ModifiedmhnPolicy CP.PHAR.01

Omalizumab (Xolair) and Omalizumab-igec (Omlyclo) Coverage Policy

Clinical coverage policy for omalizumab (Xolair) and omalizumab-igec (Omlyclo) for Medicaid line of business, describing indications, prior authorization criteria, continued therapy, dosing limits, and prescriber requirements.

Policy Summary

Payermhn (Medicaid)

PolicyOmalizumab (Xolair) and Omalizumab-igec (Omlyclo) Coverage Policy

Policy CodePolicy CP.PHAR.01

Change TypeMaterial updates (new food allergy indication, biosimilar added, dosing/criteria revisions)

Effective Date10.01.08

Next Review Date

Key ActionSubmit prior authorization with documentation demonstrating diagnosis, age, required biomarkers (including pre-treatment IgE), weight, prior therapy trials, and adherence where applicable.

SourceLink

POLICY UPDATE CHANGES

1Q2025: For asthma initial approval criteria, added allowance for ER visit and removed intubation option; for immune checkpoint inhibitor-related severe pruritus, added requirement for no response to 1 month of gabapentinoid therapy per NCCN.

Added newly approved biosimilar Omlyclo and HCPCS code Q5154.

Added new FDA-labeled indication of IgE-mediated food allergy and moved immunotherapy-related pruritus appendix information to Appendix I.

Added off-label indications and criteria for systemic mastocytosis and immunotherapy-related pruritus per NCCN; updated formulations to include strengths of prefilled syringe and autoinjectors.

RT4: FDA labeled indication revised from 'nasal polyps' to 'CRSwNP' per updated prescribing information.

Defined adherence for asthma continuation criteria as PDC of 0.8.

6 monthsInitial approval duration

12 monthsContinued therapy duration

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≥6Minimum age (asthma)

≥1Minimum age (food allergy)

Listed biologicsConcurrent biologic exclusions

J2357, Q5154HCPCS codes

Coverage Criteria for Omalizumab / Omlyclo

Initial Therapy - Moderate to Severe Persistent Asthma

Covered when ALL of the following are met

Asthma initial criteria: 1. Diagnosis of asthma; 2. Age >= 6 years; 3. Member has experienced >= 2 exacerbations within the last 12 months requiring either (a) oral/systemic corticosteroid treatment (or increase in dose if already on oral corticosteroid) OR (b) urgent care/ER visit or hospital admission despite adherent controller therapy (medium- to high-dose ICS plus either a LABA or LTRA if LABA contraindicated/intolerant); 4. Positive skin test or in vitro reactivity to a perennial aeroallergen; 5. Total serum IgE >= 30 IU/mL; 6. Omalizumab/Omlyclo prescribed concurrently with an ICS plus either a LABA or LTRA; 7. Not prescribed concurrently with Cinqair, Fasenra, Nucala, Dupixent, or Tezspire; 8. Dose does not exceed 375 mg every 2 weeks;

Approval duration: 6 months

Initial Therapy - Chronic Spontaneous Urticaria

Covered when ALL of the following are met

CSU initial criteria: 1. Diagnosis of chronic spontaneous urticaria (CSU); 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. Not prescribed concurrently with Cinqair, Fasenra, Nucala, Dupixent, or Tezspire; 5. Dose does not exceed 300 mg every 4 weeks;

Approval duration: 6 months

Initial Therapy - CRSwNP

Covered when ALL of the following are met

CRSwNP initial criteria: 1. Diagnosis of CRSwNP with documentation of (a) presence of nasal polyps AND (b) signs/symptoms for >= 12 weeks; 2. Prescribed by or in consultation with an allergist, immunologist, or otolaryngologist; 3. Age >= 18 years; 4. Prescribed concurrently with an intranasal corticosteroid unless contraindicated; 5. Not prescribed concurrently with Cinqair, Fasenra, Nucala, Dupixent, or Tezspire; 6. Dose does not exceed 600 mg every 2 weeks;

Approval duration: 6 months

Initial Therapy - IgE-Mediated Food Allergy

Covered when ALL of the following are met

Food allergy initial criteria: 1. Diagnosis of IgE-mediated food allergy; 2. Prescribed by or in consultation with an allergist or immunologist; 3. Age >= 1 year; 4. Confirmation by one of: (a) positive skin prick test with wheal >= 4 mm greater than control; (b) food-specific serum IgE >= 6 kUA/L; or (c) positive oral food challenge; 5. History of significant allergic reaction to the food such that prescriber deemed past reaction significant enough to require a prescription for injectable epinephrine AND omalizumab/Omlyclo is prescribed concurrently with injectable epinephrine; 6. Medical justification supports necessity despite food avoidance (e.g., inability to reliably avoid allergen); 7. Not prescribed concurrently with Palforzia, Cinqair, Fasenra, Nucala, Dupixent, or Tezspire; 8. Dose does not exceed 600 mg every 2 weeks;

