CurrentCentenePolicy HIM.PA.153

Clinical Policy: Inhaled Agents for Asthma and COPD

Defines prior authorization, step therapy, and coverage criteria for inhaled short-acting and long-acting bronchodilators, inhaled corticosteroids, combinations, and related agents for members with asthma or COPD under Centene plans.

Policy Summary

PayerCentene

PolicyClinical Policy: Inhaled Agents for Asthma and COPD

Policy CodePolicy HIM.PA.153

Change TypeNo material changes noted

Effective Date03/01/2021

Next Review DateN/A

Key ActionSubmit prior authorization with supporting clinical documentation showing diagnosis, prior therapies, dosing, and physiologic data when required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

~30listed inhaled products

12 monthsapproval duration

≥18minimum age (COPD)

FEV1/FVC <0.70Ohtuvayre physiologic criteria

Ohtuvayrenew agent added

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Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

Initial Approval - Inhaled Agents for Asthma or COPD: 1. Diagnosis of asthma or COPD consistent with the FDA‑approved indications for the requested agent (see FDA Approved Indications). 2. Age meets the product-specific requirement: for asthma — age appropriate per prescribing information; for COPD — ≥ 18 years. 3. Failure of required formulary step therapy agent(s) at up to maximally indicated doses unless clinically significant adverse effects occur or agents are contraindicated (agent-specific step agents are listed in the policy). 4. For agents with a digital component (e.g., Digihaler products): medical justification for the digital component is provided (rationale why inhaler usage cannot be tracked manually). 5. For Ohtuvayre (ensifentrine) only: a. Member has moderate‑to‑severe COPD evidenced by either (i) pre‑ and post‑albuterol FEV1/FVC < 0.70 OR (ii) post‑albuterol FEV1 ≥ 30% and ≤ 70% predicted; AND b. Ohtuvayre is not prescribed in combination with Daliresp (roflumilast). 6. Request meets one of the following: a) requested quantity does not exceed the health plan quantity limit; b) requested dose does not exceed the FDA‑approved maximum dose for the indication; or c) request is for a Georgia member for asthma or other life‑threatening bronchial ailments as prescribed by the treating physician.approval duration 12 months

Agent‑specific step therapy exceptions (e.g., inability to use inhaler devices, contraindications to excipients, nebulized preparations) and per‑product step agents are detailed in the policy.

Continuation Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

Continued Therapy - Inhaled Agents for Asthma or COPD: 1. Member meets one of the following: a) currently receiving the medication via the Centene benefit or b) member is currently receiving medication and is enrolled in a state/product with continuity of care provisions. 2. Member is responding positively to therapy (clinical benefit). 3. If a dose increase is requested, the request meets one of: a) requested quantity does not exceed the health plan quantity limit; b) requested dose does not exceed the FDA‑approved maximum dose for the relevant indication; or c) request is for a Georgia member with asthma or other life‑threatening bronchial ailments as prescribed by the treating physician.approval duration 12 months

Continuation approvals require evidence of clinical benefit or prior meeting of initial criteria; documentation should be submitted (chart notes, labs).

Other Indications — Other uses (must meet one)

Other uses (must meet one):

Other diagnoses/indications: 1. If the drug has undergone a label change within the last 6 months that is not yet reflected in this policy, follow the applicable policy: a) for drugs on formulary/PDL refer to the no coverage criteria policy (HIM.PA.33) or b) for drugs NOT on formulary/PDL refer to the non‑formulary policy (HIM.PA.103). 2. If the requested use (diagnosis, age, dosing) is not specifically listed under the policy’s 'Diagnoses/Indications for which coverage is NOT authorized' section and criterion 1 does not apply, refer to the off‑label use policy for the relevant line of business (HIM.PA.154).

Non‑FDA approved indications not addressed in this policy require sufficient documentation of efficacy and safety per off‑label policy; otherwise coverage is not authorized.

General coverage criteria — approve when BOTH product dosing limits and clinical indications are met per labeling/guidelines

Approve when BOTH product dosing limits and clinical indications align with labeling and guideline‑directed therapy:

Product indication and dosing: Requested agent is being used for an FDA‑indicated condition (asthma or COPD) and the prescribed dose/quantity does not exceed the product maximum dose or plan quantity limit as listed in the Dosage and Administration section.per‑product max dose

See per‑product maximum doses in the Dosage and Administration section (e.g., chunks 23–26).

