ModifiedmeridianPolicy MDN.PMN.259

Inhaled Agents for Asthma and COPD

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Defines prior authorization requirements, medical necessity criteria, and coverage parameters for inhaled corticosteroids, bronchodilators, and combination inhalers used to treat asthma and chronic obstructive pulmonary disease (COPD) for Meridian members (Illinois Medicaid line of business noted).

Policy Summary

Payermeridian

PolicyInhaled Agents for Asthma and COPD

Policy CodePolicy MDN.PMN.259

Change TypeAnnual review — criteria and coding updates

Effective DateOct 1, 2023

Last ReviewJan 17, 2025

Next Review DateJan 17, 2025

Key ActionSubmit prior authorization with supporting clinical documentation demonstrating diagnosis, prior step therapy failures, and dosing to meet approval criteria.

SourceLink

POLICY UPDATE CHANGES

Updated FDA approved indications table; updated language in initial criteria section; added ohtuvayre; added coding; added diagnosis clarification per PA team request; references reviewed.

Typo corrected, levalbuterol and QVAR added to the criteria.

Added language for increased quantity limit for Symbicort; updated table in initial criteria.

Added HCPCS code J7601 for ensifentrine inhalation suspension (3 mg) administered through DME.

1Q2025Most recent annual review

No PAGenerics exempt from PA

≤3/mo

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ModifiedmeridianPolicy MDN.PMN.259

Inhaled Agents for Asthma and COPD

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Policy Summary

Payermeridian

PolicyInhaled Agents for Asthma and COPD

Policy CodePolicy MDN.PMN.259

Change TypeAnnual review — criteria and coding updates

Effective DateOct 1, 2023

Last ReviewJan 17, 2025

Next Review DateJan 17, 2025

Key ActionSubmit prior authorization with supporting clinical documentation demonstrating diagnosis, prior step therapy failures, and dosing to meet approval criteria.

SourceLink

POLICY UPDATE CHANGES

Updated FDA approved indications table; updated language in initial criteria section; added ohtuvayre; added coding; added diagnosis clarification per PA team request; references reviewed.

Typo corrected, levalbuterol and QVAR added to the criteria.

Added language for increased quantity limit for Symbicort; updated table in initial criteria.

Added HCPCS code J7601 for ensifentrine inhalation suspension (3 mg) administered through DME.

1Q2025Most recent annual review

No PAGenerics exempt from PA

≤3/mo

Symbicort quantity limit

J7601HCPCS code added

EnumeratedContraindications noted

Coverage Criteria for Inhaled Agents

Initial Approval Criteria

Covered when ALL of the following are met:

Diagnosis of asthma or chronic obstructive pulmonary disease (COPD) consistent with the FDA‑approved indication for the requested agent

See FDA Approved Indications section for agent‑specific indications and age limits

Age requirement: Age meets one of the following: (a) Asthma: appropriate age per the prescribing information for the requested agent (examples: Flovent HFA: ≤12 years; other agents per PI); OR (b) COPD: ≥18 years

Agent‑specific age limits are listed in the FDA Approved Indications section

Step therapy failures: Failure of the specified formulary agent(s) at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated

Required step‑through agents are enumerated per requested agent (see policy tables listing required step agents, e.g., trials of generic albuterol HFA products before brand SABAs; trials of listed ICS/LABA/LAMA alternatives)

Digital component justification: For agents with a digital component (e.g., Digihaler products): medical justification supports the necessity of the digital component

Rationale must explain why inhaler usage cannot be tracked manually

Quantity/dose limits: Requested quantity/dose does not exceed one of: (a) the health plan quantity limit; (b) Symbicort only: ≤3 inhalers per month (exceptions for school, foster placement, daycare, or multiple caregiver residences); or (c) the FDA‑approved maximum dose for the indication

Symbicort special quantity limit and listed exceptions apply

Continued Therapy

Continued therapy covered when ALL of the following are met:

Ongoing status: Member is currently receiving the medication via the health plan benefit or previously met initial approval criteria; OR member is currently receiving medication and continuity‑of‑care regulations apply for the state/product

Refer to state‑specific addendums for continuity of care (CC.PHARM.03A/03B) when applicable

Clinical response: Member is responding positively to therapy with clinical improvement documented

