MP 5.01.18 Xlair (Omalizumab) Medical Plicy Sectin Prescriptin Drugs Issu12:2013e 4:2006 Original Plicy Date 12:2013 Last Review Status/Date Lcal plicy/12:2013 Return t Medical Plicy Index Disclaimer Our medical plicies are designed fr infrmatinal purpses nly and are nt an authrizatin, r an explanatin f benefits, r a cntract. Receipt f benefits is subject t satisfactin f all terms and cnditins f the cverage. Medical technlgy is cnstantly changing, and we reserve the right t review and update ur plicies peridically. Descriptin Xlair (Omalizumab) is a recmbinant DNA-derived humanized IgG1k mnclnal antibdy that selectively binds t human immunglbulin E (IgE). It is prduced by a Chinese hamster vary cell suspensin culture in a nutrient medium cntaining the antibitic gentamicin which is nt detectable in the final prduct accrding t the prduct insert. Omalizumab inhibits the binding f IgE t the high-affinity n the surface f mast cells and basphils. Reductin in surface-bund IgE n the receptr (FceRI bearing) cells limits the degree f release f mediatrs f the allergic respnse. Treatment als reduces the number f FceRI receptrs n basphilsf allergic patients. Omalizumab is indicated fr adults and adlescents (12 years f age and abve) with mderate t severe persistent asthma wh have a psitive skin test. Xlair has been shwn t decrease the incidence f asthma exacerbatins in these patients. Safety and efficacy have nt been established in ther allergic cnditins. Backgrund Accrding t the glbal strategy fr asthma management and preventin f the Natinal Heart, Lung and Bld Institute (NHLBI), patients with mderate persistent asthma exhibit sme f the fllwing characteristics: Symptms daily Exacerbatins may affect activity and sleep Daily use f inhaled shrt-acting beta2-agnist PEF 60 t 80% f persnal best 42 Memrial Drive Suite 1 Pinehurst, N.C. 28374 Phne (910) 715-8100 Fax (910) 715-8101
Diurnal PEF variatin greater than 30% Fr patients with severe persistent asthma, they have sme f the fllwing characteristics: Symptms daily Frequent exacerbatins PEF less than r equal t 60% f persnal best Diurnal PEF variatin greater than 30% The preferred therapy fr patients with mderate persistent asthma is regular treatment with a cmbinatin f inhaled crticsterids and a lng-acting inhaled beta2-agnist twice daily. Fr patients with severe persistent asthma, the primary therapy includes inhaled crticsterids at higher dses plus a lng-acting inhaled beta2-agnist twice daily. Furthermre, accrding t the NHBLI guidelines, cntrl f asthma is defined as: Minimal (ideally nt) chrnic symptms, including ncturnal symptms Minimal (infrequent) exacerbatins N visits t the emergency rm Minimal (ideally n) use f p.r.n. (as needed) beta2-agnist N limitatins n activities, including exercise PEF diurnal variatin f less than 20% (Near) nrmal PEF Minimal (r n) adverse effects frm medicine. Appendex A: Estimated Cmparative Daily Dseages fr Inhaled Crticsterids Adults Drug Lw Dse Medium Dse High Dse Beclmethasne diprpinate 168-504 mcg 504-840 mcg '>840 mcg 42 mcg/puff (4-12 puffs - 42 (12-20 puffs - 42 ('>20 puffs - 42 84 mcg/puff (2-6 puffs - 84 (6-10 puffs - 42 ('10 puffs - 84 Budesnide DPI: 200 mcg/dse 200-400 mcg (1-2 inhalatins) 400-600 mcg (2-3 inhalatins) '>600 mcg ('>3 inhalatins) 42 Memrial Drive Suite 1 Pinehurst, N.C. 28374 Phne (910) 715-8100 Fax (910) 715-8101
