CurrentCignaPolicy IP0020

LAMA/LABA Combination Inhalers (Bevespi Aerosphere, Duaklir Pressair) — Coverage Criteria

Defines medical necessity criteria, continuation, authorization duration, and non-covered uses for formulary-exception coverage of two non-preferred LAMA/LABA inhalers for treatment of COPD under Cigna-administered plans.

Policy Summary

PayerCigna

PolicyLAMA/LABA Combination Inhalers (Bevespi Aerosphere, Duaklir Pressair) — Coverage Criteria

Policy CodePolicy IP0020

Change TypeNo material change

Effective DateJan 1, 2024

Next Review DateJan 1, 2025

Key ActionObtain prior authorization and document failure, contraindication, or intolerance to specified preferred LAMA/LABA products.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2non-preferred LAMA/LABA products addressed

12initial and reauthorization approval duration (months)

1clinical condition covered (COPD)

Coverage Criteria

Initial Therapy Criteria

Covered when the following criteria are met for each product

Bevespi Aerosphere initial coverage: Bevespi Aerosphere (glycopyrrolate/formoterol) is considered medically necessary for the treatment of chronic obstructive pulmonary disease (COPD) when the individual meets ONE of the following: 1) Failure, contraindication, or intolerance to BOTH Anoro Ellipta (umeclidinium/vilanterol) AND Stiolto Respimat (tiotropium/olodaterol); OR 2) For an individual with low inspiratory flow rate and unable to use a dry powder inhaler (DPI), failure, contraindication, or intolerance to Stiolto Respimat.

Prescriber must document prior failures, contraindications, or intolerances as specified

Duaklir Pressair initial coverage: Duaklir Pressair (aclidinium bromide and formoterol fumarate) is considered medically necessary for the treatment of chronic obstructive pulmonary disease (COPD) when there is documented failure, contraindication, or intolerance to BOTH of the following: 1) Anoro Ellipta (umeclidinium/vilanterol) AND 2) Stiolto Respimat (tiotropium/olodaterol).

Prescriber must document failures, contraindications, or intolerances to both preferred agents

Policy Summary

PayerCigna

PolicyLAMA/LABA Combination Inhalers (Bevespi Aerosphere, Duaklir Pressair) — Coverage Criteria

Policy CodePolicy IP0020

Change TypeNo material change

Effective DateJan 1, 2024

Next Review DateJan 1, 2025

Key ActionObtain prior authorization and document failure, contraindication, or intolerance to specified preferred LAMA/LABA products.

SourceLink

On This Page

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Provider Actions & Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial and reauthorization approvals may be granted for up to 12 months when the medical necessity criteria are met.

Initial approval: up to 12 months
Reauthorization approval: up to 12 months

Step Therapy

Step Therapy Required

Step therapy is required. Coverage for non-preferred LAMA/LABA combination products (e.g., Bevespi Aerosphere, Duaklir Pressair when non-preferred) is contingent on documented failure, contraindication, or intolerance to the specified preferred LAMA/LABA products.

Required trial/failure, contraindication, or intolerance to Anoro Ellipta (umeclidinium/vilanterol)
Required trial/failure, contraindication, or intolerance to Stiolto Respimat (tiotropium/olodaterol)

Documentation Required

Provider must document the diagnosis of chronic obstructive pulmonary disease (COPD) and evidence of failure, contraindication, or intolerance to the specified preferred LAMA/LABA products prior to approval.

Documented COPD diagnosis
Documentation of failure, contraindication, or intolerance to Anoro Ellipta and Stiolto Respimat (or to Stiolto Respimat alone for patients with low inspiratory flow unable to use a DPI, per criteria)

Denial Risk

Denial Triggers

Requests that do not meet the documented medical necessity criteria or that are for indications other than COPD are considered experimental, investigational, or unproven and may be denied.

Requests lacking documentation of COPD or required step-therapy failures
Requests for uses other than COPD (considered experimental/investigational)

Definitions (Inhaler Types)

Dry-powder inhaler (DPI)

DefinitionDry-powder inhaler (DPI): a device that delivers medication as a dry powder; suitable only when the patient can generate a forceful, deep inhalation.

Inhalation requirementRequires a forceful and deep inspiratory effort from the patient to properly disperse and inhale the powder.

Device selection noteUse of a DPI should be limited to patients who can reliably perform the required forceful/deep inhalation per guideline recommendation.

Pressurized metered‑dose inhaler (MDI)

DefinitionPressurized metered‑dose inhaler (MDI): a propellant‑driven device that delivers a metered spray of medication.

Coordination requirementMDIs require coordination between actuation and inhalation; patients must synchronize device actuation with a slow, deep inhalation.

Spacer guidanceIf coordination is problematic, a spacer or valved holding chamber should be used to facilitate delivery.

Soft‑mist inhaler

DefinitionSoft‑mist inhaler: a propellant‑free device that uses mechanical energy to generate a slow‑moving, very‑fine liquid aerosol cloud.

Inhalation techniqueRequires a slow and deep inhalation to inhale the fine liquid aerosol effectively.

Comparative noteSoft‑mist inhalers require less forceful inhalation than DPIs but, like MDIs, require coordination between actuation and inhalation; consider patient ability when selecting device.

OpenPayer

LAMA/LABA Combination Inhalers (Bevespi Aerosphere, Duaklir Pressair) — Coverage Criteria

Coverage Criteria

Coding

Provider Actions & Authorization

Background

Definitions (Inhaler Types)