Pharmacy Prior Authorization Criteria

Long-Acting Bronchodilator Combinations - PA, ST, NF

Indications for Prior Authorization

Airduo Respiclick (fluticasone propionate and salmeterol) Inhalation Powder, Airduo Digihaler (fluticasone propionate and salmeterol) Inhalation Powder

• For diagnosis of Asthma
  Indicated for the treatment of asthma in patients aged 12 years and older. Airduo should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta-2 adrenergic agonist (LABA).

  Limitations of Use: Airduo is NOT indicated for the relief of acute bronchospasm.

Bevespi Aerosphere (glycopyrrolate and formoterol fumarate)

• For diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
  Indicated for the long-term, maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

  Limitation of use: Bevespi Aerosphere is not indicated for the relief of acute bronchospasm or for the treatment of asthma.

Dulera (mometasone/formoterol) Inhalation Aerosol

• For diagnosis of Asthma
  Indicated for the treatment of asthma in patients 5 years of age and older. Dulera should be used for patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and long-acting beta-2-adrenergic agonist (LABA).

  Limitation of Use: Dulera is not indicated for the relief of acute bronchospasm.

Duaklir Pressair (aclidinium bromide and formoterol fumarate)

• For diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
  Indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

  Limitations of Use: Not indicated for the relief of acute bronchospasm or for the treatment of asthma.

Wixela Inhub (fluticasone/salmeterol) Inhalation Powder

• For diagnosis of Asthma
  Indicated for twice-daily treatment of asthma in patients aged 4 years and older. Wixela Inhub should be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and long-acting beta - adrenergic agonist (LABA).

  Limitations of Use: Wixela Inhub is NOT indicated for the relief of acute bronchospasm

• For diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
  Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

  Limitations of Use: Wixela Inhub is NOT indicated for the relief of acute bronchospasm.

Symbicort (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol, Breyna (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol

• For diagnosis of Asthma
  Indicated for the treatment of asthma in patients 6 years of age and older. Symbicort should be used for patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long-acting beta2-adrenergic agonist (LABA).

• For diagnosis of Chronic Obstructive Pulmonary Disease
  Maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. Limitations of Use: Not indicated for the relief of acute bronchospasm.

Criteria

Bevespi, Duaklir Pressair

Step Therapy

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• Trial and failure (of a minimum 30-day supply), contraindication, or intolerance to both of the following:
• Anoro Ellipta
• Stiolto Respimat

Brand Airduo Respiclick, Brand fluticasone propionate/salmeterol (Airduo Resplick ABA), Airduo Digihaler, Brand Advair Diskus, Brand Symbicort

^Brand product may be excluded, please consult client-specific resources to confirm formulary coverage. Recommend brand or generic product based on lower tier product.

Step Therapy

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• Trial and failure (of a minimum 30-day supply) or intolerance to any two of the following:
• Advair HFA (fluticasone/salmeterol)
• Breo Ellipta (fluticasone/vilanterol)
• Symbicort (budesonide/formoterol)^

Dulera

^Brand product may be excluded, please consult client-specific resources to confirm formulary coverage. Recommend brand or generic product based on lower tier product.

Step Therapy

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• One of the following:
• Patient is 5 years of age
OR
• All of the following:
• Patient is 6 years of age to 12 years of age
AND
• Trial and failure (of a minimum 30-day supply) or intolerance to Symbicort (budesonide/formoterol)^
AND
• One of the following:
• Trial and failure (of a minimum 30-day supply) or intolerance to Breo Ellipta (fluticasone/vilanterol)
OR
• Patient requires a metered dose inhaler used with a spacer device due to one of the following:
• Physical dexterity
• Inspiratory flow
• Cognitive status
OR
• Both of the following:
• Patient is 12 years of age or older
AND
• Trial and failure (of a minimum 30-day supply) or intolerance to any two of the following:
• Advair HFA (fluticasone/salmeterol)
• Breo Ellipta (fluticasone/vilanterol)
• Symbicort (budesonide/formoterol)^

Dulera

^Brand product may be excluded, please consult client-specific resources to confirm formulary coverage. Recommend brand or generic product based on lower tier product.

