Sculpher MJ, Ghushchyan V. Catalogue of EQ-5D Scores for the United Kingdom. Med Decis Making 2011;31:800-4. http://dx.doi.org/10.1177/0272989X11401031
147. McLoughlin H, Hart-Thomas A, Slough J, Capstick T. Use of a protocol to select patients for omalizumab treatment. European Respiratory Society Annual Congress. Berlin, 2008. p. 345s (P2014). URL: www.ersnet.org/learning_resources_player/abstract_print_08/search/1648.htm (last accessed 30 March 2012).
148. Lanes SF, Garcia Rodriguez LA, Huerta C. Respiratory medications and risk of asthma death. Thorax 2002;57:683-6. http://dx.doi.org/10.1136/thorax.57.8.683
149. Sturdy PM, Victor CR, Anderson HR, Bland JM, Butland BK, Harrison BDW, et al. Psychological, social and health behaviour risk factors for deaths certified as asthma: a national case-control study. Thorax 2002;57:1034-9. http://dx.doi.org/10.1136/thorax.57.12.1034
150. Hansell A, Hollowell J, McNiece R, Nichols T, Strachan D. Validity and interpretation of mortality, health service and survey data on COPD and asthma in England. Eur Respir J 2003;21:279-86. http://dx.doi.org/10.1183/09031936.03.00006102
151. Anderson HR, Ayres JG, Sturdy PM, Bland JM, Butland BK, Peckitt C, et al. Bronchodilator treatment and deaths from asthma: case-control study. BMJ 2005;330:117. http://dx.doi.org/10.1136/ bmj.38316.729907.8F
152. Harrison B, Stephenson P, Mohan G, Nasser S. An ongoing Confidential Enquiry into asthma deaths in the Eastern Region of the UK, 2001-2003. Prim Care Respir J 2005;14:303-13. http://dx.doi.org/ 10.1016/j.pcrj.2005.08.004
153. Panickar JR, Dodd SR, Smyth RL, Couriel JM. Trends in deaths from respiratory illness in children in England and Wales from 1968 to 2000. Thorax 2005;60:1035-8. http://dx.doi.org/10.1136/ thx.2005.044750
154. Sturdy PM, Butland BK, Anderson HR, Ayres JG, Bland JM, Harrison BDW, et al. Deaths certified as asthma and use of medical services: a national case-control study. Thorax 2005;60:909-15. http://dx.doi.org/10.1136/thx.2004.025593
155. Fleming DM, Cross KW, Sunderland R, Ross AM. Comparison of the seasonal patterns of asthma identified in general practitioner episodes, hospital admissions, and deaths. Thorax 2000;55:662-5. http://dx.doi.org/10.1136/thorax.55.8.662
156. Tarride J-E, Burke N, Bischof M, Hopkins RB, Goeree L, Campbell K, et al. A review of health utilities across conditions common in paediatric and adult populations. Health Qual Life Outcomes 2010;8:12. http://dx.doi.org/10.1186/1477-7525-8-12
157. Willems DCM, Joore MA, Hendriks JJE, Wouters EFM, Severens JL. Cost-effectiveness of a nurse-led telemonitoring intervention based on peak expiratory flow measurements in asthmatics: results of a randomised controlled trial. Cost Eff Resour Alloc 2007;5:10. http://dx.doi.org/10.1186/ 1478-7547-5-10
158. Burstrom K, Johannesson M, Diderichsen F. Swedish population health-related quality of life results using the EQ-5D. Qual Life Res 2001;10:621-35. http://dx.doi.org/10.1023/A:1013171831202
159. Ko Y, Coons SJ. Self-reported chronic conditions and EQ-5D index scores in the US adult population. Curr Med Res Opin 2006;22:2065-71. http://dx.doi.org/10.1185/030079906X132622
160. Lubetkin EI, Jia H, Franks P, Gold MR. Relationship among sociodemographic factors, clinical conditions, and health-related quality of life: Examining the EQ-5D in the U.S. general population. Qual Life Res 2005;14:2187-96. http://dx.doi.org/10.1007/s11136-005-8028-5
161. Polley L, Yaman N, Heaney L, Cardwell C, Murtagh E, Ramsey J, et al. Impact of cough across different chronic respiratory diseases: comparison of two cough-specific health-related quality of life questionnaires. Chest 2008;134:295-302. http://dx.doi.org/10.1378/chest.07-0141
162. Saarni SI, Härkänen T, Sintonen H, Suvisaari J, Koskinen S, Aromaa A, et al. The impact of 29 chronic conditions on health-related quality of life: a general population survey in Finland using 15D and EQ-5D. Qual Life Res 2006;15:1403-14. http://dx.doi.org/10.1007/s11136-006-0020-1
163. Garratt AM, Hutchinson A, Russell I. Patient-assessed measures of health outcome in asthma: a comparison of four approaches. Respir Med 2000;94:597-606. http://dx.doi.org/10.1053/ rmed.2000.0787
164. Sullivan P, Lawrence W, Ghushchyan V. A national catalog of preference-based scores for chronic conditions in the United States. Med Care 2005;43:736-49. http://dx.doi.org/10.1097/01. mlr.0000172050.67085.4f
165. Szende A, Leidy NK, Stahl E, Svensson K. Estimating health utilities in patients with asthma and COPD: evidence on the performance of EQ-5D and SF-6D. Qual Life Res 2009;18:267-72. http://dx.doi.org/10.1007/s11136-008-9429-z
166. McTaggart-Cowan HM, Marra CA, Yang Y, Brazier JE, Kopec JA, FitzGerald JM, et al. The validity of generic and condition-specific preference-based instruments: the ability to discriminate asthma control status. Qual Life Res 2008;17:453-62. http://dx.doi.org/10.1007/s11136-008-9309-6
167. Szende A, Svensson K, Stahl E, Meszaros A, Berta GY. Psychometric and utility-based measures of health status of asthmatic patients with different disease control level. Pharmacoeconomics 2004;22:537-47. http://dx.doi.org/10.2165/00019053-200422080-00005
168. Ferreira LN, Brito U, Ferreira PL. Quality of life in asthma patients. Rev Port Pneumol 2010;16:23-55.
169. Kardos P, Wittchen HU, Muhlig S, Ritz T, Buhl R, Rabe K, et al. Controlled and uncontrolled allergic asthma in routine respiratory specialist care-a clinical-epidemiological study in Germany. Curr Med Res Opin 2011;27:1835-47. http://dx.doi.org/10.1185/03007995.2011.606805
170. Chen H, Gould MK, Blanc PD, Miller DP, Kamath TV, Lee JH, et al. Asthma control, severity, and quality of life: quantifying the effect of uncontrolled disease. J Allergy Clin Immunol 2007;120: 396-402. http://dx.doi.org/10.1016/j.jaci.2007.04.040
171. Carroll AE, Downs SM. Improving decision analyses: parent preferences (utility values) for pediatric health outcomes. J Pediatr 2009;155:21-5. http://dx.doi.org/10.1016/j.jpeds.2009.01.040
172. Oga T, Nishimura K, Tsukino M, Sato S, Hajiro T, Mishima M. A comparison of the responsiveness of different generic health status measures in patients with asthma. Qual Life Res 2003;12:555-63. http://dx.doi.org/10.1023/A:1025051829223