Contraindications check: No documented hypersensitivity to the agent or specified components (e.g., milk proteins, racemic formoterol, ipratropium) and the use is not a contraindicated scenario (for example, LABA monotherapy in asthma).contraindications absent

Contraindications and boxed warnings are listed in Appendix C; LABA without ICS in asthma is contraindicated and may be denied.

Requests for uses that are not FDA‑approved and are not addressed in this policy will not be authorized unless the provider submits sufficient documentation of efficacy and safety in accordance with the off‑label use policy (HIM.PA.154) or applicable evidence of coverage. Documentation must demonstrate why the requested off‑label indication is clinically appropriate for the member.

The policy excludes use of listed inhaled agents as the primary treatment of status asthmaticus or acute episodes of asthma or COPD that require intensive measures. Such acute, intensive treatment settings are not appropriate indications for the outpatient inhaled products covered by this policy.

The policy has been updated to remove inhaled products that are no longer available on the market. Examples of off‑market removals include Flovent Diskus, Flovent HFA, Lonhala Magnair, Seebri Neohaler, and Utibron Neohaler; product lists and redirections were revised accordingly.

Use of a listed inhaled agent for an indication that is not FDA‑approved and not otherwise included in this policy is not authorized unless the request includes sufficient clinical justification and supporting evidence per the off‑label use policy (HIM.PA.154). Requests lacking that justification are subject to denial.

For patients with asthma, therapy with a long‑acting beta‑agonist (LABA) without a concomitant inhaled corticosteroid (ICS) is contraindicated and will be considered not medically necessary. Requests documenting LABA monotherapy in asthma may be denied unless an approved exception described elsewhere in policy applies.

Provider Actions and Requirements

Documentation Required

Dosing verification

Providers must verify dosing regimens and maximum doses for the requested inhaled agent against the policy’s Dosage and Administration section prior to submission. Ensure the prescribed frequency, strength, and daily maximum do not exceed the listed maximum dose for the specific product.

Confirm prescribed dose ≤ policy maximum dose for product
Match indication-specific dosing (asthma vs COPD)

Prior Authorization

Prior authorization and redirection requirements

Prior authorization is required for the inhaled agents listed in the policy except where a generic agent is available and explicitly excluded from PA (see drug list). Requests may be redirected to authorized generics or alternative formulary products per the redirection rules — providers should supply medical justification if redirection is not appropriate.

Generic agents noted with * do not require prior authorization
Brand agents may be redirected to authorized generic equivalents (see policy redirection table and recent SDC updates)
If requesting brand despite available authorized generic, include clinical justification for inability to use the generic (e.g., excipient contraindication)

Denial Risk

Contraindications may trigger denial

Requests may be denied if the member has any listed contraindication to the requested product (including hypersensitivity to components or product-specific contraindications) or when a LABA is prescribed as monotherapy for asthma. Review Appendix C for product-specific contraindications.

Hypersensitivity to any component of the requested agent — denial risk
Product-specific contraindications (e.g., milk protein for certain DPI products, racemic formoterol for Brovana, ipratropium for Spiriva Handihaler)
LABA monotherapy in asthma is contraindicated and may result in denial

Billing Rule

Coding inclusion/exclusion note

Inclusion or exclusion of any codes in this policy is for informational purposes only and does not guarantee coverage. Providers must verify coding and billing guidance before claim submission.

HCPCS J7601 listed as informational only
Verify current professional coding guidance prior to claim submission

Documentation Required

Required supporting documentation

Provider must submit supporting documentation such as office chart notes, prior therapy records, and relevant laboratory results (e.g., blood eosinophil counts) to demonstrate the member meets approval criteria.

Office notes documenting diagnosis and severity
Records of prior medications and dosing (to demonstrate step therapy failure or intolerance)
Relevant labs (e.g., blood eosinophils) and exacerbation history

Documentation Required

Clinical justification and prior therapy documentation

Clinical justification must document prior therapy trials and failure (or contraindication/intolerance) of required step agents per the policy. For COPD, include exacerbation history and blood eosinophil counts when applicable. For asthma, document age-appropriate indications and prior controller/reliever therapy.

Document trial of each required step-through agent at maximally indicated doses unless contraindicated
For COPD: include exacerbation history (number/severity in prior 12 months) and blood eosinophil count if considering ICS-containing therapy
For asthma: document prior controller use and that LABA is not used as monotherapy

Step Therapy

Step therapy requirement

Step therapy must be documented: requests must show failure, intolerance, or contraindication to the specified formulary/generic alternatives at up to maximally indicated doses before approval of non-formulary/brand agents, unless a step-therapy bypass applies (e.g., Illinois HIM after 1/1/2026 per IL HB 5395).

