CurrentNeighborhood Health Plan of Rhode IslandPolicy 1656-A

Omalizumab (Xolair/Omlyclo) coverage for allergic and IgE-mediated conditions

Defines medical necessity, indications, documentation, and limitations for coverage of omalizumab (brand and biosimilar) for Neighborhood Health Plan of Rhode Island members; applies to prescribers requesting prior authorization for listed indications.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOmalizumab (Xolair/Omlyclo) coverage for allergic and IgE-mediated conditions

Policy CodePolicy 1656-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and submit required documentation including prior medication trials and pre-treatment IgE or allergen testing as applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6+indications listed

>=30 IU/mLpre-treatment IgE threshold

6 monthsinitial auth duration

12 monthscontinuation auth

Initial & cont.required documentation

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Coverage Criteria

Covered Indications (summary)

Covered when the indication is an FDA-approved or accepted compendial use and all approval/documentation criteria are met and the member has no exclusions to therapy.

General coverage conditions: Request corresponds to an FDA-approved indication or listed compendial use AND required documentation (initial or continuation) is submitted AND member has no exclusions to prescribed therapy

See Documentation and Prior Authorization modules for specifics

Initial therapy — Asthma (6-month authorization)

Authorization of 6 months may be granted for treatment of moderate-to-severe asthma when all of the following criteria are met:

Asthma initial criteria: Member is 6 years of age or older; positive skin test or in vitro reactivity to at least one perennial aeroallergen; pre-treatment total serum IgE >= 30 IU/mL; uncontrolled asthma demonstrated by at least one of: two or more exacerbations requiring oral or injectable corticosteroid treatment in the past year, one or more exacerbations resulting in hospitalization or emergency medical care visits in the past year, or poor symptom control (frequent symptoms or reliever use, activity limitation, or night waking due to asthma); inadequate asthma control despite optimized medium-to-high-dose inhaled corticosteroid AND 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.

Authorization of 6 months may be granted for members >=6 years who previously received a biologic in the past year.

Initial therapy — Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) (6-month authorization)

Authorization of 6 months may be granted for treatment of CRSwNP when all of the following criteria are met:

CRSwNP initial criteria: Member is 18 years of age or older; bilateral nasal polyps and chronic sinusitis symptoms despite intranasal corticosteroid treatment for at least 4 weeks unless contraindicated or not tolerated; objective evidence of polyps by one of: bilateral nasal endoscopy/anterior rhinoscopy/CT showing polyps reaching below the lower border of the middle turbinate in each nostril, Meltzer Clinical Score >= 2 in both nostrils, OR total endoscopic nasal polyp score (NPS) >= 5 with minimum score of 2 in each nostril; member has nasal blockage/congestion/obstruction plus at least one additional symptom (rhinorrhea, reduction/loss of smell, or facial pain/pressure); member will continue daily intranasal corticosteroid while being treated unless contraindicated or not tolerated.

Authorization of 6 months may be granted for adults who previously received a biologic for CRSwNP in the past year.

Initial therapy — IgE‑Mediated Food Allergy (6-month authorization)

Authorization of 6 months may be granted for reduction of IgE‑mediated food allergy reactions when all of the following criteria are met:

Food allergy initial criteria: Member is 1 year of age or older; IgE‑mediated food allergy confirmed by either pre-treatment food allergen-specific IgE >= 6 IU/mL OR skin‑prick test wheal >= 4 mm; member has either a positive physician‑controlled oral food challenge (e.g., moderate to severe skin, respiratory, or gastrointestinal symptoms) OR a history of a systemic reaction to a food; pre-treatment total serum IgE >= 30 IU/mL; member will continue to follow a food‑allergen avoidance diet.

6-month authorization.

Initial therapy — Chronic Spontaneous Urticaria (6-month authorization)

Authorization of 6 months may be granted for treatment of chronic spontaneous urticaria when all of the following criteria are met:

CSU initial criteria: Member is 12 years of age or older; member remains symptomatic despite up‑dosing of a second‑generation H1 antihistamine for at least 2 weeks (per EAACI/GA2LEN/EuroGuiDerm/APAAACI guidelines); member has been evaluated for other causes of wheals and/or angioedema (including bradykinin-related angioedema and interleukin-1-associated urticarial syndromes); and member has had spontaneous onset of wheals, angioedema, or both for at least 6 weeks.

Authorization of 6 months may be granted for members >=12 years who previously received a biologic in the past year.

