CurrentBlue Cross Blue Shield - MassachusettsPolicy 011

Inhaled medications for Asthma and COPD (prior authorization and quantity limits)

Covers prior authorization, quantity limit (Quality Care Dosing) requirements, formulary status, and medical necessity criteria for inhaled medications used to treat Asthma and COPD for BCBSMA commercial plans; includes provider documentation and individual consideration processes.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyInhaled medications for Asthma and COPD (prior authorization and quantity limits)

Policy CodePolicy 011

Change TypeCoverage and PA requirement updates

Effective Date

Next Review Date

Key ActionProviders must obtain prior authorization for medications listed as PA required using BCBSMA Pharmacy Operations processes.

POLICY UPDATE CHANGES

7/2024: Update to remove prior authorization of Breyna and other generics of Budesonide/Formoterol.

4/2024: Require diagnosis for Trelegy and Breztri to align with rest of the policy.

2/2024: Updated to add Fluticasone/Salmeterol to COPD part of Breo Ellipta's Criteria and to other drugs where it was missing.

12+Drugs listed

MultiplePA requirements

130 daysPrior use look-back window

Coverage Summary

Formulary Medication Groups & Codes

Formulary medications covered with no PAmixedCovered

Albuterol HFA	Proair and Proventil generics - covered, no PA
Anoro Ellipta	covered, no PA
Arnuity Ellipta	covered, no PA
Breyna	covered, no PA
budesonide formoterol	covered, no PA
Fluticasone Diskus or HFA	covered, no PA
Perforomist	covered, no PA
Proair	covered, no PA
Pulmicort	covered, no PA
Qvar	covered, no PA

1–10 of 12

1/2

Medications requiring PA (PA, QCD, NFNC noted)mixedCovered

Advair Diskus	Fluticasone/Salmeterol - Covered, PA, QCD
Advair HFA	Fluticasone/Salmeterol - Covered, PA, QCD
Breztri	budesonide/glycopyrrolate/formoterol - Covered, PA, QCD
Dulera	mometasone/formoterol - Covered, PA, QCD
Fluticasone/Salmeterol (generics)	Covered, PA, QCD
Incruse Ellipta	umeclidinium - Covered, PA, QCD
Trelegy Ellipta	fluticasone/umeclidinium/vilanterol - Covered, PA, QCD
Wixela Inhub	Fluticasone/Salmeterol - PA required
AirDuo	Fluticasone/Salmeterol - NFNC, PA, QCD
Breo Ellipta	fluticasone/vilanterol - NFNC, PA, QCD

1–10 of 12

1/2

Prior Authorization & Provider Requirements

General Prior Authorization / Formulary Requirements

All requests must meet prior authorization requirements; non-covered medications require prior treatment failure with at least two covered formulary alternatives when available. Higher non-preferred cost share may apply for exceptions.

ALL of the following

Prior Authorization requirement: All requests must meet the Prior Authorizations requirement
Non-covered medication exception: For non-covered medications, member must have previous treatment failure with, or contraindication to, at least two covered formulary alternatives when available
Cost share for exceptions: Higher non-preferred cost share may be applied if exception approved for non-preferred or non-formulary/non-covered drug

Prior Authorization

Obtain prior authorization for PA-required drugs

Providers must obtain prior authorization for medications listed as PA required (examples include Advair Diskus/HFA, Breztri, Dulera, Fluticasone/Salmeterol generics, Incruse, Trelegy, Wixela, AirDuo, Breo, Symbicort). Follow BCBSMA Pharmacy Operations processes to submit PA requests; submission methods (phone, fax, mail) are listed in the policy (see Request submission methods block).

Documentation Required

Document prior use of formulary alternatives

Provide claim history or prescriber documentation demonstrating prior use/trial and failure of required formulary alternatives (include name, strength, and dates if available). The plan will use prescription claims within the previous 130 days to support prior use; additional documentation is required if claim data are not available or do not establish prior use.

Documentation Required

Provide clinical rationale for individual consideration

For individual consideration or exceptions, include supporting clinical documentation: the names and strengths of alternatives tried and failed (with dates if available), relevant clinical notes, and citations to clinical literature, guidelines, or nationally recognized drug compendia to justify the request.

