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BUDESONIDE/ GLYCOPYRROLATE/ FORMOTEROL INHL,ORAL

Clinical Criteria Summary

Exclusion Criteria

  • Diagnosis of asthma

Inclusion Criteria (All must be fulfilled)

  • Initial prescription is by or in consult with a VA/VA Community Care pulmonologist or designated expert
  • Diagnosis of chronic obstructive pulmonary disease (post-bronchodilator ratio of FEV1/FVC less than 70%)
  • Receiving ICS/LABA or LAMA/LABA but requires additional maintenance treatment for uncontrolled COPD symptoms and/or exacerbations
  • If currently receiving an ICS, patient is NOT a candidate for ICS de-escalation

Additional Inclusion Criteria (At least one must be met)

  • Documented difficulty adhering to 3-drug therapy via 2 separate inhalers (ICS/LABA + LAMA or LABA/LAMA + ICS)
  • Unable to use multiple inhalers due to underlying conditions (e.g., cognitive deficits, dexterity or visual impairment, etc.)
  • Uncontrolled COPD symptoms and/or exacerbations while using formulary LABA/LAMA + ICS or ICS/LABA + LAMA

Adjudication & Clinical Considerations

  • Additional inclusion criteria do not apply to patients already using 3 different/separate inhalation products
  • Patients doing well on 3-drug therapy via 2 separate inhalers should not be switched solely for convenience; cases adjudicated case-by-case
  • Assess adherence and inhaler technique and provide any needed patient education before switching to Breztri

Source Documents