Initial therapy — Immune Checkpoint Inhibitor–Related Toxicity (12-month authorization)

Authorization of 12 months may be granted when both criteria are met:

ICI‑related toxicity initial criteria: Member has refractory immune‑therapy related severe (Grade 3) pruritus with no response to gabapentinoids after one month AND the member has elevated IgE levels.

12-month authorization.

Initial therapy — Systemic Mastocytosis (12-month authorization)

Authorization of 12 months may be granted when both criteria are met:

Systemic mastocytosis initial criteria: Either the WHO major criterion plus at least one minor diagnostic criterion, OR three or more WHO minor diagnostic criteria are present (see Appendix for criteria details); AND the requested medication will be used in an indicated treatment setting such as: stepwise prophylactic treatment for chronic mast cell mediator‑related cardiovascular and pulmonary symptoms after trials of H1 and H2 blockers and corticosteroids, prevention of recurrent unprovoked anaphylaxis, prevention of hymenoptera or food‑induced anaphylaxis with negative specific IgE or skin test, or to improve tolerability of venom immunotherapy.

12-month authorization.

Continuation therapy — General continuation criteria (12-month authorization)

Authorization of 12 months may be granted for continuation when indicated and a positive response is documented:

Continuation criteria by indication: Asthma: member is >=6 years with improved control shown by reduced symptom/exacerbation frequency or reduced daily maintenance oral corticosteroid dose, and continued use of maintenance asthma treatments; CRSwNP: member is >=18 years with documented improvement in signs/symptoms and continued intranasal corticosteroid use; IgE food allergy: member is >=1 year with maintained positive clinical response (reduction or absence of hypersensitivity) and continued avoidance diet; CSU: member is >=12 years with positive response (e.g., improved symptoms, decreased UAS7); ICI‑related toxicity and systemic mastocytosis: member achieves or maintains positive clinical response (low disease activity or symptom improvement).

Member must not receive concomitant biologic or targeted synthetic therapy for the same indication.

Omalizumab is not indicated for the relief of acute bronchospasm or status asthmaticus. It is also not indicated for emergency treatment of allergic reactions, including anaphylaxis, nor for treatment of other forms of urticaria outside the listed indications. These limitations mean omalizumab should not be used as rescue therapy in acute respiratory or anaphylactic emergencies.

Experimental/Investigational - Not Medically Necessary

Not covered when:

Not medically necessary/excluded indications: Indications not listed among the FDA-approved or specified compendial uses are considered experimental/investigational and not medically necessary.

Compendial uses explicitly listed (immune checkpoint inhibitor–related toxicities, systemic mastocytosis) are considered exceptions; all other uses are excluded.

For all indications, concomitant use of omalizumab with any other biologic drug or targeted synthetic drug for the same indication is not allowed. Prior authorization must confirm the member is not receiving another biologic or targeted synthetic therapy for the same condition before approval is granted.

Requests will be reviewed only when the member is not receiving any other biologic or targeted synthetic therapy for the same indication; concomitant therapy with another agent in these classes is not permitted and may lead to denial of the request.

Indications beyond the FDA‑approved uses and the specifically listed compendial uses are considered experimental/investigational and not medically necessary. The policy lists immune checkpoint inhibitor–related toxicities and systemic mastocytosis as accepted compendial uses; all other off‑label indications may be denied.

Key Diagnostic Thresholds & Codes

Food allergen-specific IgE / Skin-prick test — pre-treatment thresholds for food allergy

Pre-treatment food-specific IgE>= 6 IU/mL (confirming IgE‑mediated food allergy)

Skin-prick test (SPT)Wheal diameter >= 4 mm

Required clinical confirmationPositive physician‑controlled oral food challenge or history of systemic reaction to the food

Pre-treatment total serum IgE — threshold value used across indications

Pre-treatment total serum IgE>= 30 IU/mL

Asthma requirementPre-treatment IgE >= 30 IU/mL required for asthma initial authorization

Provider Actions & Documentation Requirements

Prior Authorization

Prior Authorization Confirmation

Prior Authorization Required — approval is required for covered indications. Requests for indications not listed (including compendial uses not specified) are considered experimental/investigational and may be denied.

Denial Risk

Experimental / Investigational Exclusions

Requests for indications not listed as covered (other than the specified FDA-approved indications and listed compendial uses) are considered experimental/investigational and are not medically necessary. Such requests may be denied.

