VA Criteria for Use Formulary Advisor Reference
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FLUTICASONE/ UMECLIDINIUM/ VILANTEROL INHL,ORAL

Generic Name
FLUTICASONE/ UMECLIDINIUM/ VILANTEROL INHL
Brand Names
TRELEGY ELLIPTA
Drug Class
ANTIASTHMA,OTHER
Formulary Status
Non-Formulary Requires prior authorization
Copay Tier
3
Last Updated
May 1, 2026

Clinical Criteria Summary

Document 861: Fluticasone Furoate Umeclidinium Vilanterol TRELEGY ELLIPTA Criteria in Asthma May 2026 Final

Prescriber & Consultation Requirements

  • Initial prescription must be by or in consultation with a VA/VA Community Care Pulmonologist, Allergist/Immunologist, or designated expert.

Diagnosis & Clinical Status

  • Diagnosis of asthma or asthma/COPD overlap.
  • If currently receiving an ICS, patient is NOT a candidate for ICS de-escalation.

Current Therapy & Medication Requirements

  • Receiving at least a moderate dose ICS/LABA but requires additional maintenance treatment with LAMA for uncontrolled asthma symptoms and/or exacerbations.
  • Unable to tolerate or use budesonide-glycopyrrolate-formoterol (BREZTRI) triple inhaler.

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 asthma symptoms and/or exacerbations while using formulary LABA/LAMA + ICS or ICS/LABA + LAMA.

Clinical Practice Considerations

  • Assess adherence and inhaler technique and provide any needed patient education before switching to Trelegy Ellipta.
  • 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.

Exclusion Criteria

  • None

Document 862: Fluticasone Furoate Umeclidinium Vilanterol TRELEGY ELLIPTA Criteria in COPD May 2026 Final

Exclusion Criteria

  • None specified

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
  • Unable to tolerate or use budesonide-glycopyrrolate-formoterol (BREZTRI) triple inhaler
  • 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

Pre-Switch Assessment & Adjudication Guidelines

  • Assess adherence and inhaler technique and provide any needed patient education before switching to Trelegy Ellipta
  • 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

Source Documents

Document 861: Fluticasone Furoate Umeclidinium Vilanterol TRELEGY ELLIPTA Criteria in Asthma May 2026 Final Document 862: Fluticasone Furoate Umeclidinium Vilanterol TRELEGY ELLIPTA Criteria in COPD May 2026 Final