Approval duration: 6 months

Initial Therapy - NCCN Compendium Indications

Covered when ALL of the following are met

NCCN off-label initial criteria: 1. Diagnosis of systemic mastocytosis OR immune checkpoint inhibitor-related severe (G3) pruritus; 2. Prescribed by or in consultation with an oncologist; 3. For systemic mastocytosis, use limited to specified settings including stepwise prophylactic treatment after trials of antihistamine and corticosteroid, prevention of unprovoked anaphylaxis, prevention of hymenoptera or food-induced anaphylaxis with negative specific IgE or skin test, or to improve tolerability of immunotherapy; 4. For ICI-related severe pruritus: pruritus refractory, increased IgE level, and failed gabapentinoid after 1 month of therapy; 5. Not prescribed concurrently with Cinqair, Fasenra, Nucala, Dupixent, or Tezspire; 6. Dose is within FDA maximum for any FDA-approved indication or supported by practice guidelines/peer-reviewed literature for the off-label use (prescriber must submit supporting evidence);

Prescribed regimen must be FDA-approved or recommended by NCCN; Approval duration: 6 months

Continued Therapy - Asthma

Continued therapy covered when ALL of the following are met

Asthma continued criteria: 1. Member currently receiving medication via Centene benefit or previously met initial approval criteria, or continuity of care applies; 2. Demonstrated adherence to asthma controller therapy evidenced by PDC >= 0.8 in the last 6 months (at least 5 of the last 6 months); 3. Member is responding positively to therapy (examples: reduced exacerbations or corticosteroid dose, improved FEV1, reduced rescue therapy); 4. 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;

Approval duration: 12 months

Continued Therapy - CSU

Continued therapy covered when ALL of the following are met

CSU continued criteria: 1. Member currently receiving medication via Centene benefit or previously met initial approval criteria, or continuity of care applies; 2. Member is responding positively to therapy; 3. 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

Continued Therapy - CRSwNP

Continued therapy covered when ALL of the following are met

CRSwNP continued criteria: 1. Member currently receiving medication via Centene benefit or previously met initial approval criteria, or continuity of care applies; 2. Demonstrated adherence to an intranasal corticosteroid unless contraindicated; 3. Member is responding positively to therapy (examples: reduced nasal polyp size, reduced need for systemic corticosteroids, improved sense of smell, improved quality of life); 4. 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;

Approval duration: 12 months

Continued Therapy - IgE-Mediated Food Allergy

Continued therapy covered when ALL of the following are met

Food allergy continued criteria: 1. Member currently receiving medication via Centene benefit or previously met initial approval criteria, or continuity of care applies; 2. Member is responding positively to therapy; 3. Omalizumab/Omlyclo is prescribed concurrently with injectable epinephrine; 4. Not prescribed concurrently with Palforzia, Cinqair, Fasenra, Nucala, Dupixent, or Tezspire; 5. If request is for a dose increase, new dose does not exceed 600 mg every 2 weeks;

Approval duration: 12 months

Continued Therapy - NCCN Indications

Continued therapy covered when ALL of the following are met

NCCN continued criteria: 1. Currently receiving medication via Centene benefit or documentation supports current use for a covered indication with at least 30 days of therapy; 2. Member is responding positively to therapy; 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);

Approval duration: 6 months

General coverage criteria and exclusions

Covered when criteria in relevant sections are met; dose increases and off‑label uses have specified requirements.

Coverage permitted indications: Includes FDA-approved indications and off-label uses supported per off-label policy CP.PMN.53 or evidence of coverage; specific approvals and dosing are in other sections of the policy.

See dosing tables for asthma by age and pre-treatment IgE/weight

Dose increase requirement: If request is for a dose increase, the new dose must be within the FDA maximum limit for any FDA-approved indication OR be supported by practice guidelines or peer-reviewed literature for relevant off-label use; prescriber must submit supporting evidence; prescribed regimen must be FDA-approved or recommended by NCCN.

