ModifiedMass General Brigham Health PlanPolicy N/A

Asthma and Allergy Injectables (Dupixent, Fasenra, Nucala, Xolair) - Coverage Criteria

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Prior authorization requirements and clinical coverage criteria for Dupixent, Fasenra, Nucala, and Xolair under the commercial pharmacy benefit.

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ModifiedMass General Brigham Health PlanPolicy N/A

Asthma and Allergy Injectables (Dupixent, Fasenra, Nucala, Xolair) - Coverage Criteria

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Sign up for all Mass General Brigham Health Plan policy alerts

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Prior authorization requirements and clinical coverage criteria for Dupixent, Fasenra, Nucala, and Xolair under the commercial pharmacy benefit.

Policy Summary

PayerMass General Brigham Health Plan

PolicyAsthma and Allergy Injectables (Dupixent, Fasenra, Nucala, Xolair) - Coverage Criteria

Policy CodePolicy N/A

Change TypeCriteria revisions and program updates

Effective DateMay 1, 2026

Last ReviewFeb 11, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with required diagnostic, lab (e.g., eosinophils or IgE), prior therapy documentation, and specialty prescriber details.

SourceLink

POLICY UPDATE CHANGES

Updated Nucala COPD criteria to require eosinophil count >= 300 cells/µL to align with 2026 GOLD COPD guidelines.

Policy no longer applies to the medical benefit and Cinqair was removed from the policy.

Added initial and reauthorization criteria for Xolair for IgE-mediated food allergy and added Xolair auto-injector with quantity limits.

Updated Dupixent criteria to include COPD and added multiple supplemental indications across years (eg, CSU, bullous pemphigoid).

Clarified step therapy language to indicate member must be new to the plan within the past 90 days.

4biologic products covered

Prior Authorizationprogram type

Commercial/Exchangeplan type applicable

2026-05-01Nucala COPD change effective

2018-2026review history range

Indication-specific Coverage Criteria

Chronic Obstructive Pulmonary Disease

Covered when ALL of the following are met

COPD biologic criteria: 1. Diagnosis of chronic obstructive pulmonary disease (COPD); 2. Member is 18 years of age or older; 3. Presence of Type 2 inflammation evidenced by blood eosinophils ≥ 300 cells/µL at baseline; 4. Member is receiving ONE of the following therapies at maximally tolerated doses: (a) triple therapy (ICS + LAMA + LABA) OR (b) if ICS are contraindicated, a LAMA and a LABA; 5. Within the past 12 months the member has had either (a) ≥2 exacerbations requiring systemic corticosteroids or (b) a COPD-related hospitalization or emergency-medical visit.eosinophils ≥300 cells/µL

From COPD section

Moderate-to-Severe Atopic Dermatitis

Covered when ALL of the following are met

Atopic dermatitis criteria: 1. Diagnosis of moderate-to-severe atopic dermatitis; 2. Member is at least 6 months old; 3. Affected body surface area ≥10% OR involvement of crucial body areas (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas); 4. Trial and failure, intolerance, or contraindication to at least ONE of: (a) medium or higher potency topical corticosteroid (see Appendix), (b) pimecrolimus cream, (c) tacrolimus ointment, or (d) Eucrisa — with minimum 30-day supply for listed agents (14 days for topical corticosteroids).BSA ≥10%

From Moderate-to-Severe Atopic Dermatitis section

Prurigo Nodularis

Covered when ALL of the following are met

Prurigo nodularis criteria: 1. Diagnosis of prurigo nodularis; 2. Member is 18 years of age or older; 3. Member has at least 20 nodular lesions; 4. ONE of the following: (a) inadequate response to ONE of: medium to super-high potency topical steroid, topical calcineurin inhibitor, phototherapy (e.g., UVB, PUVA), or pharmacologic treatment with methotrexate or cyclosporine; OR (b) intolerance or clinical reason to avoid the listed topical agents and/or methotrexate/cyclosporine.