Names and strengths of alternatives tried and failed (dates if available)
Clinical notes or supporting clinical statements
Clinical literature or guideline references
Citations from drug compendia (e.g., AHFS-DI, Lexi-Drug, Clinical Pharmacology, Micromedex/Drugdex)

Billing Rule

Request submission methods

Prior authorization requests and supporting clinical information may be submitted by phone, fax, or mail to BCBSMA Pharmacy Operations. Contact: Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department, 25 Technology Place, Hingham, MA 02043. Phone: 1-800-366-7778. Fax: 1-800-583-6289. The Massachusetts Standard Form for Medication Prior Authorization Requests (eForm) is also available.

Initial / Medication-specific Medical Necessity Criteria

Medications Covered with No PA Requirements

The following medications are listed as covered with no prior authorization requirements for BCBSMA Commercial Plan:

ANY of the following

Anoro Ellipta - Covered, no PA requirements
Albuterol HFA (Proair and Proventil generics) - Covered, no PA requirements
Arnuity Ellipta - Covered, no PA requirements
Breyna - Covered, no PA requirements
Budesonide/Formoterol generics: budesonide formoterol - Covered, no PA requirements
Fluticasone Diskus/HFA: Fluticasone Diskus or HFA - Covered, no PA requirements
Perforomist - Covered, no PA requirements
Proair - Covered, no PA requirements
Pulmicort - Covered, no PA requirements
Qvar - Covered, no PA requirements
Serevent - Covered, no PA requirements
Spiriva - Covered, no PA requirements

Medications Requiring PA (PA, QCD or NFNC status noted where provided)

The following medications require prior authorization; QCD and NFNC status noted where provided.

ANY of the following

Advair Diskus (Fluticasone/Salmeterol) - Covered, PA, QCD; PA required
Advair HFA (Fluticasone/Salmeterol) - Covered, PA, QCD; PA required
Breztri (budesonide/glycopyrrolate/formoterol) - Covered, PA, QCD; PA required
Dulera (mometasone/formoterol) - Covered, PA, QCD; PA required
Fluticasone/Salmeterol generics: Fluticasone/Salmeterol (brand/generics) - Covered, PA, QCD; PA required

Dulera (mometasone/formoterol) Medical Necessity Criteria

Dulera may be considered medically necessary when ONE of the following is met:

Dulera criteria

Asthma diagnosis: A documented diagnosis of Asthma
Prior use list
- Inhaled corticosteroid
- Inhaled beta2 agonist
- Inhaled mast cell stabilizer
- Inhaled anticholinergic

Fluticasone/Salmeterol (all generics) and Wixela Inhub Criteria

Considered medically necessary when ONE of the following is met:

ANY of the following

Asthma or COPD diagnosis: A documented diagnosis of Asthma or COPD
Prior use list
- Inhaled corticosteroid
- Inhaled beta2 agonist
- Inhaled mast cell stabilizer
- Inhaled anticholinergic

Advair HFA or AirDuo Criteria

Considered medically necessary when ALL of the following are met:

ALL of the following

Asthma diagnosis: A documented diagnosis of ASTHMA
Prior use one category: Claim history or prescriber documentation of previous use of ONE of the following medications: inhaled corticosteroid; inhaled beta2 agonist; inhaled mast cell stabilizer; inhaled anticholinergic; oral theophylline containing product
Oral albuterol product
Prior use of two listed products
- Dulera (mometasone/formoterol)

Advair Diskus and Symbicort Criteria

Considered medically necessary and covered when ALL of the following criteria are met:

ALL of the following

Diagnosis Asthma or COPD: A documented diagnosis of Asthma or COPD
Prior use one category: Claim history or prescriber documentation of previous use of ONE of the following medications: inhaled corticosteroid; inhaled beta2 agonist; inhaled mast cell stabilizer; inhaled anticholinergic; oral theophylline containing product
Oral albuterol product
Prior use of two listed products
- Breyna (Budesonide/Formoterol)

Breo Ellipta / fluticasone vilanterol Inhaler (AG) Criteria

Considered medically necessary when ALL of the following criteria are met:

