Centene omalizumab coverage update: Prior Auth

Coverage Criteria and Indications

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 (a) oral/systemic corticosteroid treatment (or increase in dose) OR (b) urgent care/ER visit or hospital admission despite adherent controller therapy (medium- to high-dose inhaled corticosteroid plus either a LABA or leukotriene modifier if LABA contraindicated/intolerant); 4. Positive skin test or in vitro reactivity to a perennial aeroallergen; 5. Serum total IgE ≥ 30 IU/mL; 6. Xolair/Omlyclo is 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;see node text

Approval duration: 12 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 or contraindications; 4. Not prescribed concurrently with Cinqair, Fasenra, Nucala, Dupixent, or Tezspire; 5. Dose does not exceed 300 mg every 4 weeks;see node text

Approval duration: 12 months

Initial Therapy - Chronic Rhinosinusitis with Nasal Polyps

Covered when ALL of the following are met

CRSwNP initial criteria: 1. Diagnosis of chronic rhinosinusitis with nasal polyps (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;see node text

Approval duration: 12 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(s) to the food with (a) prescriber deeming past reaction significant enough to require prescription for injectable epinephrine and (b) Xolair/Omlyclo prescribed concurrently with injectable epinephrine; 6. Medical justification for use despite avoidance (e.g., inability to reliably avoid allergens); 7. Not prescribed concurrently with Palforzia, Cinqair, Fasenra, Nucala, Dupixent, or Tezspire; 8. Dose does not exceed 600 mg every 2 weeks;see node text

Approval duration: 12 months

Initial Therapy - NCCN Compendium Indications

Covered when ALL of the following are met

NCCN off-label criteria: 1. Diagnosis of systemic mastocytosis OR immune checkpoint inhibitor-related moderate or severe (G2 or G3) pruritus; 2. Prescribed by or in consultation with an oncologist; 3. For systemic mastocytosis, use must be in one of specified settings (stepwise prophylaxis 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 immunotherapy tolerability); 4. For checkpoint inhibitor-related pruritus: pruritus is refractory, member has increased IgE, and member has not responded to a gabapentinoid after 1 month; 5. Not prescribed concurrently with Cinqair, Fasenra, Nucala, Dupixent, or Tezspire; 6. Dose is within FDA maximum for any FDA-approved indication or is supported by practice guidelines/peer-reviewed literature for the off-label use (prescriber must submit supporting evidence);see node text

Prescribed regimen must be FDA-approved or recommended by NCCN; Approval duration: 12 months

Continued Therapy - Moderate to Severe Persistent Asthma

Covered for continuation when ALL of the following are met

Asthma continued therapy: 1. Member is currently receiving medication via Centene benefit or previously met initial approval criteria, OR is enrolled with continuity of care; 2. Demonstrated adherence to asthma controller therapy evidenced by PDC ≥ 0.8 in the last 6 months; 3. Member is responding positively to therapy (e.g., reduction in exacerbations or corticosteroid use, improved FEV1, reduced rescue use); 4. Not prescribed concurrently with Cinqair, Fasenra, Nucala, Dupixent, or Tezspire; 5. If request is for dose increase, new dose does not exceed 375 mg every 2 weeks;see node text

Approval duration: 12 months

Continued Therapy - Chronic Spontaneous Urticaria

Covered for continuation when ALL of the following are met

CSU continued therapy: 1. Member is currently receiving medication via Centene benefit or previously met initial approval criteria, OR is enrolled with continuity of care; 2. Member is responding positively to therapy; 3. Not prescribed concurrently with Cinqair, Fasenra, Nucala, Dupixent, or Tezspire; 4. If request is for dose increase, new dose does not exceed 300 mg every 4 weeks;see node text

Approval duration: 12 months

Continued Therapy - Chronic Rhinosinusitis with Nasal Polyps

Covered for continuation when ALL of the following are met

CRSwNP continued therapy: 1. Member is currently receiving medication via Centene benefit or previously met initial approval criteria, OR is enrolled with continuity of care; 2. Demonstrated adherence to an intranasal corticosteroid unless contraindicated; 3. Member is responding positively to therapy (e.g., reduced polyp size, reduced systemic corticosteroid need, improved sense of smell, improved quality of life); 4. Not prescribed concurrently with Cinqair, Fasenra, Nucala, Dupixent, or Tezspire; 5. If request is for dose increase, new dose does not exceed 600 mg every 2 weeks;see node text

Approval duration: 12 months

Continued Therapy - IgE-Mediated Food Allergy

Covered for continuation when ALL of the following are met

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

Approval duration: 12 months

Continued Therapy - NCCN Compendium Indications

Covered for continuation when ALL of the following are met

NCCN continued therapy: 1. Member is currently receiving medication via Centene benefit or documentation supports member has received Xolair/Omlyclo 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 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);see node text

