CurrentmhnPolicy CP.CPA.350

ADVAIR DISKUS (PDF)

Clinical policy defining medical necessity and prior authorization criteria for multiple inhaled agents (SABA, ICS, LABA, LAMA, ICS/LABA, LABA/LAMA, PDE3/PDE4) for asthma and COPD across commercial Centene-affiliated health plans, including required step therapies, age limits, dose limits, device/digital component justification, and continuation criteria. This is part 1 of 2 and includes appendices, product availability, dosing, contraindications and coding implications.

Policy Summary

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PolicyADVAIR DISKUS (PDF)

Policy CodePolicy CP.CPA.350

Change TypeUpdates and redirections (adds Ohtuvayre; coding updates; product removals; Symbicort Aerosphere pediatric expansion)

Effective DateMar 1, 2021

Next Review Date

Key ActionProvider must submit documentation supporting that the member meets all approval criteria, including spirometry and step-therapy documentation where required.

SourceLink

POLICY UPDATE CHANGES

HCPCS code J7601 was added for ensifentrine (11.06.24).

Ohtuvayre (ensifentrine) added to policy with redirections and clinical criteria (07.03.24).

Removed several off-market products (Flovent Diskus/HFA, Lonhala Magnair, Seebri Neohaler, Utibron Neohaler) during 1Q2026 annual review (11.12.25).

Symbicort Aerosphere indication and pediatric dosing added (05.06.26).

Redirection requirements for brands to authorized generics/generics were updated (09.21.23 and 12.23).

MultipleCovered Agents Listed

Coverage Summary

Overview: This clinical policy (Policy Number CP.CPA.350) defines medical necessity and prior authorization criteria for inhaled agents used to treat asthma and COPD across Centene-affiliated commercial health plans. Coverage stance: covered_with_criteria. Status: CURRENT. Scope: applies to multiple inhaled classes (SABA, ICS, LABA, LAMA, ICS/LABA, LABA/LAMA, PDE3/PDE4) and specifies required step therapies, age limits, dose and quantity limits, device/digital component justification, and continuation criteria. Key stats: Covered Agents Listed: Multiple; Approval Duration: 12 months; HCPCS Added: J7601; Document Portion: Policy document (Part 2 of 2); Publication Year: Centene copyright 2021. Note: This is part 1 of 2 and includes appendices, product availability, dosing, contraindications and coding implications. Effective date: 03.01.21; Last review date: 02.26.

Key thresholds and quick facts

Approval Duration12 months (initial and continued)

HCPCS addedJ7601 (ensifentrine unit dose 3 mg)

Blood eosinophil threshold (Ohtuvayre)≥ 100 cells/mcL

Spirometry requirement (Ohtuvayre)Pre- and post-albuterol FEV1/FVC < 0.70 OR post-albuterol FEV1 30–70% predicted

Ohtuvayre dosing formEnsifentrine (Ohtuvayre) inhalation suspension unit-dose 3 mg; dosing 3 mg ampule inhaled BID (max 6 mg/day)

Medical Necessity Criteria

Other diagnoses/indications (Initial)

If the requested use is not covered in Section I:

ANY of the following

Label change within 6 months: If the drug has recently (within the last 6 months) undergone a label change not yet reflected in this policy: refer to CP.CPA.190 (no coverage criteria policy) for formulary drugs or non-formulary policy for drugs not on formulary.
Off-label uses: If requested use is not listed under Section III (not-authorized diagnoses) and criterion above does not apply: refer to off-label use policy CP.CPA.09.

Continued Therapy

Covered when ALL of the following are met:

ALL of the following

Coding

HCPCS J-code added for ensifentrineHCPCS

J7601

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

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for brand inhaled agents listed in this policy. Generic versions typically do not require prior authorization. Approval duration is 12 months. Submit prior authorization requests before dispensing when applicable to avoid claim denials.

Approval duration: 12 months
Generics typically do not require prior authorization

Documentation Required

Submit supporting documentation

Providers must submit supporting clinical documentation with the prior authorization request. Acceptable documentation includes office chart notes, relevant laboratory results (e.g., blood eosinophil count when relevant), spirometry reports, and device-specific justification when the requested product includes a digital component.

