Sunflower Health Plan XOLAIR, Omalizumab Form

Omalizumab (Xolair®) is an anti-immunoglobulin E (IgE) antibody FDA Approved Indication(s) Xolair is indicated for: • Moderate to severe persistent asthma in adults and pediatric patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids • Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids, as add-on maintenance treatment • Chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment Limitation(s) of use: Xolair is not indicated for the relief of acute bronchospasm or status asthmaticus, treatment of other allergic conditions, or treatment of other forms of urticaria. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria. It is the policy of health plans affiliated with Centene Corporation® that Xolair is medically necessary when the following criteria are met: I. Initial Approval Criteria A. Moderate to Severe Persistent Asthma (must meet all): 1. Diagnosis of asthma; 2. Age ≥ 6 years; 3. Member has experienced ≥ 2 exacerbations within the last 12 months, requiring any of the following despite adherent use of controller therapy (i.e., medium- to high-dose inhaled corticosteroid [ICS] plus either a long acting beta-2 agonist [LABA] or leukotriene modifier [LTRA] if LABA contraindication/intolerance): a. Oral/systemic corticosteroid treatment (or increase in dose if already on oral corticosteroid); b. Urgent care visit or hospital admission; c. Intubation; 4. Positive skin test or in vitro reactivity to a perennial aeroallergen (see Appendix D); 5. IgE level ≥ 30 IU/mL; Page 1 of 16 CLINICAL POLICY Omalizumab 6. Xolair is prescribed concurrently with an ICS plus either a LABA or LTRA; 7. Xolair is not prescribed concurrently with Cinqair®, Fasenra®, Nucala®, Dupixent®, or Tezspire®; 8. Dose does not exceed 375 mg administered every 2 weeks (see Appendix E and F for dosing based on pre-treatment IgE level, weight, and age). Approval duration: 6 months B. Chronic Spontaneous Urticaria (must meet all): 1. Diagnosis of CSU (formerly known as chronic idiopathic urticaria [CIU]); 2. Age ≥ 12 years; 3. Failure of one antihistamine at maximum indicated doses used for ≥ 2 weeks, unless clinically significant adverse effects are experienced or all are contraindicated; 4. Xolair is not prescribed concurrently with Cinqair, Fasenra, Nucala, Dupixent, or Tezspire; 5. Dose does not exceed 300 mg every 4 weeks Approval duration: 6 months C. Chronic Rhinosinusitis with Nasal Polyps (must meet all): 1. Diagnosis of CRSwNP with documentation of both of the following (a and b): a. Presence of nasal polyps; b. Member has experienced signs and symptoms (e.g., nasal congestion/blockage/ obstruction, loss of smell, rhinorrhea) for ≥ 12 weeks; 2. Prescribed by or in consultation with an allergist, immunologist, or otolaryngologist; 3. Age ≥ 18 years; 4. Xolair is prescribed concurrently with an intranasal corticosteroid, unless contraindicated or clinically significant adverse effects are experienced (see Appendix B for examples); 5. Xolair is not prescribed concurrently with Cinqair, Fasenra, Nucala, Dupixent, or Tezspire; 6. Dose does not exceed 600 mg every 2 weeks (see Appendix G for dosing based on pre-treatment IgE level and weight). Approval duration: 6 months D. NCCN Compendium Indications (off-label) (must meet all): 1. Diagnosis of one of the following (a or b): a. Systemic mastocytosis; b. Immune checkpoint inhibitor-related severe (G3; see Appendix H) pruritus and both of the following (i and ii): i. Pruritus is refractory; ii. Member has an increased IgE level; 2. Prescribed by or in consultation with an oncologist; 3. For systemic mastocytosis, prescribed in one of the following settings (a, b, c, or d): a. As stepwise prophylactic treatment