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Centene omalizumab (Xolair/Omlyclo) Coverage Update | OpenPayer

ModifiedCentenePolicy CP PHAR.0I

Omalizumab (Xolair) and biosimilar omalizumab-igec (Omlyclo)

Medical necessity and coverage criteria for Xolair and Omlyclo for multiple indications (asthma, chronic spontaneous urticaria, chronic rhinosinusitis with nasal polyps, IgE-mediated food allergy, and select NCCN off-label uses) for Centene lines of business.

Policy Summary

PayerCentene

PolicyOmalizumab (Xolair) and biosimilar omalizumab-igec (Omlyclo)

Policy CodePolicy CP PHAR.0I

Change TypeMultiple — additions and revisions (biosimilar addednew food allergy indicationcoding updates)

Effective DateOct 1, 2008

Next Review Date

Key ActionSubmit prior authorization with documentation showing diagnosis, pre-treatment total IgE and body weight, and evidence the member meets indication-specific criteria

SourceLink

POLICY UPDATE CHANGES

Added newly approved biosimilar Omlyclo to the policy.

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

Added new FDA-labeled indication of IgE-mediated food allergy.

Added off-label indications and criteria for systemic mastocytosis and immunotherapy-related pruritus per NCCN.

HCPCS code Q5154 was added to coding.

6 monthsInitial approval duration

12 monthsContinued approval duration

>=30 IU/mL

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Coverage Criteria and Medical Necessity

Initial therapy — Moderate to severe persistent asthma

Covered when ALL of the following are met:

Asthma initial criteria: 1. Diagnosis of asthma; 2. Moderate to Severe Persistent Asthma; 3. Age >= 6 years; 4. Member has experienced >= 2 exacerbations within the last 12 months requiring systemic corticosteroid treatment or an urgent/ER visit or hospitalization; 5. Positive skin test or in vitro reactivity to a perennial aeroallergen; 6. IgE level >= 30 IU/mL; 7. Prescribed concurrently with an inhaled corticosteroid plus either a long-acting beta-2 agonist (LABA) or a leukotriene receptor antagonist (LTRA) if LABA is contraindicated or not tolerated; 8. Not prescribed concurrently with Cinqair, Fasenra, Nucala, Dupixent, or Tezspire; 9. Dose does not exceed 375 mg every 2 weeks.

Initial therapy — Chronic Spontaneous Urticaria (CSU)

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 H1-antihistamine at maximum indicated doses for >= 2 weeks unless contraindicated or clinically intolerable; 4. Dose does not exceed 300 mg every 4 weeks; 5. Not prescribed concurrently with Cinqair, Fasenra, Nucala, Dupixent, or Tezspire.

Initial therapy — Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Covered when ALL of the following are met:

CRSwNP initial criteria: 1. Diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP) with documented presence of nasal polyps and signs/symptoms for >= 12 weeks; 2. Age > 18 years; 3. Prescribed by or in consultation with an allergist, immunologist, or otolaryngologist; 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.

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. Age >= 1 year; 3. Prescribed by or in consultation with an allergist or immunologist; 4. Positive skin prick test (wheal >= 4 mm greater than control) OR food-specific serum IgE >= 6 kUA/L OR positive oral food challenge; 5. Prescriber deems past allergic reaction significant enough to require prescription for injectable epinephrine and member has history of significant allergic reaction(s) to the food; 6. Prescribed concurrently with injectable epinephrine; 7. Medical justification supports necessity despite food allergen avoidance (e.g., inability to avoid); 8. Not prescribed concurrently with Palforzia, Cinqair, Fasenra, Nucala, Dupixent, or Tezspire; 9. Dose does not exceed 600 mg every 2 weeks.

Initial therapy — NCCN Compendium (selected off-label) indications

Covered when ALL of the following are met:

NCCN off-label criteria: 1. Diagnosis consistent with an NCCN-recommended indication (examples include systemic mastocytosis or immune checkpoint inhibitor–related severe pruritus); 2. Prescribed by or in consultation with an oncologist when specified; 3. For systemic mastocytosis: used in specified stepwise prophylactic settings after alternatives tried or contraindicated (e.g., corticosteroid); 4. For immune checkpoint inhibitor–related severe pruritus: pruritus is refractory, member has not responded to a gabapentinoid after one month, and member has increased IgE; 5. Not prescribed concurrently with Cinqair, Fasenra, Nucala, Dupixent, or Tezspire; 6. Prescribed regimen must be FDA-approved or recommended by NCCN; 7. Dose is within FDA maximum limits for any FDA-approved indication or is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence).