From Prurigo Nodularis section

Eosinophilic Esophagitis

Covered when ALL of the following are met

EoE criteria: 1. Diagnosis of eosinophilic esophagitis as evidenced by BOTH: (a) chronic symptoms of esophageal dysfunction (e.g., dysphagia, food impaction, food refusal, abdominal pain, heartburn, regurgitation, chest pain, odynophagia) AND (b) esophageal biopsy findings showing eosinophil-predominant inflammation; 2. Member is at least 1 year of age and weighs at least 15 kg; 3. Poor control requiring additional treatment despite a trial of a proton pump inhibitor unless intolerant or contraindicated.age ≥1 year; weight ≥15 kg

From Eosinophilic Esophagitis section

Asthma (Moderate-to-Severe and Severe)

Covered when ONE of the following criterion sets is met (nested logic preserved)

Asthma criteria option A: Member has inadequate asthma control (e.g., hospitalization or emergency medical care visit within the past year) despite current treatment with ALL of the following medications at optimized doses: (i) inhaled corticosteroid; (ii) an additional controller (long-acting beta2-agonist, leukotriene modifier, or sustained-release theophylline); and (iii) oral glucocorticoids (≥5 mg/day prednisone or equivalent).

Asthma option a from Moderate-to-Severe Asthma

Asthma criteria option B: Member has a baseline blood eosinophil count ≥150 cells/µL and inadequate asthma control (e.g., hospitalization or emergency medical care visit within the past year) despite current treatment with BOTH: (i) inhaled corticosteroid and (ii) an additional controller (long-acting beta2-agonist, leukotriene modifier, or sustained-release theophylline) at optimized doses.eosinophils ≥150 cells/µL

Asthma option b from Moderate-to-Severe Asthma

Severe asthma eosinophilic biologic criteria: For severe asthma: diagnosis of severe asthma; member is ≥6 years of age; baseline blood eosinophils ≥150 cells/µL; inadequate asthma control despite BOTH: inhaled corticosteroid and an additional controller at optimized doses; member will not use the biologic as monotherapy.

Chronic Rhinosinusitis with Nasal Polyps

Covered when ALL of the following are met

CRSwNP criteria: 1. Age criterion (Dupixent: ≥12 years; other products/sections may reference ≥18 years where specified); 2. Diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP); 3. Medication will be used in combination with another agent for CRSwNP (e.g., intranasal corticosteroid); 4. Prescribed by or in consultation with an Allergist/Immunologist, Otolaryngologist, or Pulmonologist.

CRSwNP sections

Chronic Spontaneous Urticaria

Covered when ALL of the following are met

CSU criteria: 1. Diagnosis of chronic spontaneous urticaria (CSU); 2. Member is ≥12 years of age; 3. Both of the following: (a) persistent symptoms (itching and hives) for ≥6 consecutive weeks despite concurrent use of a second-generation H1 antihistamine unless contraindicated/intolerant; and (b) a minimum 2-week trial of up-dosing (e.g., up to 4x dose) of the second-generation H1 antihistamine unless contraindicated/intolerant; 4. Requested medication will be used concurrently with a second-generation H1 antihistamine unless contraindicated/intolerant.

CSU section

Bullous Pemphigoid

Covered when ALL of the following are met

Bullous pemphigoid criteria: 1. Diagnosis of bullous pemphigoid; 2. Member is 18 years of age or older; 3. Inadequate response, adverse reaction, or contraindication to at least ONE of: oral corticosteroid (e.g., prednisone), high or super-high potency topical corticosteroid, or tetracycline antibiotics (e.g., doxycycline); 4. Requested medication will be initiated in combination with a tapering course of oral corticosteroids unless contraindicated.

