Neighborhood Health Plan RI omalizumab Coverage

Coverage Criteria for Omalizumab (Xolair)

inv-01: Asthma - Initial Therapy

Covered when ALL of the following are met

Asthma initial criteria: Member is ≥6 years of age; Xolair (omalizumab) is prescribed by, or in consultation with, a pulmonologist or allergist/immunologist; documentation of weight between 20 kg and 150 kg; positive skin test or in vitro reactivity to at least one perennial aeroallergen; pre-treatment total IgE within age-based ranges (≥30 IU/mL and ≤700 IU/mL for age ≥12, or ≥30 IU/mL and ≤1300 IU/mL for age 6 to <12); documentation of moderate or severe asthma (see Appendix); adherence to optimized therapy with both a high‑dose inhaled corticosteroid and an additional controller (long‑acting beta2‑agonist, long‑acting muscarinic antagonist, or leukotriene modifier) unless contraindicated; inadequate asthma control with two or more exacerbations in the previous year requiring additional medical treatment (e.g., oral corticosteroids, ED/urgent care visits, or hospitalizations); and documentation of baseline measurement of at least one clinical status metric (systemic corticosteroid use, inhaled corticosteroid use, or healthcare utilization).see node text

See Appendix for components defining moderate/severe

inv-02: Asthma - Usage limits and administration

Asthma administration: Xolair (omalizumab) is to be used as add‑on maintenance treatment and not for treatment of acute bronchospasm, status asthmaticus, or emergency allergic conditions; dosing for allergic asthma is 75–375 mg administered subcutaneously every 2 or 4 weeks; billing unit = 5 mg (1 billable unit) with a maximum of 75 billable units every 14 days; therapy should not be used concomitantly with other biologic agents.dose ranges as specified

Will not be used concomitantly with other biologics.

inv-03: Chronic Spontaneous Urticaria - Initial Therapy

Covered when ALL of the following are met

CSU initial criteria: Member is ≥12 years of age; Xolair (omalizumab) is prescribed by, or in consultation with, an allergist/immunologist or dermatologist; evaluation has ruled out other causes of urticaria (including bradykinin‑related angioedema and IL‑1‑associated urticarial syndromes); member is avoiding triggers; baseline objective clinical evaluation score (e.g., UAS7, AAS, DLQI, AE‑QoL, UCT, AECT, CU‑QoL) is provided; symptoms present for ≥6 weeks; and member remains symptomatic despite up‑dosing of a second‑generation H1 antihistamine up to fourfold for at least 2 weeks.UAS7/AAS/DLQI/etc. baseline required

Renewals require documented score within previous 6 months.

inv-04: CRSwNP - Initial Therapy

Covered when ALL of the following are met

CRSwNP initial criteria: Member is ≥18 years of age; Xolair (omalizumab) is prescribed by, or in consultation with, an allergist, immunologist, or otolaryngologist; documentation of bilateral symptomatic sino‑nasal polyposis lasting at least 8 weeks; failure of at least 8 weeks of daily intranasal corticosteroid therapy; and documentation of ONE of the following: systemic corticosteroid course of ≥5 days within the prior 2 years, contraindication to systemic corticosteroids, or prior nasal polyp surgery. Member must not have antrochoanal polyps, nasal septal deviation occluding a nostril, disease lacking signs of type 2 inflammation, cystic fibrosis, or mucoceles; other causes of nasal obstruction must be ruled out; baseline disease severity must be assessed with an objective measure; and therapy will be used with intranasal corticosteroids unless contraindicated.see node text

inv-05: IgE-mediated Food Allergy - Initial Therapy

Covered when ALL of the following are met

Food allergy initial criteria: Member is ≥1 year of age; Xolair (omalizumab) is prescribed by, or in consultation with, an allergist/immunologist; member is avoiding known food allergens; documentation that member is allergic to peanut AND at least one other food; allergy confirmation by all of the following: positive skin prick test (wheal ≥4 mm larger than saline control); food‑specific IgE ≥6 IU/mL at screening or within 3 months; and positive double‑blind placebo‑controlled food challenge (DBPCFC) with dose‑limiting symptoms at a single dose of ≤100 mg peanut protein and ≤300 mg other food protein. Xolair will not be used for emergency treatment of allergic reactions, including anaphylaxis.SPT ≥4 mm; IgE ≥6 IU/mL; DBPCFC thresholds as stated.

inv-06: Continuation Therapy

Covered when ALL of the following per indication are met

Asthma continuation: Member is ≥6 years of age; prescriber specialty as above; documentation of weight between 20 kg and 150 kg; member is tolerating treatment; demonstration of improved or stabilized asthma control from baseline as shown by reduction in frequency/severity of symptoms or exacerbations, or reduction in daily maintenance oral corticosteroid dose; therapy is used as add‑on maintenance and not concomitantly with other biologics.clinical improvement documented

Asthma continuation criteria

CSU continuation: Member is ≥12 years of age; prescriber specialty as above; member is tolerating treatment; documentation of clinical improvement since initiation as evidenced by improvement from baseline using an objective clinical evaluation tool (e.g., UAS7, AAS, DLQI, AE‑QoL, UCT) within the previous 6 months.documented objective score improvement

CRSwNP continuation: Documentation of improvement in signs and symptoms compared to baseline in one or more of the following: nasal obstruction symptoms, improvement of sinus opacifications on CT, or improvement on a disease activity scoring tool (e.g., NPS, nasal congestion score, SNOT‑22).

