ModifiedMass General Brigham Health PlanPolicy N/A

Asthma and Allergy Injectables (biologic therapies) — Prior Authorization and Coverage Criteria

Prior authorization and coverage criteria for specific injectable biologic therapies for asthma, allergy, and related eosinophilic disorders for Mass General Brigham Health Plan members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyAsthma and Allergy Injectables (biologic therapies) — Prior Authorization and Coverage Criteria

Policy CodePolicy N/A

Change TypeMaterial revisions and benefit routing updates

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with specialist documentation, indication-specific dosing and evidence of prior therapy response as specified per agent.

SourceLink

POLICY UPDATE CHANGES

Dupixent removed from medical criteria as it is managed via pharmacy benefit only and is available on MHDL.

Nucala for EGPA removed trial/failure requirement of azathioprine and methotrexate and added step-through with Fasenra.

Expanded indication for Dupixent in prurigo nodularis added and once-weekly dosing included in appendix.

Requirement for trial with leukotriene receptor antagonist (LTRA) removed for CRSwNP and CIU criteria due to safety concerns with montelukast.

Dupixent initial approval duration changed from 6 months to 1 year and some Dupixent systemic-immunomodulatory-agent requirements removed for atopic dermatitis.

Cinqair (reslizumab) made available through the medical benefit.

10+distinct indications referenced

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Coverage Criteria for Biologic Therapies

Xolair — Chronic Spontaneous Urticaria

Covered when ALL of the following are met:

Xolair_CSU: Diagnosis of chronic spontaneous urticaria; prescriber is a specialist (allergist/immunologist or dermatologist) or consult notes from a specialist are provided; member is ≥ 12 years of age; ONE of the following: inadequate response (defined as ≥ 14 days of therapy) or adverse reaction to at least ONE different second-generation H1 antihistamine, OR contraindication to ALL second-generation H1 antihistamines. Prior inadequate response may include increased dose of a second-generation H1 antihistamine (up to 4x), second-generation H1 antihistamine combined with an H2 antihistamine, second-generation H1 antihistamine combined with a leukotriene receptor antagonist, or second-generation H1 antihistamine combined with a first-generation H1 antihistamine at bedtime; documentation must include clinical rationale if dose escalation is not possible; appropriate dosing 150 mg or 300 mg every 28 days (see appendix for requests > 300 mg every 28 days); if request is for 150 mg or 300 mg syringe/auto-injection, provide medical necessity for syringe versus vial (e.g., self-administration).age ≥12; prior antihistamine therapy trials; dosing 150 or 300 mg q28d

See appendix for dosing >300 mg and examples of contraindications.

Xolair — Nasal Polyps

Covered when ALL of the following are met:

Xolair_NasalPolyps: Diagnosis of nasal polyps; member is ≥ 18 years of age; prescriber is a specialist (allergist, immunologist, otolaryngologist, pulmonologist) or consult notes provided; inadequate response or adverse reaction to ONE or contraindication to BOTH oral corticosteroid and intranasal corticosteroid; inadequate response or adverse reaction to prior nasal surgery; documentation that agent will be used as adjunctive therapy; appropriate dosing 75 to 600 mg every 14 to 28 days based on weight and total serum IgE; if request is for 150 mg syringe, provide medical necessity for syringe versus vial (e.g., self-administration).age ≥18

Xolair — Systemic Mastocytosis (off-label)

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

Xolair_Mastocytosis: Diagnosis of systemic mastocytosis; prescriber is a specialist or consult notes from a specialist are provided (e.g., hematologist, oncologist, allergist, immunologist); inadequate response, adverse reaction, or contraindication to ALL of the following: corticosteroids, H1 antihistamine, and H2 antihistamine; appropriate dosing 150 to 300 mg subcutaneously every 28 days; if request is for 150 mg or 300 mg syringe/auto-injection, provide medical necessity for syringe versus vial (e.g., self-administration).

Off-label indication.

