CurrentAdvanced HealthPolicy N/A

Non-Preferred Inhaler Drug Use Criteria

Customize your policy alerts

Sign up for all advancedhealth policy alerts

Know when advancedhealth releases new policies or updates existing guidance.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

This policy governs prior authorization and medical-necessity review for non-preferred inhalers used for funded asthma, COPD, or qualifying comorbid conditions. It requires an FDA-approved indication and adequate trial and failure of a preferred inhaler, with separate renewal durations for asthma and COPD.

Policy Summary

PayerAdvanced Health

PolicyNon-Preferred Inhaler Drug Use Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionVerify an FDA-approved indication, funded condition, and adequate trial and failure of a preferred inhaler before approving an initial request.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsInitial approval period

6 monthsAsthma renewal period

12 monthsCOPD renewal period

FDA-approvedIndication standard

Preferred inhaler failure

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

CurrentAdvanced HealthPolicy N/A

Non-Preferred Inhaler Drug Use Criteria

Customize your policy alerts

Sign up for all advancedhealth policy alerts

Know when advancedhealth releases new policies or updates existing guidance.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Policy Summary

PayerAdvanced Health

PolicyNon-Preferred Inhaler Drug Use Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionVerify an FDA-approved indication, funded condition, and adequate trial and failure of a preferred inhaler before approving an initial request.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsInitial approval period

6 monthsAsthma renewal period

12 monthsCOPD renewal period

FDA-approvedIndication standard

Preferred inhaler failure

Coverage Criteria

Initial therapy

Covered for an initial request when all of the following requirements are met, in sequence:

Initial request

Covered condition basis
- Funded condition: The medication is prescribed for a funded condition.
- Qualifying comorbid condition: If the condition is not funded, a comorbid condition allows coverage of the medication.
FDA-approved indication: The medication is prescribed for an FDA-approved indication.
Preferred inhaler trial and failure: The member has had an adequate trial and failure of a preferred inhaler.

Continuation therapy

Covered on renewal when the pulmonary condition has improved and continued therapy is supported:

Condition-specific renewal

Asthma renewal: The pulmonary condition has improved and continued treatment for asthma is supported.
Approve for up to 6 months.
COPD renewal: The pulmonary condition has improved and continued treatment for COPD is supported.
Approve for up to 12 months.

Class-specific clinical criteria

The requested product must meet the applicable clinical-use criterion for its medication class:

Short-acting beta agonist (SABA): Asthma rescue, COPD rescue, or Group A use.
Step therapy is required for levalbuterol.
ICS/LABA combination inhaler: Asthma that is not adequately controlled on ICS alone, or COPD with asthma overlap.
ICS/LABA is not encouraged in COPD per GOLD guidelines; when there is an indication for an ICS, LAMA/LABA/ICS is preferred.
Long-acting muscarinic antagonist (LAMA): COPD with moderate to severe airflow limitation.
Use the preferred LAMA alternative where appropriate.
LABA/LAMA combination inhaler:

Off-label use of the medication is not a covered benefit under the Oregon Health Plan. Coverage requires use for an FDA-approved indication.

Treatment of a non-funded condition is excluded unless a qualifying comorbid condition permits coverage of the medication.

Renewal is not supported when submitted chart notes do not document improvement of the pulmonary condition or a continued need for therapy.

Authorization and Provider Actions

Prior Authorization

Initial Authorization Requirements

For an initial non-preferred inhaler request, verify that the medication is prescribed for a funded condition or a qualifying comorbid condition, is being used for an FDA-approved indication, and that the member has had an adequate trial and failure of a preferred inhaler. If criteria are met, authorization may be approved for up to 12 months.

Confirm the funded condition or qualifying comorbid condition.
Confirm the FDA-approved indication.
Document an adequate trial and failure of a preferred inhaler.

Prior Authorization

Renewal Authorization Requirements

For renewal requests, submit chart documentation showing that the pulmonary condition has improved and that continued therapy remains necessary. Approval may be granted for up to 6 months for asthma or 12 months for COPD.

Asthma: approve for up to 6 months when improvement and continued need are supported.

Policy Background

This policy addresses inhaled therapies for asthma and chronic obstructive pulmonary disease (COPD), including short-acting rescue agents, inhaled corticosteroids, ICS/LABA combinations, LAMA agents, LAMA/LABA combinations, and triple therapy. Preferred formulary alternatives are used to support cost-effective inhaler use.

Inhaler Class Definitions

Definition

SABAShort-acting beta agonist

Definition

ICS/LABAInhaled corticosteroid/long-acting beta agonist combination

Definition

LAMALong-acting muscarinic antagonist

Definition

LAMA/LABALong-acting muscarinic antagonist/long-acting beta agonist combination

Initial Therapy Criteria

Initial request

Initial approval requires all of the following:

Covered condition basis
- The medication is prescribed for a funded condition.
- If the condition is not funded, a comorbid condition allows coverage of the medication.
The medication is prescribed for an FDA-approved indication.
The member has had an adequate trial and failure of a preferred inhaler.

Class-specific initial therapy

Continuation Therapy Criteria

Renewal request

Renewal requires documentation of improvement and continued medical need:

Condition-specific renewal

Asthma: The pulmonary condition has improved and continued treatment for asthma is supported.
Approve for up to 6 months.
COPD: The pulmonary condition has improved and continued treatment for COPD is supported.
Approve for up to 12 months.