Non Formulary

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• One of the following:
• Patient is 5 years of age
OR
• All of the following:
• Patient is 6 years of age to 12 years of age
AND
• Submission of chart notes (e.g., chart notes) or paid claims confirming trial and failure (of a minimum 30-day supply) or intolerance to Symbicort (budesonide/formoterol)^
AND
• Submission of chart notes (e.g., chart notes) and/or paid claims confirming one of the following:
• Trial and failure (of a minimum 30-day supply) or intolerance to Breo Ellipta (fluticasone/vilanterol)
OR
• Patient requires a metered dose inhaler used with a spacer device due to one of the following:
• Physical dexterity
• Inspiratory flow
• Cognitive status
OR
• Both of the following:
• Patient is 12 years of age or older
AND
• Submission of chart notes (e.g., chart notes) and/or paid claims confirming trial and failure (of a minimum 30-day supply) or intolerance to any two of the following:
• Advair HFA (fluticasone/salmeterol)
• Breo Ellipta (fluticasone/vilanterol)
• Symbicort (budesonide/formoterol)^

Generic budesonide/formoterol, Breyna

Prior Authorization, Non Formulary

Length of Approval: 12 Month(s)

• One of the following:
• Requested drug is FDA-approved for the condition being treated
OR
• If requested for an off-label indication, the off-label guideline approval criteria have been met
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming at least 6 months of use of brand Symbicort within the previous 365 days
AND
• Justification provided for why the generic is expected to provide benefit when brand Symbicort has not been shown to be effective

Generic fluticasone/salmeterol powder, Wixela Inhub

Step Therapy

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• Trial and failure (of a minimum 30-day supply) or intolerance to one of the following:
• Advair HFA (fluticasone/salmeterol)
• Breo Ellipta (fluticasone/vilanterol)
• Brand Symbicort

P & T Revisions

2024-04-18, 2024-04-08, 2024-01-30, 2023-12-01, 2023-10-23, 2023-08-14, 2023-02-22, 2022-10-13, 2022-03-01, 2021-11-17, 2021-02-22, 2020-10-08, 2020-05-18, 2020-03-06, 2019-10-02

References

1. Dulera Prescribing Information. Merck & Co., Inc. Whitehouse, NJ. March 2023.
2. Bevespi Aerosphere Prescribing Information. AstraZeneca Pharmaceuticals LP. Wilmington, DE. March 2023.
3. Airduo Respiclick Prescribing Information. Teva Respiratory, LLC. Frazer, PA. February 2024.
4. Airduo Digihaler Prescribing Information. Teva Respiratory, LLC. Frazer, PA. January 2023.
5. Duaklir Pressair Prescribing Information. Circassia Pharmaceuticals Inc. Morrisville, NC. January 2022.
6. Wixela inhub Prescribing Information. Mylan Pharmaceuticals Inc. Morgantown, WV. August 2022

---

Revision History

• 2024-04-18: GPI table clean up
• 2024-04-08: 2024 UM Annual Review. Added in minimum 30 day trial duration to ST criteria. For Dulera, removed step requirement for patients 5 years of age. For patients 6-12 years of age, updated step requirement to try both Symbicort and Breo, unless patient requires a spacer use. Background updates
• 2024-01-30: Program update to clarify preferred alternative for Wixela Inhub and generic fluticasone/salmeterol.
• 2023-12-01: Program update for generic Advair Diskus/Wixela.
• 2023-10-23: 1/1/24 updates to guideline
• 2023-08-14: Program update to add generic budesonide/formoterol and Breyna.
• 2023-02-22: 2023 UM Annual Review. Removed Utibron as target drug on guideline, as it is obsolete. Updated background and references
• 2022-10-13: GPI Reclassification
• 2022-03-01: Program update to include Airduo Respiclick ABA product
• 2021-11-17: Program update to include generic fluticasone/salmeterol and Wixela inhub
• 2021-02-22: Annual review, no updates
• 2020-10-08: added airduo digihaler
• 2020-05-18: clarified what criteria for 6 & above
• 2020-03-06: Added 50 mcg/5 mcg strength to Dulera criteria
• 2019-10-02: Added Duaklir as a target to Utibron. Updated Dulera Step therapy requirements to allow for patient to be 5 years of age and have a trial and failure or intolerance to one of the listed fluticasone-salmeterol products.

---