Approval duration: 6 months

Not authorized conditions: Non-FDA approved indications not addressed in this policy without sufficient off-label documentation and acute bronchospasm or status asthmaticus are excluded from coverage.

Refer to CP.PMN.53 for off-label documentation requirements

Dose selection criteria

Covered when ALL of the following are met

Insufficient data: Some IgE/weight combinations are marked 'Insufficient Data to Recommend a Dose' or '*' — dosing is not recommended/undefined for those cells.

Manufacturer recommends dose adjustments for significant weight changes during treatment.

Indication-specific dosing summaries

Dosing and indication summaries (as presented):

Asthma dosing: Dosing regimen: 75 to 375 mg subcutaneously every 2 or 4 weeks based on serum total IgE measured before start of treatment and body weight; adjust doses for significant weight changes; maximum dose 375 mg every 2 weeks.IgE + body weight based

Manufacturer weight/IgE tables provided in appendices.

Chronic spontaneous urticaria (CSU): Dosing regimen: 150 mg or 300 mg subcutaneously every 4 weeks; maximum dose 300 mg every 4 weeks; do not administer more than 150 mg per injection site (divide larger doses).none

Injection site limit specified by manufacturer.

CRSwNP dosing: Dosing regimen: 75 to 600 mg subcutaneously every 2 or 4 weeks based on serum total IgE measured before start of treatment and body weight; adjust for weight changes; maximum dose 600 mg every 2 weeks.

Highlighted updated criteria

Policy criteria have been updated per indication; highlights below reflect changes recorded in this portion of the document.

CRSwNP intranasal steroid trial: One prior intranasal steroid trial is required and one of the tried intranasal steroids must be Xhance; trial duration was changed from 8 weeks to 4 weeks.4 weeks

Per 2021 consensus panel.

Asthma adherence for continuation: For asthma continuation criteria, adherence is defined as PDC >= 0.8 (at least 5 of the last 6 months).PDC >= 0.8

Added 1Q2022.

Asthma initial approval modification: Initial approval criteria were modified to allow ER visit as a qualifying exacerbation event and removed intubation option (hospital admission encompasses intubation).

1Q2025 review.

Omalizumab (Xolair) and its biosimilar Omlyclo are not indicated for the relief of acute bronchospasm or status asthmaticus, for treatment of other forms of urticaria beyond chronic spontaneous urticaria (CSU), or for emergency treatment of allergic reactions including anaphylaxis. Requests for these acute/emergent situations will not meet coverage criteria under this policy.

Non‑FDA approved (off‑label) uses are not covered by default. Such requests will be denied unless the prescriber submits sufficient documentation of efficacy and safety consistent with the Health Plan off‑label use policy (CP.PMN.53) or evidence of coverage. The policy was updated to add certain NCCN‑listed uses (e.g., systemic mastocytosis, immunotherapy‑related pruritus) with specified criteria; other off‑label indications remain subject to the off‑label documentation requirements.

Certain cells in the manufacturer dosing tables are marked with an asterisk or explicitly labeled as "Insufficient data to recommend a dose". Those IgE/weight combinations lack manufacturer‑provided dosing guidance and therefore dosing is not recommended for those specific combinations without additional supporting evidence.

Per the prescribing information, Xolair and Omlyclo are not approved for use in patients weighing more than 150 kg. Dosing determinations and coverage assessments should account for this weight limit.

Concurrent use of omalizumab/omalizumab‑igec with other biologic agents is prohibited under this policy. Requests that document concomitant therapy with listed agents (for example Cinqair, Fasenra, Nucala, Dupixent, Tezspire) will be ineligible for coverage. The policy history reflects additions to the list of excluded concurrent biologics (e.g., Tezspire) and reiterates that such combinations are contraindicated for approval.

Explicit concurrent‑use exclusions include Cinqair, Fasenra, Nucala, Dupixent, Tezspire; for the IgE‑mediated food allergy indication concurrent use with Palforzia is also excluded. Any request that shows concurrent prescription with these agents will be considered not authorized under this policy.

Uses that are non‑FDA approved and not supported by the required off‑label documentation will be considered not authorized (not medically necessary) under this policy. Providers should follow CP.PMN.53 for off‑label evidence requirements when requesting coverage for non‑labeled indications.

An asterisk or the explicit phrase "Insufficient data to recommend a dose" on the dosing tables indicates the manufacturer has not provided dosing guidance for that specific IgE/weight combination. Such markings mean a recommended dose is undefined for that cell and dosing should not be selected from that cell without additional supporting evidence.

