Centene inhaled asthma COPD Prior Auth Update

Coverage Criteria for Inhaled Agents

Initial Therapy — Covered when ALL of the following are met for initial approval

Covered when ALL of the following are met for initial approval:

Initial approval criteria (Inhaled Agents for Asthma or COPD): 1. Diagnosis of asthma or COPD consistent with the FDA‑approved indication for the requested agent (see FDA Approved Indications). 2. Age requirement: (a) for asthma, age appropriate per the product prescribing information; OR (b) for COPD, age ≥ 18 years. 3. Failure of required formulary step‑through agent(s) at up to maximally indicated doses unless there is documented contraindication or clinically significant adverse effects (specific step agents listed per requested brand). 4. For agents with a digital component (e.g., Digihaler products): medical justification supports the necessity of the digital component. 5. For Ohtuvayre (ensifentrine): (a) member has moderate‑to‑severe COPD documented by either pre/post‑bronchodilator FEV1/FVC < 0.70 OR post‑albuterol FEV1 ≥ 30% and ≤ 70% predicted; AND (b) Ohtuvayre is not prescribed in combination with Daliresp (roflumilast). 6. Requested quantity and dose do not exceed the health plan quantity limits or the FDA‑approved maximum dose for the indication (exceptions: Georgia dose/quantity limit bypass when applicable).

Approval duration: 12 months

Continuation Therapy — Covered when ALL of the following are met for continued therapy

Covered when ALL of the following are met for continued therapy:

Continued therapy criteria (Inhaled Agents for Asthma or COPD): 1. Member is currently receiving the requested medication via the Centene benefit or previously met initial approval criteria OR member is receiving therapy and is in a continuity‑of‑care scenario as defined by state/product regulations. 2. Member is responding positively to therapy. 3. For dose increase requests: requested quantity does not exceed the health plan quantity limit OR requested dose does not exceed the FDA‑approved maximum dose for the indication OR the request meets the Georgia emergency bypass provision for members with life‑threatening bronchial ailments prescribed by the treating physician.

Approval duration: 12 months

Not Medically Necessary / Not Authorized

Not authorized indications: Non‑FDA approved indications that are not addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety in accordance with the off‑label use policy (HIM.PA.154) or supporting evidence of coverage documents.

Coverage when consistent with labeled use — Covered when prescribed consistent with labeled indication and dosing

Covered when prescribed consistent with labeled indication and dosing:

Labeled indication and dosing: Agent is prescribed for an FDA‑approved indication (e.g., asthma, COPD, bronchospasm, or exercise‑induced bronchospasm) and the prescribed regimen is at or below the product's labeled dosing regimen and maximum dose as specified in Section V (Dosage and Administration).per‑product maximums listed in V. Dosage and Administration

See product‑specific dosing entries in the Dosage and Administration section (chunks 23–26).

GOLD-based COPD coverage logic — Coverage preference/step logic for COPD per GOLD 2023

Coverage preference/step logic for COPD per GOLD 2023:

COPD therapy selection: Per GOLD recommendations: for symptomatic or exacerbation‑prone patients (Groups B and E), use combination inhaled therapy — LAMA+LABA or triple therapy (ICS+LAMA+LABA) depending on symptoms, exacerbation history, and blood eosinophil count. For more severe symptoms consider LAMA+LABA; for inadequate control or eosinophils ≥ 300 cells/µL consider triple therapy (ICS+LAMA+LABA). LABA+ICS is de‑emphasized; when an ICS is indicated, triple therapy is preferred over LABA+ICS. Ohtuvayre may be considered for persistent dyspnea despite LABA+LAMA but is not recommended for exacerbation prevention when triple therapy would be preferred.eosinophils >= 300 cells/uL cited for considering triple therapy

Aligns therapy sequencing with GOLD 2023 guidance.

Conditional coverage with redirection and step therapy — Coverage is conditional and includes redirection/step therapy to generics/authorized generics and prior authorization for certain branded agents

Coverage is conditional and includes redirection/step therapy to generics/authorized generics and prior authorization for certain branded agents.

Redirection requirement: Requests for branded inhaled agents are subject to redirection to specified authorized generics or alternate formulary agents per the policy redirection tables (examples: brand Symbicort redirected to generic/authorized generic Symbicort; brand Flovent/Advair redirected to fluticasone propionate authorized generics).