Background & Evidence

Background summary: The policy lists inhaled agents requiring prior authorization (SABA, ICS, LABA, LAMA, ICS/LABA, LABA/LAMA, and PDE3/PDE4 agents) and summarizes FDA-approved indications, product availability, dosing, contraindications/boxed warnings, and therapeutic alternatives. It implements step therapy and redirection to generics/authorized generics where applicable and requires documentation of failure or contraindication to specified formulary agents prior to approval. Special provisions added for newer agents include specific redirections and clinical criteria for Ohtuvayre (ensifentrine) (e.g., required step-through options, blood eosinophil-based redirections, and spirometric documentation for COPD severity) and coding implications (HCPCS code J7601 for ensifentrine unit-dose 3 mg). The policy also requires medical justification when a requested product includes a digital inhaler component (e.g., Digihaler products) to support necessity of the digital feature.

Evidence

Revision History

09.21.23/12.23Clarified

Redirection requirements updated to favor authorized generics/generics (e.g., fluticasone-propionate HFA for Flovent HFA/Diskus; Advair HFA redirected to Advair HFA authorized generic; Breo Ellipta allowed as brand or authorized generic).

07.03.24Added

Ohtuvayre (ensifentrine) added to policy with detailed step-therapy redirections and clinical criteria including spirometric requirements and eosinophil-based escalation (for members with blood eosinophil count ≥ 100 cells/mcL) and note that prior failure of triple therapy satisfies dual therapy failure.

11.06.24Added

Policy Summary

Payermhn

PolicyADVAIR DISKUS (PDF)

Policy CodePolicy CP.CPA.350

Change TypeUpdates and redirections (adds Ohtuvayre; coding updates; product removals; Symbicort Aerosphere pediatric expansion)

Effective DateMar 1, 2021

Next Review Date

Key ActionProvider must submit documentation supporting that the member meets all approval criteria, including spirometry and step-therapy documentation where required.

SourceLink

On This Page

Continuity of care: Member currently receiving medication via Centene benefit or has previously met initial approval criteria; OR member is currently receiving medication and is enrolled in a state/product with continuity of care regulations (refer to CC.PHARM.03A and CC.PHARM.03B).
Response: Member is responding positively to therapy.
Dose increase: If request is for a dose increase, request does not exceed the health plan quantity limit OR the FDA-approved maximum dose for the relevant indication (see Section V).

Diagnoses/Indications Not Authorized

Coverage NOT authorized when:

ALL of the following

Non-FDA indications: Non-FDA approved indications not addressed in this policy, unless sufficient documentation of efficacy and safety per off-label use policies CP.CPA.09 or evidence of coverage documents.

Step Therapy

Step therapy/redirection requirements

Step therapy and redirection requirements must be documented. The request must show failure, intolerance, or contraindication to the specified step-through agent(s) prior to approval. Per-agent redirection rules and acceptable alternative agents are detailed in the clinical criteria; document which specific step agents were tried, doses, durations, and reasons for failure or contraindication.

Document failure/intolerance/contraindication to required step-through agents at up to maximally indicated doses
If requesting a brand because of inability to use an alternative device, include medical justification for device-related limitations
Note: Prior failure of triple therapy (ICS/LABA/LAMA) satisfies dual therapy (LABA/LAMA) requirements where applicable

Billing Rule

Quantity/dose limits

Requests must comply with plan quantity limits and FDA maximum dosing. Do not request quantities or dose increases that exceed the health plan's quantity limit or the FDA‑approved maximum dose for the indication. For dose-increase requests, include rationale and documentation that the member is responding to therapy and that increases remain within allowable limits.

Requests must not exceed the health plan quantity limit
Requests must not exceed the FDA‑approved maximum dose for the relevant indication
Dose-increase requests require documentation of clinical response and remain subject to quantity/dose limits

Documentation Required

Provider responsibility and medical judgment

Providers are responsible for submitting accurate, complete clinical information and exercising independent medical judgment in prescribing. Coverage determinations are based on the policy criteria; clinical judgment and documentation supporting medical necessity must be supplied. Providers should ensure claims and attestations adhere to contractual requirements and submit claims with correct codes and quantity information.

Provider responsibility to submit accurate, complete documentation that supports medical necessity
Clinical judgment remains with the prescriber; however, approval is contingent on meeting policy criteria
Ensure claim submissions follow contractual requirements and include correct codes, quantities, and any required modifiers or attachments

Denial Risk

Policy noncompliance and plan rights

Noncompliance with policy criteria may result in denial or retrospective claim adjustment. The plan reserves the right to deny, audit, or request additional information, and to recover payments if claims are not consistent with coverage rules. Adherence to contractual terms, timely and accurate claims submission, and retention of supporting documentation are required.

Policy noncompliance may result in denial of coverage or retrospective recoupment
The plan reserves rights to audit, request additional clinical information, and enforce contractual terms
Maintain and provide supporting documentation upon request; failure to do so may increase denial risk