Clinical improvement must be documented in supporting records

Dose increase limits: If the request is for a dose increase, the new request does not exceed one of: (a) the health plan quantity limit; (b) Symbicort only: ≤3 inhalers per month (exceptions as noted); or (c) the FDA‑approved maximum dose for the indication

Same quantity/dose limits apply as for initial approval

Other diagnoses/indications

Other uses:

Recent label change: If the drug label changed within the last 6 months and the change is not yet reflected in this policy, follow the applicable formulary policies: for drugs on formulary/PDL use the no coverage criteria policy (CP.PMN.255 for Medicaid); for drugs not on formulary/PDL use the non‑formulary policy (CP.PMN.16 for Medicaid)

Applies to newly approved indications, age expansions, or dosing regimens not yet in this policy

Off‑label use: If the requested use (diagnosis, age, dosing) is not listed in the policy sections and the recent‑label rule does not apply, refer to the off‑label use policy (CP.PMN.53 for Medicaid)

Off‑label coverage requires meeting the referenced off‑label policy criteria

Initial and revised coverage criteria (summary)

Policy contains initial criteria and updated language for coverage decisions (including additions of specific agents and quantity limits).

Summary: This policy maintains distinct initial approval criteria for inhaled agents and includes recent revisions: corrections and additions (e.g., levalbuterol and QVAR added) and modification of Symbicort quantity limits; Ohtuvayre and coding updates were added during the 1Q2025 annual review.

Detailed AND/OR logic and exact required step‑through agent listings and agent‑specific indications are documented in other sections of the policy

Non–FDA approved indications that are not specifically addressed in this policy are not authorized unless the prescriber provides sufficient documentation demonstrating efficacy and safety in accordance with the Health Plan's off‑label use policy (CP.PMN.53 for Medicaid) or the member's evidence of coverage documents.

Use of a long‑acting beta‑2 agonist (LABA) without an inhaled corticosteroid (ICS) in patients with asthma is a contraindication for certain listed agents (for example: Anoro Ellipta, Arcapta Neohaler, Bevespi Aerosphere, Brovana, Duaklir Pressair, Stiolto Respimat, Striverdi Respimat, Perforomist, Utibron Neohaler). Requests inconsistent with this contraindication may be denied.

Coverage under this clinical policy is subject to the terms, conditions, exclusions and limitations of the member's coverage documents and to applicable state and federal requirements. Where state Medicaid provisions conflict with this policy, the state provisions take precedence.

Coverage is not authorized for non‑FDA approved indications that are not addressed in this policy unless the off‑label use criteria are met and adequate supporting documentation is provided in accordance with the Health Plan's off‑label use policy (CP.PMN.53) or the member's evidence of coverage.

Primary treatment of status asthmaticus or acute episodes of asthma or COPD requiring intensive measures is a contraindication for multiple inhaled agents listed in the policy (for example: Advair HFA/Diskus, AirDuo Digihaler/RespiClick, Alvesco, ArmonAir Digihaler, Asmanex Twisthaler, Breo Ellipta, Dulera, Flovent Diskus/HFA, Pulmicort Flexhaler/Respules, Trelegy Ellipta). Such uses are not appropriate for outpatient maintenance coverage and may be denied.

Codes referenced in this clinical policy are provided for informational purposes only. Inclusion or exclusion of codes in this policy does not by itself establish medical necessity or guarantee coverage; providers should consult current coding guidance prior to claim submission.

Provider Actions, Prior Authorization & Documentation

Prior Authorization

Prior authorization required for brand inhaled agents

Prior authorization is required for the listed brand inhaled agents for asthma and/or COPD; generic agents do not require prior authorization.

Policy lists specific inhaled SABAs, ICS, LABAs, LAMAs, and combination products that require prior authorization.
The policy notes: "Generic agents do not require prior authorization."

Prior Authorization

Some therapeutic alternatives may require prior authorization

Preferred therapeutic alternatives are listed in Appendix B and may require prior authorization depending on the line of business; check the therapeutic alternatives table when selecting a preferred agent.

Appendix B lists dosing and notes that the table provides preferred alternative therapy recommended in approvals and that these drugs may not be formulary for all lines of business.