Flunisnde 500-1000 mcg 1000-2000 mcg '>2000 mcg 250 mcg/puff (2-4 puffs) (4-8 puffs) ('>8 puffs) 88-264 mcg />660 mcg Fluticasne MDI: 44, 110, 220 mcg/ puff (2-6 puffs - 44 OR (2 puffs - 110 264-660 mcg (2-6 puffs - 110 ('>6 puffs - 110 OR ('>3 puffs - 220 DPI: 50, 100, 250 mcg/dse (2-6 inhalatins - 50 (3-6 inhalatins - 100 ('>6 inhalatins - 100 OR ('>2 inhalatins - 250 Triamcinlne acetnide 100 mcg/puff 400-1000 mcg (4-10 puffs) 1000-2000 mcg (10-20 puffs) '>2000 mcg ('>20 puffs) Children Beclmethasne diprpinate 42 mcg/puff 84-336 mcg (2-8 puffs - 42 336-672 mcg (8-10 puffs - 42 '>672 mcg ('>16 puffs - 42 84 mcg/puff (1-4 puffs - 84 (1-4 puffs - 84 ('>8 puffs - 84 Budesnide DPI: 200 mcg/dse 100-200 mcg 200-400 mcg (1-2 inhalatins - 200 '>400 mcg ('>2 inhalatins - 200 Flunisnde 500-750 mcg 1000-1250 mcg '>1250 mcg 250 mcg/puff (2-3 puffs) (4-5 puffs) ('>5 puffs) Fluticasne MDI: 44, 110, 220 mcg/ puff 88-176 mcg (2-4 puffs - 44 176-440 mcg (4-10 puffs - 44 OR (2-4 puffs - 110 '>440 mcg ('>4 puffs - 110OR('>2 puffs - 220 42 Memrial Drive Suite 1 Pinehurst, N.C. 28374 Phne (910) 715-8100 Fax (910) 715-8101
DPI: 50, 100, 250 mcg/dse (2-4 inhalatins - 50 (2-4 inhalatins - 100 ('>4 inhalatins - 100OR('>2 inhalatins - 250 Triamcinlne acetnide 100 mcg/puff 400-800 mcg (4-8 puffs) 800-1200 mcg (8-12 puffs) '>1200 mcg ('>12 puffs) DPI (dry pwder inhaler) dses are expressed as the amunt f drug in the inhaler fllwing activatin. MDI (metered-dse inhaler) dsages are expressed as the actuater dse (the amunt f drug leaving the actuater and delivered t the patient), which is the labeling required in the United States. Adapted frm: Natinal Asthma Educatinal Preventin Prgram Expert Panel Reprt 2: Guidelines fr the Diagnsis and Management f Asthma. NIH Publicatin N 97-4051, July 1997. Available at: http://www.nhlbi.nih.gv/guidelines/asthma/asthgdln.pdf. Appendix B: Dsing Schedule fr Subcutaneusly Administered Omalizumab Baseline Serum IgE Level Bdy Weight 30-60 kg 61-70 kg 71-80 kg 81-90 kg 91-150 kg IU/ml Dse in milligrams 30-100 150 150 150 150 300 101-200 300 300 300 300 225 201-300 300 225 225 225 300 301-400 225 225 300 300 401-500 300 300 375 375 501-600 300 375 601-700 375 Adapted frm Strunk & Blmberg, 2006. The recmmended dse is 0.016 mg per kilgram f bdy weight per internatinal unit f IgE every fur weeks, administered subcutaneusly at either fur-week (italic) r tw-week (rman) intervals fr adults and adlescents (persns 12 42 Memrial Drive Suite 1 Pinehurst, N.C. 28374 Phne (910) 715-8100 Fax (910) 715-8101
years f age r lder) with allergic asthma. Dashes indicate that n dse shuld be prescribed. Plicy Omalizumab is cnsidered medically necessary when all f the fllwing cnditins are met: The request fr apprval cmes frm an allergist, immunlgist, r pulmnlgist wh is currently treating the patient. The patient is an adult r adlescent (12 years f age r abve). The patient has mderate r severe persistent asthma as defined by the current NAEPP clinical guidelines fr the management f asthma. The patient has a psitive skin test r in vitr reactivity t a specific perennial aerallergen. The patient's symptms are inadequately cntrlled with apprpriate dses f inhaled crticsterids There is dcumentatin f pr asthma cntrl r recurrent exacerbatins such as thse that require hspitalizatins r treatment with repeated curses f ral crticsterids. Triggers f asthma t which the patient is expsed are apprpriately managed Omalizumab is cnsidered nt medically necessary when used fr the fllwing cnditins: -allergic rhinitis -preventin r therapy fr peanut r ther fd allergies Omalizumab is cnsidered investigatinal when used fr all ther cnditins. Administratin may nt exceed 375 mg every 2 weeks. Omalizumab is nt a selfinjectable medicatin. Cntinued treatment with malizumab beynd six mnths is cnsidered medically necessary fr members wh meet all f the fllwing criteria: Member had met criteria fr malizumab set frth by BCI at initiatin f malizumab therapy; and treatment with malizumab has resulted in clinical imprvement as dcumented by ne r mre f the fllwing: Decreased utilizatin f rescue medicatins; r Decreased frequency f exacerbatins (defined as wrsening f asthma that requires increase in inhaled crticsterid des r treatment with systemic crticsterids); r 42 Memrial Drive Suite 1 Pinehurst, N.C. 28374 Phne (910) 715-8100 Fax (910) 715-8101