for chronic mast cell mediator-related cardiovascular and pulmonary symptoms when the member has tried both of the Page 2 of 16 CLINICAL POLICY Omalizumab following, unless clinically significant adverse effects are experienced or all are contraindicated (i and ii): i. Antihistamine (i.e., H1 blocker, H2 blocker); ii. Corticosteroid; b. For prevention of unprovoked anaphylaxis; c. For prevention of hymenoptera (e.g., bees, wasps, hornets) or food-induced anaphylaxis and one of the following (i or ii): i. Member has negative specific IgE; ii. Member has negative skin test; d. To improve tolerability of immunotherapy; 4. Xolair is not prescribed concurrently with Cinqair, Fasenra, Nucala, Dupixent, or Tezspire; 5. Dose is within FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).* *Prescribed regimen must be FDA-approved or recommended by NCCN Approval duration: 6 months E. Other diagnoses/indications (must meet 1 or 2): 1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.PMN.16 for Medicaid; or 2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.PMN.53 for Medicaid. II. Continued Therapy A. Moderate to Severe Persistent Asthma (must meet all): 1. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B); 2. Demonstrated adherence to asthma controller therapy (an ICS plus either a LABA or LTRA) as evidenced by proportion of days covered (PDC) of 0.8 in the last 6 months (i.e., member has received asthma controller therapy for at least 5 of the last 6 months); Page 3 of 16 CLINICAL POLICY Omalizumab 3. Member is responding positively to therapy (examples may include but are not limited to: reduction in exacerbations or corticosteroid dose, improvement in forced expiratory volume over one second since baseline, reduction in the use of rescue therapy); 4. Xolair is not prescribed concurrently with Cinqair, Fasenra, Nucala, Dupixent, or Tezspire; 5. If request is for a dose increase, new dose does not exceed 375 mg every 2 weeks (see Appendix E and F for dosing based on pre-treatment IgE level, weight, and age). Approval duration: 12 months B. Chronic Spontaneous Urticaria (must meet all): 1. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B); 2. Member is responding positively to therapy; 3. Xolair is not prescribed concurrently with Cinqair, Fasenra, Nucala, Dupixent, or Tezspire; 4. If request is for a dose increase, new dose does not exceed 300 mg every 4 weeks. Approval duration: 12 months C. Chronic Rhinosinusitis with Nasal Polyps (must meet all): 1. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B); 2. Demonstrated adherence to an intranasal corticosteroid, unless contraindicated or clinically significant adverse effects are experienced; 3. Member is responding positively to therapy (examples may include but are not limited to: reduced nasal polyp size, reduced need for systemic corticosteroids, improved sense of smell, improved quality of life); 4. Xolair is not prescribed concurrently with Cinqair, Fasenra, Nucala, Dupixent, or Tezspire; 5. If request is for a dose increase, new dose does not exceed 600 mg every 2 weeks (see Appendix G for dosing based on pre-treatment IgE level and weight). Approval duration: 12 months D. NCCN Compendium Indications (off-label): 1. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Xolair for a covered indication and has received this medication for at least 30 days; 2. Member is responding positively to therapy; Page 4 of 16 CLINICAL POLICY Omalizumab 3. If request is for a dose increase, new dose is within FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).