Denial Risk

Concomitant Biologic/Targeted Therapy Restriction

For all indications, the member must not be receiving any other biologic or targeted synthetic agent for the same indication concurrently. Authorization may be denied if the member is using another biologic/targeted synthetic therapy for the same condition. Additionally, if the member is a current smoker or vaper, document counseling on harmful effects and available cessation options.

Definitions & Diagnostic Criteria

Omalizumab indications — age thresholds and indication list (asthma, CRSwNP, food allergy, CSU, compendial uses)

Age thresholdsAllergic asthma: >= 6 years; CRSwNP: >= 18 years; IgE‑mediated food allergy: >= 1 year; CSU: >= 12 years

Covered indicationsModerate‑to‑severe allergic asthma, chronic rhinosinusitis with nasal polyps, IgE‑mediated food allergy (to reduce reactions), chronic spontaneous urticaria

Compendial usesIncludes immune checkpoint inhibitor–related toxicities and systemic mastocytosis (per policy)

Major and minor diagnostic criteria for systemic mastocytosis — overview of WHO criteria

WHO diagnostic overviewSystemic mastocytosis diagnosis requires either the major criterion plus >=1 minor criterion, or >=3 minor criteria

Major criterion

Background

Omalizumab is a monoclonal antibody that binds circulating immunoglobulin E (IgE) and is used as an add‑on therapy for IgE‑driven allergic conditions. It is indicated for moderate‑to‑severe allergic asthma in patients aged >= 6 years, for chronic rhinosinusitis with nasal polyps in adults, for chronic spontaneous urticaria in patients aged >= 12 years, and for reduction of reactions from IgE‑mediated food allergy in patients aged >= 1 year. It is not intended for acute rescue treatment such as anaphylaxis or acute bronchospasm.

Revision History

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOmalizumab (Xolair/Omlyclo) coverage for allergic and IgE-mediated conditions

Policy CodePolicy 1656-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and submit required documentation including prior medication trials and pre-treatment IgE or allergen testing as applicable.

SourceLink

On This Page

Food allergy requirementPre-treatment serum total IgE >= 30 IU/mL required for food allergy initial authorization

Nasal polyp score — Endoscopic nasal polyp score threshold and alternatives

Endoscopic nasal polyp score (NPS)Total endoscopic NPS >= 5 with minimum score of 2 per nostril

Alternative Meltzer scoreMeltzer Clinical Score >= 2 in both nostrils

Endoscopy/CT findingPolyps reaching below the lower border of the middle turbinate or beyond in each nostril on endoscopy/CT

Baseline serum tryptase — threshold for systemic mastocytosis minor criterion

Baseline serum tryptase criterion> 20 ng/mL (WHO minor biochemical criterion)

Adjustment noteTryptase level could be adjusted in the case of known hereditary alpha‑tryptasemia (H α T)

ContextApplies in absence of an associated myeloid neoplasm per WHO guidance

Mast cell aggregate size — WHO major criterion threshold

Mast cell aggregate threshold>= 15 mast cells in multifocal dense aggregates (WHO major criterion)

Tissue sitesDetected in bone marrow and/or other extracutaneous organs on sectioned specimens

RoleDefines the WHO major diagnostic criterion for systemic mastocytosis

Atypical mast cell proportion — WHO minor morphologic criterion threshold

Atypical mast cell proportion> 25% of all mast cells showing spindle or immature morphology (WHO minor morphologic criterion)

Assessment methodDetermined on bone marrow smears or in other extracutaneous organ specimens

Morphologic featuresIncludes spindle shape or immature mast cell morphology

Documentation Required

Initial Request Documentation

Initial request documentation must include relevant chart notes/medical records as described below. Where applicable include pre-treatment laboratory or testing (e.g., total or specific IgE, skin-prick test, CT/endoscopy findings, physician‑controlled oral food challenge) and documentation of prior medication trials with drug name, dose, frequency, duration, or clinical rationale for not using listed therapies.

Pre-treatment IgE and/or allergen-specific IgE (where applicable)
Skin-prick test results or physician-controlled oral food challenge (where applicable)
Nasal endoscopy/anterior rhinoscopy/CT details, Meltzer Clinical Score or endoscopic nasal polyp score (where applicable)
Chart notes or claims history documenting prior medication trials: drug, dose, frequency, duration, and response; or rationale for avoiding therapy

Documentation Required

Continuation Request Documentation

Continuation requests must include chart notes or medical record documentation demonstrating clinical improvement or a positive response to therapy appropriate to the indication (examples: improved asthma control or reduced exacerbations; decreased nasal polyp size or symptoms; reduced hypersensitivity reactions to food allergens; improvement in urticaria activity scores; or low disease activity for systemic mastocytosis).

