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Pharmacy Medical Policy Asthma and Chronic Obstructive Pulmonary Disease Medication Management Table of Contents Authorization Information Coverage Criteria
Description
Appendix Policy History
Coding Information References Endnotes
Policy Number: 011 BCBSA Reference Number: N/A Related Policies • Quality Care Dosing guidelines may apply to the following medications and can be found in Medical Policy #621A.

Prior Authorization Information

Policy ☒ Prior Authorization ☐ Step Therapy ☒ Quality Care Dosing ☐ Administrative Reviewing Department Pharmacy Operations: Tel: 1-800-366-7778 Fax: 1-800-583-6289 To request for coverage: Providers may call, fax, or mail the attached form (Formulary Exception/Prior Authorization form) to the address below.
Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department 25 Technology Place Hingham, MA 02043
Tel: 1-800-366-7778 Fax: 1-800-583-6289

Individual Consideration for the atypical patient: Policy for requests that do not meet clinical criteria of this policy, see section labeled Individual Consideration
Policy Last Updated 1/15/2026 Pharmacy (Rx) or Medical (MED) benefit coverage ☒ Rx ☐ MED Policy applies to Commercial members with BCBSMA formulary:
• Managed Care (HMO/POS) • PPO/EPO
• Indemnity
• MEDEX with Rx plans • Managed Blue for Seniors Policy does NOT apply to: • Medicare Advantage
Provider Documentation Requirements: Documentation from the provider to support a reason preventing trial of formulary alternative(s) must include the name and strength of alternatives tried and failed (if alternatives were tried, including dates if available) and specifics regarding the treatment failure. Documentation to support clinical basis preventing switch to formulary alternative should also provide specifics around clinical reason. We may also use prescription claims records to establish prior use of formulary alternatives or to show if step therapy criteria has been met. We will require the provider to share additional information when prescription claims data is either not available or the medication fill history fails to establish use of preferred formulary medications or that step therapy criteria has been met. Other documentation requirements, if any, are outlined in prior authorization criteria.

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See Appendix for additional information. The following is a comprehensive policy covering prior authorization and quantity limit requirements for inhaled medications used for the treatment of Asthma and/or chronic obstructive pulmonary disease (COPD). Formulary status/requirements of the medications affected by this policy: Drug Formulary Status
(BCBSMA Commercial Plan) Special Considerations Covered Advair Diskus (Fluticasone/Salmeterol)

PA, QCD

Advair HFA (Fluticasone/Salmeterol) Breztri
(budesonide/glycopyrrolate/formoterol) Dulera (mometasone/formoterol) Fluticasone/Salmeterol
Incruse Ellipta (umeclidinium) Trelegy Ellipta
(fluticasone/umeclidinium/vilanterol) Wixela Inhub (Fluticasone/Salmeterol) Non-Formulary Non-Covered AirDuo (Fluticasone/Salmeterol)

NFNC, PA, QCD

Breo Ellipta (fluticasone /vilanterol) Fluticasone /Vilanterol Inhaler
(Breo Ellipta Authorized Generic) Symbicort (Budesonide/Formoterol) PA – Prior Authorization; NFNC – Non-formulary, Non-Covered; QCD (Quality Care Dosing – refer to Policy 621b)
Approval Length: 12 months, unless otherwise specified in Clinical Guideline Coverage Criteria

No Requirements BCBSMA formulary coverage options for inhalers, include, but may not be limited to: Albuterol HFA (Proair & Proventil generics) Anoro Ellipta Arnuity Ellipta

Breyna
budesonide / formoterol fluticasone propionate

Perforomist Proair
Pulmicort Qvar Serevent Spiriva

Clinical Guideline Coverage Criteria: Dulera Dulera may be considered MEDICALLY NECESSARY and covered when ONE (1) of the following criteria is met:

1. A documented diagnosis of Asthma, OR
2. Claim history or prescriber documentation of previous use of ONE (1) of the following medications:

