CurrentmhnPolicy CP.PHAR.01

Omalizumab (Xolair) and biosimilar Omalizumab-igec (Omlyclo) coverage criteria

Clinical coverage policy for omalizumab and its biosimilar for Medicaid line of business. Defines medical necessity criteria for initial and continued therapy across FDA indications (asthma, CRSwNP, CSU, IgE-mediated food allergy), select off-label NCCN uses, dosing limits, contraindications and required documentation.

Policy Summary

Payermhn

PolicyOmalizumab (Xolair) and biosimilar Omalizumab-igec (Omlyclo) coverage criteria

Policy CodePolicy CP.PHAR.01

Change TypeMultiple updates (added indications, biosimilar, dosing/strengths, duration revisions)

Effective DateOct 1, 2008

Next Review DateN/A

Key ActionProvider must submit office notes, labs, or other clinical documentation demonstrating the member meets all approval criteria including diagnosis, objective testing, prior therapies, exacerbation history, IgE level, and adherence where applicable.

SourceLink

POLICY UPDATE CHANGES

Added coverage for moderate (G2) immune checkpoint inhibitor-related pruritus per NCCN and clarified IgE and refractory disease requirements for moderate pruritus.

Added newly approved biosimilar Omlyclo and HCPCS code Q5154 for omalizumab-igec.

For asthma initial approval criteria, allowance for ER visit added and intubation option removed (hospital admission encompasses intubation).

RT4: added FDA-labeled indication of IgE-mediated food allergy and moved immunotherapy-related pruritus information to Appendix I.

Added eosinophilic esophagitis as an indication not covered due to lack of demonstrated efficacy and guideline recommendation against use.

12 monthsStandard approval duration for approved indications

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Medical Necessity Criteria and Authorization Rules

Initial Approval Criteria — Moderate to Severe Persistent Asthma

Approved when ALL of the following are met:

ALL of the following

Diagnosis of asthma
Age ≥ 6 years
Exacerbation history and controller therapy
- Member has experienced ≥ 2 exacerbations within the last 12 months requiring either systemic corticosteroid treatment/increase OR urgent care/ER visit or hospital admission
Positive skin test OR in vitro reactivity to a perennial aeroallergen
Total serum IgE level ≥ 30 IU/mL
Omalizumab is prescribed concurrently with an ICS plus either a LABA or LTRA
Not prescribed concurrently with Cinqair, Fasenra, Nucala, Dupixent, or Tezspire
Dose does not exceed 375 mg every 2 weeks
See Appendix E and F for dosing tables by pretreatment IgE, weight, and age

(Approval duration: 12 months)

Initial Approval Criteria — Chronic Spontaneous Urticaria (CSU)

Approved when ALL of the following are met:

ALL of the following

Diagnosis of CSU (chronic idiopathic urticaria)
Age ≥ 12 years
Failure of one antihistamine at maximum indicated doses used for ≥ 2 weeks, unless adverse effects or contraindication
Not prescribed concurrently with Cinqair, Fasenra, Nucala, Dupixent, or Tezspire
Dose does not exceed 300 mg every 4 weeks
Maximum dose 300 mg every 4 weeks

Initial Approval Criteria — Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Approved when ALL of the following are met:

ALL of the following

Diagnosis of CRSwNP with documentation of presence of nasal polyps
Symptoms (e.g., nasal congestion/obstruction, loss of smell, rhinorrhea) present for ≥ 12 weeks
Prescribed by or in consultation with an allergist, immunologist, or otolaryngologist
Age ≥ 18 years
Prescribed concurrently with an intranasal corticosteroid unless contraindicated or significant adverse effects are experienced

Initial Approval Criteria — IgE-Mediated Food Allergy

Approved when ALL of the following are met:

ALL of the following

Diagnosis of IgE-mediated food allergy
Prescribed by or in consultation with an allergist or immunologist
Age ≥ 1 year
Objective confirmation (one required)
- Positive skin prick test with wheal diameter ≥ 4 mm greater than control
- Food-specific serum IgE ≥ 6 kUA/L

Initial Approval Criteria — NCCN Compendium Indications (selected off-label)

Approved (off-label) when ALL of the following are met:

ALL of the following

Diagnosis (one required)
- Systemic mastocytosis
- Immune checkpoint inhibitor–related moderate or severe (G2 or G3) pruritus (see Appendix I)
Prescribed by or in consultation with an oncologist
For systemic mastocytosis one of the following settings is required
- Stepwise prophylactic treatment for chronic mast cell mediator-related cardiovascular and pulmonary symptoms after trial of antihistamine (H1/H2) and corticosteroid unless contraindicated