Listed HCPCS/CPT codes in this policy are provided for informational purposes only. Inclusion or exclusion of codes does not guarantee coverage; providers should reference current professional coding guidance and the Health Plan prior to claim submission.

The policy reiterates that concurrent use with newly identified agents (for example Tezspire) remains prohibited. Any request documenting simultaneous therapy with these updated agents will be ineligible for approval under the concurrent‑use exclusion.

Coding, Biomarkers, and Dose Limits

Referenced HCPCS codesHCPCS

J2357	Injection, omalizumab, 5 mg.
Q5154	Injection, omalizumab-igec (omlyclo), biosimilar, 5 mg.

HCPCS additionsHCPCS

Q5154

HCPCS code added for biosimilar Omlyclo

inv-27: Total IgE for asthma — biomarker threshold

ThresholdTotal serum IgE ≥ 30 IU/mL required for asthma initial approval

Use in dosingPre-treatment total IgE is used with body weight to select omalizumab dose from dosing tables

UnitIU/mL (reported as total serum IgE)

inv-28: Food-specific serum IgE — biomarker threshold for food allergy indication

ThresholdFood-specific serum IgE ≥ 6 kUA/L qualifies as confirmation for IgE‑mediated food allergy

Alternative confirmationsPositive skin prick test ≥ 4 mm over control or positive oral food challenge may also confirm diagnosis

Provider Requirements, Documentation, and Prior Authorization

Documentation Required

Initial approval requirements and required documentation

Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that the member has met all approval criteria. Initial approval requests require documentation listed under the specific indication (e.g., asthma exacerbation history, positive skin test or in vitro reactivity, baseline IgE, body weight, prior therapy trials). Missing required documentation (office notes, labs, prior trial records, pre-treatment IgE, weight, age/indication) may trigger denial or delay.

Office/clinic notes documenting diagnosis and clinical course
Relevant labs (pre-treatment serum total IgE) and body weight
Documentation of prior therapy trials and durations per indication

Prior Authorization

Dose increase prior authorization and recent label change documentation

If the request is for a dose increase, prescriber must provide supporting evidence that the new dose is within the FDA maximum for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use. For recent label changes or new dosing regimens not yet reflected in this policy, follow the formulary/off‑formulary or off‑label policies as directed and submit supporting documentation.

Background and Indication Overview

Omalizumab (Xolair) and the biosimilar omalizumab‑igec (Omlyclo) are monoclonal antibodies that bind circulating immunoglobulin E (IgE), preventing IgE from attaching to receptors on mast cells and basophils and thereby reducing IgE‑mediated allergic responses. They are FDA‑labeled for multiple IgE‑mediated indications including moderate to severe persistent asthma (age ≥ 6 years), chronic spontaneous urticaria (age ≥ 12 years), CRSwNP (age ≥ 18 years), and reduction of allergic reactions in IgE‑mediated food allergy (age ≥ 1 year). Dosing is determined by pre‑treatment total serum IgE and body weight, and maximum dose limits differ by indication (e.g., asthma up to 375 mg every 2 weeks; CSU up to 300 mg every 4 weeks; CRSwNP and food allergy up to 600 mg every 2 weeks).

Key Definitions and Terms

inv-56: Omalizumab / Omalizumab-igec — product definition

DefinitionOmalizumab (Xolair) and omalizumab‑igec (Omlyclo) are anti‑immunoglobulin E (IgE) monoclonal antibodies

ProductsXolair (omalizumab) and biosimilar Omlyclo (omalizumab‑igec)

Primary actionUsed to reduce IgE‑mediated allergic responses across labeled indications

inv-57: Limitation(s) of use — not for acute bronchospasm or status asthmaticus etc.

Not indicated for emergenciesNot for relief of acute bronchospasm or status asthmaticus or emergency treatment of allergic reactions including anaphylaxis

Concurrent biologicsNot to be prescribed concurrently with certain biologics (e.g., Cinqair, Fasenra, Nucala, Dupixent, Tezspire) per policy exclusions

Policy Summary

Payermhn (Medicaid)

PolicyOmalizumab (Xolair) and Omalizumab-igec (Omlyclo) Coverage Policy

Policy CodePolicy CP.PHAR.01

Change TypeMaterial updates (new food allergy indication, biosimilar added, dosing/criteria revisions)

Effective Date10.01.08

Next Review Date

Key ActionSubmit prior authorization with documentation demonstrating diagnosis, age, required biomarkers (including pre-treatment IgE), weight, prior therapy trials, and adherence where applicable.