Bullous Pemphigoid section

Eosinophilic Granulomatosis with Polyangiitis (EGPA)

Covered when ALL of the following are met

EGPA major criteria: 1. Diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA); 2. Member is 18 years of age or older; 3. History or presence of eosinophil count >1000 cells/µL or blood eosinophils >10%; 4. At least TWO disease characteristics (e.g., biopsy with eosinophilic vasculitis; neuropathy; pulmonary infiltrates non-fixed; sino-nasal abnormality; cardiomyopathy; glomerulonephritis; alveolar hemorrhage; palpable purpura; ANCA positive); 5. ONE of: currently on corticosteroid therapy or has contraindication/intolerance to corticosteroids; 6. Disease has relapsed or is refractory to standard of care (corticosteroids with/without immunosuppressive therapy).eosinophils >1000 cells/µL or >10%

EGPA sections

Hypereosinophilic Syndrome

Covered when ALL of the following are met

HES criteria: 1. Diagnosis of hypereosinophilic syndrome (HES) without another identifiable non-blood-related cause; 2. Member is ≥12 years of age; 3. At least 2 HES flares within the past 12 months; 4. Inadequate response (≥30 days of therapy), adverse reaction, or contraindication to one of: systemic steroid, immunosuppressive, or cytotoxic therapy; 5. Absolute eosinophil count ≥1000 cells/µL for >6 months; 6. Prescriber is a specialist (allergist, cardiologist, hematologist, or immunologist).AEC ≥1000 cells/µL for >6 months

HES section

Moderate to Severe Asthma

Covered when ALL of the following are met

Asthma initial criteria: 1. Diagnosis of moderate to severe asthma; 2. Member is ≥6 years of age; 3. Positive skin test or in vitro reactivity to at least one perennial aeroallergen; 4. Pre-treatment IgE ≥30 IU/mL; 5. Inadequate asthma control despite optimized inhaled corticosteroid AND an additional controller (LABA, leukotriene modifier, or sustained-release theophylline); 6. Medication will not be used as monotherapy.IgE ≥30 IU/mL

Moderate to Severe Asthma (Xolair-specific)

Hypereosinophilic Syndrome (HES)

Covered when ALL of the following are met

HES initial criteria: 1. Diagnosis of HES; 2. Member is ≥12 years of age; 3. HES without another identifiable non-blood related cause; 4. ≥2 HES flares within the past 12 months; 5. Inadequate response/adverse reaction/contraindication to systemic steroid, immunosuppressive, or cytotoxic therapy (≥30 days); 6. Absolute eosinophil count ≥1000 cells/µL for >6 months; 7. Prescriber is a specialist (allergist, cardiologist, hematologist, or immunologist).

Chronic Obstructive Pulmonary Disease (COPD)

Covered when ALL of the following are met

COPD initial criteria: 1. Diagnosis of COPD; 2. Member is ≥18 years of age; 3. Presence of Type 2 inflammation evidenced by blood eosinophils ≥300 cells/µL at baseline; 4. Receiving maximally tolerated therapy: either triple therapy (ICS + LAMA + LABA) or if ICS contraindicated, LAMA + LABA; 5. Within past 12 months either ≥2 exacerbations requiring systemic corticosteroids or COPD-related hospitalization/ED visit.

Chronic Spontaneous Urticaria (CSU)

Covered when ALL of the following are met

CSU initial criteria: 1. Diagnosis of chronic spontaneous urticaria; 2. Member is ≥12 years of age; 3. a) Persistent symptoms for ≥6 consecutive weeks despite concurrent use of a second-generation H1 antihistamine unless contraindicated; b) Minimum 2-week trial of up-dosing (e.g., up to 4x dose) of the second-generation H1 antihistamine unless contraindicated; 4. Requested medication will be used concurrently with a second-generation H1 antihistamine unless contraindicated.

IgE-Mediated Food Allergy

Covered when ALL of the following are met

IgE-mediated food allergy initial criteria: 1. Diagnosis of IgE-mediated food allergy; 2. Member is ≥1 year of age; 3. Serum IgE ≥30 IU; 4. Requested medication is prescribed by or in consultation with an allergist or immunologist; 5. Medication will be used in conjunction with allergen avoidance.

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); 2. Member is ≥18 years of age; 3. Prescribed by or in consultation with an Allergist/Immunologist, Otolaryngologist, or Pulmonologist; 4. Medication will be used in combination with another agent for nasal polyps (e.g., intranasal corticosteroid).

