Omalizumab (Xolair) and related biologics coverage
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Clinical prior authorization guidelines for Xolair (omalizumab) and summary coverage rules for several other allergy / asthma biologics under the Mass General Brigham Health Plan medical benefit. Applies to providers requesting authorization for covered indications and members under the listed plan programs.
6/10/26 review updated step-through requirements: a trial with Dupixent and Fasenra is required before Xolair; other biologic step-through requirements added for related agents.
Initial and reauthorization approval durations for Fasenra were changed to 12 months.
Removed Appendix C of dosing table for Xolair and updated Appendix B.
Added Exdensur 100 mg/mL injection to the medical benefit only with prior authorization.
Coverage Criteria and Clinical Necessity
Chronic Spontaneous Urticaria (CSU) - Xolair
Covered when ALL of the following are met:
See appendix for examples and dosing >300 mg requests
IgE‑Mediated Food Allergy - Xolair
Covered when ALL of the following are met:
Dosing interval 14–28 days
Moderate to Severe Allergy‑Related Asthma - Xolair
Covered when ALL of the following are met:
Unit limits noted for vial/syringe formulations
Nasal Polyps - Xolair
Covered when ALL of the following are met:
Adjunctive therapy required
Systemic Mastocytosis (Off‑Label) - Xolair
Considered when ALL of the following are met:
Off‑label indication
Eosinophilic Granulomatosis with Polyangiitis (EGPA) - Nucala
Covered when ALL of the following are met:
Nucala specific
Hypereosinophilic Syndrome (HES) - Nucala
Covered when ALL of the following are met:
Nucala specific
Chronic Rhinosinusitis with Nasal Polyps - Xolair
Covered when ALL of the following are met:
Adjunctive therapy required
Severe Eosinophilic Asthma - Multiple agents
Covered when ALL of the following are met (agent‑specific thresholds differ):
Agent‑specific age, eosinophil and dosing thresholds apply as shown in document
Reslizumab (Cinqair) - Severe Eosinophilic Asthma
Covered when ALL of the following are met:
Reslizumab specific
Benralizumab (Fasenra) - EGPA and Severe Eosinophilic Asthma
Covered when ALL of the following are met (indication dependent):
Fasenra EGPA
Fasenra asthma dosing stratified by age/weight
Eosinophilic granulomatosis with polyangiitis (EGPA) - Initial Therapy
Covered when ALL of the following are met
Severe Eosinophilic Asthma - Initial Therapy (children and adults)
Covered when ALL of the following are met
Severe Asthma (≥12 years) - Initial Therapy
Covered when ALL of the following are met
Nested AND/OR logic for biologic failures or non‑eosinophilic phenotype
Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) - Initial Therapy
Covered when ALL of the following are met
Requires prior failures to Dupixent and Nucala
Severe Eosinophilic Asthma (≥12 years) - Alternative dosing and step therapy
Covered when ALL of the following are met
Specifies requirement to fail both Dupixent and Fasenra
Continuation of Therapy
Covered when prescriber submits resubmission indicating response
No additional objective response metric specified in this section
Updated step-through and duration criteria
Policy updates affecting coverage sequencing and approval durations
Specific indication‑level logic (e.g., asthma phenotype documentation, other step‑throughs for Nucala/Tezspire) should be referenced in the full policy document.
When evaluating continuation requests for members who are currently receiving therapy and are new to the plan, the authorization team will review such cases on a case‑by‑case basis. Products obtained as samples or through a manufacturer's patient assistance program may be excluded from consideration for continuation coverage for new plan members; document the source of prior drug supply as part of the submission.
This policy does not present a separate "Not Medically Necessary" section. Instead, conditions or requests that do not meet the listed coverage criteria or required prior‑therapy/step‑through obligations are considered noncovered under the plan; providers should ensure submitted documentation directly addresses each applicable criterion.
Previously, the policy included an appendix addressing omalizumab requests for members with very high total serum IgE (>700 IU/mL) or with body weight outside a specified range (<30 kg or >150 kg). That appendix has been removed from the guidelines; requests for members with elevated IgE or atypical weight should now be evaluated using the main criteria and any updated dosing appendices referenced in the current policy.
If a request does not satisfy the explicit coverage criteria (including diagnosis, age, required prior therapies, specialist prescriber or consult documentation, and any required step‑through trials), the request is considered not medically necessary and may be denied. Providers should include complete documentation to demonstrate how the member meets each criterion to avoid implied noncoverage.
