Mass General Brigham Health Plan Asthma Allergy Coverage Update

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:

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

OpenPayer

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

Indication-specific Coverage Criteria

Key Laboratory Thresholds and Coding Values

Prior Authorization, Documentation, and Step Therapy Requirements

Clinical and Policy Background

Key Definitions and Appendix

Policy Changes and Review Log