Coding and Billing

HCPCS CodesHCPCS

J7601

Ensifentrine, inhalation suspension, fda approved final product, non- compounded, administered through dme, unit dose form, 3 mg

Background

Asthma and COPD are managed primarily with inhaled therapies including short‑acting beta‑2 agonists (SABAs), inhaled corticosteroids (ICS), long‑acting beta‑2 agonists (LABAs), long‑acting muscarinic antagonists (LAMAs), and combination inhalers. This policy identifies inhaled agents that require prior authorization, summarizes FDA‑approved indications and age limits for many products, and references guideline sources such as GINA and GOLD to inform step‑therapy sequencing and combination therapy recommendations.

Definitions and Guideline References

chronic obstructive pulmonary disease — COPD

TermChronic obstructive pulmonary disease (COPD)

DefinitionChronic progressive respiratory disease characterized by airflow limitation (abbreviated in policy as COPD).

Use in policyPrimary diagnosis category for many inhaled agents addressed by this policy (see initial approval criteria).

short acting beta-2 agonist — SABA

TermShort acting beta-2 agonist (SABA)

DefinitionRapid-onset bronchodilator class used for reliever therapy in asthma and COPD (abbreviated in policy as SABA).

Policy note

Policy Summary

Payermeridian

PolicyInhaled Agents for Asthma and COPD

Policy CodePolicy MDN.PMN.259

Change TypeAnnual review — criteria and coding updates

Effective DateOct 1, 2023

Last ReviewJan 17, 2025

Next Review DateJan 17, 2025

Key ActionSubmit prior authorization with supporting clinical documentation demonstrating diagnosis, prior step therapy failures, and dosing to meet approval criteria.

SourceLink

On This Page

Prior Authorization

Prior authorization criteria and coding updated

The policy was updated with revised prior authorization language, added FDA‑indication clarifications, and a new HCPCS code; specific PA criteria, quantity limits, and diagnosis clarifications were added during reviews.

Revision history notes: typo corrections and additions (levalbuterol and QVAR) and Symbicort quantity limit language were added.
1Q2025 Annual Review: updated FDA indications table; updated initial criteria language; added ohtuvayre; added coding; added diagnosis clarification per PA team request.

Step Therapy

Step therapy: required trials before approval

Approval generally requires documented failure of specified formulary agent(s) at up to maximally indicated doses (step therapy); required step‑through agents are enumerated per requested agent in the initial criteria table.

Initial criteria require "Failure of the following formulary agent(s) at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated."
The per‑agent tables list required step‑through agents (e.g., generic albuterol products required before brand SABAs; required trials of specific ICS/LABA/LAMA combinations).

Step Therapy

Guideline‑informed sequencing for COPD

Stepwise sequencing follows guideline-based recommendations for COPD: escalate to LAMA+LABA for more symptomatic patients and consider triple therapy (ICS+LAMA+LABA) for inadequately controlled or high‑risk patients.

GOLD guidance cited: LAMA+LABA for more severe symptoms; triple therapy for those inadequately controlled by dual therapy or with higher eosinophils.
2023 guideline update de-emphasizes LABA+ICS alone and prefers LABA+LAMA+ICS when an ICS is indicated.

Step Therapy

Step therapy and criteria revisions noted

The step therapy language was revised (typo corrections and additions such as levalbuterol and QVAR) and Symbicort quantity limit language was added during prior revisions.

Revision history documents correction: "Typo corrected, levalbuterol and QVAR added to the criteria."
Additional revision: added language for increased quantity limit for Symbicort and updated initial criteria table.

Documentation Required

Submit supporting clinical documentation

Providers must submit supporting clinical documentation (e.g., office chart notes, lab results, or other clinical information) demonstrating that the member meets all approval criteria.

Policy states: "Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria."

Documentation Required

Document indication and dosing per listed regimens

Document the indication and dosing consistent with the policy’s listed dosing regimens and therapeutic alternatives; prior authorization may be required for certain non‑preferred agents as noted in the therapeutic alternatives table.

Prescribers should document indication and dosing consistent with dosing regimens in Appendix D (Dosage and Administration).
Therapeutic alternatives table notes some agents may not be formulary for all lines of business and may require PA.

Note

Coverage subject to member contract and regulations

Coverage and coverage determinations are governed by the member’s evidence of coverage and applicable legal and regulatory requirements; the policy is a guide and does not guarantee payment.