ALL of the following

Diagnosis Asthma or COPD: A documented diagnosis of Asthma or COPD
Prior use one category: Claim history or prescriber documentation of previous use of ONE of the following medications: inhaled corticosteroid; inhaled beta2 agonist

Continuation & Disease-specific Criteria

Breztri Criteria

Considered medically necessary and covered when ALL of the following criteria are met (for COPD):

ALL of the following

Diagnosis COPD: A documented diagnosis of COPD
Prior use one category: Claim history or prescriber documentation of previous use of ONE of the following: inhaled corticosteroid; inhaled beta2 agonist; inhaled mast cell stabilizer; inhaled anticholinergic; oral albuterol product; oral theophylline containing product; long-acting muscarinic antagonist-containing product; inhaled corticosteroid/long-acting beta agonist; long-acting beta agonist-containing product
Prior use alternate list: Claim history or prescriber documentation of previous use of ONE of the following: Breyna (Budesonide/Formoterol); Budesonide Formoterol; Anoro Ellipta; Stiolto (tiotropium bromide and olodaterol); Fluticasone/Salmeterol (most generics, including Wixela Inhub, excluding AirDuo generics)

Incruse Ellipta Criteria (partial text present)

Incruse Ellipta may be considered medically necessary and covered when ALL of the following criteria are met (criteria text partially present in document).

ALL of the following

Partial text note: Documented criteria required (full criteria not fully provided in policy text excerpt)

Trelegy Ellipta Criteria

Considered medically necessary and covered when ALL of the following criteria are met:

ALL of the following

Diagnosis Asthma or COPD: A documented diagnosis of Asthma OR COPD
Prior use one category: Claim history or prescriber documentation of previous use of ONE of the following: inhaled corticosteroid; inhaled beta2 agonist; inhaled mast cell stabilizer; inhaled anticholinergic; oral theophylline containing product; oral albuterol product; inhaled corticosteroid/long-acting beta agonist; long-acting beta agonist-containing product; long-acting muscarinic antagonist-containing product
Prior use alternate list: Claim history or prescriber documentation of previous use of ONE of the following: Breyna; Budesonide Formoterol; Dulera; Fluticasone/Salmeterol (all generics, including Wixela Inhub); Anoro Ellipta; Stiolto

Background & Definitions

This policy addresses inhaled therapies for Asthma and COPD and defines formulary status, prior authorization requirements, Quality Care Dosing application, and medical necessity criteria for BCBSMA commercial members. Clinically, Asthma is commonly diagnosed in childhood with variable symptoms such as chest tightness, cough, wheeze, and episodic breathlessness, often worse at night or early morning, whereas COPD is typically diagnosed in middle to older aged adults with progressive exertional dyspnea and possible chronic cough or sputum production; approximately 20% of patients with obstructive lung disease may have overlapping features. The policy lists drugs with no PA requirements and those requiring PA/QCD/NFNC and provides criteria and documentation expectations for prior use and exceptions.

Term	Definition
PA
Prior Authorization
QCD
Quality Care Dosing (refer to policy #626)
NFNC
Non-formulary, non-covered

Revision History

7/2024policy_revisionLatest

Update to remove prior authorization of Breyna and other generics of Budesonide/Formoterol: Breyna moved to covered with no PA requirements. (Policy History entry: 7/2024; Prior Authorization table shows Breyna covered with no PA.)

4/2024policy_revision

Require diagnosis for Trelegy and Breztri to align with rest of the policy: adds explicit diagnosis requirement for Trelegy and Breztri. (Policy History entry: 4/2024; Trelegy and Breztri criteria in document require documented diagnosis.)

2/2024policy_revision

Updated to add Fluticasone/Salmeterol to COPD part of Breo Ellipta's Criteria and to other drugs where it was missing: expanded COPD indication alignment. (Policy History entry: 2/2024; Breo/Breztri/Trelegy criteria reference fluticasone/salmeterol in COPD criteria.)

OpenPayer

Inhaled medications for Asthma and COPD (prior authorization and quantity limits)

Coverage Summary

Formulary Medication Groups & Codes

Prior Authorization & Provider Requirements

Initial / Medication-specific Medical Necessity Criteria

Continuation & Disease-specific Criteria

Background & Definitions

Clinical Evidence & Notes

Revision History