Original Policy Date 12:2013

Transcription

1 MP 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 Phne (910) Fax (910)

2 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 mcg mcg '>840 mcg 42 mcg/puff (4-12 puffs - 42 (12-20 puffs - 42 ('>20 puffs mcg/puff (2-6 puffs - 84 (6-10 puffs - 42 ('10 puffs - 84 Budesnide DPI: 200 mcg/dse mcg (1-2 inhalatins) mcg (2-3 inhalatins) '>600 mcg ('>3 inhalatins) 42 Memrial Drive Suite 1 Pinehurst, N.C Phne (910) Fax (910)

3 Flunisnde mcg mcg '>2000 mcg 250 mcg/puff (2-4 puffs) (4-8 puffs) ('>8 puffs) mcg />660 mcg Fluticasne MDI: 44, 110, 220 mcg/ puff (2-6 puffs - 44 OR (2 puffs mcg (2-6 puffs ('>6 puffs OR ('>3 puffs DPI: 50, 100, 250 mcg/dse (2-6 inhalatins - 50 (3-6 inhalatins ('>6 inhalatins OR ('>2 inhalatins Triamcinlne acetnide 100 mcg/puff mcg (4-10 puffs) mcg (10-20 puffs) '>2000 mcg ('>20 puffs) Children Beclmethasne diprpinate 42 mcg/puff mcg (2-8 puffs mcg (8-10 puffs - 42 '>672 mcg ('>16 puffs mcg/puff (1-4 puffs - 84 (1-4 puffs - 84 ('>8 puffs - 84 Budesnide DPI: 200 mcg/dse mcg mcg (1-2 inhalatins '>400 mcg ('>2 inhalatins Flunisnde mcg mcg '>1250 mcg 250 mcg/puff (2-3 puffs) (4-5 puffs) ('>5 puffs) Fluticasne MDI: 44, 110, 220 mcg/ puff mcg (2-4 puffs mcg (4-10 puffs - 44 OR (2-4 puffs '>440 mcg ('>4 puffs - 110OR('>2 puffs Memrial Drive Suite 1 Pinehurst, N.C Phne (910) Fax (910)

4 DPI: 50, 100, 250 mcg/dse (2-4 inhalatins - 50 (2-4 inhalatins ('>4 inhalatins - 100OR('>2 inhalatins Triamcinlne acetnide 100 mcg/puff mcg (4-8 puffs) 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 , July Available at: Appendix B: Dsing Schedule fr Subcutaneusly Administered Omalizumab Baseline Serum IgE Level Bdy Weight kg kg kg kg kg IU/ml Dse in milligrams Adapted frm Strunk & Blmberg, The recmmended dse is 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 Memrial Drive Suite 1 Pinehurst, N.C Phne (910) Fax (910)

5 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 Phne (910) Fax (910)

6 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 Phne (910) Fax (910)

7 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. Easthpe, S and Garvis, B 'Omalizumab' Drugs 2001;61(2): Prenner, BM 'Asthma 2008: targeting immunglbulin E t achieve disease cntrl.' J Asthma Aug;45(6): 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 Natinal Institute fr Health and Clinical Excellence (NICE). Omalizumab fr severe persistent allergic asthma. Technlgy Appraisal Guidance N 133. Lndn, UK: NICE; Nvember Strunk RC, Blmberg GR. Omalizumab fr asthma. N Engl J Med. 2006;354(25): Cdes Cdes Number Descriptin HCPCS J2357 Injectin, Omalizumab, 5 mg ICD-9 diagnsis Asthma, exgenus 42 Memrial Drive Suite 1 Pinehurst, N.C Phne (910) Fax (910)