CurrentMass General Brigham Health PlanPolicy N/A

Arformoterol and Formoterol Inhalation Solution (nebulized) coverage

This policy governs prior authorization, quantity limits, and continuation criteria for arformoterol and formoterol inhalation solutions (nebulized long-acting beta-agonists) for members of the Mass General Brigham Health Plan pharmacy benefit.

Policy Summary

PayerMass General Brigham Health Plan

PolicyArformoterol and Formoterol Inhalation Solution (nebulized) coverage

Policy CodePolicy N/A

Change TypeMaterial revisions — reauthorization criteria and duration added

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization showing a COPD diagnosis and clinical rationale that the member cannot use a non-nebulized LABA; approvals granted for 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

Updated language for members new to the Plan and added reauthorization criteria specifying that the member must meet initial criteria.

Approval duration for initial authorizations and reauthorizations is specified as 12 months.

12 moinitial and reauthorization approval duration

2 vials/dayquantity limit

90 daysnew-to-plan window

COPDindication required

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria

Initial Therapy

Approval will be granted when ALL of the following are met:

Initial approval criteria: Member has a diagnosis of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema

Initial approval criteria: Clinical rationale that the member is unable to use a non‑nebulized long‑acting beta‑agonist and no claims for inhalers within the prior 30 days

Continuation Therapy

Reauthorization (Continuation of Therapy)

Reauthorization: Member meets initial criteria

Reauthorization requests will be approved when member continues to meet the initial criteria

Duration: Initial approvals and reauthorizations will be granted for 12 months12 months

For members who are new to the plan within the past 90 days, prior authorization may be granted to continue a nebulized arformoterol or formoterol product when the member is currently receiving the requested medication at the time of enrollment. Coverage under this continuity provision does not apply when the medication was obtained only as samples or through a manufacturer’s patient assistance program. Reviewers should confirm the member’s recent use of the same nebulized product when applying this 90‑day continuity guidance.

Nebulized arformoterol or formoterol should be reserved for members with a documented diagnosis of COPD (including chronic bronchitis or emphysema). If the request lacks a COPD diagnosis, or if there is no clinical justification explaining why the patient cannot use a non‑nebulized long‑acting beta‑agonist (LABA)—for example, evidence of recent inhaler claims or no documented inhaler intolerance—then alternative non‑nebulized LABA therapy should be considered and the request may be considered not medically necessary. Documentation should include the clinical rationale for nebulized delivery and any attempts or contraindications to using inhaler formulations.

Coding and Quantity Limits

Header benefit/program codesmixed

No codes listed

Quantity limit — arformoterol

ProductArformoterol inhalation solution vial for nebulization

Quantity limit2 vials per day

Applies toNeubulized arformoterol (vial) only

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for coverage. Members new to the plan (enrolled ≤ 90 days) who are currently receiving the requested medication may be eligible for authorization to maintain continuity of care. Authorization is not granted for products obtained only as samples or through manufacturer patient assistance programs.

Prior authorization required
Continuity eligibility: members new to plan ≤ 90 days receiving therapy
Excludes sample- or manufacturer patient assistance–obtained product

Step Therapy

Plan-level Step Therapy

Step therapy is referenced at the plan level; applicable step-therapy requirements should be checked at the member's plan header prior to submitting an authorization request.

Plan-level Step Therapy noted at plan header
Check member-specific plan header for step requirements

Background

Arformoterol and formoterol are long‑acting beta‑agonists (LABAs) approved for the maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Nebulized formulations are typically used when a patient is unable to reliably use non‑nebulized inhaler formulations; the policy requires documentation of that clinical rationale when requesting coverage for nebulized LABA therapy.

Definitions

COPD — definition

DefinitionChronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema

IndicationArformoterol and formoterol are long-acting beta-agonists approved for maintenance treatment of COPD

Documentation requiredDiagnosis of COPD must be documented for authorization

Non-nebulized LABA — definition and policy preference

DefinitionNon‑nebulized long-acting beta-agonist (LABA) — inhaler formulations (e.g., metered-dose or dry-powder inhalers)

Policy preferenceNon-nebulized inhaler formulations are preferred when the patient can use them; clinical rationale is required if the patient is unable to use a non-nebulized LABA

Revision History

2025-09-01effective_dateLatest

Policy effective date updated to reflect title change and reauthorization criteria; initial approvals and reauthorizations specified for 12 months.

2025-08-13review

Reviewed and updated at August P&T: language for members new to the Plan revised and policy title updated to reflect generic availability; reauthorization criteria added specifying member must meet initial criteria.

2023-10-11review

Policy Summary

PayerMass General Brigham Health Plan

PolicyArformoterol and Formoterol Inhalation Solution (nebulized) coverage

Policy CodePolicy N/A

Change TypeMaterial revisions — reauthorization criteria and duration added

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization showing a COPD diagnosis and clinical rationale that the member cannot use a non-nebulized LABA; approvals granted for 12 months when criteria are met.

SourceLink

On This Page

Documentation Required

Required Clinical Information

Document the diagnosis and clinical rationale. Provide: (1) diagnosis of COPD (including chronic bronchitis or emphysema), (2) explanation why a non-nebulized long-acting beta-agonist (LABA) cannot be used, and (3) evidence of recent medication use or lack of inhaler claims when applicable.

Required documentation: confirmed COPD diagnosis (chronic bronchitis or emphysema)
Clinical rationale why non-nebulized LABA is not appropriate or feasible for the member
Medication history: recent use of the requested nebulized product or absence of inhaler claims within the past 30 days, as applicable

Denial Risk

Applications may be denied if required documentation is missing or criteria are not met.

Denial triggers: no COPD diagnosis documented
Denial triggers: no clinical rationale for nebulized therapy provided
Denial triggers: absent recent inhaler claim or insufficient medication history when required

Claims reviewPolicy considers absence of inhaler claims within the prior 30 days as part of the rationale for nebulized therapy

Reviewed and updated at October P&T; approval duration for initial authorizations and reauthorizations added (effective 2024-01-01).

2021-07-21review

Reviewed at July P&T; Perforomist became generic and criteria updated to include formoterol; 'started and stabilized' language changed to 'members new to the plan' (effective 2021-10-01).

2019-09-18review

Added disclaimer on other inhaler use.