Pharmacy Prior Authorization Criteria

Long-Acting Bronchodilators - PA, ST, NF

Indications for Prior Authorization

Tudorza (aclidinium bromide)

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

Incruse Ellipta (umeclidinium inhalation)

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

Spiriva Handihaler (tiotropium bromide)

• For diagnosis of Chronic Obstructive Pulmonary Disease
  Indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Tiotropium bromide inhalation powder is indicated to reduce exacerbations in COPD patients.

Criteria

Tudorza Pressair, Incruse Ellipta

^Brand product may be excluded, please consult client-specific resources to confirm formulary coverage.

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), intolerance or contraindication to brand Spiriva^

Generic tiotropium bromide capsule

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 Spiriva Handihaler within the previous 365 days
AND
• Justification provided for why the generic is expected to provide benefit when brand Spiriva Handihaler has not been shown to be effective

Brand Spiriva Handihaler

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), intolerance or contraindication to generic tiotropium inhalation capsules

P & T Revisions

2024-03-29, 2024-02-21, 2023-09-05, 2023-02-23, 2022-03-01, 2021-11-16, 2021-02-22, 2020-10-20, 2020-10-20, 2020-02-19

References

1. Tudorza [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals; February 2021.
2. Incruse [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; December 2023.
3. Tiotropium Bromide Prescribing Information. Lupin Pharmaceuticals, Inc. Baltimore, MD. December 2023.
4. Spiriva Handihaler Prescribing Information. Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT. January 2022.

---

Revision History

• 2024-03-29: Modified ST for Tudorza Pressair and Incruse Ellipta to clarify the trial is through the "brand" Spiriva. Created new ST criteria for brand Spiriva Handihaler.
• 2024-02-21: 2024 UM Annual Review. Added in minimum 30 day trial duration to ST criteria. Background updates.
• 2023-09-05: Addition of criteria for tiotropium bromide capsule
• 2023-02-23: 2023 UM Annual Review. Removed Arcapta Neohaler from guideline as it now obsolete. Updated background
• 2022-03-01: 2022 Annual Review - added criterion "Requested drug is being used for FDA-approved indication", removed GPI for Seebri (obsolete), updated background information
• 2021-11-16: Program update. Removed fluticasone/salmeterol as a step requirement
• 2021-02-22: annual review no updates
• 2020-10-20: incruse added as Target eff 1.1.20
• 2020-10-20: added Striverdi as a alternative
• 2020-02-19: annual review - no changes to clinical criteria updated references

---