Xolair (omalizumab) is not for the treatment of acute bronchospasm or status asthmaticus and must not be used for emergency treatment of allergic reactions, including anaphylaxis. Providers should ensure Xolair is prescribed and administered as add-on maintenance therapy rather than for acute care situations. For patients considered for self-administration, follow the policy’s selection criteria: the patient must have no prior history of anaphylaxis, have received at least 3 provider-administered doses without hypersensitivity reactions, and demonstrate the ability (patient or caregiver) to recognize and appropriately treat anaphylaxis and perform subcutaneous injections per instructions. Note that for patients <12 years old, prefilled syringes should be administered by a caregiver.

The policy does not enumerate additional explicit drug-specific exclusions beyond those noted for acute or emergency use; instead coverage is restricted to the listed, covered ICD-10 diagnoses. See Appendix 1 for the complete list of covered diagnosis codes (examples include J33.0, J45.40, L50.1, and the specified Z91.* food allergy codes) that must be used when documenting the indication for omalizumab.

Use of omalizumab at doses or for clinical conditions that are not recognized as medically accepted indications (per standard compendia or peer-reviewed literature) is considered investigational and is not covered. Providers should reference standard drug compendia (e.g., AHFS‑DI, Micromedex DrugDex, Clinical Pharmacology, Lexi‑Drugs) or applicable peer‑reviewed evidence to determine whether an intended use is an accepted indication.

Coding, Units, and Lab Thresholds

Applicable HCPCS/CPT CodesHCPCSCovered

J2357

Injection, omalizumab, 5 mg

Covered Diagnosis Codes (ICD-10)ICD-10Covered

J33.0	Polyp of nasal cavity
J33.1	Polypoid sinus degeneration
J33.8	Other polyp of sinus
J33.9	Nasal polyp, unspecified
J45.40	Moderate persistent asthma, uncomplicated
J45.50	Severe persistent asthma, uncomplicated
L29.89	Other pruritus
L29.9	Pruritus, unspecified
L50.0	Allergic urticaria
L50.1	Idiopathic urticaria

1–10 of 21

1/3

Covered ICD-10 Codes (Appendix 1)ICD-10Covered

J33.0	Polyp of nasal cavity
J33.1	Polypoid sinus degeneration
J33.8	Other polyp of sinus
J33.9	Nasal polyp, unspecified
J45.40	Moderate persistent asthma, uncomplicated
J45.50	Severe persistent asthma, uncomplicated
L29.89	Other pruritus
L29.9	Pruritus, unspecified
L50.0	Allergic urticaria
L50.1	Idiopathic urticaria

1–10 of 21

1/3

Pretreatment total IgE — age-specific thresholds and ranges

Age ≥12 yearsPretreatment total IgE ≥30 IU/mL and ≤700 IU/mL

Age 6 to <12 yearsPretreatment total IgE ≥30 IU/mL and ≤1300 IU/mL

Minimum IgE for eligibilityAll ages eligible per indications require pretreatment IgE ≥30 IU/mL

Maximum billable units — indication-specific maximum units and intervals

Allergic asthmaMaximum 75 billable units every 14 days (1 billable unit = 5 mg)

Chronic spontaneous urticaria (CSU)Maximum 60 billable units every 28 days

Prior Authorization, Documentation, and Billing Actions

Prior Authorization

Diagnosis required for prior authorization

Prior authorization requires documentation of a covered diagnosis from Appendix 1 (ICD-10). Include the specific ICD-10 code that corresponds to the treated condition when submitting the PA request.

Use one of the ICD-10 codes listed in Appendix 1 when documenting the indication.
Claims or prior authorization requests using diagnosis codes not listed in Appendix 1 may be denied.

Denial Risk

Concomitant biologic therapy prohibition

Do not prescribe Xolair (omalizumab) in combination with other biologic monoclonal antibodies that target IgE, IL-4, IL-5, or similar pathways. Concurrent use with agents such as dupilumab (Dupixent), benralizumab (Fasenra), mepolizumab (Nucala), omalizumab (Xolair) in duplicate, tezepelumab (Tezspire), or other anti-IgE/anti-IL4/anti-IL5 monoclonals is prohibited.

Background and Context

Omalizumab (Xolair) is a monoclonal anti‑IgE antibody indicated as add‑on maintenance therapy for certain allergic conditions. The policy describes use for allergic asthma (as add‑on maintenance treatment with dosing typically between 75–375 mg subcutaneously every 2 or 4 weeks), chronic spontaneous urticaria, chronic rhinosinusitis with nasal polyps, and selected IgE‑mediated food allergy indications. Dosing and eligibility differ by indication and require diagnostic confirmation and baseline severity assessment. Administration is intended for maintenance use, not for acute bronchospasm or emergency allergic reactions; criteria for transitioning to self‑administration include no prior anaphylaxis and at least 3 provider‑administered doses without hypersensitivity prior to home use.

Definitions and Administration Details

Self-administration criteria — requirements for self-administration eligibility

No prior anaphylaxisPatient should have no prior history of anaphylaxis to Xolair or other agents

Three provider-administered dosesPatient must receive at least 3 doses under healthcare provider supervision with no hypersensitivity reactions

Ability to recognize and treat anaphylaxisPatient or caregiver must be able to recognize and appropriately treat anaphylaxis

Ability to perform injectionsPatient or caregiver must be able to perform SC injections correctly per Instructions for Use; note: patients <12 years require caregiver administration

Covered diagnoses — Appendix 1 lists covered ICD-10 diagnosis codes for listed indications

Nasal polyps

OpenPayer

Omalizumab (Xolair) — Medical Necessity and Coverage Criteria

Coverage Criteria for Omalizumab (Xolair)

Coding, Units, and Lab Thresholds

Prior Authorization, Documentation, and Billing Actions

Background and Context

Definitions and Administration Details