Approval duration: 12 months

NCCN Compendium Off-label Indications (Continuation/Dose Increase)

NCCN Compendium Indications (off-label) — all of the following must be met:

NCCN off-label continuation criteria: 1) Member is currently receiving medication via Centene benefit, or documentation supports member has been receiving Xolair/Omlyclo 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 for any FDA-approved indication OR is supported by practice guidelines or peer-reviewed literature for the relevant off-label use and prescriber must submit supporting evidence. Prescribed regimen must be FDA-approved or recommended by NCCN.

Approval duration: 12 months

Handling of other/new indications or uses

Other diagnoses/indications — one of the following must be met:

Other diagnoses/indications handling: 1) If this drug has recently (within the last 6 months) undergone a label change that is not yet reflected in this policy, refer to the no coverage criteria or non-formulary policies for the relevant line of business (e.g., CP.PMN.255, CP.PMN.16); OR 2) If the requested use is not specifically listed under section III and criterion 1 does not apply, refer to the off-label use policy (CP.PMN.53).

Dosing-based coverage criteria

Coverage and dosing determinations should follow the appended IgE and body-weight based dosing tables for each indicated population and age group.

General dosing logic: Dosing is determined by pre-treatment total serum IgE range and body weight; frequency is typically every 4 weeks or every 2 weeks for higher IgE/weight ranges as specified in appendices for asthma (age ≥12 and 6–<12), CRSwNP (age ≥18), and IgE-mediated food allergy (age ≥1).see appendix tables

Manufacturer recommends dose adjustments for significant body weight changes during treatment.

Indication evidence notes

Clinical-effectiveness considerations

Supported indications: Omalizumab is supported as second-line add-on therapy for chronic spontaneous urticaria after inadequate response to high-dose second-generation H1-antihistamines (up to 4x standard dose).

2021 international guidelines recommend this use.

Limited or not recommended indications: Randomized trials showed no significant benefit for idiopathic anaphylaxis; evidence is insufficient for atopic dermatitis and omalizumab is not recommended for eosinophilic esophagitis per the cited guideline; these evidence limitations may influence coverage decisions.

Indication-specific dosing criteria

Dosing must follow indication-specific regimens based on baseline serum total IgE and body weight; manufacturer tables map IgE and weight to specific dose and frequency.

Asthma dosing: Administer 75 to 375 mg subcutaneously every 2 or 4 weeks based on serum total IgE measured before start of treatment and body weight; maximum dose 375 mg every 2 weeks; adjust doses for significant changes in body weight during treatment.IgE and body weight table mapping (see dosing tables)

Do not administer more than 150 mg per injection site; divide larger doses among multiple sites.

Chronic spontaneous urticaria (CSU): Administer 150 mg or 300 mg subcutaneously every 4 weeks; maximum dose 300 mg every 4 weeks.fixed doses

Chronic rhinosinusitis with nasal polyps (CRSwNP): Administer 75 to 600 mg subcutaneously every 2 or 4 weeks based on serum total IgE measured before start of treatment and body weight; maximum dose 600 mg every 2 weeks; adjust doses for significant changes in body weight during treatment.

Updated authorization and pruritus criteria

Policy-level coverage posture and updated requirements

Initial approval duration extended to 12 months for all indications.12 months

Applied across indications as of 1Q 2026.

Continued approval for NCCN compendial uses: Continued approval duration revised to 12 months for NCCN compendial uses.12 months

Applied as of 1Q 2026.

Immune checkpoint inhibitor-related pruritus requirements: For severe and moderate (G2) ICI-related pruritus, requirements include elevated IgE and refractory disease that has not responded to a gabapentinoid trial of at least 1 month.gabapentinoid trial >=1 month

Moderate pruritus coverage added per NCCN; requirements clarified to also apply to moderate pruritus.

Xolair (omalizumab) and its biosimilar Omlyclo are not indicated for relief of acute bronchospasm or status asthmaticus, for treatment of other forms of urticaria outside chronic spontaneous urticaria, or for emergency treatment of allergic reactions including anaphylaxis.

Coverage will not be authorized for uses that are non‑FDA indications not addressed in this policy without sufficient supporting documentation or evidence. The policy also explicitly excludes coverage for acute bronchospasm or status asthmaticus, and for eosinophilic esophagitis (see policy section III). If a recent label change within the last 6 months is not reflected in this policy, providers should follow the referenced formulary/non‑formulary or off‑label policies for the applicable line of business.