Nucala — COPD

Covered when ALL of the following are met:

Nucala_COPD: Diagnosis of moderate to severe COPD; prescriber is a specialist (pulmonologist, allergist, or immunologist) or consult notes provided; appropriate dosing per product labeling; BOTH of the following: evidence of inadequate response (defined as ≥ 90 days of therapy within a 120-day period) or adverse reaction to one of the listed inhaler regimens (or equivalent combinations), OR inadequate response/contraindication to inhaled corticosteroid (e.g., history of pneumonia); evidence of an eosinophilic phenotype (peripheral blood eosinophils ≥ 150 cells/μl); for members with eosinophils ≥ 300 cells/μl require inadequate response, adverse reaction, or contraindication to dupilumab (dupixent); requested agent will be used adjunctively with dual or triple inhaled therapy.eosinophils ≥150 cells/μl (≥300 cells/μl for Dupixent step)

Specific inhaler alternatives listed in policy.

EGPA and HES

Covered when ALL of the following are met:

EGPA: Diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA); member is ≥ 18 years of age (where specified); prescriber is a specialist (allergist, cardiologist, hematologist, immunologist, pulmonologist, rheumatologist, etc.) or consult notes provided; inadequate response (defined as ≥ 30 days of therapy) or adverse reaction to ONE systemic glucocorticoid, or contraindication to ALL systemic glucocorticoids; appropriate dosing as specified for agent (examples include 300 mg subcutaneously every 28 days or 30 mg subcutaneously every 28 days depending on agent).age ≥18; inadequate response ≥30 days

Agent-specific dosing differences present.

HES: Diagnosis of hypereosinophilic syndrome without an identifiable non-hematologic secondary cause; prescriber is a specialist or consult notes provided; member is ≥ 12 years of age; inadequate response (defined as ≥ 30 days of therapy) or adverse reaction to ONE systemic glucocorticoid or contraindication to ALL systemic glucocorticoids and to other agents (hydroxyurea, methotrexate, interferon alfa); appropriate dosing 300 mg subcutaneously every 28 days.age ≥12; inadequate response ≥30 days

Severe Eosinophilic Asthma / Tezspire

Covered when ALL of the following are met (agent-specific thresholds applied):

Tezspire_SevereAsthma: Diagnosis of severe asthma; member is ≥ 12 years of age; prescriber is an asthma specialist or consult notes provided; member is symptomatic despite receiving ONE specified controller regimen (combination inhaler or ICS+LABA or chronic oral corticosteroids >90 days in last 120 days); appropriate dosing per product labeling required.age ≥12

Coverage and dosing guidance

Coverage guidance and authorization durations (applies across indications):

Continuation of Therapy: Resubmission by the prescriber will be considered evidence of a positive clinical response to therapy.

Approval Durations: Initial approvals: Chronic idiopathic urticaria (CIU) — 4 months; all other indications — 6 months. Reauthorizations: CIU — 4 months; all other diagnoses — 12 months.

CIU higher-dose temporary approvals: Requests for 450 mg every 4 weeks or 150 mg every 2 weeks can be approved for 3 months. If inadequate response, escalation to 600 mg every 4 weeks or 300 mg every 2 weeks can be considered for a 3-month approval if the provider submits a request. Recertification for either escalated dosing requires documentation of positive response.

Dosing by indication and weight: Appendix B contains weight-based dosing tables for multiple indications (including pediatric allergy-related asthma and adult nasal polyps) with specific mg doses and frequencies every 2 or 4 weeks; tables include 'Do Not Dose' entries and instruction to refer to package insert for weight > 125 kg where applicable.

For members new to the plan who are already receiving and stable on a medication, the plan may perform a case‑by‑case review to consider continuation. Medications obtained solely as samples or through a manufacturer's patient assistance program are excluded from consideration for case‑by‑case continuation and therefore should not be relied on as evidence of ongoing therapy when submitting a continuation request.

Dose selection for weight‑based indications follows the tables in Appendix B. The appendix includes explicit "Do Not Dose" entries for specific weight and dosing‑frequency combinations and states to refer to the package insert for members weighing >125 kg. Providers should follow the appendix and the manufacturer's labeling when requesting doses outside standard weight ranges.

The policy was updated to remove the prior requirement for a trial of a leukotriene receptor antagonist (LTRA) — for example, montelukast — from the CRSwNP and CIU/Xolair criteria. This change reflects safety concerns and updated guidance about montelukast and means an LTRA trial is no longer required as part of prior‑therapy step requirements for those indications.

Within this portion of the policy there are no agents explicitly labeled as Not Medically Necessary (NMN). Off‑label uses (for example, systemic mastocytosis with omalizumab) are addressed with specific clinical requirements rather than an NMN designation.

