Neighborhood Health Plan RI Xolair Coverage | OpenPayer

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Neighborhood Health Plan RI Xolair Coverage | OpenPayer

Coverage Criteria for Xolair (omalizumab)

Initial Therapy - Asthma

Covered when ALL of the following are met

Asthma initial criteria: Member is >=6 years; positive skin test or in vitro reactivity to at least one perennial aeroallergen; pre-treatment IgE >= 30 IU/mL; uncontrolled asthma within the past year as demonstrated by one of: (a) two or more exacerbations requiring oral or injectable corticosteroids; (b) one or more exacerbations resulting in hospitalization or emergency medical care; or (c) poor symptom control (frequent reliever use, activity limitation, or night waking); inadequate control despite optimized therapy with both (a) medium-to-high-dose inhaled corticosteroid and (b) an additional controller (e.g., LABA, LAMA, leukotriene modifier, or sustained-release theophylline); and member will continue maintenance asthma treatments in combination with the requested medication.see node text

Authorization of 6 months may be granted

Initial Therapy - CRSwNP

Covered when ALL of the following are met

CRSwNP initial criteria: Member is >=18 years; bilateral nasal polyps and chronic sinusitis symptoms despite intranasal corticosteroid treatment for at least 2 months unless contraindicated or not tolerated; objective evidence with one of: (a) bilateral nasal endoscopy/anterior rhinoscopy/CT showing polyps reaching below the lower border of the middle turbinate or beyond in each nostril; (b) Meltzer Clinical Score >=2 in both nostrils; or (c) total endoscopic nasal polyp score (NPS) >=5 with minimum score >=2 per nostril; member has nasal blockage/congestion/obstruction plus at least one additional symptom (rhinorrhea, loss of smell, or facial pain/pressure); and member will continue daily intranasal corticosteroid while being treated unless contraindicated.see node text

Authorization of 6 months may be granted

Initial Therapy - IgE-mediated food allergy

Covered when ALL of the following are met

Food allergy initial criteria: Member is >=1 year; food allergy confirmed by either pre-treatment allergen-specific IgE >=6 IU/mL OR skin-prick test with wheal diameter >=4 mm; AND either a positive physician-controlled oral food challenge (moderate-to-severe skin, respiratory, or GI symptoms) OR history of a systemic reaction to the food; pre-treatment total serum IgE >=30 IU/mL; and member will continue a food-allergen avoidance diet.see node text

Authorization of 6 months may be granted

Initial Therapy - CSU

Covered when ALL of the following are met

CSU initial criteria: Member is >=12 years; remains symptomatic despite up-dosing of a second-generation H1 antihistamine for at least 2 weeks (per EAACI/GA2LEN/EDF/WAO guidance); has been evaluated for other causes of urticaria (e.g., bradykinin-related angioedema, IL-1–associated urticarial syndromes, urticarial vasculitis); and has had spontaneous wheals, angioedema, or both for at least 6 weeks.see node text

Authorization of 6 months may be granted

Initial Therapy - Immune checkpoint inhibitor-related toxicity

Covered when ALL of the following are met

ICI-toxicity initial criteria: Member has refractory immune checkpoint inhibitor–related severe (Grade 3) pruritus and elevated IgE levels.see node text

Authorization of 6 months may be granted

Initial Therapy - Systemic mastocytosis

Covered when ALL of the following are met

Systemic mastocytosis initial criteria: Major plus at least one minor diagnostic criterion present OR three or more minor criteria present (per WHO 2022 diagnostic criteria); AND the requested medication will be used in one of the following settings: (a) stepwise prophylactic treatment for chronic mast cell mediator–related cardiovascular or pulmonary symptoms after trials of H1 and H2 blockers and corticosteroids; (b) prevention of recurrent unprovoked anaphylaxis; (c) prevention of hymenoptera- or food-induced anaphylaxis when specific IgE and skin testing are negative; or (d) to improve tolerability of venom immunotherapy.see node text