The use of over‑the‑counter second‑generation H1 antihistamines may be recorded in the clinical history but such products are not covered under the plan. Documentation of their use may be considered when evaluating prior therapy for chronic spontaneous urticaria but will not be reimbursed as a plan‑covered medication.

Per the dosing and administration section and appendices, Xolair and Omlyclo are not approved for use in patients weighing more than 150 kg. Administering doses must also respect the single‑injection limit of 150 mg per injection site and larger doses should be divided among multiple sites.

Eosinophilic esophagitis is listed among diagnoses for which coverage is not authorized. This reflects randomized trial data that did not demonstrate benefit and the 2025 American College of Gastroenterology guideline recommendation against use, and the policy therefore treats eosinophilic esophagitis as an indication not covered in section III.

Requests for uses that are not listed among the policy’s approved indications or criteria should be processed according to the applicable formulary/non‑formulary or off‑label policies (e.g., CP.PMN.255, CP.PMN.16, CP.PMN.53) as described in the policy’s handling of other or new indications.

Use of omalizumab for eosinophilic esophagitis is not supported by randomized controlled trial evidence and the cited guideline recommends against its use; therefore the policy does not support coverage for this indication absent new, persuasive evidence.

The referenced gastroenterology evidence and guideline explicitly recommend against omalizumab for eosinophilic esophagitis given lack of demonstrated clinical benefit in trials, and the policy aligns with that guidance by listing eosinophilic esophagitis as an indication for which coverage is not authorized.

Coding, Dosing Limits, and Related Key Values

Policy identifiersmixed

CP.PHAR.01

Policy reference number (internal)

HCPCS Codes referencedHCPCS

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

Dose maximums by indication

Asthma maximum≤ 375 mg every 2 weeks (dose must not exceed 375 mg q2w)

Chronic spontaneous urticaria (CSU) maximum≤ 300 mg every 4 weeks

Chronic rhinosinusitis with nasal polyps (CRSwNP) maximum≤ 600 mg every 2 weeks

IgE-mediated food allergy maximum≤ 600 mg every 2 weeks

IgE level for asthma

Minimum total IgE for asthma eligibility≥ 30 IU/mL

Use in dosing tables

Prior Authorization, Documentation, and Administration Requirements

Prior Authorization

Reference dosing tables for prior authorization

Prior authorization required — Provider must reference indication-specific dosing tables (Appendices E–H and G) when requesting prior authorization. Dosing for asthma, CRSwNP, IgE‑mediated food allergy, and other indications is determined by pre-treatment serum total IgE (IU/mL) and body weight (kg); include those values on the PA request to support the selected dose and frequency.

Reference dosing tables (Appendices E, F, G, H) to determine appropriate dose and dosing frequency based on pre-treatment serum total IgE and body weight.
For NCCN compendium off-label uses where dose differs from FDA labeling, prescriber must submit supporting practice guideline or peer‑reviewed literature evidence.

Documentation Required

Dosing justification and administration

Dosing must be justified and administration limits observed. Document pre-treatment serum total IgE and current body weight; adjust doses for significant weight changes during therapy. Do not administer more than 150 mg per single injection site — split doses >150 mg across two or more injection sites. Omalizumab/omalizumab-igec is not approved for patients >150 kg for some indications; consult the dosing appendices for limits.

Clinical Background and Evidence Context

Omalizumab (Xolair) and the biosimilar omalizumab‑igec (Omlyclo) are anti‑IgE monoclonal antibodies indicated to reduce IgE‑mediated allergic responses. They are approved for multiple indications including moderate‑to‑severe persistent asthma, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, and for reducing allergic reactions from accidental food exposures in patients with IgE‑mediated food allergy; dosing, patient selection, and exclusions are specified in the policy appendices and sections.

Definitions and Term Clarifications

Omalizumab / Omalizumab-igec

Mechanism of actionAnti-immunoglobulin E (IgE) antibodies

Products coveredOmalizumab (Xolair) and biosimilar omalizumab-igec (Omlyclo)

Therapeutic effectReduces IgE-mediated allergic responses

Proportion of Days Covered (PDC)

DefinitionProportion of Days Covered (PDC) = days covered in timeframe ÷ number of days in timeframe

Adherence benchmarkPDC ≥ 0.8 corresponds to ~144 of the last 180 days

Use in policy

OpenPayer

Omalizumab (Xolair) and biosimilar Omlyclo coverage

Coverage Criteria and Indications

Coding, Dosing Limits, and Related Key Values

Prior Authorization, Documentation, and Administration Requirements

Clinical Background and Evidence Context

Definitions and Term Clarifications