Select updated coverage criteria and programmatic changes

Policy includes indication-specific criteria for biologics (examples summarized):

Nucala COPD criteria: Members with COPD considered for Nucala must have eosinophil count ≥300 cells/µL per 05/01/2026 update to align with 2026 GOLD guidelines.>=300 cells/µL

Change effective 05/01/2026

Removal of Cinqair: Cinqair has been removed from this combined policy and will have a separate policy effective 01/01/2026.

Policy no longer applies to the medical benefit as of 01/01/2026

Xolair additions: Initial and reauthorization criteria for Xolair for IgE-mediated food allergy were added and an Xolair auto-injector formulation with quantity limits was added (effective 10/1/2024).

Added effective 10/1/2024

This policy applies to the Commercial/Exchange pharmacy benefit only and does not describe coverage under MassHealth UPPL or the medical benefit. The agents listed are designated as specialty medications and must be dispensed through a contracted specialty pharmacy as indicated in the plan benefit information.

For certain asthma and related indications, the policy explicitly prohibits use of the biologic agent as monotherapy. For example, Xolair (omalizumab) must not be used as monotherapy and is only covered when the member remains on an optimized inhaled corticosteroid plus an additional controller. Prior authorization approvals are contingent on meeting indication-specific diagnostic, age, laboratory, and treatment history requirements, including documentation that the biologic will be used in combination with standard controller therapy rather than alone.

Cinqair (reslizumab) has been removed from this combined Asthma and Allergy Injectables policy and is no longer included among the agents covered here; it will be managed under its own separate policy effective 01/01/2026, per the policy review history.

Key Laboratory Thresholds and Coding Values

Eosinophil or IgE thresholds — examples across indications

COPD (example)Blood eosinophils ≥ 300 cells/µL at baseline

Severe asthma (baseline)Baseline blood eosinophils ≥ 150 cells/µL

HES (absolute count)Absolute eosinophil count ≥ 1000 cells/µL (see HES criteria)

EGPA (example)Eosinophil count > 1000 cells/µL or blood eosinophils >10%

Pre-treatment IgE (asthma/Xolair)Pre-treatment IgE ≥ 30 IU/mL

Pre-treatment IgE threshold

Xolair pre-treatment IgE threshold

Prior Authorization, Documentation, and Step Therapy Requirements

Prior Authorization

Prior Authorization Required

Prior authorization and specialty dispensing — PA required; specialty pharmacy dispensing requirement

Prior Authorization is required for these agents.
This medication is designated specialty and must be dispensed by a contracted specialty pharmacy.

Documentation Required

New member documentation requirement

If member is new to the plan (coverage effective date ≤ 90 days), submit medical records documenting the member is currently receiving the requested drug (exclude samples or manufacturer patient assistance program supply).

New‑to‑plan documentation required when plan coverage ≤ 90 days.
Records should demonstrate ongoing treatment with the requested agent.

Clinical and Policy Background

The covered products in this policy are biologic monoclonal antibodies used as add-on maintenance therapies for eosinophilic, atopic, and IgE-mediated diseases. Indications across the agents include severe and moderate-to-severe asthma, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, eosinophilic granulomatosis with polyangiitis (EGPA), hypereosinophilic syndrome (HES), atopic dermatitis, prurigo nodularis, bullous pemphigoid, eosinophilic esophagitis, and IgE-mediated food allergy (for omalizumab). These agents are intended to be used in conjunction with standard-of-care controller therapies and are subject to prior authorization and specialty pharmacy dispensing requirements under the Commercial/Exchange pharmacy benefit.