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• Inhaled corticosteroid • Inhaled beta2 agonist • Inhaled mast cell stabilizer • Inhaled anticholinergic • Oral albuterol product
• Oral theophylline containing product
• Dulera • Breyna • Budesonide / Formoterol • Fluticasone/Salmeterol (all generics, including Wixela Inhub) Clinical Guideline Coverage Criteria: Fluticasone/Salmeterol, Wixela Inhub Fluticasone/Salmeterol (all generics) and Wixela Inhub may be considered MEDICALLY NECESSARY and covered when ONE (1) of the following criteria is met:

1. A documented diagnosis of Asthma or COPD, OR
2. Claim history or prescriber documentation of previous use of ONE (1) of the following medications: • Inhaled corticosteroid • Inhaled beta2 agonist • Inhaled mast cell stabilizer • Inhaled anticholinergic • Oral albuterol product
   • Oral theophylline containing product.
   • Dulera • Breyna • Budesonide / Formoterol • Fluticasone/Salmeterol (all generics, including Wixela Inhub) Clinical Guideline Coverage Criteria: Advair HFA or AirDuo Advair HFA, or AirDuo may be considered MEDICALLY NECESSARY and covered when ALL of the following criteria are met:
3. A documented diagnosis of asthma, AND
4. Claim history or prescriber documentation of previous use of ONE (1) of the following medications, • Inhaled corticosteroid • Inhaled beta2 agonist • Inhaled mast cell stabilizer • Inhaled anticholinergic • Oral albuterol product
   • Oral theophylline containing product, AND
5. Claim history or prescriber documentation of previous use of TWO (2) of the following medications: • Dulera (mometasone/formoterol) • Breyna (Budesonide/Formoterol) • Budesonide / Formoterol • Fluticasone/Salmeterol (all generics, including Wixela Inhub)

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Clinical Guideline Coverage Criteria: Advair Diskus, Symbicort Advair Diskus, Symbicort (Budesonide/Formoterol) may be considered MEDICALLY NECESSARY and covered when ALL of the following criteria are met:

1. A documented diagnosis of Asthma or COPD, AND
2. Claim history or prescriber documentation of previous use of ONE (1) of the following medications: • Inhaled corticosteroid • Inhaled beta2 agonist • Inhaled mast cell stabilizer • Inhaled anticholinergic • Oral albuterol product
   • Oral theophylline containing product, AND
3. Claim history, or prescriber documentation of previous use of, TWO (2) of the following medications: • Breyna (Budesonide/Formoterol) • Budesonide / Formoterol • Fluticasone/Salmeterol (all generics, including Wixela Inhub) Clinical Guideline Coverage Criteria: Breo Ellipta, fluticasone/vilanterol (authorized generic) Breo Ellipta or fluticasone /vilanterol Inhaler (Authorized Generic) may be considered MEDICALLY NECESSARY and covered when ALL of the following criteria are met:
4. A documented diagnosis of Asthma or COPD, AND
5. Claim history or prescriber documentation of previous use of ONE (1) of the following medications: • Inhaled corticosteroid • Inhaled beta2 agonist • Inhaled mast cell stabilizer • Inhaled anticholinergic • Oral albuterol product
   • Oral theophylline containing product, AND
6. For diagnosis of Asthma, claim history or prescriber documentation of previous use of TWO (2) of the following medications.
   • Dulera (mometasone/formoterol) • Breyna (Budesonide/Formoterol) • Budesonide / Formoterol • Fluticasone/Salmeterol (all generics, including Wixela Inhub), OR
7. For diagnosis of COPD, claim history or prescriber documentation of previous use of ONE (1) of the following: • Breyna (Budesonide/Formoterol) • Budesonide / Formoterol • Fluticasone/Salmeterol (Most generics, including Wixela Inhub, but excluding AirDuo generics)

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Clinical Guideline Coverage Criteria: Breztri Breztri may be considered MEDICALLY NECESSARY and covered when ALL of the following criteria are met:

1. A documented diagnosis of COPD; AND
2. Claim history or prescriber documentation of previous use of ONE (1) of the following medications: • Inhaled corticosteroid • Inhaled beta2 agonist • Inhaled mast cell stabilizer • Inhaled anticholinergic • Oral albuterol product
   • Oral theophylline containing product.
   • Inhaled Corticosteroid /Long-acting Beta agonist • Long-acting muscarinic antagonist -containing product. • Long-acting Beta agonist -containing product, AND
3. Claim history or prescriber documentation of previous use of ONE (1) of the following medications: • Breyna (Budesonide/Formoterol) • Budesonide / Formoterol • Anoro Ellipta (umeclidinium bromide and vilanterol trifenatate) • Stiolto (tiotropium bromide and olodaterol • Fluticasone/Salmeterol (Most generics, including Wixela Inhub, but excluding AirDuo generics) Clinical Guideline Coverage Criteria: Incruse Ellipta Incruse Ellipta may be considered MEDICALLY NECESSARY and covered when ALL of the following criteria are met:
4. A documented diagnosis of COPD, AND
5. Claim history or prescriber documentation of previous use of Spiriva (tiotropium bromide). Clinical Guideline Coverage Criteria: Trelegy Ellipta Trelegy Ellipta may be considered MEDICALLY NECESSARY and covered when ALL of the following criteria are met:
6. A documented diagnosis of Asthma OR COPD, AND
7. Claim history or prescriber documentation of previous use of ONE (1) of the following medications:
   • Inhaled corticosteroid • Inhaled beta2 agonist • Inhaled mast cell stabilizer • Inhaled anticholinergic • Oral albuterol product
   • Oral theophylline containing product.
   • Inhaled Corticosteroid /Long-acting Beta agonist • Long-acting muscarinic antagonist -containing product. • Long-acting Beta agonist -containing product,
   AND
8. Claim history or prescriber documentation of previous use of ONE (1) of the following medications :

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• Breyna ™ (Budesonide/Formoterol) • Budesonide / Formoterol • Dulera ® (mometasone/formoterol) • Fluticasone/Salmeterol (all generics, including Wixela Inhub ®) • Anoro Ellipta (umeclidinium bromide and vilanterol Trifenatate • Stiolto (tiotropium bromide and olodaterol) Description Asthma and chronic obstructive pulmonary disease (COPD) are both common inflammatory airway diseases. Even though distinct disorders, about 20 percent of patients with obstructive lung disease have features of both. When this overlap is suspected, diagnosis is based on symptoms and assessment of lung function and airway inflammation.
Asthma is commonly diagnosed in childhood when symptoms such chest tightness, cough, wheezing, and breathlessness are present typically with variability from day to day but worse at night and early morning. Other allergic conditions such as rhinitis and eczema may be present. COPD is however typically diagnosed in middle to older aged adults and is characterized by dyspnea that worsens with exercise or exertion and progresses over time. A history of recurrent infections, intermittent cough with our without sputum production and wheezing may also be present.
Appendix Formulary Status For non-covered medications, in addition to the prior authorization criteria, the member must also have had a previous treatment failure with, or contraindication to, at least two covered formulary alternatives when available. See section on individual consideration for more information if you require an exception to any of these criteria requirements for an atypical patient. Member cost share consideration A higher non-preferred cost share may be applied if an exception request is approved for coverage of a non-preferred or a non-formulary/non-covered drug. Prior Use Criteria The plan uses prescription claim records to support criteria for prior use within previous 130 days or the trial and failure of formulary alternatives when available. Additional documentation will be required from the provider when historic prescription claim data is either not available or the medication fill history fails to establish criteria for prior use or trial and failure of formulary alternatives. Documentation will also be required to support any clinical reasons preventing the trial and failure of formulary alternatives. Please see the section on documentation requirements for more information. Forms To request prior authorization using the Massachusetts Standard Form for Medication Prior Authorization Requests (eForm), click the link below: https://www.bluecrossma.org/medical- policies/sites/g/files/csphws2091/files/acquiadam- assets/023%20E%20Form%20medication%20prior%20auth%20instruction%20prn.pdf OR Print and fax, Massachusetts Standard Form for Medication Prior Authorization Requests #434