SourceLink

On This Page

IgE + body weight based

Per dosing appendices.

IgE-mediated food allergy dosing: Dosing regimen: 75 to 600 mg subcutaneously every 2 or 4 weeks based on serum total IgE measured before start of treatment and body weight; adjust for weight changes; maximum dose 600 mg every 2 weeks.IgE + body weight based

New FDA-labeled indication; dosing per appendices.

Immune checkpoint inhibitor-related severe pruritus: Require no response to 1 month of gabapentinoid therapy per NCCN prior to approval for ICI-related severe (G3) pruritus.1 month

1Q2025 update.

CSU prior therapy: Trial redirection requirement modified to require only one antihistamine trial at maximum indicated doses for CSU initial approval.

1Q2023 update.

ContextUsed as one criterion among others (age ≥ 1 year, prescriber specialty, concurrent epinephrine prescription)

inv-29: Skin prick test wheal — diagnostic threshold

ThresholdSkin prick test wheal ≥ 4 mm greater than control qualifies as confirmation for IgE‑mediated food allergy

Alternative confirmationsFood-specific serum IgE ≥ 6 kUA/L or positive oral food challenge acceptable alternatives

UseAccepted as diagnostic confirmation when prescribing omalizumab for food allergy indication

inv-30: Asthma exacerbations in prior 12 months — required history threshold

Threshold≥ 2 asthma exacerbations in the prior 12 months required for initial asthma approval

Qualifying eventsExacerbations defined as requiring (a) oral/systemic corticosteroid treatment (or dose increase) OR (b) urgent care/ER visit or hospital admission

ContextMust occur despite adherent controller therapy (medium‑ to high‑dose ICS plus LABA or LTRA)

inv-31: Proportion of days covered (PDC) for controller therapy — adherence metric

ThresholdProportion of days covered (PDC) ≥ 0.8 over the last 6 months (i.e., controller therapy for at least 5 of last 6 months)

Applies toDemonstrated adherence to an ICS plus either LABA or LTRA for continued asthma therapy

Measurement periodLast 6 months (documented PDC)

inv-32: Maximum dose by indication — listed maxima for indications

Asthma maximumMaximum dose for asthma: 375 mg every 2 weeks

CSU maximumMaximum dose for chronic spontaneous urticaria (CSU): 300 mg every 4 weeks

CRSwNP & Food Allergy maximumMaximum dose for CRSwNP and IgE‑mediated food allergy: 600 mg every 2 weeks

inv-33: Adherence threshold (PDC) — reiterated policy threshold

Adherence threshold (PDC)PDC of 0.8 (defined for asthma continuation criteria)

OperationalizationInterpreted as at least 5 of the last 6 months of controller therapy

DocumentationProviders must submit evidence (e.g., pharmacy fills/chart notes) supporting PDC calculation

Submit literature/guideline support or FDA labeling for dose increases
If a drug label changed within the last 6 months, refer to CP.PMN.255, CP.PMN.16, or CP.PMN.53 as applicable

Billing Rule

Prior authorization updates and affected codes

PA and coding updates: the biosimilar Omlyclo was added and corresponding HCPCS code Q5154 was created. Inclusion or exclusion of codes does not guarantee payment — providers should verify current professional coding guidance prior to claim submission.

New HCPCS: Q5154 — Injection, omalizumab-igec (omlyclo), 5 mg
Existing HCPCS: J2357 — Injection, omalizumab, 5 mg

Billing Rule

Prior authorization and coding note

Prior authorization is required for Xolair and Omlyclo. Note that Q5154 was added for the Omlyclo biosimilar; coding listed in this policy is informational only and does not guarantee coverage.

PA required for Xolair and Omlyclo
Q5154 added for Omlyclo — verify code use on claims

Denial Risk

Concurrent biologic therapy exclusion

Concurrent prescribing of listed biologics will preclude coverage. Requests that show concurrent use with excluded agents will be denied.

Not authorized concurrently with: Cinqair, Fasenra, Nucala, Dupixent, Tezspire
Also not authorized concurrently with Palforzia (for food allergy) where listed

Denial Risk

Dose‑table mismatch risk and verification

Dose-table mismatch risk: reviewers should confirm that prescribed dose/frequency aligns with the dosing tables for the member's age, indication, pre-treatment IgE, and body weight. Mismatch between prescribed dose and the appropriate dosing table may prompt clarification or denial.

