Estimated Prevalence and Economic Burden of Severe, Uncontrolled Asthma in the United States

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Estimted Prevlence nd Economic Burden of Severe, Uncontrolled Asthm in the United Sttes Cheryl S. Hnkin 1 ; Amy Bronstone 1 ; Zhohui Wng 1 ; Mry Butti-Smll 2 ; Philip O. Buck 2 1 BioMedEcon, Moss Bech, CA; 2 Tev Phrmceuticls, Inc., Frzer, PA Funding for this reserch ws provided by Tev Phrmceuticls 1

Bckground: There re no stndrd terms / definitions of sthm severity nd control 1,2 Concepts of sthm severity nd control re importnt in evluting ptients nd their response to tretment s well s for public helth, registries, nd reserch (clinicl trils, epidemiologic, genetic, nd mechnistic studies), but the terminology pplied is not stndrdized, nd terms re often used interchngebly. 1 [Proceedings from the World Helth Orgniztion meeting of experts held April 2009 to propose uniform definition of severe sthm.] Other terms used: 1,2 Severe sthm Refrctory sthm Steroid-dependent Resistnt sthm Difficult to control sthm Poorly controlled sthm Brittle sthm Irreversible sthm Therpy-resistnt sthm Definitions of these terms hve evolved since 2000, but cited reserch rrely specifies definitions tht were used. Underlying pthologies of sthm subtypes my differ. 2 1. Proceedings of the ATS workshop on refrctory sthm: current understnding, recommendtions, nd unnswered questions. Americn Thorcic Society. Am J Respir Crit Cre Med. 2000;162(6):2341-51. 2. Bousquet J, Mntzournis E, Cruz AA, Ait-Khled N, Ben-Cgnni CE, Bleecker ER, Brightling CE, Burney P, Bush A, Busse WW, Csle TB, Chn-Yeung M, Chen R, Chowdhury B, Chung KF, Dhl R, Drzen JM, Fbbri LM, Holgte ST, Kuffmnn F, Hhtel T, Khltev N, Kiley JP, Msjedi MR, Mohmmd Y, O'Byrne P, Prtridge MR, Rbe KF, Togis A, vn Weel C, Wenzel S, Zhong N, Zuberbier T. Uniform definition of sthm severity, control, nd excerbtions: document presented for the World Helth Orgniztion Consulttion on Severe Asthm. J Allergy Clin Immunol. 2010;126(5):926-38. 2

Asthm costs vry by definitions nd methods used to identify disese severity nd control 1 Venue of Cre Method used to determine severity Asthm Severity All ptients with sthm Severe Modertely Severe Asthm Men (SD) Men (SD) Men (SD) Men (SD) P-vlue Inptient 1 SR Not vilble $304 ($1,698) $192 ($1,111) $137 ($1,198) p<0.05 severe vs. mild Inptient 2 SR $788 $3,610 $366 $174 p<0.05 ll pirwise comprisons Inptient 3 CD Not vilble $2,448 ($12,605) $2,318 ($32,091) $1,536 ($8,539) Not Significnt Outptient 1 SR Not vilble $999 ($1,230) $716 ($723) $608 ($629) p<0.0001 severe vs. mild ; b p<0.05 severe vs. moderte Outptient 2 SR $582 $1,417 $551 $337 p<0.05 ll pirwise comprisons Outptient 3 CD $4,385 ($11,934) $2,924 ($5,769) $2,622 ($4,494) P<0.01 moderte vs. mild, severe vs. mild; P<0.05 severe vs. moderte ED 1 SR Not vilble $37 ($164) $42 ($174) $81 ($369) Not Significnt ED 2 SR $488 $1,693 $320 $219 p<0.05 ll pirwise comprisons ED 3 CD Not vilble $27,502 ($3,313) $2,034 ($2,702) $2,050 ($2,651) p<0.01 moderte vs. mild, severe vs. mild; p<0.05 severe vs. moderte Medictions 1 SR Not vilble $1,460 ($1,282) $1,016 ($935) $814 ($869) p<0.0001 severe vs. mild; b p<0.05 severe vs. moderte Medictions 2 SR $2,731 $4,090 $2,971 $2,130 p<0.05 ll pirwise comprisons Medictions 3 CD Not vilble $27,502 ($3,313) $2,034 ($2,702) $2,050 ($2,651) TOTAL 1 SR Not vilble $2,801 ($3,005) $1,965 ($1,693) $1,641 ($1,827) p<0.01 moderte vs. mild, severe vs. moderte, severe vs. mild p<0.0001 severe vs. mild; b p<0.05 severe vs. moderte; c p<0.05 moderte vs. mild TOTAL 2 SR $4,589 $10,811 $4,208 $2,860 p<0.05 ll pirwise comprisons TOTAL 3 CD Not vilble $10,766 ($20,620) $8,161 ($35,583) $6,433 ($12,630) p<0.01 severe vs. mild; severe vs. moderte SR=Self Report CD = Clims Dt 1.Birnbum HG, Ivnov JI, Yu AP, Hsieh M, Sel B, Emni S, Rosiello R, Colice GL.. J Asthm. 2009;46(1):67-72. 2.Cisterns MG, Blnc PD, Yen IH, Ktz PP, Ernest G, Eisner MD, Shiboski S, Yelin EH. J Allergy Clin Immunol. 2003;111(6):1212-8. 3.Colice G, Wu EQ, Birnbum H, Dher M, Mrynchenko MB, Vrghese S.. J Occup Environ Med. 2006;48(8):794-802. 3