Continued therapy criteria (by indication)

Covered for continuation when ONE of the following is met and additional criteria per indication apply:

Continued therapy general: 1. Member currently receiving medication via Centene benefit OR member previously met initial approval criteria; 2. Member is responding positively to therapy (examples: reduced exacerbations or steroid use, improved FEV1, reduced rescue therapy; reduced polyp size; improved sense of smell; improved quality of life); 3. Demonstrated adherence to controller therapy where applicable (e.g., PDC >= 0.8 in the last 6 months for asthma); 4. Not prescribed concurrently with Cinqair, Fasenra, Nucala, Dupixent, or Tezspire; 5. Dose increases must not exceed indication-specific maximums (asthma: 375 mg q2w; CSU: 300 mg q4w; CRSwNP and food allergy: 600 mg q2w; NCCN: within FDA limits or supported by literature).

NCCN Compendium / Off-label continuation and other indications

Coverage for NCCN compendium indications (off-label) requires all listed conditions to be met; other diagnoses follow formulary or off‑label policies as specified.

NCCN Compendium continuation: 1. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Xolair/Omlyclo for a covered indication and has received this medication for at least 30 days; 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 (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN.

Approval duration: 6 months

Other diagnoses / formulary status routing

If an indication is not specifically listed, follow formulary or non‑formulary routing or off‑label policy.

Other diagnoses routing: 1. For drugs on the formulary or PDL, follow the no coverage criteria policy for the relevant line of business (e.g., CP PMN.255 for Medicaid). 2. For drugs not on the formulary or PDL, follow the non‑formulary policy or the off‑label policy for the relevant line of business.

If the drug had a recent label change within the last 6 months not reflected here, refer to the listed policies.

Dose selection by IgE and body weight

Dose selection requires matching the patient's pre-treatment total IgE band and body weight to the manufacturer dosing table for the specific indication/age group.

Manufacturer dosing match: Select dose and dosing frequency based on pre-treatment total IgE band and body weight per the manufacturer tables (multiple tables provided for pediatric and adult asthma, CRSwNP, IgE-mediated food allergy, etc.).IgE band and weight strata match required

Tables include Q2 or Q4 week frequencies; some IgE×weight combinations state 'Insufficient Data to Recommend Dose'

Indication-specific dosing and limits

Dosing and indication rules

Asthma dosing: Dose 75 to 375 mg SC every 2 or 4 weeks based on pre-treatment serum total IgE and body weight; maximum dose 375 mg every 2 weeks; allow ER/urgent care visit as an initial approval criterion per policy update; adjust doses for significant changes in body weight during treatment.max 375 mg/2 weeks

Chronic spontaneous urticaria (CSU): 150 mg or 300 mg SC every 4 weeks; maximum 300 mg every 4 weeks.max 300 mg/4 weeks

CRSwNP: 75 to 600 mg SC every 2 or 4 weeks based on pre-treatment serum total IgE and body weight; maximum 600 mg every 2 weeks. For patients with multiple indications, dosing determination should be based on the primary diagnosis.max 600 mg/2 weeks

Omalizumab products are not indicated for the relief of acute bronchospasm or status asthmaticus, nor for treatment of other forms of urticaria beyond chronic spontaneous urticaria (CSU), or for emergency treatment of allergic reactions including anaphylaxis. These limitations reflect the FDA‑labeled indications and limitation(s) of use for Xolair and Omlyclo.

Requests for omalizumab for acute bronchospasm or status asthmaticus are excluded from coverage and will be denied. This exclusion is explicit in the policy and aligns with the products’ labeled limitations of use.

The policy clarifies that over‑the‑counter H1 antihistamines are not a covered benefit. OTC H1 antihistamine use may be credited when assessing prior therapy failure, but these agents themselves are not reimbursable under the plan.

Xolair and Omlyclo are not approved for use in patients weighing more than 150 kg. Dosing guidance in the policy also specifies a maximum of 150 mg per injection site and recommends dividing doses >150 mg across multiple injection sites.

When state Medicaid coverage provisions conflict with this clinical policy, the state Medicaid provisions take precedence. Providers should consult the applicable state Medicaid manual for any differing coverage requirements.