Authorization of 12 months may be granted

Continuation Therapy - Asthma

Covered when ALL of the following are met

Asthma continuation criteria: Member is >=6 years; asthma control has improved on Xolair as demonstrated by at least one of: (a) reduction in frequency and/or severity of symptoms and exacerbations; or (b) reduction in daily maintenance oral corticosteroid dose; and member will continue maintenance asthma treatments in combination with Xolair.see node text

Authorization of 12 months may be granted

Continuation Therapy - CRSwNP

Covered when ALL of the following are met

CRSwNP continuation criteria: Member is >=18 years; member has experienced a positive response evidenced by improvement in signs and symptoms (e.g., nasal congestion, polyp size, smell, rhinorrhea, sino-nasal inflammation, facial pressure/pain) or reduction in corticosteroid use; and member will continue daily intranasal corticosteroid while being treated unless contraindicated.see node text

Authorization of 12 months may be granted

Continuation Therapy - IgE-mediated food allergy

Covered when ALL of the following are met

Food allergy continuation criteria: Member is >=1 year; member has achieved or maintained a positive clinical response to therapy as evidenced by decreased hypersensitivity to the food allergen (e.g., reduced moderate-to-severe skin, respiratory, or GI symptoms); and member will continue a food-allergen avoidance diet.see node text

Authorization of 12 months may be granted

Continuation Therapy - CSU

Covered when ALL of the following are met

CSU continuation criteria: Member is >=12 years; member has experienced a positive response since initiation of therapy (e.g., improved symptoms, decreased UAS7).see node text

Authorization of 12 months may be granted

Authorization and Diagnostic Criteria

Coverage and authorization considerations referenced in this portion of the policy include the following requirement sets and diagnostic standards.

Continuation therapy authorization: All members (including new members) requesting authorization for continuation of therapy must meet all initial authorization criteria.

See initial criteria in earlier document sections.

Concomitant therapy exclusion: Member cannot use the requested medication concomitantly with any other biologic drug or targeted synthetic drug for the same indication.

Applies for all indications.

Systemic mastocytosis diagnostic criteria: Diagnosis should meet WHO 2022 Major and/or Minor criteria: major (multifocal dense mast cell infiltrates) or >=3 minor criteria including atypical mast cell morphology, activating KIT mutation(s), aberrant CD2/CD25/CD30 expression, or baseline serum tryptase >20 ng/mL (adjusted for hereditary alpha-tryptasemia).3 minor or 1 major + 1 minor per WHO rules

All indications for Xolair (omalizumab) that are not explicitly listed as FDA‑approved or included among the policy’s specified compendial uses are considered experimental/investigational and not medically necessary and, therefore, are excluded from coverage.

This exclusion aligns with the policy’s stated FDA‑approved and compendial indication list which enumerates covered uses (e.g., allergic asthma, CRSwNP, IgE‑mediated food allergy, CSU, immune checkpoint inhibitor‑related toxicities, and systemic mastocytosis) and declares other uses outside those categories as investigational.

For all indications addressed in this policy, concurrent use of Xolair with any other biologic drug or targeted synthetic drug for the same indication is prohibited. Requests that propose concomitant therapy with another biologic or targeted synthetic agent for the same condition will be denied.

Xolair is not indicated for relief of acute bronchospasm or status asthmaticus, nor for emergency treatment of allergic reactions including anaphylaxis; it is also not indicated for treatment of other allergic conditions or forms of urticaria not specified in the FDA‑approved indications. These limitations of use mean Xolair should not be used as an acute rescue therapy.

Key Lab and Score Thresholds / Coding

Pre-treatment serum IgE — threshold value used in eligibility

Threshold>= 30 IU/mL

Clinical useRequired for asthma eligibility as pre-treatment total serum IgE

Age relevanceApplies to members >=6 years for asthma indication

Pre-treatment allergen-specific IgE for food allergy — threshold

Threshold>= 6 IU/mL (allergen-specific IgE)

ContextOne of two objective confirmations required for IgE-mediated food allergy eligibility

Accompanying requirements

Prior Authorization, Documentation, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization is required for all indications. Requests should include indication-specific documentation (see documentation callout) and will be reviewed against the applicable clinical criteria; typical approvals are for 6 months (12 months for systemic mastocytosis when criteria met). Continuation/renewal requests must meet the same initial authorization criteria.