Laboratory Thresholds and Coding-Adjacent Values

Serum IgE and peripheral blood eosinophil thresholds (by indication)

IgE thresholds for Xolair (food allergy)Baseline serum IgE 30 to 1,850 IU/mL (IgE‑mediated food allergy)

IgE thresholds for Xolair (allergy-related asthma)Baseline serum IgE 30 to 700 IU/mL (moderate to severe allergy‑related asthma; appendix available for higher IgE levels)

Peripheral blood eosinophil threshold (general eosinophilic asthma/COPD)Peripheral blood eosinophil count ≥150 cells/µL (eosinophilic phenotype required for severe eosinophilic asthma and Nucala COPD indication)

Higher eosinophil threshold (step requirement)For members with eosinophils ≥300 cells/µL (Nucala COPD), an inadequate response/adverse reaction/contraindication to dupilumab is required before Nucala

Eosinophil threshold for some adult severe asthma criteriaPeripheral blood eosinophil count ≥400 cells/µL referenced in select adult severe eosinophilic asthma criteria

Provider Required Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for the agents and indications covered by this policy. Submit documentation of the diagnosis, relevant prior therapies, dosing requested, member age, and involvement of an appropriate specialist. Requests from members new to the plan who are stable on therapy will be reviewed on a case‑by‑case basis; authorization may be granted when adequate supporting documentation is provided. Absent documentation (e.g., no specialist notes or treatment history) may result in delay or denial.

Prior authorization required for all covered indications
Provide diagnosis, prior treatment history, dosing, age, and specialist involvement
New‑to‑plan continuation considered case‑by‑case — documentation required

Prior Authorization

Approval Durations and Limited Approvals for Escalated Dosing

Initial approvals and reauthorizations follow indication‑specific durations. Initial approvals: chronic idiopathic urticaria (CIU/CSU) — 4 months; all other indications — 6 months. Reauthorizations: CIU/CSU — 4 months; all other diagnoses — 12 months. Limited approvals (e.g., escalated or nonstandard dosing) will be granted for shorter trial periods (typically 3 months) to assess response; continued approval for higher‑than‑standard dosing requires documentation of clinical benefit at recertification.

Background and Scope

This policy addresses multiple monoclonal antibody biologic therapies used as add‑on or disease‑modifying treatments across allergic and eosinophilic disorders, including agents such as omalizumab (Xolair), mepolizumab (Nucala), reslizumab (Cinqair), benralizumab, tezepelumab and others. Covered indications span chronic spontaneous urticaria, IgE‑mediated food allergy, allergic asthma, chronic rhinosinusitis with nasal polyps, eosinophilic granulomatosis with polyangiitis (EGPA), hypereosinophilic syndrome (HES), and severe eosinophilic asthma. The policy requires prior authorization with documentation of diagnosis, specialist involvement or consult notes, appropriate dosing and age criteria, and evidence of inadequate response or contraindication to specified prior therapies where noted; it also includes indication‑specific laboratory thresholds (for example, eosinophil counts or serum IgE ranges), weight‑based dosing tables, and defined approval durations.

Key Definitions and Phenotypes

Eosinophilic phenotype — peripheral blood eosinophil thresholds and related markers

DefinitionEosinophilic phenotype is evidenced by peripheral blood eosinophil count (thresholds vary by indication: e.g., ≥150 cells/µL or ≥300 cells/µL), elevated sputum eosinophils, or elevated FeNO.

Common threshold for pediatric/adult severe eosinophilic asthmaPeripheral blood eosinophils ≥150 cells/µL used for many severe eosinophilic asthma criteria (including pediatric ages >6 years)

Higher-threshold adult criterionSome adult severe asthma criteria use a peripheral blood eosinophil count ≥400 cells/µL (agent-specific)

Actionable requirement (most relevant)Document peripheral blood eosinophil count meeting the applicable threshold (commonly ≥150 cells/µL) to establish eosinophilic phenotype for biologic coverage

CRSwNP — definition and relation to biologic indications

Policy Summary

PayerMass General Brigham Health Plan

PolicyAsthma and Allergy Injectables (biologic therapies) — Prior Authorization and Coverage Criteria

Policy CodePolicy N/A

Change TypeMaterial revisions and benefit routing updates

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with specialist documentation, indication-specific dosing and evidence of prior therapy response as specified per agent.

