BUDESONIDE/ GLYCOPYRROLATE/ FORMOTEROL INHL,ORAL
Clinical Criteria Summary
Document 231: Budesonide Glycopyrrolate Formoterol BREZTRI Criteria in Asthma
Indication & Clinical Status
- Diagnosis of asthma or asthma/COPD overlap
- Uncontrolled asthma symptoms and/or exacerbations
- If currently receiving an ICS, patient is NOT a candidate for ICS de-escalation
Treatment History & Regimen Requirements
- Receiving at least a moderate dose ICS/LABA
- Requires additional maintenance treatment with LAMA
- Uncontrolled asthma symptoms and/or exacerbations while using formulary LABA/LAMA + ICS or ICS/LABA + LAMA
Prescriber & Consultation Requirements
- Initial prescription is by or in consultation with a VA/VA Community Care Pulmonologist, Allergist/Immunologist or designated expert
Adherence & Device Considerations
- 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.)
Management & Adjudication Guidelines
- Assess adherence and inhaler technique and provide any needed patient education before switching to Breztri
- Patients doing well on 3-drug therapy via 2 separate inhalers should not be switched solely for convenience; these cases require case-by-case adjudication
Document 860: Budesonide Glycopyrrolate Formoterol BREZTRI Criteria in COPD
Exclusion Criteria
- None
Core Inclusion Criteria (All must be met)
- Initial prescription is by or in consultation with a VA/VA Community Care Pulmonologist, Allergist/Immunologist or designated expert
- Diagnosis of chronic obstructive pulmonary disease [COPD] (post-bronchodilator ratio of FEV1/FVC less than 70%)
- Receiving ICS/LABA or LABA/LAMA 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 (One of the following 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
Clinical Management & Adjudication Requirements
- Assess adherence and inhaler technique and provide any needed patient education before switching to Breztri
- Patients doing well on 3-drug therapy via 2 separate inhalers should not be switched solely for convenience; these cases should be adjudicated on a case-by-case basis