Use of omalizumab that does not meet the specific diagnostic, age, concurrent therapy, prior therapy, dosing, or documentation requirements listed in the initial and continued therapy criteria is not authorized as medically necessary. Prior authorization decisions require supporting documentation (e.g., chart notes, labs) showing criteria have been met and, for continuation or dose changes, evidence of current therapy and positive response.

Non‑FDA approved indications that are not addressed by this policy are not authorized unless sufficient off‑label documentation is provided in accordance with the applicable off‑label use policy (e.g., CP.PMN.53). For NCCN‑listed off‑label uses included in this policy, prescribers must submit supporting evidence per the NCCN and the policy’s requirements.

Available evidence is insufficient to support routine use of omalizumab for atopic dermatitis and idiopathic anaphylaxis. The policy cites randomized trials and current guideline statements indicating that data do not support routine prescribing for these conditions.

Inclusion or exclusion of specific billing or HCPCS/CPT codes in this clinical policy does not by itself guarantee that a request will be covered. Coverage determinations remain subject to the member’s benefit documents, plan terms, and prior authorization requirements; providers should follow professional coding guidance and plan policies when submitting claims.

Codes, Dosing Tables, and Key Parameters

Dosing IgE/weight groups (policy-specific table identifiers)mixed

230-100	IgE range/dosing bucket (documented in dosing table)
100-200	IgE range/dosing bucket (documented in dosing table)
200-300	IgE range/dosing bucket (documented in dosing table)
300-400	IgE range/dosing bucket (documented in dosing table)
400-500	IgE range/dosing bucket (documented in dosing table)
500-600	IgE range/dosing bucket (documented in dosing table)
600-700	IgE range/dosing bucket (documented in dosing table)

Referenced drug codesHCPCS

J2357	Injection, omalizumab; 5 mg
05154	Injection_omalizumab-igec (omlyclo)_biosimilar_5mg_
Q5154	HCPCS code added (Q5154) referenced in policy

IgE level for asthma — Minimum threshold

Minimum total IgE for asthma indication>= 30 IU/mL

ContextRequired as part of initial asthma criteria when combined with positive skin test or in vitro reactivity to a perennial aeroallergen

Measurement timingSerum total IgE measured before start of treatment

Age for food allergy indication — Minimum age

Minimum age for food allergy indication>= 1 year

Prescriber requirementPrescribed by or in consultation with an allergist or immunologist

Prior Authorization, Documentation, and Provider Responsibilities

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must include documentation that the member meets all approval criteria, including diagnosis and clinical criteria. Approval durations: initial and continuation approvals are generally for 6 months; continuation/renewal requires evidence the member is currently receiving the medication for a covered indication and has received it for at least 30 days and is responding positively to therapy. For dose increase requests, prescriber must document the new dose is within FDA maximum limits or supported by practice guidelines or peer-reviewed literature.

Approval duration: 6 months (initial and typical renewal interval)
Continuation requirement: documentation member has received therapy ≥30 days and is responding positively
Dose increases: submit supporting evidence showing dose within FDA limits or guideline/peer-reviewed support

Note

Policy Assists Coverage Decisions (Not a Guarantee)

This clinical policy is intended to assist in making coverage decisions and administering benefits but does not guarantee payment. Coverage decisions remain subject to the terms, conditions, exclusions, and limitations of the member's coverage documents and applicable law.

Background and Clinical Context

Omalizumab (Xolair) and its biosimilar omalizumab‑igec (Omlyclo) are anti‑IgE monoclonal antibodies indicated to reduce allergic responses in IgE‑mediated conditions, including moderate to severe persistent asthma (age ≥ 6 years), chronic spontaneous urticaria (age ≥ 12 years), chronic rhinosinusitis with nasal polyps (age ≥ 18 years), and IgE‑mediated food allergy (age ≥ 1 year). These agents bind circulating IgE to reduce downstream allergic inflammation.

Definitions and Key Terms

Omalizumab / omalizumab-igec — Anti-IgE antibodies

Agents includedOmalizumab (Xolair) and biosimilar omalizumab-igec (Omlyclo)

MechanismAnti-immunoglobulin E (IgE) monoclonal antibodies

Product formsSingle-dose vial (150 mg) and prefilled syringes noted in product availability

Limitation of use — Not indicated for acute/emergency management

Not indicated forRelief of acute bronchospasm or status asthmaticus

Other exclusionsNot indicated for treatment of other forms of urticaria beyond CSU or emergency treatment of allergic reactions including anaphylaxis