CurrentUnitedHealthcarePolicy N/A

Prior authorization and medical necessity criteria for nebulized LAMA therapy (Lonhala Magnair and Yupelri)

Prior authorization and medical necessity criteria for Lonhala Magnair (glycopyrrolate inhalation solution) and Yupelri (revefenacin inhalation solution) for maintenance treatment of COPD; applies to UnitedHealthcare pharmacy benefit management programs.

Policy Summary

PayerUnitedHealthcare

PolicyNebulized LAMA therapy (Lonhala Magnair and Yupelri) — Prior authorization/medical necessity

Policy CodePolicy N/A

Change TypeNo material change

Effective Date2/1/2024

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis of moderate to severe COPD plus required step-therapy history or documented inability to use handheld inhalers.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period

2agents in program

<60 L/minPIFR threshold

2023 P 2151-8program ID

Coverage and Medical Necessity Criteria

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Reauthorization

Reauthorization requirement: Documentation of positive clinical response to therapy.

Lonhala Magnair (glycopyrrolate inhalation solution) is noted in the policy as typically excluded from coverage. This exclusion is called out directly in the coverage criteria section and should be considered when submitting prior authorization requests for nebulized long‑acting muscarinic antagonist (LAMA) therapy.

The policy does not present an explicit “not medically necessary” statement for Lonhala Magnair; instead it documents that Lonhala Magnair is typically excluded from coverage. Providers should rely on the exclusion note in the policy and follow prior authorization procedures if requesting coverage exceptions.

Provider Requirements and Prior Authorization Workflow

Prior Authorization

Prior Authorization Required

Prior authorization is required for Lonhala Magnair and Yupelri. Approvals are contingent on diagnosis of moderate to severe COPD and meeting the step/clinical criteria below. Authorization (when approved) will be issued for up to 12 months.

Applies to Lonhala Magnair and Yupelri
Authorization length: up to 12 months

Step Therapy

Step Therapy and Alternatives

Step therapy applies. Members must have trialed preferred inhaled long-acting muscarinic antagonist (LAMA) options prior to coverage of Lonhala Magnair or Yupelri unless there is documented inability to use or intolerance/contraindication. Preferred agents include Spiriva Handihaler or Spiriva Respimat (tiotropium) and Yupelri (revefenacin) where clinically appropriate.

Step options: Spiriva Handihaler (tiotropium)
Spiriva Respimat (tiotropium)
Yupelri (revefenacin)

Documentation Required

Required Clinical Documentation

Documented clinical evidence is required to support approvals. For members who cannot use handheld inhalers, provide objective and narrative documentation: clinical reason for inability to use (e.g., cognitive or physical impairment such as cognitive decline or hand arthritis) and/or objective inspiratory flow testing (e.g., documented peak inspiratory flow rate < 60 L/min where measured). If claiming intolerance or contraindication to a preferred agent, include prior trial details and reason for discontinuation.

Document cognitive or physical impairment limiting use of handheld devices
Document PIFR if claiming inadequate inspiratory force (e.g., < 60 L/min)
Provide history of failure, intolerance, or contraindication to preferred agents with dates and clinical rationale

Denial Risk

Documentation and Step Therapy Gaps — Denial Risk

Denial risk exists if required step therapy trials or supporting documentation are missing. Requests lacking evidence of prior trial of preferred agents (or documented inability/intolerance) or missing objective testing will be denied.

Missing step therapy trial of Spiriva Handihaler or Respimat (tiotropium) or Yupelri may lead to denial
Insufficient documentation of impairment or PIFR testing increases denial risk
Lack of dates or clinical rationale for prior medication failure/intolerance = denial risk

Key Definitions

Inability to use handheld inhaler — definition & examples

DefinitionClinical or functional limitations that prevent effective use of metered‑dose, dry powder, or slow‑mist handheld inhalers

Examples — cognitive impairmentCognitive decline or other cognitive impairment that limits the patient’s ability to coordinate inhaler technique (document impairment)

Examples — physical impairmentPhysical limitations such as arthritis in the hands that impair coordination needed for handheld devices (document impairment)

Examples — inadequate inspiratory forceInability to generate adequate inspiratory flow (PIFR < 60 L/min) preventing effective use of dry powder or slow‑mist devices (document measurement)