Evidence of improved control or positive clinical response specific to the indication (e.g., symptom reduction, decreased exacerbations, improved objective scores)
Ongoing use of required background therapies where applicable (e.g., maintenance inhaled corticosteroid and controller for asthma; daily intranasal corticosteroid for CRSwNP; food‑allergen avoidance diet for food allergy)

Note

Prescriber Specialty Requirements

Prescriber specialty requirements vary by indication. Ensure the medication is prescribed by or in consultation with the required specialist listed below.

Asthma: allergist/immunologist or pulmonologist
CRSwNP: allergist/immunologist or otolaryngologist
IgE‑mediated food allergy: allergist/immunologist
Chronic spontaneous urticaria: allergist/immunologist or dermatologist
Immune checkpoint inhibitor‑related toxicity: dermatologist, hematologist, or oncologist

Step Therapy

Step Therapy / Prior Medication Requirements

Step therapy and prior medication requirements must be met prior to approval for certain indications. Examples include: for asthma and chronic spontaneous urticaria, members must have trialed and had inadequate control on recommended prior therapies or have documented rationale for avoiding them. Specific indication criteria (age limits, diagnostic testing, pre‑treatment IgE thresholds, and prior biologic use history) must be met as outlined in the indication-specific criteria.

Asthma: optimized inhaled corticosteroid plus an additional controller at adequate doses and documented inadequate control; peri‑allergen sensitization and pre‑treatment IgE ≥30 IU/mL
Chronic spontaneous urticaria: trial of up‑dosed second‑generation H1 antihistamine for at least 2 weeks and evaluation for other causes
Authorization duration and prior biologic history (e.g., prior biologic within past year may affect initial authorization length)

Multifocal, dense infiltrates of mast cells (>=15 mast cells in aggregates) in bone marrow and/or other extracutaneous organs

Minor criteria listAtypical mast cell morphology >25%; KIT p.D816V or other activating KIT mutation; aberrant expression of CD2/CD25/CD30; baseline serum tryptase >20 ng/mL

WHO Major Criterion for Systemic Mastocytosis — mast cell aggregate threshold

WHO Major CriterionMultifocal, dense infiltrates of mast cells with at least 15 mast cells in aggregates detected in sections of bone marrow and/or other extracutaneous organs

Finding locationDetected on sectioned bone marrow or extracutaneous organ specimens

SignificanceRepresents the single major histopathologic criterion for systemic mastocytosis per 2024 WHO guidance

WHO Minor Morphologic Criterion — atypical mast cell proportion threshold

WHO Minor Morphologic Criterion> 25% atypical (spindle or immature) mast cell morphology among all mast cells on bone marrow smears or extracutaneous organs

Morphology examplesSpindle shape or immature appearance

Specimen typesAssessed on bone marrow smears or other extracutaneous organ samples

WHO Minor Molecular Criterion — KIT p.D816V or other activating KIT mutation requirement

WHO Minor Molecular CriterionDetection of KIT p.D816V mutation or other activating KIT mutation(s) in peripheral blood, bone marrow, or other extracutaneous organ(s)

Test sitesPeripheral blood, bone marrow, or extracutaneous organ specimens may be used

RoleOne of the WHO minor criteria; contributes to diagnosis when combined with other criteria

WHO Minor Immunophenotypic Criterion — aberrant CD2/CD25/CD30 expression

WHO Minor Immunophenotypic CriterionMast cells aberrantly express one or more antigens: CD2, CD25, or CD30

AssessmentDetermined by immunophenotyping of mast cells in bone marrow or other involved tissues

Diagnostic roleCounts as one minor criterion toward diagnosis of systemic mastocytosis

WHO Minor Biochemical Criterion — baseline serum tryptase threshold and adjustment note

WHO Minor Biochemical CriterionBaseline serum tryptase > 20 ng/mL (in absence of an associated myeloid neoplasm)

Adjustment for H α TTryptase level could be adjusted in the case of known hereditary alpha‑tryptasemia (H α T)

Diagnostic contributionCounts as one minor criterion; combined with other criteria per WHO to establish diagnosis