Initial Approval Criteria — Other diagnoses/indications

If use is not listed above, follow one of the two items below:

ANY of the following

If drug had recent label change not yet reflected in policy, follow no-coverage or non-formulary policies CP.PMN.255 or CP.PMN.16 as applicable
If requested use is not listed under section III (not-authorized) and recent label change does not apply, refer to the off-label policy CP.PMN.53

Continued Therapy Criteria — General pattern

For each indication continued therapy approval requires ALL listed criteria (specifics vary by indication):

ALL of the following

Member is currently receiving medication via Centene benefit or previously met initial approval criteria OR member is in a continuity-of-care situation per state/product addendum
Member is responding positively to therapy (examples provided per indication)
Not prescribed concurrently with Cinqair, Fasenra, Nucala, Dupixent, or Tezspire
If request is for dose increase, new dose must not exceed indication-specific maximums or must be supported per off-label guidance

Continued Therapy — Asthma (additional requirement)

All of the following must be met for continued asthma approval:

ALL of the following

Demonstrated adherence to asthma controller therapy as evidenced by proportion of days covered (PDC) ≥ 0.8 in last 6 months (i.e., at least 144 of last 180 days)
Member is responding positively to therapy (examples: reduction in exacerbations or steroid dose, improvement in FEV1 since baseline, reduced rescue therapy use)
Dose increase does not exceed 375 mg every 2 weeks

Continued Therapy — CSU

All of the following must be met:

ALL of the following

Member currently receiving medication via Centene benefit or previously met initial approval criteria OR is in continuity-of-care situation
Member is responding positively to therapy
Dose increase does not exceed 300 mg every 4 weeks

Continued Therapy — CRSwNP

All of the following must be met:

ALL of the following

Member currently receiving medication via Centene benefit or previously met initial approval criteria OR is in continuity-of-care situation
Demonstrated adherence to intranasal corticosteroid unless contraindicated
Member is responding positively to therapy (examples: reduced polyp size, reduced systemic steroid need, improved smell or QoL)
Dose increase does not exceed 600 mg every 2 weeks

Continued Therapy — IgE-mediated Food Allergy

All of the following must be met:

ALL of the following

Member currently receiving medication via Centene benefit or previously met initial approval criteria OR is in continuity-of-care situation
Member is responding positively to therapy
Omalizumab is prescribed concurrently with injectable epinephrine
Dose increase does not exceed 600 mg every 2 weeks

Continued Therapy — NCCN/off-label indications

All of the following must be met:

ALL of the following

Member currently receiving medication via Centene benefit or has documentation of receiving omalizumab for a covered indication for at least 30 days
Member is responding positively to therapy
Dose increase must be within FDA maximum limit for any FDA-approved indication OR supported by practice guidelines / peer-reviewed literature with prescriber submission of supporting evidence

Not Authorized / Exclusions

Coverage is NOT authorized for the following diagnoses/indications:

ALL of the following

Non-FDA approved indications not addressed in this policy unless sufficient documentation per off-label policy (CP.PMN.53) or evidence of coverage is provided
Acute bronchospasm or status asthmaticus
Eosinophilic esophagitis

Dosing — Asthma

Dosing determined by pre-treatment serum total IgE (IU/mL) and body weight (kg); adjust for significant weight changes during treatment.

ALL of the following

Dose range 75 to 375 mg subcutaneously every 2 or 4 weeks based on serum total IgE level measured before start of treatment and body weight.
Maximum dose 375 mg every 2 weeks. Do not administer >150 mg per injection site; split doses >150 mg across sites.

Dosing — Chronic Spontaneous Urticaria (CSU)

Standard CSU dosing and limits

ALL of the following

150 mg or 300 mg subcutaneously every 4 weeks.
Maximum dose 300 mg every 4 weeks.

Dosing — Chronic rhinosinusitis with nasal polyposis (CRSwNP)

Dosing determined by pre-treatment serum total IgE and body weight

ALL of the following

Dose range 75 to 600 mg subcutaneously every 2 or 4 weeks based on pre-treatment serum total IgE and body weight.
Maximum dose 600 mg every 2 weeks; adjust doses for significant changes in body weight during treatment.