Key Definitions and Appendix

Type 2 inflammation / eosinophilic phenotype — clinical phenotype used for eligibility

DefinitionType 2 inflammation / eosinophilic phenotype: clinical phenotype characterized by eosinophilic inflammation often evidenced by elevated blood eosinophil counts

Policy useUsed as an eligibility criterion for select indications (e.g., COPD, asthma) where elevated blood eosinophils are required

Example threshold (COPD)Evidenced by baseline blood eosinophils ≥ 300 cells/µL for COPD indications

Type 2 inflammation (policy context) — baseline blood eosinophils ≥ 300 cells/µL for COPD

Policy threshold (COPD)Baseline blood eosinophils ≥ 300 cells/µL constitutes Type 2 inflammation for COPD eligibility

Indication specificsApplies to adults (≥18 years) with COPD considered for add-on biologic therapy

Policy Changes and Review Log

2026-05-01material_updateLatest

Updated Nucala (mepolizumab) COPD criteria to require baseline blood eosinophils >=300 cells/µL to align with 2026 GOLD COPD guidelines (effective per 02/11/2026 review).

2026-01-01material_update

Policy no longer applies to the medical benefit and Cinqair was removed from this combined policy (effective 01/01/2026).

2025-12-01material_update

Policy Summary

PayerMass General Brigham Health Plan

PolicyAsthma and Allergy Injectables (Dupixent, Fasenra, Nucala, Xolair) - Coverage Criteria

Policy CodePolicy N/A

Change TypeCriteria revisions and program updates

Effective DateMay 1, 2026

Last ReviewFeb 11, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with required diagnostic, lab (e.g., eosinophils or IgE), prior therapy documentation, and specialty prescriber details.

SourceLink

On This Page

eosinophils ≥150 cells/µL

Severe Asthma section

Xolair-specific asthma criteria: For Xolair (omalizumab) in moderate-to-severe asthma: diagnosis of moderate-to-severe asthma; member is ≥6 years of age; positive skin test or in vitro reactivity to at least one perennial aeroallergen; pre-treatment IgE ≥30 IU/mL; inadequate control despite inhaled corticosteroid and an additional controller at optimized doses; Xolair will not be used as monotherapy.IgE ≥30 IU/mL

Xolair-specific criteria

Pre-treatment IgE ≥ 30 IU/mL required for moderate-to-severe asthma and IgE-mediated food allergy criteria

ContextPositive skin test or in vitro reactivity to at least one perennial aeroallergen is also required for Xolair asthma criteria

Age relevanceApplies in asthma indications for patients ≥6 years and in food allergy for patients ≥1 year (per product labeling)

HES absolute eosinophil count requirement

HES absolute eosinophil count requirementAbsolute eosinophil count ≥ 1000 cells/µL for greater than six months

Flares requiredAt least 2 HES flares within the past 12 months required for initial approval

Prior therapy requirementInadequate response (≥30 days), adverse reaction, or contraindication to systemic steroid, immunosuppressive, or cytotoxic therapy is required

COPD blood eosinophils threshold

COPD blood eosinophils (policy)Baseline blood eosinophils ≥ 300 cells/µL (evidence of Type 2 inflammation)

Age requirementMember must be ≥18 years of age for COPD biologic criteria

Therapy backgroundMember must be receiving maximally tolerated therapy (triple therapy or LAMA+LABA if ICS contraindicated)

Eosinophil count for Nucala in COPD (updated threshold)

Updated Nucala COPD eosinophil thresholdMembers considered for Nucala for COPD must have blood eosinophil count ≥ 300 cells/µL (effective 05/01/2026)

AlignmentChange made to align with 2026 GOLD COPD guidelines per February 2026 update

Denial risk noteRequests not meeting the updated Nucala COPD eosinophil threshold may be denied

Denial Risk

Asthma eligibility risks (common reasons for denial)

Common reasons for denial for asthma requests include: missing or incorrect diagnosis, member not meeting age criteria, absent pre‑treatment IgE or allergen reactivity documentation, or inadequate control despite optimized controller therapy.

Ensure documentation of: positive skin test or in vitro reactivity to ≥1 perennial aeroallergen.
Pre‑treatment IgE ≥ 30 IU/mL must be provided for asthma approvals.
Evidence of inadequate asthma control despite an inhaled corticosteroid plus an additional controller (e.g., LABA, leukotriene modifier, or theophylline).

Denial Risk

HES eligibility risks (common reasons for denial)

Common reasons for denial for HES requests include insufficient flare history, inadequate eosinophil counts, or lack of prior trial of systemic therapy.