List of required step-through agents varies by product class (see policy step tables)
Provide documentation of inadequate response, adverse effects, or contraindication to each required agent
Illinois HIM: step therapy bypass applies as specified in policy effective 1/1/2026

Step Therapy

COPD step-up therapy expectation

Per GOLD guidance and the policy’s General Information, COPD step-up therapy is expected to escalate to LAMA + LABA for more symptomatic patients and to triple therapy (ICS + LAMA + LABA) for those with frequent exacerbations or high eosinophils; document prior dual/triple therapy trials or rationale for selecting agents like Ohtuvayre versus guideline-preferred regimens.

For patients inadequately controlled on monotherapy, escalate to LAMA + LABA per GOLD
Consider triple therapy (ICS + LAMA + LABA) for exacerbation-prone patients or eosinophils ≥ thresholds noted in policy
Prior failure of triple therapy satisfies dual therapy failure requirement when applicable

Step Therapy

Step therapy redirections and state-specific adjustments

Step therapy redirections and state-specific dose/quantity adjustments are applied per the policy. Providers should anticipate redirection to authorized generics or formulary alternatives and note any state-specific exceptions (e.g., dose/quantity limit bypasses or legislative overrides).

Many brand products redirect to authorized generics or specific formulary alternatives (see policy redirection table)
Dose/quantity limit bypasses may exist for specific states or circumstances (e.g., Georgia life-threatening bronchial ailments)
If requesting an agent excluded from redirection, include clinical justification for why redirection is inappropriate

Note

References and prescribing information citation requirement

Providers should reference up-to-date prescribing information and guideline sources cited in the policy when preparing documentation; include relevant prescribing details (indication, dosing limits, contraindications) from manufacturer labeling as needed.

Cite current FDA-approved indications and prescribing information to support dose/age appropriateness
Use guideline sources (e.g., GOLD, GINA) when justifying step-up therapy choices

Definitions and Abbreviations

FEV1 — Forced expiratory volume

DefinitionForced expiratory volume (FEV1) — the volume of air that can be forcibly exhaled in one second

Use in policyFEV1 values (absolute and percent predicted) are used in COPD severity criteria, including Ohtuvayre thresholds

Measurement noteFEV1 is reported pre- and post-bronchodilator for diagnostic and severity assessment

FVC — Forced vital capacity

DefinitionForced vital capacity (FVC) — the total volume of air that can be forcibly exhaled after full inspiration

Use in policyFVC is used with FEV1 to calculate the FEV1/FVC ratio for COPD diagnostic thresholds

Measurement noteFEV1/FVC ratio < 0.70 (pre- and post-albuterol) is one COPD physiologic criterion in the policy

SABA / LABA / ICS / LAMA — Abbreviations

SABAShort-acting beta-2 agonist (SABA)

LABALong-acting beta-2 agonist (LABA)

ICSInhaled corticosteroid (ICS)

LAMALong-acting muscarinic antagonist (LAMA)

Triple therapy (ICS + LAMA + LABA)

DefinitionTriple therapy = combination inhaled regimen including an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA), and a long-acting beta-agonist (LABA)

Guideline contextRecommended by GOLD for COPD patients with persistent symptoms or exacerbations; preferred over LABA+ICS where ICS indicated

Clinical useConsidered for patients inadequately controlled on dual therapy or with eosinophils ≥ 300 cells/μL

As-needed ICS reliever strategy

DefinitionAs-needed ICS reliever strategy = use of an inhaled corticosteroid together with a short-acting beta agonist as needed for symptom relief to provide early anti-inflammatory therapy

Guideline originRecommended by GINA and adopted in subsequent national guidance for asthma management

Clinical implicationShifts reliever strategy from SABA-only to ICS-containing reliever to reduce exacerbation risk

Ohtuvayre (ensifentrine)

Agent and classOhtuvayre (ensifentrine) — a PDE3/PDE4 inhibitor recently added to the policy

Prescribing/dosingDosing regimen: 3 mg (one ampule) inhaled via nebulizer BID; maximum 6 mg/day; not to be prescribed with Daliresp (roflumilast)

Policy actionsAdded to policy with redirections per SDC and HCPCS code J7601 referenced for ensifentrine administration

OpenPayer

Clinical Policy: Inhaled Agents for Asthma and COPD

Coverage Criteria

Coding and Product Parameters

Provider Actions and Requirements

Background

Definitions and Abbreviations