Pharmacy Prior Authorization Criteria

Inhaled Corticosteroids - ST, NF

Indications for Prior Authorization

Alvesco (ciclesonide) Inhalation Aerosol

• For diagnosis of Asthma
  Indicated for the maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older.

  Important Limitations of Use: Alvesco is NOT indicated for the relief of acute bronchospasm or for children under 12 years of age.

ArmonAir Digihaler (fluticasone propionate) Inhalation Powder

• For diagnosis of Asthma
  Indicated for the maintenance treatment of asthma as prophylactic therapy in patients 12 years of age and older.

  Limitations of Use: ArmonAir Digihaler is not indicated for the relief of acute bronchospasm.

Asmanex HFA (mometasone furoate) Inhalation Aerosol

• For diagnosis of Asthma
  Indicated for the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older.

  Important Limitations of Use: Asmanex HFA is NOT indicated for the relief of acute bronchospasm.

Asmanex (mometasone furoate) Inhalation Powder

• For diagnosis of Asthma
  Indicated for the maintenance treatment of asthma as prophylactic therapy in patients 4 years of age and older.

  Limitations of Use: Asmanex Twisthaler is NOT indicated for the relief of acute bronchospasm or in children less than 4 years of age.

Flovent (fluticasone propionate aerosol) HFA

• For diagnosis of Asthma
  Indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients aged 4 years and older.

  Limitations of Use FLOVENT HFA is not indicated for the relief of acute bronchospasm.

Flovent (fluticasone propionate powder) Diskus

• For diagnosis of Asthma
  Indicated for the maintenance treatment of asthma as prophylactic therapy in patients aged 4 years and older.

  Important Limitation of Use FLOVENT DISKUS is NOT indicated for the relief of acute bronchospasm.

Pulmicort (budesonide aerosol) Flexhaler

• For diagnosis of Asthma
  Indicated for the maintenance treatment of asthma as prophylactic therapy in patients six years of age or older.

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

Criteria

Armonair Digihaler*, Asmanex Twisthaler*, Flovent Diskus, Pulmicort Flexhaler, Brand Fluticasone Propionate Diskus

*Product may be excluded depending on the plan.

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 preferred brands:
• Arnuity Ellipta
• QVAR Redihaler

Flovent HFA, Brand Fluticasone Propionate HFA, Alvesco*, Asmanex HFA*

*Product may be excluded depending on the plan.

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:
• Trial and failure (of a minimum 30-day supply), contraindication, or intolerance to both of the following preferred brands:
• Arnuity Ellipta
• QVAR Redihaler
OR
• Submission of medical records (e.g., chart notes) confirming patient requires a metered dose inhaler used with a spacer device due to one of the following:
• Physical dexterity
• Inspiratory flow
• Cognitive status

Flovent HFA, Brand Fluticasone Propionate HFA, Alvesco, Asmanex HFA

Non Formulary

Length of Approval: 12 Month(s)

• One of the following:
• Both of the following:
• Requested drug is FDA-approved for the condition being treated
AND
• Additional requirements listed in the "Indications and Usage" sections of the prescribing information (or package insert) have been met (e.g., first line therapies have been tried and failed, any testing requirements have been met, etc.)
OR
• If requested for an off-label indication, the off-label guideline approval criteria have been met
AND
• One of the following:
• Submission of medical records (e.g., chart notes) confirming patient requires a metered dose inhaler used with a spacer device due to one of the following: [A, 9]
• Physical dexterity
• Inspiratory flow
• Cognitive status
OR
• Submission of medical records (e.g., chart notes) or paid claims documenting patient has tried and failed, or has contraindication or intolerance to at least 3 formulary alternatives. If only 1 or only 2 alternatives are available, the patient must have failed or had contraindications or intolerance to all available formulary alternatives

P & T Revisions

2024-07-05, 2024-03-15, 2024-03-15, 2024-02-14, 2024-01-10, 2024-01-05, 2023-12-14, 2023-10-25, 2023-02-22, 2022-10-13, 2022-03-22, 2021-10-12, 2021-02-22, 2020-10-08, 2020-03-02

References

1. Alvesco [prescribing information]. Zug 6300, Switzerland: Covis Pharma; February 2023.
2. ArmonAir Digihaler [prescribing information]. Parsippany, NJ: Teva Respiratory, LLC; September 2022.
3. Asmanex [prescribing information]. Jersey City, NJ: Organon LLC; June 2021.
4. Asmanex HFA [prescribing information]. Jersey City, NJ: Organon LLC; March 2023.
5. Flovent HFA Prescribing Information. GlaxoSmithKline. Durham, NC. September 2023.
6. Flovent Diskus Prescribing Information. GlaxoSmithKline. Durham, NC. August 2023.
7. Pulmicort Flexhaler Prescribing Information. AstraZeneca Pharmaceuticals LP. Wilmington DE. October 2019.
8. Fluticasone Propionate Diskus Prescribing Information. Prasco Laboratories Mason OH. May 2023.
9. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention 2023. Updated July 2023. Available from www.ginaasthma.org

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Revision History

• 2024-07-05: Program update. Alvesco and Asmanex HFA criteria were updated to allow a bypass to the trial of Arnuity Ellipta and Qvar Redihaler.
• 2024-03-15: 2024 UM Annual Review. Added in minimum 30 day trial duration to ST criteria. Background updates.
• 2024-03-15: Operational update to require submission of medical records for Flovent spacer criteria
• 2024-02-14: Updated criteria related to requirement of a spacer.
• 2024-01-10: Guideline update
• 2024-01-05: Added drug-specific Non-Formulary criteria for Flovent HFA, Flovent HFA ABA.
• 2023-12-14: Addition of Fluticasone Propionate Diskus as target to guideline. Updated criteria for brand Fluticasone HFA to allow a bypass of the trial of Arnuity Ellipta and Qvar Redihaler for pediatric patients who require use of a spacer with their meter dose inhalers.
• 2023-10-25: Removed Flovent Diskus/HFA and Pulmicort Flexhaler as alternatives and added them as targets to ST. Added Brand Fluticasone HFA as target drug.
• 2023-02-22: 2023 UM Annual Review. Removed QVAR as ST1 alt option since it is now obsolete. Updated references
• 2022-10-13: GPI Reclassification
• 2022-03-22: 2022 Annual Review - added criterion "Requested drug is being used for FDA-approved indication" , updated background information
• 2021-10-12: Add EHB formulary to the guideline.
• 2021-02-22: Annual review
• 2020-10-08: Added Armonair as a target
• 2020-03-02: Added New 50 mcg strength/GPI to existing step for Asmanex HFA

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