Redirections and target generics/authorized generics have been updated across reviews.

New agent addition: Ensifentrine (Ohtuvayre) has been added to the policy with associated redirection and prior authorization rules and referenced HCPCS coding (J7601).

See coding entries and HCPCS J7601 addition.

Step therapy bypass: A state‑level step therapy bypass (Illinois HIM per IL HB 5395) exists allowing step therapy requirements not to apply for eligible Illinois members as specified by statute.

Requests for coverage of indications that are not FDA‑approved and are not explicitly addressed in this policy are excluded unless the prescriber supplies sufficient documentation of efficacy and safety in accordance with the Centene off‑label use policy (HIM.PA.154) or the member’s applicable evidence of coverage. Coverage will only be considered when that supporting documentation meets the requirements of the off‑label policy.

These maintenance inhaler products are not intended for primary treatment of status asthmaticus or acute severe exacerbations. Requests that indicate use as the primary therapy for status asthmaticus or other acute episodes of asthma or COPD requiring intensive measures will be denied; such acute care should be managed with appropriate emergency or inpatient treatments rather than routine maintenance inhalers listed in this policy.

Known hypersensitivity to any component of the requested product is a contraindication to coverage. The policy specifically notes certain excipient/product sensitivities (for example, milk proteins with some dry powder devices, racemic formoterol for Brovana, and ipratropium for Spiriva Handihaler). Requests for members with documented hypersensitivity to the active ingredient or specified excipients will be denied.

The policy removes several off‑market products from the coverage reference lists. The following products are no longer included in the policy tables and references: Flovent Diskus, Flovent HFA, Lonhala Magnair, Seebri Neohaler, and Utibron Neohaler.

Use of inhaled agents for indications that are not FDA‑approved and not addressed in this policy is not authorized unless the prescriber provides adequate evidence of safety and efficacy per the off‑label use policy (HIM.PA.154) or the member’s evidence of coverage. Absent that documentation, requests for non‑labeled uses will be denied.

For asthma care, the policy lists as contraindicated the use of a long‑acting beta‑agonist (LABA) without a concurrent inhaled corticosteroid (ICS). Requests for LABA monotherapy for asthma (for example, products cited in the policy such as Anoro Ellipta, Bevespi Aerosphere, Brovana, Duaklir Pressair, Perforomist when used without an ICS) are considered not medically necessary and may be denied.

Coding information in this policy is provided for informational purposes only. Inclusion or omission of specific procedure or HCPCS codes does not guarantee coverage. Providers must follow their payer’s current coding and prior authorization guidance when submitting claims and should verify codes against up‑to‑date professional coding resources prior to billing.

Coding and Product References

Covered drug classesmixedCovered

SABA	Short acting beta-2 agonists — e.g., albuterol (ProAir Digihaler)
ICS	Inhaled corticosteroids — e.g., budesonide (Pulmicort Respules), ciclesonide (Alvesco), fluticasone (ArmonAir Digihaler), mometasone (Asmanex HFA, Asmanex Twisthaler)
LABA	Long acting beta-2 agonists — e.g., arformoterol (Brovana), formoterol (Perforomist)
LAMA	Long acting muscarinic antagonists — e.g., aclidinium bromide (Tudorza Pressair), revefenacin (Yupelri), tiotropium bromide monohydrate (Spiriva Handihaler)
ICS/LABA	Combination inhaled corticosteroid and long-acting beta agonist — e.g., budesonide/formoterol (Symbicort), fluticasone/salmeterol (Advair), mometasone/formoterol (Dulera)
LABA/LAMA	Combination long-acting beta agonist and long-acting muscarinic antagonist — e.g., aclidinium/formoterol (Duaklir), glycopyrrolate/formoterol (Bevespi Aerosphere), umeclidinium/vilanterol (Anoro Ellipta)
PDE3/PDE4 inhibitor	Phosphodiesterase 3 and 4 inhibitor — ensifentrine (Ohtuvayre)

Example agents by classmixedCovered

Albuterol	ProAir Digihaler (SABA)
Budesonide	Pulmicort Respules (ICS)
Ciclesonide	Alvesco (ICS)
Fluticasone	ArmonAir Digihaler (ICS)
Mometasone	Asmanex HFA; Asmanex Twisthaler (ICS)
Arformoterol	Brovana (LABA)
Formoterol	Perforomist (LABA)
Aclidinium	Tudorza Pressair (LAMA)
Revefenacin	Yupelri (LAMA)
Tiotropium	Spiriva Handihaler (LAMA)