Dosing — IgE-mediated food allergy (age ≥1 year)

Manufacturer/label-based dosing table by pre-treatment total IgE and body weight (appendix)

ALL of the following

Dose range 75 to 600 mg subcutaneously every 2 or 4 weeks based on pre-treatment serum total IgE and body weight.
Maximum dose 600 mg every 2 weeks. Manufacturer recommends dose adjustments for significant body weight changes during treatment.
Appendix H contains detailed dosing tables mapping IgE ranges and body-weight categories to mg doses and dosing frequency (Q4 weeks or Q2 weeks for higher IgE ranges).
Tables are extensive; excerpted values include several mappings (e.g., for ≥30–100 IU/mL many low-weight categories = 75 mg Q4w; for higher IgE ranges doses escalate to 150–600 mg).

Product administration constraints

Operational administration limits

ALL of the following

Do not administer more than 150 mg (contents of one vial) per injection site; divide doses >150 mg among two or more injection sites.
Xolair and Omlyclo are not approved for use in patients weighing more than 150 kg (see appendices).

Immunotherapy-related (immune checkpoint inhibitor) pruritus — Appendix I

NCCN-based grading and coverage additions

ANY of the following

Policy now covers moderate (G2) immune checkpoint inhibitor–related pruritus per NCCN (added 1Q 2026).
For immune checkpoint inhibitor-related pruritus, the requirements for increased IgE level and refractory disease that has not responded to a gabapentinoid also apply to moderate pruritus.
NCCN grading provided: G1 (mild/localized), G2 (moderate; intense/widespread; limiting instrumental ADLs), G3 (severe; limiting self-care ADLs or sleep).
For severe pruritus, prior requirement included lack of response to 1 month of gabapentinoid therapy (policy update 1Q2025).
Moderate pruritus now also requires increased IgE and refractory to gabapentinoid per 1Q2026 update.

Exclusions / Not covered (documented in revision history)

Policy explicitly notes certain uses are not supported

ANY of the following

Eosinophilic esophagitis is listed as an indication not covered due to lack of demonstrated efficacy and guideline recommendation against use (1Q2026 update).

Codes and Billing Identifiers

Policy identifier / metadatamixed

CP.PHAR.01	Policy reference number for omalizumab
CP.PMN.255	No coverage criteria policy (Medicaid) referenced
CP.PMN.16	Non-formulary policy (Medicaid) referenced
CP.PMN.53	Off-label use policy (Medicaid) referenced

HCPCS codes for omalizumab productsHCPCS

J2357	Injection, omalizumab, 5 mg (Xolair)
Q5154	Injection, omalizumab-igec (Omlyclo), biosimilar, 5 mg

What Providers Must Do — Prior Auth, Documentation, and Billing Rules

Prior Authorization

Prior authorization required with justification for off-label NCCN uses

Prescriber must submit supporting evidence when dosing or use is outside FDA limits or when treating NCCN compendium (off‑label) indications; NCCN uses must be prescribed by or in consultation with an oncologist and include justification for the regimen.

Prescriber must submit supporting evidence when dose is outside FDA maximums or when off‑label use is requested (per policy requirement).
NCCN compendium indications must be prescribed by or in consultation with an oncologist.

Documentation Required

Submit supporting clinical documentation

Provider must submit office chart notes, laboratory results and other clinical information demonstrating that the member meets the applicable initial or continued criteria.

Diagnosis and age documentation appropriate to the indication (e.g., asthma age ≥6, CSU ≥12, CRSwNP ≥18, food allergy ≥1).

Key Numeric & Clinical Thresholds

Key thresholds and limits

Asthma exacerbations≥ 2 exacerbations in last 12 months requiring systemic corticosteroid use or urgent care/ER/hospital admission

IgE (asthma)Total serum IgE ≥ 30 IU/mL

Food allergy skin testSkin prick wheal diameter ≥ 4 mm greater than control

Food-specific IgEFood-specific serum IgE ≥ 6 kUA/L

CSU antihistamine trialFailure of one antihistamine at maximum indicated doses for ≥ 2 weeks

PDC adherence for asthma controllersPDC ≥ 0.8 over last 6 months (≥144/180 days)

Dose caps & administration limits

Clinical and Pharmacologic Context

Omalizumab is an anti‑IgE monoclonal antibody (anti‑immunoglobulin E) indicated for moderate to severe persistent allergic asthma, chronic spontaneous urticaria (CSU), chronic rhinosinusitis with nasal polyps (CRSwNP), and for reduction of allergic reactions to foods in patients with IgE‑mediated food allergy (used with allergen avoidance).

The therapy works by binding circulating IgE and preventing IgE‑mediated allergic cascade activation. Clinical guidance notes variable efficacy by indication; benefits in asthma include reductions in exacerbations and rescue use but are modest, and omalizumab provides clinically meaningful symptom improvement in CSU and selected patients with CRSwNP or IgE‑mediated food allergy when criteria are met.