* *Prescribed regimen must be FDA-approved or recommended by NCCN. Approval duration: 6 months E. Other diagnoses/indications (must meet 1 or 2): 1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.PMN.16 for Medicaid; or 2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.PMN.53 for Medicaid. III. Diagnoses/Indications for which coverage is NOT authorized: A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.PMN.53 for Medicaid or evidence of coverage documents; B. Acute bronchospasm or status asthmaticus. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key AAAAI: American Academy of Allergy, Asthma, and Immunology ADL: activity of daily living CIU: chronic idiopathic urticaria CRSwNP: chronic rhinosinusitis with nasal polyps CSU: chronic spontaneous urticaria EAACI: European Academy of Allergy and Clinical Immunology EDF: European Dermatology Forum EPR3: Expert Panel Report 3 FDA: Food and Drug Administration GA2LEN: Global Allergy and Asthma European Network GINA: Global Initiative for Asthma ICS: inhaled corticosteroids IgE: immunoglobulin E LABA: long-acting beta-agonist LTRA: leukotriene modifier PDC: proportion of days covered WAO: World Allergy Organization Appendix B: Therapeutic Alternatives This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization. Page 5 of 16 CLINICAL POLICY Omalizumab Drug Name Dosing Regimen Asthma – ICS (medium – high dose) Qvar (beclomethasone) budesonide (Pulmicort) Alvesco (ciclesonide) Flovent (fluticasone propionate) Arnuity Ellipta (fluticasone furoate) Asmanex (mometasone) Dose Limit/ Maximum Dose 4 actuations BID 2 actuations BID 2 actuations BID 2 actuations BID 1 actuation QD 2 inhalations BID 1 inhalation BID 4 actuations per day 1 actuation QD 1 actuation BID 1 actuation BID 2 actuations BID > 100 mcg/day 40 mcg, 80 mcg per actuation 1-4 actuations BID > 200 mcg/day 90 mcg, 180 mcg per actuation 2-4 actuations BID > 80 mcg/day 80 mcg, 160 mcg per actuation 1-2 actuations BID > 100 mcg/day 44-250 mcg per actuation 2-4 actuations BID ≥ 50 mcg/day 100 mcg, 200 mcg per actuation 1 actuation QD ≥ 100 mcg/day HFA: 100 mcg, 200 mcg per actuation Twisthaler: 110 mcg, 220 mcg per actuation 1-2 actuations QD to BID 50 mcg per dose 1 inhalation BID 100/5 mcg, 200/5 mcg per actuation 2 actuations BID 100/25 mcg, 200/25 mcg per actuation 1 actuation QD Diskus: 100/50 mcg, 250/50 mcg, 500/50 mcg per actuation HFA: 45/21 mcg, 115/21 mcg, 230/21 mcg per actuation 1 actuation BID 55/13 mcg, 113/14 mcg, 232/14 mcg per actuation 1 actuation BID 80 mcg/4.5 mcg, 160 mcg/4.5 mcg per actuation 2 actuations BID 4 to 10 mg PO QD 10 to 20 mg PO BID 1,200 mg PO BID 10 mg per day 40 mg per day 2,400 mg per day Page 6 of 16 Asthma - LABA Serevent (salmeterol) Asthma – Combination products (ICS + LABA) Dulera (mometasone/ formoterol) Breo Ellipta (fluticasone/vilanterol) Advair (fluticasone/ salmeterol) fluticasone/salmeterol (Airduo RespiClick®) Symbicort (budesonide/ formoterol) Asthma - LTRA montelukast (Singulair) zafirlukast (Accolate) zileuton ER (Zyflo CR) CLINICAL POLICY Omalizumab Drug Name Dosing Regimen Zyflo (zileuton) Asthma – Oral corticosteroids dexamethasone (Decadron) methylprednisolone (Medrol) prednisolone (Millipred, Orapred ODT) prednisone (Deltasone) 600 mg PO QID 0.75 to 9 mg/day PO in 2 to 4 divided doses 40 to 80 mg PO in 1 to 2 divided doses 40 to 80 mg PO in 1 to 2 divided doses 40 to 80 mg PO in 1 to 2 divided doses Dose Limit/ Maximum Dose 2,400 mg per day Varies Varies Varies Varies CSU hydroxyzine (Vistaril®) diphenhydramine (Benadryl®) chlorpheniramine (Aller- Chlor®) cetirizine (Zyrtec®) levocertirizine (Xyzal®) loratadine (Claritin®) desloratadine (Clarinex®) fexofenadine (Allegra®) CRSwNP Intranasal corticosteroids beclomethasone (Beconase AQ, Qnasl) budesonide (Rhinocort Aqua, Rhinocort) flunisolide fluticasone propionate (Flonase) mometasone (Nasonex) Omnaris, Zetonna (ciclesonide) Adult: 25 mg PO TID to QID Age ≥ 6 years: 50 mg-100 mg/day in divided doses Adult: 25 mg to 50 mg PO TID to QID Pediatric: 12.5 mg to 25 mg PO TID to QID or 5 mg/kg/day or 150 mg/m²/day Immediate Release: 4 mg PO every 4 to 6 hours Extended Release: 12 mg PO every 12 hours 5 to 10 mg PO QD 2.5 mg to 5 mg PO QD 10 mg PO QD 5 mg PO QD 60 mg PO BID or 180 mg QD Adult: Will vary according to condition Age ≥ 6 years: 50 mg- 100 mg/day in divided doses Adult: Will vary according to condition Children: 300 mg/day Do not exceed 24 mg/day 10 mg/day 5 mg/day 10 mg/day Will vary according to condition 180 mg/day 1-2 sprays IN BID 2 sprays/nostril BID 128 mcg IN QD or 200 mcg IN BID 2 sprays IN BID 1-2 sprays IN BID 1-2 inhalations/nostril/ day 2 sprays/nostril TID 2 sprays/nostril BID 2 sprays IN BID Omnaris: 2 sprays IN QD Zetonna: 1 spray IN QD 2 sprays/nostril BID Omnaris: 2 sprays/ nostril/day Page 7 of 16 CLINICAL POLICY Omalizumab Drug Name Dosing Regimen Dose Limit/ Maximum Dose Zetonna: 2 sprays/ nostril/day 2 sprays/ nostril/day 744 mcg/day Varies Varies 2 sprays IN QD 1 to 2 sprays (93 mcg/spray) to nostril IN BID triamcinolone (Nasacort) Xhance™ (fluticasone propionate) Systemic mastocytosis, Immunotherapy-related pruritus antihistamines, H1 blockers: examples – diphenhydramine, chlorpheniramine, hydroxyzine, cetirizine, loratadine, fexofenadine antihistamines, H2 blockers: examples – cimetidine, famotidine, corticosteroids: examples – betamethasone, dexamethasone, methylprednisolone, prednisolone, prednisone Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Varies Varies Varies Varies Appendix C: Contraindications/Boxed Warnings • Contraindication(s): hypersensitivity • Boxed warning(s): anaphylaxis Appendix D: General Information • Allergic asthma: o The definition of moderate to severe allergy varied among the clinical trials. The definition most often used was a patient who required oral systemic steroid bursts or unscheduled physician office visits for “uncontrolled” asthma exacerbations despite maintenance inhaled steroid use. Patients in the clinical trials most often were required to have an FEV1 between 40% and 80% of predicted. No patients were enrolled with an FEV1 greater than 80% of predicted. o Xolair has been shown to be marginally effective in decreasing the incidence of asthma exacerbations in patients who have met all the criteria described above. o Xolair provides little therapeutic benefit over existing therapies. Use in patients on inhaled corticosteroids or chronic oral steroids plus or minus a second controller agent decreased asthma exacerbation by 0.5 to 1 per year. Use of rescue beta- agonists declined by 1 inhalation per day. Small changes in pulmonary function tests were also seen. An analysis of unpublished data indicated that hospital admissions declined by 3 per hundred patient years, emergency department (ED) visits by 2 per hundred patient years, and Page 8 of 16 CLINICAL POLICY Omalizumab unscheduled physician office visits by 14 per one hundred patient years. o The 2007 National Heart, Lung and Blood Institute’s Expert Panel Report 3 (EPR3) Guidelines for the Diagnosis and Management of Asthma recommend Xolair may be considered as adjunct therapy for patients 12 years and older with allergies and Step 5 or 6 (severe) asthma whose symptoms have not been controlled by ICS and LABA. o The Global Initiative for Asthma (GINA) guidelines recommend Xolair be considered as adjunct therapy for patients 6 years of age and older with exacerbations or poor symptom control despite taking at least high dose ICS/LABA and who have allergic biomarkers or need maintenance oral corticosteroids. o The four perennial aeroallergens most commonly tested