Provider Requirements, Documentation, and Prior Authorization
Prior authorization required; case‑by‑case review for new‑to‑plan members
Prior authorization is required for the listed biologics under the Mass General Brigham medical benefit; requests for members new to the plan who are currently receiving treatment and stable on the medication will be reviewed on a case‑by‑case basis. Products obtained as samples or via manufacturer's patient assistance programs may be excluded from continuation consideration for new plan members.
Approval duration and reauthorization rules
Initial approval durations vary by indication (chronic idiopathic urticaria: 4 months; Fasenra initial approvals: 12 months; all other agents: 6 months). Reauthorizations are granted for 12 months and stability on listed agents may support approval without documenting failures of conventional therapies.
Exdensur 100 mg/mL added to medical benefit with PA
Exdensur 100 mg/mL injection has been added to the medical benefit and requires prior authorization for coverage under the plan.
CSU step requirements: antihistamine trial and adjunct criteria
For chronic spontaneous urticaria (CSU), the policy requires a trial with at least one second‑generation H1 antihistamine with inadequate response (≥14 days) or documentation of contraindication to all; additional adjunct trials or contraindications as specified in the CSU criteria must be documented before approval.
- Document inadequate response defined as ≥14 days of therapy with a second‑generation H1 antihistamine or a contraindication to ALL second‑generation H1 antihistamines.
- Document either an inadequate response (≥14 days) to one of the listed combination regimens (e.g., increased antihistamine dose up to 4x, H1+H2, H1+leukotriene receptor antagonist, H1+first‑generation at bedtime) OR both contraindications to H2, first‑generation H1, and leukotriene receptor antagonists plus clinical rationale why the second‑generation H1 dose cannot be increased.
Biologic step therapy: trials of alternate biologics required
For multiple severe asthma and CRSwNP indications, approval requires documented trial and inadequate response or contraindication to specified alternative biologics (examples include Dupixent and Fasenra) as described in the indication‑specific criteria.
- Severe asthma (≥12 years) requires either evidence of eosinophilic phenotype plus inadequate response/adverse reaction/contraindication to BOTH Dupixent and Fasenra, or absence of an eosinophilic phenotype.
- CRSwNP requires inadequate response/adverse reaction/contraindication to Dupixent and to Nucala prior to approval.
Biologic step‑through trials required (Dupixent and Fasenra) before Xolair
A step‑through trial with Dupixent (dupilumab) and Fasenra (benralizumab) is now required prior to approval of Xolair in applicable indications; related step‑throughs for Nucala and other agents are also specified where indicated.
- Policy update (6/10/26) requires documented trials with Dupixent and Fasenra before Xolair approval in applicable indications.
- Nucala criteria in some indications were updated to require a step‑through trial with Dupixent.
CSU documentation: diagnosis, specialist, age ≥12, prior therapy and dosing rationale
For CSU, required documentation includes the diagnosis, specialist prescriber or specialist consult notes, member age (≥12 years), and documentation of inadequate response or contraindication to antihistamine therapy; include dosing rationale and justification for syringe versus vial when self‑administration is requested.
- Diagnosis of chronic spontaneous urticaria.
- Specialist prescriber (allergist/immunologist or dermatologist) or consult notes provided.
- Member ≥12 years of age.
- Documentation of inadequate response (≥14 days) or adverse reaction to required antihistamine therapy.
- Appropriate dosing (150 mg or 300 mg every 28 days) and medical necessity for syringe vs vial if requesting syringe for self‑administration.
Allergy‑related asthma documentation: diagnosis, age ≥6, prior controller failure, IgE and sensitization
For moderate to severe allergy‑related asthma, document the diagnosis, member age (≥6 years), evidence of prior controller therapy failure (one of the listed controller regimens), baseline serum IgE (30–700 IU/mL unless higher levels addressed in appendix), evidence of specific allergic sensitization, specialist prescriber or consult notes, and dosing justification including syringe vs vial rationale if self‑administration is requested.
- Diagnosis of moderate to severe allergy‑related asthma and member ≥6 years.
- Evidence the member is symptomatic despite one required controller regimen (e.g., combination inhaler, ICS+LABA, or chronic OCS defined as ≥90 days in last 120 days).
- Baseline serum IgE within 30–700 IU/mL (see appendix for higher IgE levels).
- Evidence of specific allergic sensitivity (positive skin or blood test).
- Specialist prescriber or consult notes and dosing/unit limits documentation; justification for 150 mg syringe vs vial if requested.
Required documentation: diagnosis, age, specialist consult, prior therapies and dosing rationale
All prior authorization requests must include: diagnosis, member age, specialist prescriber or specialist consult notes, and evidence of prior therapies with inadequate response, adverse reaction, or contraindication; also include dosing rationale.
