CurrentUnitedHealthcarePolicy N/A

Nebulized LAMA therapy (Lonhala Magnair, Yupelri) for COPD — Prior Authorization Criteria

Prior authorization and medical necessity criteria for Lonhala Magnair (glycopyrrolate) and Yupelri (revefenacin) as nebulized long-acting antimuscarinic agents for maintenance treatment of moderate to severe COPD for UnitedHealthcare members.

Policy Summary

PayerUnitedHealthcare

PolicyNebulized LAMA therapy (Lonhala Magnair, Yupelri) for COPD — Prior Authorization Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateFeb 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization; approvals issued for 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 moauthorization duration

Lonhala excludedcoverage note

Tiotropium trialYupelri step

11/2023P&T review

Coverage and Medical Necessity Criteria

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Initial Authorization — Yupelri

Covered when ALL of the following are met:

Yupelri initial criteria: Diagnosis of moderate to severe chronic obstructive pulmonary disease (COPD)

Authorization issued for 12 months

Yupelri step and inability criteria

ONE of: History of failure, contraindication, or intolerance to Spiriva Handihaler or Respimat (tiotropium)
OR - Patient unable to use handheld inhaler
- CAUSES: Cognitive or physical impairment limiting coordination of handheld devices (e.g., cognitive decline, arthritis)
  Document impairment
- OR: Inability to generate adequate inspiratory force (peak inspiratory flow rate <60 L/min)<60 L/min

Reauthorization Criteria

Covered when ALL of the following are met:

Reauthorization: Documentation of positive clinical response to therapy (for Lonhala Magnair or Yupelri)

Authorization will be issued for 12 months when criteria are met

Lonhala Magnair (glycopyrrolate) is typically excluded from coverage. Coverage may still vary based on member-specific benefits and applicable state mandates, and any federal regulatory requirements may also affect coverage. Other policies and utilization management programs may apply and could modify coverage determinations for individual members.

Coding and Clinical Thresholds

Peak inspiratory flow rate (PIFR) — value used for inhaler suitability

PIFR thresholdPeak inspiratory flow rate (PIFR) <60 L/min

Use in criteriaInsufficient PIFR is a documented reason for inability to use handheld inhalers when considering nebulized LAMA (e.g., Yupelri).

Measurement contextPIFR referenced as measured against inhaler resistance to determine adequacy of inspiratory force for metered‑dose, dry powder, or slow‑mist inhalers.

Provider Requirements and Authorization Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for Yupelri (revefenacin) and approvals for initial and re‑authorization will be issued for 12 months when criteria are met.

Authorization length: 12 months for initial approvals and re-authorizations when criteria are met

Step Therapy

Yupelri Step Requirements

Step therapy requirement: member must have a history of failure, contraindication, or intolerance to tiotropium (Spiriva Handihaler or Respimat), OR documentation that the patient is unable to use metered‑dose, dry powder, or slow mist handheld inhalers.

Required trial: Spiriva Handihaler or Spiriva Respimat (tiotropium) — history of failure, contraindication, or intolerance
Alternate path: Documented inability to use handheld inhalers (see documentation requirements)

Documentation Required

Documentation of Impairment

Document the specific reason the patient cannot use handheld inhalers. Acceptable documentation includes cognitive or physical impairment limiting coordination (e.g., cognitive decline, arthritis) or inability to generate adequate inspiratory force (e.g., peak inspiratory flow rate < 60 L/min).

Examples of acceptable documentation: cognitive impairment, hand arthritis, or measured PIFR < 60 L/min
If relying on inability to use inhaler instead of trialing tiotropium, include clear clinical evidence in the chart

Denial Risk

Automated Approval / Denial Logic

Automated approval and denial logic may be used. UnitedHealthcare may approve initial or re‑authorization requests based solely on prior claim/medication history, diagnosis codes (ICD‑10), and/or claim logic. Supply limits may apply. Be aware that mismatches between diagnosis codes, prior therapy history, or exceeded supply limits can trigger automated denials.

Approvals can be based on prior claims/medication history and ICD‑10 diagnosis codes without additional documentation
Potential denial triggers: lack of corroborating prior therapy claims, diagnosis‑code mismatches, or exceeding supply/quantity limits
Supply limits and program‑specific automated processes may vary

Key Definitions

Nebulized LAMA — Definition

DefinitionLong-acting antimuscarinic (anticholinergic) agent delivered via nebulizer for maintenance treatment of COPD.

Examples (documented in policy)Lonhala Magnair (glycopyrrolate inhalation solution) and Yupelri (revefenacin inhalation solution)

IndicationLong‑term maintenance treatment of airflow obstruction in patients with COPD.

Inability to use handheld inhaler — Definition and examples

DefinitionInability to use handheld inhaler includes cognitive or physical impairment limiting coordination of handheld devices or inability to generate adequate inspiratory force.

Cognitive/physical examplesCognitive decline or arthritis in the hands (document impairment).

Inspiratory force examplePeak inspiratory flow rate (PIFR) resistance <60 L/min indicating inadequate inspiratory effort for dry powder or other handheld inhalers.

Background and Clinical Context

Lonhala Magnair (glycopyrrolate inhalation solution) and Yupelri (revefenacin inhalation solution) are nebulized long-acting antimuscarinic (LAMA) agents indicated for long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). These agents are intended for use in patients with moderate to severe COPD when handheld inhaler delivery is unsuitable or after trial/failure of indicated inhaled LAMA therapies. When authorized, initial approvals are issued for 12 months.