SourceLink

On This Page

Billing Rule

Update PA Processes to Reflect Formulary and Criteria Changes

Ensure PA workflows and routing reflect current formulary and program changes (examples: Dupixent moved to pharmacy benefit and is managed via the MHDL; certain agents may be routed to the medical benefit). Update internal checklists to align with the latest criteria and benefit routing to avoid administrative denials.

Update benefit routing when agents move between pharmacy and medical benefits (e.g., Dupixent removed from medical criteria effective 6/1/25)
Cinqair (reslizumab) is available via the medical benefit (effective 4/1/23)
Align internal PA forms with current indication and age updates to prevent misrouting

Documentation Required

Recertification Requires Documentation of Positive Response

Recertification/continuation requests must include documentation demonstrating a positive clinical response to therapy. Per policy, prescriber resubmission implies benefit, but explicit objective or clinical documentation (symptom improvement, reduced exacerbations/steroid use, spirometry, eosinophil counts, or validated symptom scores) should be provided, especially when requesting ongoing high or escalated dosing.

Resubmission alone implies positive response but include objective clinical data when possible
Requests for maintenance of escalated dosing require documented improvement during the limited approval period
Absence of response documentation on recertification may lead to denial

Step Therapy

Step Therapy / Prior Treatment Requirements

Step‑therapy or prior treatment requirements must be documented. For many biologic indications, the provider must show inadequate response, intolerance, or contraindication to specified prior therapies (e.g., trials of inhaled controller regimens for asthma, trials of second‑generation H1 antihistamines with up‑dosing for CIU/CSU, prior intranasal/oral corticosteroids or surgery for nasal polyps). When criteria specify a trial (duration thresholds apply), provide dates and objective evidence of inadequate response.

Document inadequate response, intolerance, or contraindication to required prior therapies
Include dates, agents, doses, and duration of prior trials (e.g., 2×90 days within 120 days where specified)
If a required trial is bypassed, provide rationale (e.g., contraindication, intolerance, or disease severity)

Step Therapy

Step Therapy Adjustments for Biologics

Some biologic-specific step therapy and step‑through pathways have been modified; providers must follow the updated step logic in the policy (examples include Nucala, Fasenra, Dupixent, and Xolair). When the policy allows step‑through (e.g., using one biologic after inadequate response to another) or removes prior-agent requirements, document prior biologic exposure and reasons for switching.

Follow updated step‑through and step adjustments (e.g., Nucala/Fasenra sequencing, Dupixent criteria changes)
Document prior biologic use, response, and rationale for switching
Check the policy revision history for recent changes to step therapy logic

Documentation Required

Specialist Prescriber or Consult Notes Required

Specialist prescriber or consult notes are frequently required. Appropriate specialists include allergist/immunologist, dermatologist, otolaryngologist, pulmonologist, or asthma specialist as indicated by the disease state. If the prescriber is not a specialist, include consult notes from a specialist documenting evaluation and recommendation.

Include specialist prescriber information or specialist consult documentation
Acceptable specialties: allergist/immunologist, dermatologist, otolaryngologist (ENT), pulmonologist, asthma specialist

Billing Rule

Benefit Routing Documentation

Document benefit routing on the PA submission (medical vs pharmacy) to ensure correct processing. Administrative changes in the review history (e.g., agents moving between benefits) must be reflected on the PA form to route to the correct benefit and avoid denials.

Indicate whether drug is requested via medical or pharmacy benefit
Reference recent routing changes (e.g., Dupixent managed via pharmacy as of 6/1/25, Cinqair medical benefit effective 4/1/23)

EGPA — definition and relation to updated biologic criteria

DefinitionEGPA = eosinophilic granulomatosis with polyangiitis; included as a covered indication for agents such as mepolizumab (Nucala) and now Fasenra per updates.

Authorization age and prescriberCriteria specify adult age (e.g., ≥18 years where indicated) and prescriber specialist involvement (allergist, cardiologist, hematologist, immunologist, pulmonologist, rheumatologist) or consult notes.

Prior treatment/step changesNucala EGPA criteria were updated to remove trial/failure requirements for azathioprine and methotrexate and to add step‑through with Fasenra; document inadequate response (defined as ≥30 days) to systemic glucocorticoid or contraindication to systemic glucocorticoids as required per agent.

Dosing noteAgent‑specific dosing applies (examples in policy include 300 mg SC q28d or 30 mg SC q28d depending on agent).