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Referenced HCPCS CodesHCPCS

J7601

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

Prescribing information and referencesmixed

ProAir Digihaler PI	Teva Pharmaceuticals USA, Inc; September 2020 (see policy references)
Alvesco PI	Sunovion Pharmaceuticals Inc.; February 2023
ArmonAir Digihaler PI	Teva Pharmaceuticals USA, Inc.; April 2022
Asmanex HFA PI	Organon & Co.; June 2025
Asmanex Twisthaler PI	Organon & Co.; June 2021
Pulmicort Respules PI	AstraZeneca; October 2019
Brovana PI	Sunovion Pharmaceuticals Inc.; May 2019
Perforomist PI	Mylan Specialty L.P.; May 2019
Spiriva Handihaler PI	Boehringer Ingelheim Pharmaceuticals, Inc.; December 2024
Tudorza Pressair PI	AstraZeneca; August 2022

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Ohtuvayre COPD severity criteria

Ohtuvayre COPD severity criteriaMember has moderate-to-severe COPD evidenced by either pre- and post-albuterol FEV1/FVC < 0.70 OR post-albuterol FEV1 ≥ 30% and ≤ 70% of predicted normal

Ohtuvayre additional requirementOhtuvayre is not prescribed in combination with Daliresp (roflumilast)

Maximum dosing examples

Maximum dosing examplesAdvair Diskus maximum dose = 500/50 mcg BID (asthma); Advair Diskus COPD max = 250/50 mcg BID; Symbicort max = 320/9 mcg BID; ProAir Digihaler max = 12 inhalations/day

Maximum dosing example (Ohtuvayre)Refer to Section V dosing — approval requires requested dose not exceed FDA-approved maximum dose

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required — verify dosing against label

Prior authorization is required for specified inhaled agents for asthma and COPD. The prior authorization review will verify that the prescribed dose and regimen match FDA‑approved dosing in the policy's Dosage and Administration section. Requests should specify the exact product, strength, route (e.g., inhalation via nebulizer or inhaler), and dosing frequency to allow dose verification.

Verify prescribed dose and regimen against policy Appendix V: Dosage and Administration (see examples for Advair, Symbicort, Ohtuvayre, ProAir Digihaler, Pulmicort Respules, etc.)
Requests for ensifentrine (Ohtuvayre) reference HCPCS J7601 (ensifentrine, inhalation suspension, unit dose 3 mg) for billing informational purposes

Documentation Required

Providers must submit supporting clinical documentation with the prior authorization request. Failure to provide required documentation may result in denial or delay of the request.

Background

Asthma and chronic obstructive pulmonary disease (COPD) are chronic obstructive airway disorders managed primarily with inhaled therapies. Common classes include short‑acting beta agonists (SABAs) for relief, inhaled corticosteroids (ICS) for anti‑inflammatory control, long‑acting beta agonists (LABAs), long‑acting muscarinic antagonists (LAMAs), fixed ICS/LABA and LABA/LAMA combinations, and newer inhaled agents such as the PDE3/PDE4 inhibitor ensifentrine (Ohtuvayre). Product approvals, age indications, dosing, and device features (including digital components) vary by product, and this policy requires use consistent with FDA‑approved indications and labeled dosing.

Definitions and Key Terms

inv-35: FEV1/FVC — definition and threshold for COPD airflow obstruction (< 0.70)

DefinitionFEV1/FVC = forced expiratory volume divided by forced vital capacity; used to define airflow obstruction in COPD.

COPD airflow obstruction thresholdAirflow obstruction defined as FEV1/FVC ratio < 0.70 (pre- or post-bronchodilator per policy criteria).

Usage in policyFEV1/FVC is cited as evidence for COPD severity when assessing eligibility for agents such as Ohtuvayre.

inv-36: EIB — Exercise-induced bronchospasm definition

DefinitionExercise-induced bronchospasm (EIB): bronchospasm occurring with or after exercise; listed as an indication for rescue inhalers and documented dosing for prevention prior to exercise.

EIB prophylaxis dosing example

OpenPayer

Inhaled Agents for Asthma and COPD

Coverage Criteria for Inhaled Agents

Coding and Product References

Provider Requirements, Prior Authorization, and Documentation

Background

Definitions and Key Terms