Study Objective nd Methods Objective Estimte U.S. prevlence nd nnul direct costs of severe, uncontrolled sthm Methods Review published epidemiologicl nd cost studies to estimte: 1. The number of people in the U.S. with sthm 2. % of sthmtics with severe disese 3. % of those with severe sthm who re uncontrolled 4. Aggregte nnul direct costs of sthm in the U.S. 5. % of sthm-relted direct costs ttributble to ptients with severe disese 6. % of sthm-relted direct costs ttributble to ptients with severe disese who re uncontrolled 4 4

Estimted U.S. Annul Direct Costs of Severe, Uncontrolled Asthm Approximtely 8.4% of the U.S. popultion (26 million) currently hs sthm 1 19 million dults (ge 18 yrs) 7.0 million children An estimted 5-10% of those with sthm (1.3 2.6 million) hve severe disese 2-4 50% of those with severe sthm remin uncontrolled 5 Estimted U.S. nnul sthmrelted direct costs re $56 billion 6 Approximtely 50% of costs ($28 billion) incurred by ptients with severe sthm 2,3,7 Ptients with uncontrolled, severe sthm incur up to 3 times greter sthm-relted costs thn those with controlled, severe sthm 8,9 $21 billion (75% of $28 billion) 1. Akinbmi LJ. NCHS dt brief, no 94. Hyttsville, MD: Ntionl Center for Helth Sttistics; 2012. 2. Ntionl Asthm Cmpign. Report on the Cost of Asthm in Austrli. 1992. 3. Glxo Cnd. Princeton, NJ: Communictions Medi for Eduction; 1993. 4. Sdtsfvi M. Cn Respir J. 2010;17(2):74-80. 5. Peters SP, et l. J Allergy Clin Immunol. 2007;119(6):1454-61. 6. Brnett SB. J Allergy Clin Immunol. 2011;127(1):145-52. 7. Serr-Btlles J. Eur Respir J. 1998;12:1322-1326. 8. Sullivn SD. Allergy. 2007;62(2):126-33. 9. Breekveldt-Postm Current Medicl Reserch nd Opinion.2008;24(4:1473-4877. Annul, sthm-relted direct costs per severe, uncontrolled sthm ptient re $16,154 to $32,308 ($21 billion / 650,000 to 1.3 million ptients) 26 million Americns with sthm 1 $56 billion 6 5-10% (1.3 to 2.6 million) hve severe sthm 2-4 50% (650,000 to 1.3 million) remin uncontrolled 5 $28 billion 2,3,7 $21 billion 8,9 38% of totl nnul U.S. sthm-relted costs ($21 billion / $56 billion) re incurred by 2.5% to 5% of ll sthm ptients (650,000 / 26 million to 1.3 / 26 million) 5

Comprisons: Averge Annul Per-Ptient Direct Costs of Asthm nd Other Chronic Diseses Of the 26 million Americns with sthm 1 At n estimted nnul cost of $21 billion, this represents nnul per ptient direct estimted costs for severe, uncontrolled sthm of $16,000 to $32,000 $32,308 $34,188 5-10% (1.3 to 2.6 million) hve severe sthm 2-4 Averge Annul Per-Ptient Direct Costs of Chronic Diseses $10,185 $16,154 50% (650,000 to 1.3 million) remin uncontrolled 5 $2,414 Arthritis nd other rheumtologic disorders (1,2) $5,787 Dibetes All Cncers (4,5) (dignosed nd undignosed) (3) Severe Uncontrolled sthm (lower estimte) Severe Uncontrolled sthm (higher estimte) Lung cncer (4,6) 1. Akinbmi LJ. NCHS dt brief, no 94. Hyttsville, MD: Ntionl Center for Helth Sttistics; 2012. 2. Ntionl Asthm Cmpign. Report on the Cost of Asthm in Austrli. 1992. 3. Glxo Cnd. The cost of dult sthm in Cnd. Princeton, NJ: Communictions Medi for Eduction; 1993. 4. Sdtsfvi M. Cn Respir J. 2010;17:74-80. 5. Peters SP, et l. J Allergy Clin Immunol. 2007;119:1454-61. 1. Yelin E, Cisterns M, Foremn A, Pst D, Murphy L, Helmick C. Ntionl nd stte medicl expenditures nd lost ernings ttributble to rthritis nd other rheumtic conditions United Sttes, 2003. Morbidity nd Mortlity Weekly Report 2007;56(1):4 7. 2. http://www.cdc.gov/rthritis/dt_sttistics/fqs/cost_nlysis.htm 3. http://www.cdc.gov/dibetes/pubs/estimtes07.htm#10 4. http://www.cncer.org/cncer/cncerbsics/cncer-prevlence 5. http://www.cncer.org/cncer/cncerbsics/economic-impct-of-cncer 6. http://lungcncer.bout.com/od/whtislungcncer//lungcncerstts.htm 6 6

Conclusions 38% of totl nnul U.S. sthm-relted direct costs ($21 billion/$56 billion) re incurred by the 2.5-5% of sthm ptients with severe, uncontrolled disese. Annul direct per-ptient estimted costs of severe, uncontrolled sthm: $16,154 ($21 billion/1.3 million) to $32,308 ($21 billion/650,000) At lest 3 times greter thn reported estimte for dibetes ($5,787) Our higher estimte is roughly equivlent to estimted costs reported for lung cncer ($34,188) 7