Document at least 2 HES flares within the past 12 months.
Provide absolute eosinophil count history showing ≥ 1000 cells/µL for > 6 months.
Document prior trial (≥ 30 days) of systemic steroid, immunosuppressive, or cytotoxic therapy or provide contraindication/intolerance.

Documentation Required

Evidence of clinical response required for reauthorization

Reauthorization requires submission of medical records supporting clinical improvement on therapy.

For atopic dermatitis: chart notes documenting lower disease activity (e.g., clear or almost clear skin) or improvement in signs/symptoms (redness, itching, oozing/crusting).
For asthma/COPD/other pulmonary indications: documented improvement in control or reduction in exacerbations and/or reduction in maintenance oral corticosteroid dose.
For HES and CRSwNP: objective or clinical evidence of decreased eosinophils and improvement in condition or symptom measures.

Documentation Required

Required documentation overview

Required documentation overview — reviewers will verify age limits, required prior trials or failures, specialty prescriber or consults when specified, and evidence of clinical response for reauthorization.

Include diagnosis, member age, baseline labs (e.g., IgE, absolute eosinophil counts) when indicated.
Include documentation of prior trials, failures, intolerances, or contraindications to standard therapies per indication.
Include specialty prescriber information or consultation notes when required (e.g., allergist, immunologist, otolaryngologist, pulmonologist, hematologist).
For new members (coverage ≤ 90 days), include records demonstrating current receipt of the requested drug.

Step Therapy

Step therapy expectations and new‑to‑plan requirement

Step therapy and new‑to‑plan requirement — where step or prior‑therapy requirements apply, approvals are contingent on documented failure, intolerance, or contraindication to standard therapies; when step restrictions are applied, the member must be new to the plan within the past 90 days for certain exceptions.

Document trial and failure (or intolerance/contraindication) of required prior agents for the specific diagnosis (e.g., topical corticosteroids for atopic dermatitis; ICS + additional controller for asthma).
When a step or 'new‑to‑plan' allowance is referenced, the member must have been new to the plan (coverage effective ≤ 90 days) to qualify for exceptions or continuity of therapy without completing step trials.
Provide dates and duration of prior trials (minimum durations are specified in indication criteria, e.g., 30 days unless otherwise noted).

Therapy requirementMember must be on maximally tolerated COPD therapy (e.g., ICS+LAMA+LABA) in addition to meeting eosinophil threshold

HES flare (policy context) — policy requires at least 2 HES flares in past 12 months for initial approval

HES flare (policy definition)An exacerbation event; policy requires at least 2 HES flares within the past 12 months for initial approval

Associated requirementsAlso requires AEC ≥1000 cells/µL for >6 months and prior inadequate response to systemic steroid, immunosuppressive, or cytotoxic therapy

Prescriber specialtyPrescriber must be a specialist (allergist, cardiologist, hematologist, or immunologist) for HES approvals

Topical corticosteroid potency groups — Appendix A potency classes (I–VII) with examples

Potency groups (overview)Appendix A groups topical corticosteroids into potency classes I–VII with example drugs, dosage forms, and strengths

High potency examples (Group III)Examples include fluocinonide, betamethasone dipropionate, triamcinolone acetonide in cream/ointment/foam forms

Lower-mid and low potency examples (Groups V–VI)Examples include desonide, hydrocortisone valerate, prednicarbate with specified dosage forms and strengths

Least potent (Group VII)Hydrocortisone (base, <2%) and other low-strength formulations listed as Group VII

Updated initial and reauthorization Nucala COPD criteria and adjusted age requirements for certain indications (effective 12/01/2025).

2024-10-01material_update

Added initial and reauthorization criteria for Xolair for IgE-mediated food allergy and added Xolair auto-injector with quantity limitations (effective 10/01/2024).

2023-12-13update

Reviewed and updated policy language across multiple indications (Dec P&T), including changes to concomitant biologic wording and Dupixent/Nucala/Xolair criteria (effective 01/01/2024 noted in entry).