Omalizumab carries a boxed warning for anaphylaxis. Anaphylactic reactions have occurred after any dose, including the first dose, and may be immediate (within two hours) or delayed (up to 24 hours or longer); this risk is described in the product safety information and the policy appendices.

Dosing is individualized and determined by the member’s pre‑treatment total serum IgE (IU/mL) and current body weight (kg), with manufacturer tables mapping IgE and weight to dose and frequency. Operational limits include a per‑injection maximum of 150 mg per site (split larger doses across sites) and indication‑specific maximums: asthma ≤ 375 mg every 2 weeks, CSU ≤ 300 mg every 4 weeks, and CRSwNP and IgE‑mediated food allergy up to 600 mg every 2 weeks. Product availability includes multiple vial and prefilled syringe/autoinjector strengths for Xolair and Omlyclo formulations.

Defined Terms

Definitions

CSUChronic spontaneous urticaria (formerly chronic idiopathic urticaria): spontaneous wheals/angioedema ≥ 6 weeks

CRSwNPChronic rhinosinusitis with nasal polyps

ICSInhaled corticosteroid

LABALong-acting beta-agonist

LTRALeukotriene receptor antagonist (leukotriene modifier)

PDCProportion of days covered — adherence metric (days covered/total days); PDC ≥ 0.8 required for asthma continued therapy (previously defined as 0.8 in prior revisions)

Q2 weeks / Q4 weeksDosing frequency shorthand indicating every 2 weeks (Q2w) or every 4 weeks (Q4w)

Material Policy Changes

2026-01-29policy revision (1Q2026)Latest

Added coverage for moderate (G2) immune checkpoint inhibitor–related pruritus per NCCN; extended initial approval duration from 6 to 12 months for all indications and revised continued approval durations for NCCN compendial uses from 6 to 12 months; added eosinophilic esophagitis to exclusions; added Omlyclo 300 mg/2 mL strength to product availability and clarified IgE and refractory disease requirements for moderate pruritus.

2025-09-11coding update / product addition

Added HCPCS code Q5154 for the newly approved biosimilar omalizumab-igec (Omlyclo) and updated product availability to include Omlyclo strengths.

2025-03-25

Policy Summary

Payermhn

PolicyOmalizumab (Xolair) and biosimilar Omalizumab-igec (Omlyclo) coverage criteria

Policy CodePolicy CP.PHAR.01

Change TypeMultiple updates (added indications, biosimilar, dosing/strengths, duration revisions)

Effective DateOct 1, 2008

Next Review DateN/A

SourceLink

On This Page

Documentation Required

Concurrent therapy restrictions

Omalizumab must not be prescribed concurrently with Cinqair, Fasenra, Nucala, Dupixent, or Tezspire for any covered indication; for IgE‑mediated food allergy do not prescribe concurrently with Palforzia. When food allergy indication is requested, document that omalizumab will be prescribed concurrently with injectable epinephrine.

Concurrent use prohibited with: Cinqair, Fasenra, Nucala, Dupixent, Tezspire (all indications).
For IgE‑mediated food allergy do not combine with Palforzia; must document concurrent prescription of injectable epinephrine.

Documentation Required

Use pre-treatment serum total IgE and body weight to determine dose

Determine omalizumab dosing using a pre‑treatment total serum IgE level (IU/mL) and current body weight (kg); adjust doses for significant weight changes during treatment. Relevant HCPCS codes: J2357 (omalizumab 5 mg) and Q5154 (omalizumab‑igec 5 mg).

Dosing tables in Appendices E–H map pre‑treatment IgE and weight to mg dose and frequency.
Manufacturer recommends dose adjustments for significant body weight changes during treatment.

Documentation Required

For immune checkpoint inhibitor–related pruritus prior therapy requirement

For immune checkpoint inhibitor–related moderate or severe (G2/G3) pruritus, document that pruritus is refractory, that the member has an increased IgE level, and that the member has not responded to a gabapentinoid after at least 1 month of therapy, per NCCN‑based criteria.

Requirement applies to both moderate (G2) and severe (G3) pruritus per policy update.
Prescriber must document increased IgE and ≥1 month trial of a gabapentinoid without response.

Omalizumab (Xolair) and biosimilar Omalizumab-igec (Omlyclo) coverage criteria

Medical Necessity Criteria and Authorization Rules

Codes and Billing Identifiers

What Providers Must Do — Prior Auth, Documentation, and Billing Rules

Key Numeric & Clinical Thresholds

Clinical and Pharmacologic Context

Defined Terms

Material Policy Changes

Policies to Read With This Document