for in the clinical trials were dog dander, cat dander, cockroach, and house dust mite. o Serious and life-threatening allergic reactions (anaphylaxis) in patients after treatment with Xolair have been reported. Usually these reactions occur within two hours of receiving a Xolair subcutaneous injection. However, these new reports include patients who had delayed anaphylaxis—with onset two to 24 hours or even longer- after receiving Xolair treatment. Anaphylaxis may occur after any dose of Xolair (including the first dose), even if the patient had no allergic reaction to the first dose. o Patients could potentially meet asthma criteria for both Xolair and Nucala, though there is insufficient data to support the combination use of multiple asthma biologics. The combination has not been studied. Approximately 30% of patients in the Nucala MENSA study also were candidates for therapy with Xolair. o PDC is a measure of adherence. PDC is calculated as the sum of days covered in a time frame divided by the number of days in the time frame. To achieve a PDC of 0.8, a member must have received their asthma controller therapy for 144 days out of the last 180 days, or approximately 5 months of the last 6 months. • CSU: o CSU is classified as spontaneous onset of wheals, angioedema, or both, for more than 6 weeks due to an unknown cause. o Clinical studies have shown that Xolair 150 mg and 300 mg significantly improved the signs and symptoms of chronic idiopathic urticaria compared to placebo in patients who had remained symptomatic despite the use of approved dose of H1- antihistamine. o The Joint Task Force on Practice Parameters representing various American allergy organizations include Xolair in combination with H1-antihistamines as a fourth line treatment option following a stepwise approach starting with a second generation antihistamine. This is followed by one or more of the following: a dose increase of the second generation antihistamine, or the addition of another second generation antihistamine, H2-antagonist, LTRA, or first generation antihistamine. Treatment with hydroxyzine or doxepin can be considered in patients whose symptoms remain poorly controlled. o The EAACI/GA2LEN/EDF/AAAAI/WAO Guideline for the Management of Urticaria include Xolair in combination with H1-antihistamines as a third line treatment option in patients who have failed to respond to higher doses of H1- antihistamines. Page 9 of 16 CLINICAL POLICY Omalizumab o Xolair is the first medicine in its class approved for CSU since non-sedating antihistamines. o The use of over-the-counter H1 antihistamines may not be a benefit to the treatment of CIU. Credit will be given for their use, but will not be covered under plan. o Anaphylaxis has occurred as early as after the first dose of Xolair, but also occurred beyond 1 year after beginning regularly administered treatment. • Idiopathic anaphylaxis: A randomized, double-blind, placebo-controlled study in 19 patients with frequent episodes (≥ 6/year) of idiopathic anaphylaxis found Xolair to have no significant difference compared to placebo in the number of anaphylactic episodes at 6 months (Carter MC et al). 30-60 kg > 60-70 kg Dosing Frequency Appendix E: Age ≥ 12 Years: Asthma Dosing Based on Pre-treatment IgE and Body Weight† Pre- treatment serum IgE IU/mL ≥ 30-100 > 100-200 > 200-300 > 300-400 Q 2 weeks > 400-500 > 500-600 > 600-700 150 mg 300 mg 225 mg 300 mg 375 mg Insufficient Data to Recommend a Dose 150 mg 300 mg 300 mg 225 mg 300 mg 300 mg 375 mg 150 mg 300 mg 225 mg 225 mg 300 mg 375 mg Body Weight > 70-90 kg 300 mg 225 mg 300 mg > 90-15 kg Q 4 weeks †The manufacturer recommends dose adjustments for significant body weight changes during treatment. > 70- 80 kg > 50- 60 kg > 80- 90 kg > 25- 30 kg > 30- 40 kg > 40- 50 kg Q 4 weeks Dosing Freq- uency Body Weight > 60- 70 kg Appendix F: Age 6 to < 12 Years: Asthma Dosing Based on Pre-treatment IgE and Body Weight† Pre- treatment serum IgE IU/mL ≥ 30-100 > 100-200 > 200-300 > 300-400 > 400-500 > 500-600 > 600-700 > 700-800 > 800-900 > 900-1,000 > 1,000- 1,100 > 1,100- 1,200 > 1,200- 1,300 †The manufacturer recommends dose adjustments for significant body weight changes during treatment. 