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Individual Consideration (for Atypical Patients) Our medical policies are written for most people with a given condition. Each policy is based on peer reviewed clinical evidence. We also take into consideration the needs of atypical patient populations and diagnoses.
If the coverage criteria outlined is unlikely to be clinically effective for the prescribed purpose, the health care provider may request an exception to cover the requested medication based on an individual’s unique clinical circumstances. This is also referred to as “individual consideration” or an “exception request.”
Some reasons why you may need us to make an exception include: therapeutic contraindications; history of adverse effects; expected to be ineffective or likely to cause harm (physical, mental, or adverse reaction).
To facilitate a thorough and prompt review of an exception request, we encourage the provider to include additional supporting clinical documentation with their request. This may include: • Clinical notes or supporting clinical statements; • The name and strength of formulary alternatives tried and failed (if alternatives were tried) and specifics regarding the treatment failure, if applicable; • Clinical literature from reputable peer reviewed journals; • References from nationally recognized and approved drug compendia such as American Hospital Formulary Service® Drug Information (AHFS-DI), Lexi-Drug, Clinical Pharmacology, Micromedex or Drugdex®; and • References from consensus documents and/or nationally sanctioned guidelines Providers may call, fax or mail relevant clinical information, including clinical references for individual patient consideration, to: 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 Samples Requests based exclusively on the use of samples will not meet coverage criteria for exception. Additional clinical information demonstrating medical necessity of the desired medication must be submitted by the requesting prescriber for review.

Policy History

Date Action 1/15/2026 Annual Review: Updated formatting and references. 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. 1/2024 Updated to move Symbicort to Non-formulary Non-Covered in the policy. 10/2023 Reformatted Policy and updated IC to align with 118E MGL § 51A. Updated to include summary of COPD, Asthma, and drugs with no coverage requirements. Added Breyna to the policy with UM criteria like Symbicort. 7/2023 Updated to move Wixela with the other Advair Generics. 4/2023 Updated to add generic Advair AG to same criteria as AirDuo Generic.
8/2022 Updated to add fluticasone /vilanterol Inhaler (Breo Ellipta ®** Authorized Generic [AG]) to the policy. 7/2022 Clarified coding for non-preferred medications for Asthma vs COPD.

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2/2022 Updated to add an additional option in criteria and add additional options to allow approval for the triple inhalers at the request of P & T. 1/2022 Updated to add Trelegy Ellipta® & Breztri™ to the policy. 6/2020 Updated to add AG of Symbicort to the policy as non-covered. 1/2020 Updated criteria for IncruseTM Ellipta® and clarify criteria for non-preferred.
3/2019 Updated to include Wixela Inhub & the AG to Advair Discus as Preferred and PA required. 1/2019 Updated to add Breo Ellipta™ back into the policy and it is still non covered medication. 1/2018 Updated to Include Fluticasone/Salmeterol, AirDuoTM and to modify Advair®/ AirDuoTM Criteria. 6/2017 Updated address for Pharmacy Operations. 9/2016 Updated to remove Step from policy. This resulted in the removal of Singulair®, AnoroTM ElliptaTM, StioltoTM Respimat® and BreoTM ElliptaTM from the policy. 6/2016 Updated to add SeebriTM Neohaler® and UtibronTM Neohaler® to step 3. 12/2015 Updated by adding IncruseTM Ellipta® to step 3. 8/2015 Added StioltoTM Respimat® to step 3 & removed Zyflo & Accolate from policy. 7/2015 Added new indication for BreoTM ElliptaTM 10/2014 Added AnoroTM ElliptaTM to the policy. 4/2014 Updated by moving montelukast & zafirlukast to Step 1 and Advair to step 3. 3/2014 Added BreoTM ElliptaTM to the policy. 1/2014 Updated ExpressPAth language and remove Blue Value. 8/2012 Updated to include coverage criteria for new generic montelukast. 11/2011- 4/2012 Medical policy ICD 10 remediation: Formatting, editing and coding updates.
No changes to policy statements.
1/1/2012 Updated to include coverage criteria for COPD diagnosis and to remove physician documented use criteria for requested medications.
5/2011 Reviewed - Medical Policy Group - Pediatrics and Endocrinology. No changes to policy statements. 3/2011 Reviewed - Medical Policy Group - Allergy/Asthma/Immunology and ENT/Otolaryngology. No changes to policy statements. 1/2011 Updated to include coverage criteria for new generic zafirlukast.
1/1/2011 Updated coverage criteria to require previous use of one inhaled corticosteroid, one inhaled beta2 agonist, one inhaled mast cell stabilizer, one oral albuterol product or one oral theophylline containing product by the patient within the previous 130 days for a diagnosis of Asthma.
11/2010 Updated to include coverage criteria of new FDA approved medication Dulera®.
5/2010 Reviewed - Medical Policy Group - Pediatrics. No changes to policy statements. 3/2010 Reviewed - Medical Policy Group - Pulmonology, Allergy and ENT/Otolaryngology. No changes to policy statements. 1/2010 Updated to change coverage criteria for Advair® Diskus and Advair ®HFA.
9/2009 Policy updated to change 180 day look back period to 130 days, remove Medicare Part D criteria from Medical Policy and update sample language.
5/2008 Reviewed - Medical Policy Group - Pediatrics. No changes to policy statements. 3/2008 Reviewed - Medical Policy Group - Pulmonology, Allergy and ENT/Otolaryngology. No changes to policy statements. 1/2008 Updated include prior authorization requirements for Advair Diskus®,Advair® HFA and Symbicort. 5/2007 Reviewed - Medical Policy Group - Pediatrics. No changes to policy statements. 3/2007 Reviewed - Medical Policy Group - Pulmonology, Allergy and ENT/Otolaryngology. No changes to policy statements. 2/2003 New policy, effective 2/2003, describing covered and non-covered indications.