Increase in percent predicted FEV-1 frm pretreatment baseline; r Reductin in reprted symptms (decrease in asthma symptm scre), as evidenced by decreases in frequency r magnitude f ne r mre f the fllwing symptms: Sleep disturbances, night wakening, r symptms upn wakening; r Shrtness f breath; r Wheezing/heavy breathing/fighting fr air; r Chest tightening r heaviness; r Asthma attacks; r Difficulty taking deep breath r difficulty breathing ut; r Cughing r clearing thrat; r Tiredness; and Member has nt exhibited symptms f anaphylaxis (brnchspasm, hyptensin, syncpe, urticara, and/r angiedema) after administratin fmalizumab. Plicy Guidelines Omalizumab is cnsidered medically necessary as a secnd line treatment, when all f the fllwing cnditins are met: The request fr apprval cmes frm an allergist, immunlgist, r pulmnlgist wh is currently treating the patient. The patient is an adult r adlescent (12 years f age r abve). The patient has mderate r severe persistent asthma as defined by the current NAEPP clinical guidelines fr the management f asthma. The patient has a psitive skin test r in vitr reactivity t a specific perennial aerallergen. The patient s symptms are inadequately cntrlled with apprpriate dses f inhaled crticsterids. There is dcumentatin f pr asthma cntrl r recurrent exacerbatins such as thse that require hspitalizatins r treatment with repeated curses f ral crticsterids. Triggers f asthma t which the patient is expsed are apprpriately managed Mderate persistent asthma has daily daytime symptms and nighttime symptms >1 night/week and a PEF r FEV1 f greater than 60% - less than 80% and PEF variability if greater than 30%. Since clinical trials invlved patients 12 t 76 years f age, administratin is limited t thse age grups. 42 Memrial Drive Suite 1 Pinehurst, N.C. 28374 Phne (910) 715-8100 Fax (910) 715-8101
Clinical trials did nt invlve patients wh weighed mre than 150 kg and there is n evidence f efficacy fr patients abve that weight. Ttal serum IgE levels shuld be between 30 and 700 internatinal units/ml, but n higher than 700 internatinal units. Dsage is t be determined by pre-treatment IgE level as nted in the prduct insert. Omalizumab is nt indicated fr cnditins ther than asthma. Cst effectiveness is unlikely unless the patient has severe persistent asthma with frequent exacerbatins requiring hspitalizatin. References: Xlair (Omalizumab) prduct insert Genentech, Inc./ Nvartis Pharmaceuticals Crpratin April 2006 NAEPP Stepwise Apprach fr Managing Asthma in Adults and Children Older than 5 Years f Age: Treatment May 2003 'The Allergy Reprt' American Academy f Allergy, Asthma and Immunlgy. http://www.theallergyreprt.rg/reprtindex.html. Easthpe, S and Garvis, B 'Omalizumab' Drugs 2001;61(2):253-60. Prenner, BM 'Asthma 2008: targeting immunglbulin E t achieve disease cntrl.' J Asthma. 2008 Aug;45(6):429-36. Natinal Asthma Educatin and Preventin Prgram (NAEPP). Guidelines fr the diagnsis and management f asthma. Expert Panel reprt 3. Bethesda, MD: Natinal Institutes f Health (NIH), Natinal Heart, Lung and Bld Institute (NHLBI); August 2007. Natinal Institute fr Health and Clinical Excellence (NICE). Omalizumab fr severe persistent allergic asthma. Technlgy Appraisal Guidance N 133. Lndn, UK: NICE; Nvember 2007. Strunk RC, Blmberg GR. Omalizumab fr asthma. N Engl J Med. 2006;354(25):2689-2695 Cdes Cdes Number Descriptin HCPCS J2357 Injectin, Omalizumab, 5 mg ICD-9 diagnsis 493.00 Asthma, exgenus 42 Memrial Drive Suite 1 Pinehurst, N.C. 28374 Phne (910) 715-8100 Fax (910) 715-8101