Typical approval duration: 6 months for most indications; 12 months for systemic mastocytosis when criteria met.
Continuation requests: must meet all initial authorization criteria.

Denial Risk

No Concurrent Biologic/Targeted Therapy

Requests will be denied if the member is prescribed another biologic or targeted synthetic agent for the same indication concomitantly. Prior authorization will not be approved for concurrent use of two biologic/targeted therapies to treat the same condition.

Background on Omalizumab (Xolair)

Omalizumab (Xolair) is a humanized monoclonal antibody that binds circulating IgE and reduces free IgE levels, thereby decreasing IgE‑mediated allergic inflammation. It is indicated as add‑on therapy for allergic asthma in patients aged ≥6 years with positive skin or in vitro reactivity to a perennial aeroallergen whose symptoms are inadequately controlled with inhaled corticosteroids; for chronic rhinosinusitis with nasal polyps (CRSwNP) in adults with inadequate response to intranasal corticosteroids; for reduction of reactions from IgE‑mediated food allergy in patients aged ≥1 year (used with allergen avoidance); and for chronic spontaneous urticaria (CSU) in patients ≥12 years who remain symptomatic despite H1 antihistamines. The policy also lists certain compendial uses such as immune checkpoint inhibitor‑related toxicities and systemic mastocytosis.

Definitions and Diagnostic Criteria

Pre-treatment serum IgE definition — lab measurement and thresholds

DefinitionLaboratory measurement of total serum IgE (IU/mL) used as part of eligibility assessments

Threshold for asthma and food allergy>= 30 IU/mL

TimingMeasured pre-treatment and documented in chart notes for authorization

Endoscopic nasal polyp score (NPS) — definition and scoring

DefinitionEndoscopic nasal polyp score (NPS): total score from bilateral nasal endoscopy assessing polyp size per nostril

Scoring requirementPolicy accepts total NPS >=5 with minimum score >=2 for each nostril as objective evidence

Documentation Required

Required Documentation per Indication

Submit the following documentation according to the requested indication to support medical necessity and prior authorization review.

Asthma (initial): pre-treatment total IgE level; chart notes/medical record documenting prior medications tried (drug, dose, frequency, duration); evidence of uncontrolled asthma and current maintenance therapies.
Asthma (continuation): chart notes documenting improvement in asthma control.
CRSwNP (initial): nasal endoscopy/anterior rhinoscopy/CT details (polyp location/size) or Meltzer Clinical Score or endoscopic nasal polyp score (NPS); chart notes or claims history documenting prior therapies (drug, dose, frequency, duration) or clinical rationale if therapy contraindicated.
CRSwNP (continuation): chart notes documenting positive response to therapy.
IgE‑mediated food allergy (initial): pre‑treatment allergen‑specific IgE level and/or skin‑prick test wheal diameter; pre‑treatment serum total IgE; documentation of positive physician‑controlled oral food challenge or history of systemic reaction to the food; documentation of planned food‑allergen avoidance diet.
IgE‑mediated food allergy (continuation): chart notes documenting decreased hypersensitivity or positive response to therapy.
Chronic spontaneous urticaria (initial): chart notes or claims history showing inadequate response to up‑dosing of a second‑generation H1 antihistamine (drug, dose, duration); evaluation for other causes of urticaria; documentation of ≥6 weeks of spontaneous wheals/angioedema.
Chronic spontaneous urticaria (continuation): chart notes documenting positive response to therapy.
Immune checkpoint inhibitor‑related toxicity (initial): chart notes showing refractory severe (G3) pruritus and elevated IgE level.
Systemic mastocytosis (initial): chart notes or medical records supporting diagnosis per 2022 WHO Diagnostic Criteria (see diagnostic callout); chart notes or claims history of prerequisite therapies (e.g., H1 and H2 blockers, corticosteroids) when applicable.