Ensure dosing is based on pre-treatment IgE and body weight
Do not exceed indication-specific maximum doses (e.g., asthma 375 mg/2 weeks; CSU 300 mg/4 weeks; CRSwNP 600 mg/2 weeks)

Documentation Required

Required dose‑selection and dosing documentation

Required dose‑selection documentation: prescribers must provide pre-treatment serum total IgE, current body weight, patient age and indication to support dose selection. Adjustments for significant weight changes during treatment should be documented.

Pre-treatment serum total IgE (IU/mL)
Body weight (kg) at treatment start and documentation of significant weight changes
Age and specific indication for dosing table selection

Step Therapy

Step therapy for systemic mastocytosis (NCCN-listed)

Step therapy for systemic mastocytosis (NCCN-listed): for systemic mastocytosis, omalizumab may be used as stepwise prophylactic treatment when the member has tried both an antihistamine (H1 or H2) and a corticosteroid unless contraindicated; documentation of prior trials or contraindications is required.

Document trial of antihistamine (H1 and/or H2) and corticosteroid unless contraindicated
Prescriber must be an oncologist or in consultation with one for NCCN indications

Note

Historical step therapy and template changes

Historical step therapy/template changes: policy history includes removal of some specialist prescriber requirements, modification of CSU trial requirements to a single antihistamine trial, and additions of new indications (e.g., CRSwNP, IgE‑mediated food allergy) and biosimilar Omlyclo. Review prior revisions when interpreting prior authorizations that span change dates.

Template changes applied to continued therapy and other indications in 2022–2024
RT4 updates added IgE‑mediated food allergy and NCCN off‑label indications in 2024

Step Therapy

Step therapy and required prior trials

Step therapy / required prior trials by indication: document required prior therapies per indication (e.g., asthma — adherent use of medium‑ to high‑dose ICS plus LABA or LTRA; CSU — failure of one antihistamine at maximum indicated doses for ≥ 2 weeks unless contraindicated; CRSwNP — concurrent intranasal corticosteroid trial, with Xhance specified where applicable).

Asthma: adherence to ICS + LABA (or LTRA if LABA contraindicated) and ≥2 exacerbations in last 12 months
CSU: failure of one antihistamine at max dose for ≥2 weeks (or contraindication/adverse effects)
CRSwNP: trial of an intranasal corticosteroid (one specified agent may be Xhance) prior to approval

Non‑FDA usesNon‑FDA approved indications without sufficient off‑label documentation are not authorized

inv-58: CSU — definition of chronic spontaneous urticaria

DefinitionChronic spontaneous urticaria (CSU): spontaneous onset of wheals, angioedema, or both for more than 6 weeks due to an unknown cause

Clinical positioningOmalizumab is used after failure of H1 antihistamine therapy per stepwise specialty guidance

Approved ageIndication applies to adults and adolescents ≥ 12 years per labeling

inv-59: Pre-treatment IgE — definition and units

Definition and unitsPre‑treatment IgE refers to total serum IgE measured before starting treatment, reported in IU/mL

Use in dosingPre‑treatment IgE is used with body weight to determine the appropriate omalizumab dosing cell

Documentation requirementRecord pre‑treatment IgE, patient weight, and age to support dose selection

inv-60: CRSwNP — definition

DefinitionCRSwNP: chronic rhinosinusitis with nasal polyps — labeled indication for adults ≥ 18 years with inadequate response to nasal corticosteroids

Dosing noteCRSwNP dosing is determined by pre‑treatment IgE and body weight; maximum 600 mg every 2 weeks

Prescriber guidancePrescribed by or in consultation with an allergist, immunologist, or otolaryngologist per initial criteria

inv-61: Immunotherapy-related pruritus — definition and appendix reference

DefinitionImmunotherapy‑related pruritus refers to pruritus associated with immune checkpoint inhibitor therapy; grading and agents described in Appendix I (G1–G3 per NCCN)

Approval conditionFor ICI‑related severe (G3) pruritus, NCCN requires failure of 1 month of gabapentinoid therapy prior to approval per policy update

PrescriberTypically managed with oncology consultation and documented per NCCN guidance

inv-62: PDC — definition of proportion of days covered adherence metric

DefinitionProportion of days covered (PDC): adherence metric defined in this policy as PDC ≥ 0.8 for asthma continuation criteria

InterpretationEquivalent to receiving controller therapy for at least 5 of the last 6 months

DocumentationPDC should be evidenced by pharmacy fills or chart documentation of controller therapy during the measurement period