20- 25 kg 75 150 150 225 225 300 300 225 225 225 225 75 150 225 300 225 225 225 300 300 375 375 75 150 150 225 300 300 225 225 225 300 300 150 300 300 225 225 300 300 375 375 > 90- 125 kg 300 225 300 Insufficient Data to Recommend a Dose 150 300 300 225 300 300 375 150 300 225 225 300 375 150 300 225 300 375 150 300 225 300 375 Q 2 weeks 300 300 300 375 > 125- 150 kg 300 300 375 Page 10 of 16 CLINICAL POLICY Omalizumab Q 4 weeks Dosing Frequency Appendix G: Age ≥ 18 Years: CRSwNP Dosing Based on Pre-treatment IgE and Body Weight† Pre- treatment serum IgE IU/mL ≥ 30-100 > 100-200 > 200-300 > 300-400 > 400-500 > 500-600 > 600-700 > 700-800 > 800-900 > 900-1,000 > 1,000-1,100 > 1,100-1,200 > 1,200-1,300 > 1,300- 1,500 Body Weight > 70- 80 kg 150 300 450 600 375 450 450 525 600 > 40- 50 kg 150 300 300 450 450 600 600 375 375 450 450 525 525 600 > 30- 40 kg 75 150 225 300 450 450 450 300 300 375 375 450 450 525 > 50- 60 kg 150 300 300 450 600 600 375 450 450 525 600 600 > 60- 70 kg 150 300 450 450 600 375 450 450 525 600 > 80- 90 kg 150 300 450 600 375 450 525 600 > 90- 125 kg 300 450 600 450 525 600 Q 2 weeks Insufficient Data to Recommend a Dose > 125- 150 kg 300 600 375 525 600 †The manufacturer recommends dose adjustments for significant body weight changes during treatment. Appendix H: Immunotherapy-related Pruritus • Immunotherapy refers to immune checkpoint inhibitors. Immune checkpoint inhibitors comprise a class of agents that target immune cell checkpoints, such as programmed cell death-1 (PD-1; e.g., Opdivo®, Keytruda®) and PD-1 ligand (PD-L1; e.g., Tecentriq®, Bavencio®, Imfinzi®), as well as cytotoxic T-lymphocyte–associated antigen 4 (e.g., Yervoy®, Imjudo®). • NCCN grading of pruritus o G1: Mild or localized o G2: Moderate. Intense or widespread; intermittent; skin changes from scratching (e.g., edema, papulation, excoriations, lichenification, oozing/crusts); limiting instrumental ADLs o G3: Severe. Intense or widespread; constant; limiting self-care ADLs or sleep V. Dosage and Administration Indication Dosing Regimen Asthma* 75 to 375 mg SC every 2 or 4 weeks based on serum total IgE level (IU/mL) measured before the start of treatment, and body weight (kg). Adjust doses for significant changes in body weight during treatment Maximum Dose 375 mg/2 weeks Xolair is not approved for use in patients weighing more than 150 kg (see Appendix E and F) Do not administer more than 150 mg (contents of one vial) per injection site. Divide doses of more than 150 mg amongst two or more injection sites 150 mg or 300 mg SC every 4 weeks CSU 300 mg/4 weeks Page 11 of 16 CLINICAL POLICY Omalizumab Indication Dosing Regimen CRSwNP* 75 to 600 mg SC every 2 or 4 weeks based on serum total IgE level (IU/mL) measured before the start of treatment, and body weight (kg). Adjust doses for significant changes in body weight during treatment Maximum Dose 600 mg/2 weeks *For patients with both asthma and CRSwNP, dosing determination should be based on the primary diagnosis for which Xolair is being prescribed. VI. Product Availability • Single-dose vial: 150 mg • Single-dose prefilled syringes: 75 mg/0.5 mL, 150 mg/mL, and 300 mg/2mL • Single-dose prefilled autoinjectors: 75 mg/0.5 mL, 150 mg/mL, and 300 mg/2 mL VII.