CurrentCignaPolicy IP0089

Nebulized Long-Acting Muscarinic Antagonists (Lonhala Magnair, Yupelri)

Cigna coverage policy for formulary exceptions and medical necessity review for nebulized LAMA products Lonhala Magnair (glycopyrrolate) and Yupelri (revefenacin) for long-term maintenance treatment of COPD in adults.

Policy Summary

PayerCigna

PolicyNebulized Long-Acting Muscarinic Antagonists (Lonhala Magnair, Yupelri)

Policy CodePolicy IP0089

Change TypeNo material change

Effective DateNov 1, 2023

Next Review DateNov 1, 2024

Key ActionSubmit formulary exception or medical necessity request with documentation of age ≥18 and either failure/contraindication/intolerance to listed LAMAs or inability to use a DPI/soft-mist inhaler.

POLICY UPDATE CHANGES

No material clinical or coverage changes in this update.

2Nebulized LAMA products covered (Lonhala, Yupelri)

18+Minimum age for coverage

12 monthsInitial authorization duration (max)

Coverage Summary

Coverage stance: covered_with_criteria — Nebulized LAMA products Lonhala Magnair (glycopyrrolate) and Yupelri (revefenacin) are covered with medical necessity criteria for long‑term maintenance treatment of COPD in adults, per the policy scope. Scope: formulary exceptions and medical necessity review for these nebulized LAMA products for long‑term maintenance COPD treatment in adults. Key facts: • Minimum age: 18+. • Initial authorization duration (max): 12 months.

Initial Therapy Criteria

Lonhala Magnair (glycopyrrolate inhalation solution) - Initial Therapy

Lonhala Magnair is considered medically necessary when for the treatment of chronic obstructive pulmonary disease (COPD) when ALL of the following are met:

ALL of the following

Patient is 18 years of age or older
ONE of the following
- Documented failure, contraindication, or intolerance to ONE of the following LAMA products: Incruse Ellipta, Spiriva Respimat, Spiriva HandiHaler
- Documented inability to use a dry-powder inhaler (DPI) or a soft-mist inhaler (for example, low inspiratory flow, unable to coordinate breath and actuation of device)

ALL of the following

Patient is 18 years of age or older
ONE of the following
- Documented failure, contraindication, or intolerance to ONE of the following LAMA products: Incruse Ellipta, Spiriva Respimat, Spiriva HandiHaler, Tudorza Pressair
- Documented inability to use a dry-powder inhaler (DPI) or a soft-mist inhaler (for example, low inspiratory flow, unable to coordinate breath and actuation of device)

Yupelri (revefenacin inhalation solution) - Initial Therapy

Yupelri is considered medically necessary for the treatment of chronic obstructive pulmonary disease (COPD) when ALL of the following are met:

ALL of the following

Patient is 18 years of age or older
ONE of the following
- Documented failure, contraindication, or intolerance to ONE of the following LAMA products: Incruse Ellipta, Spiriva Respimat, Spiriva HandiHaler
- Documented inability to use a dry-powder inhaler (DPI) or a soft-mist inhaler (for example, low inspiratory flow, unable to coordinate breath and actuation of device)

ALL of the following

Legacy Yupelri - Initial Therapy

Legacy coverage statement (older/other benefit designs):

ALL of the following

Patient is 18 years of age or older
ONE of the following
- Documented failure, contraindication, or intolerance to ONE of the following LAMA products: Incruse Ellipta, Spiriva Respimat, Spiriva HandiHaler, Tudorza Pressair
- Documented inability to use a dry-powder inhaler (DPI) or a soft-mist inhaler (for example, low inspiratory flow, unable to coordinate breath and actuation of device)

Continuation / Reauthorization Criteria

Reauthorization / Continuation Therapy

Continuation of nebulized LAMA products is considered medically necessary when all criteria are met:

ALL of the following

Above medical necessity criteria (for the applicable product) are met
Documentation of beneficial response to therapy

Documentation Required

Document beneficial response for reauthorization

For reauthorization, documentation of beneficial response to the nebulized LAMA is required in addition to meeting initial criteria. (Documentation action)

Provider Actions & Billing Rules

Prior Authorization

Medical necessity review / formulary exception required

Formulary exceptions and medical necessity review are required for coverage of nebulized Lonhala Magnair and Yupelri; documentation must show age ≥18 and either failure, contraindication, or intolerance to one of the listed LAMA products (Incruse Ellipta, Spiriva Respimat, Spiriva HandiHaler) or documented inability to use a dry-powder inhaler (DPI) or a soft-mist inhaler.

J7677

Billing Rule

Dose and device-specific administration

When covered, dosage, frequency, duration, and site of care should be clinically appropriate and supported by evidence. Lonhala Magnair: one unit-dose vial (25 mcg/1 mL glycopyrrolate) twice daily (BID) using the Magnair (eFlow® Closed System) nebulizer device (intended only for use with Lonhala). Yupelri: one single-dose vial (175 mcg/3 mL revefenacin) once daily (QD) administered via any standard jet nebulizer.

J7677

Site‑of‑care / device considerations: device selection should be tailored to the individual and consider the patient’s ability to use inhaler devices (for example, low inspiratory flow or inability to coordinate breath and actuation), since proper training and device technique are critical and many patients make handling errors.

Background & Definitions

Policy position: This policy supports use of nebulized LAMA therapies for maintenance treatment of COPD in adults. Device selection should consider the patient’s ability to use inhaler devices. The two products covered are Lonhala Magnair (glycopyrrolate inhalation solution) and Yupelri (revefenacin inhalation solution).

DPI = Dry‑powder inhaler

LAMA = Long‑acting muscarinic antagonist

Quick facts — Nebulized LAMAs

Nebulized LAMA products covered (Lonhala, Yupelri)2

Minimum age for coverage18+

Initial authorization duration (max)12 months

Policy Summary

PayerCigna

PolicyNebulized Long-Acting Muscarinic Antagonists (Lonhala Magnair, Yupelri)

Policy CodePolicy IP0089

Change TypeNo material change

Effective DateNov 1, 2023

Next Review DateNov 1, 2024

On This Page

OpenPayer

Nebulized Long-Acting Muscarinic Antagonists (Lonhala Magnair, Yupelri)

Coverage Summary

Initial Therapy Criteria

Continuation / Reauthorization Criteria

Provider Actions & Billing Rules

Applicable Codes

Clinical Evidence

Background & Definitions

Revision History