Important Reminder: coverage decisions and administration of benefits are subject to all terms, conditions, exclusions and limitations of coverage documents and applicable state/federal requirements.

Denial Risk

Denial risk if supporting documentation not provided

Failure to submit required documentation (office notes, labs, or other clinical information) showing the member meets approval criteria may result in denial of the request.

Policy states: "Failure to submit documentation (e.g., office notes, labs or other clinical information) supporting that member meets approval criteria may trigger denial."

Denial Risk

Contraindications (hypersensitivity/excipients) may trigger denial

Requests may be denied if the patient has known hypersensitivity to any component of the requested agent or to specified excipients (e.g., milk proteins) or if the agent is contraindicated per Appendix C.

Appendix C lists contraindications: hypersensitivity to components and specific excipient-related contraindications (e.g., milk proteins for multiple products; racemic formoterol for Brovana).
Use of a LABA without an ICS in patients with asthma for listed agents is contraindicated and may lead to denial.

Billing Rule

Coding listed in policy does not guarantee coverage

Inclusion or exclusion of codes in this policy is informational only and does not guarantee coverage; providers should reference current professional coding guidance before submitting claims.

Coding section: "Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up‑to‑date sources of professional coding guidance prior to submission of claims."
HCPCS code J7601 is listed for ensifentrine inhalation suspension administered through DME.

Required step therapy frequently specifies trial of generic albuterol HFA products before brand SABAs.

inhaled corticosteroid — ICS

TermInhaled corticosteroid (ICS)

DefinitionAnti-inflammatory controller therapy delivered by inhalation (abbreviated in policy as ICS).

Guideline contextGINA recommends early initiation of ICS in asthma management; NHLBI/NAEPP guidance also referenced.

long acting beta-2 agonist — LABA

TermLong acting beta-2 agonist (LABA)

DefinitionLong-acting bronchodilator class used as controller therapy (abbreviated in policy as LABA).

Contraindication noteUse of a LABA without an ICS in patients with asthma is contraindicated for certain agents (see contraindications appendix).

long acting muscarinic antagonist — LAMA

TermLong acting muscarinic antagonist (LAMA)

DefinitionLong-acting antimuscarinic bronchodilator class (abbreviated in policy as LAMA).

Role in COPDRecommended in combination with LABA (and with ICS for triple therapy) for patients with more severe symptoms per GOLD guidance.

Triple therapy — Combination of ICS + LAMA + LABA recommended for COPD patients who are very symptomatic or at high risk of exacerbation and for some unco...

TermTriple therapy (ICS + LAMA + LABA)

DefinitionCombination regimen of inhaled corticosteroid plus long-acting muscarinic antagonist plus long-acting beta-2 agonist.

IndicationRecommended for COPD patients who are very symptomatic or at high risk of exacerbation, and for some patients inadequately controlled on dual therapy (per GOLD).

Contraindication (examples) — Hypersensitivity to components (e.g., milk proteins), racemic formoterol; use of LABA without ICS in patients with asthma is contraindica...

ExamplesHypersensitivity to any component of the requested agent (general contraindication).

Specific excipientsMilk proteins: listed for multiple products (e.g., Advair Diskus, AirDuo Digihaler/RespiClick, Anoro Ellipta, Asmanex Twisthaler, Breo Ellipta, Flovent products, Pulmicort Flexhaler, Trelegy Ellipta).

Agent-specificBrovana: racemic formoterol is a contraindication for that product.

Therapeutic useUse of a LABA without an ICS in patients with asthma is contraindicated for specified agents (e.g., Anoro Ellipta, Arcapta Neohaler, Bevespi Aerosphere, Brovana, Duaklir Pressair, Stiolto Respimat, Striverdi Respimat, Perforomist, Utibron Neohaler).

Guidelines referenced — National Heart, Lung, and Blood Institute Expert Panel Report 3; GINA Global Strategy for Asthma; GOLD Global Strategy for COPD.

NHLBI/NAEPPNational Heart, Lung, and Blood Institute Expert Panel Report 3 (NAEPP/NHLBI).

GINAGlobal Initiative for Asthma: Global strategy for asthma management and prevention (GINA 2022 referenced).

GOLDGlobal Initiative for Chronic Obstructive Lung Disease: GOLD 2023 report (guidance cited for COPD combination and triple therapy).