Step-Therapy Requirements

Step	Required action	Coverage outcome
1	Complete an adequate trial of a preferred formulary inhaler and document failure.	Covered after the preferred inhaler trial and failure requirement is met.
2	Request approval for the non-preferred inhaler after the required preferred-inhaler trial and failure.	Non-preferred inhaler approval may be considered for up to 12 months.

Medication	Step-therapy requirement	Coverage outcome
Levalbuterol	Step therapy is required within the short-acting beta-agonist class.	Covered when the step-therapy requirement is met.

Policy Summary

PayerAdvanced Health

PolicyNon-Preferred Inhaler Drug Use Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionVerify an FDA-approved indication, funded condition, and adequate trial and failure of a preferred inhaler before approving an initial request.

SourceLink

On This Page

COPD Group B or Group E, or symptoms not adequately controlled on existing therapy.

Use the preferred LABA/LAMA alternative where appropriate.

Triple therapy (ICS + LABA + LAMA): For asthma, add-on therapy for patients age 6 or older with severe asthma that is not controlled on ICS/LABA; or for COPD, Group E with continued symptoms or exacerbations.Age 6 or older for the asthma pathway

Requires specialist documentation and an adequate trial with first-line therapy; prior authorization is required for products in this section.

COPD: approve for up to 12 months when improvement and continued need are supported.

If support is insufficient, recommend a formulary alternative or forward the request to the medical director for review.

Step Therapy

Preferred Inhaler Trial Required

Before requesting a non-preferred inhaler, document an adequate trial and failure of an appropriate preferred inhaler or formulary alternative. Requests without this step-therapy documentation may not meet criteria.

Document the preferred product tried, duration or adequacy of the trial, and the clinical outcome or failure.
Use the applicable preferred alternative for the medication class.

Step Therapy

Levalbuterol Step Therapy

Levalbuterol requires short-acting beta-agonist step therapy before authorization. Confirm that the member has tried and failed an appropriate preferred SABA or formulary alternative.

Apply SABA step therapy for rescue treatment of asthma or COPD.
Document the preferred SABA trial and failure before requesting levalbuterol.

Unsupported block type: documentation καθutionary

Documentation Required

Triple-Therapy Specialist Documentation

For triple therapy (ICS + LABA + LAMA) used as add-on treatment for severe asthma, document that the patient is at least 6 years old, remains inadequately controlled on ICS/LABA, and has been evaluated by a specialist. The request must also include specialist documentation and an adequate trial with first-line therapy; prior authorization is required.

Asthma: severe asthma requiring add-on therapy in a patient age 6 or older.
Document inadequate control on ICS/LABA.
Provide specialist documentation and an adequate trial with first-line therapy.
COPD: support Group E disease with continued symptoms or exacerbations, as applicable.
Submit the request for prior authorization.

Denial Risk

Unfunded Condition

Coverage is not available when the medication is prescribed solely for a condition that is not funded and no qualifying comorbid condition supports coverage. Such requests should be denied as not meeting criteria.

Confirm that the treated condition is funded or that a qualifying comorbid condition permits coverage.
The Oregon Health Plan does not pay for treatment of an unfunded condition.

Denial Risk

Non-FDA-Approved Indication

Coverage should be denied when the requested medication is used for an indication that is not FDA approved. Off-label use is not a covered benefit under the Oregon Health Plan.

Verify the requested use against the medication's FDA-approved indications.
Document the approved indication in the clinical record.

Denial Risk

Preferred Alternative Not Tried and Failed

A non-preferred inhaler request may be denied when the member has not completed an adequate trial and failed an appropriate preferred inhaler. Recommend the applicable formulary alternative and document the step-therapy history before resubmission.

Do not request non-preferred therapy without adequate preferred-inhaler trial and failure documentation.
For levalbuterol, complete the required preferred SABA step therapy.
Use the applicable preferred product identified for the medication class.

Denial Risk

Insufficient Renewal Support

Renewal authorization may be denied when submitted chart notes do not establish improvement in the pulmonary condition or continued medical need for therapy. Consider a formulary alternative or forward the request to the medical director for review.

Document clinical improvement for the treated pulmonary condition.
Document the ongoing need for continued therapy.
Asthma renewals may be approved for up to 6 months; COPD renewals may be approved for up to 12 months when supported.

The requested inhaler must meet the applicable class-specific clinical rationale:

Applicable class-specific use

SABA: Asthma rescue, COPD rescue, or Group A use.
Step therapy is required for levalbuterol.
ICS/LABA: Asthma that is not adequately controlled on ICS alone, or COPD with asthma overlap.
ICS/LABA is not encouraged in COPD per GOLD guidelines.
LAMA: COPD with moderate to severe airflow limitation.
LABA/LAMA: COPD Group B or Group E, or symptoms not adequately controlled on existing therapy.
Triple therapy: For asthma, add-on therapy for patients age 6 or older with severe asthma that is not controlled on ICS/LABA; or for COPD, Group E with continued symptoms or exacerbations.Age 6 or older for the asthma pathway
Requires specialist documentation and an adequate trial with first-line therapy; prior authorization is required for products in this section.