- Diagnosis and member age as required by the specific indication.
- Specialist prescriber or consult notes.
- Dates and outcomes of prior therapies showing inadequate response, adverse reaction, or contraindication.
- Dosing plan and rationale (including unit/formulation choice).
Documentation required for step‑through trials with preferred agents
When the policy requires step‑through sequencing, prior authorization must document trials with the preferred agents (for example, Dupixent and Fasenra) including dates, outcomes, and relevant member phenotype information.
- Document dates and outcomes of trials with the preferred agents (Dupixent, Fasenra, or others as specified).
- Include member phenotype documentation (e.g., eosinophil counts, IgE, skin/blood test results) when applicable.
New‑to‑plan continuation review: case‑by‑case evaluation
Members new to the plan who are stable on treatment may be considered for continuation on a case‑by‑case basis; note that products provided as samples or via manufacturer's patient assistance programs may be excluded from continuation consideration.
Denial risk if prior controller therapy requirements not met or member not symptomatic
Requests may be denied if the member is not symptomatic despite receiving required prior controller therapies (for example, combination inhalers, ICS+LABA, or chronic oral corticosteroids as defined in policy).
- Chronic oral corticosteroids are defined as ≥90 days of therapy within the last 120 days.
- Documented ongoing symptoms despite the specified controller regimens are required to support approval.
Specialist prescriber requirement; risk of denial without specialist or consult notes
Requests may be denied if the prescriber is not a listed specialist and no specialist consult notes are provided; many indications require an allergy/immunology, pulmonology, otolaryngology or other specialist prescriber or consult documentation.
- CSU requires an allergist/immunologist or dermatologist prescriber or consult notes.
- Asthma and eosinophilic indications require an asthma specialist (allergist, immunologist, pulmonologist) or consult notes.
- CRSwNP requires an appropriate specialist (allergist, immunologist, otolaryngologist, pulmonologist) or consult notes.
Denial risk for missing step‑through trials (Dupixent and Fasenra) for Xolair
Failure to document the required step‑through trials with Dupixent and Fasenra (when indicated by the policy updates) may result in denial of a prior authorization request for Xolair.
- Policy update effective 7/1/26 requires step‑through trials with Dupixent and Fasenra for applicable indications prior to Xolair approval.
- CRSwNP and some severe eosinophilic asthma alternatives explicitly require prior inadequate response to Dupixent and Fasenra (or other named agents) before approval.
Clinical Thresholds, Laboratory and Dosing Parameters
Definitions and Conceptual Notes
Background and Clinical Context
Xolair (omalizumab) is a monoclonal antibody that targets circulating IgE and is indicated for several allergic conditions. It is used as add‑on therapy for moderate to severe persistent allergic asthma, for chronic spontaneous (idiopathic) urticaria in eligible patients, and for treatment of nasal polyps in adults. Within this policy, Xolair is positioned among other biologics for allergic and eosinophilic phenotypes and requires prior authorization under the medical benefit with indication‑specific documentation, dosing, and step‑therapy requirements.
Policy Revision History
Reviewed and updated: removed Appendix C from Xolair dosing table; updated Appendix B; added Exdensur 100 mg/mL injection to the medical benefit only with prior authorization; implemented step-through trials requiring Dupixent and Fasenra (and additional step-throughs involving Dupixent and Nucala/Tezspire) and updated Fasenra initial and reauthorization approval durations to 12 months.
Added EGPA criteria for Fasenra and IgE-mediated food allergy indication for Xolair; Fasenra expanded age indication to ≥6 years; added Systemic Mastocytosis to Xolair; added step-through with Fasenra for Nucala EGPA; effective 7/1/25.
Cinqair (reslizumab) made available through the medical benefit (admin update effective 4/1/23).
Updated references and alignment with formulary (MH UPPL); Dupixent initial approvals changed from 6 months to 1 year; added Appendix for CIU omalizumab requests >300 mg every 4 weeks; effective 7/1/22.
Updated following FDA-expanded indication for Nucala in CRSwNP and removed the appendix for omalizumab requests for members with high IgE (>700 IU/mL) or extreme weight; CIU LTRA trial requirement removed and other appendix updates made.
The guideline history notes removal of the appendix titled "Omalizumab requests for members with high (>700 IU/mL) IgE levels or weight (<30 kg or >150 kg)." This historical change means that prior special‑case language for extreme IgE or weight values is no longer in a standalone appendix and related requests should follow the updated main policy and dosing appendices.
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