References

1. 2020 Focused Updates to the Asthma Management Guidelines: A Report from the National Asthma Education and Prevention Program Coordinating Committee Expert Panel Working Group.

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http://nhlbi.nih.gov/resources/2020-focused-updates-asthma-management-guidelines. Accessed 10/9/2025.

2. 2025 Report: Global Initiative for Chronic Obstructive Lung Disease. https://goldcopd.org/2025-gold- report/. Accessed on 10/9/2025.
3. AirDuo [package insert]. Jerusalem, Israel: Teva Respiratory, LLC, July 2021.
4. Anoro Ellipta [package insert]. Research Triangle Park, NC: GlaxoSmithKline, June 2023.
5. Breo Ellipta [package insert]. Research Triangle Park, NC: GlaxoSmithKline, November 2024.
6. Curr Opin Allergy Clin Immunol 2(5):395-401, 2002. © 2002 Lippincott Williams & Wilkins.
7. Drazen JM, Israel E, O'Byrne PM. Treatment of Asthma with drugs modifying the leukotriene pathway. N Engl J Med 1999, 340:197-206.
8. Fluticasone/salmeterol [package insert]. Jerusalem, Israel: Teva Respiratory, LLC, July 2021.
9. Gibson PG, McDonald VM. Asthma-COPD overlap 2015: now we are six. Thorax 2015,70:683-91
10. Incruse Ellipta [package insert]. Research Triangle Park, NC: GlaxoSmithKline, December 2023.
11. Krawiec, ME., Jarjour,NJ, Leukotriene Receptor Antagonists 95(7):775-779, 2002. © 2002 Southern Medical Association.
12. McDonald VM, Gibson PG. “To define is to limit”: perspectives on Asthma-COPD overlap syndrome and personalized medicine. Eur Respir J 2017,49:1700336
13. National Asthma Education and Prevention Program Expert Panel Report 2: Guidelines for the Diagnosis and Management of Asthma 1997. Located at: http://www.nhlbi.nih.gov/guidelines/Asthma/index.htm. Accessed on: 11/3/2005.
14. National Asthma Education and Prevention Program Expert Panel Report 2: Guidelines for the Diagnosis and Management of Asthma—Update on Selected Topics 2002. Located at: http://www.nhlbi.nih.gov/guidelines/Asthma/index.htm. Accessed on: 11/3/2005.
15. Palmer LJ, Silverman ES, Weiss ST, Drazen JM. Pharmacogenetics of Asthma. Am J Respir Crit Care Med 2002, 165:861-866.
16. Semin Respir Crit Care Med 23(4):399-410, 2002. © 2002 Thieme Medical Publishers.
17. Stiolto Respimat [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharm., Inc., January 2025.