CurrentUnitedHealthcarePolicy N/A

Yupelri (revefenacin) prior authorization

Prior authorization and medical necessity criteria for Yupelri (revefenacin inhalation solution) for maintenance treatment of COPD for UnitedHealthcare members.

Policy Summary

PayerUnitedHealthcare

PolicyYupelri (revefenacin) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateFeb 15, 2026

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis of moderate to severe COPD plus either prior trial failure/contraindication/intolerance to tiotropium or inability to use handheld inhalers with supporting documentation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

COPDIndicated condition

12 monthsAuthorization duration

Prior authProgram type

TiotropiumStep requirement

Positive responseReauthorization

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Initial Therapy — Initial Authorization

Initial Authorization: Covered when ALL of the following are met

Initial Authorization: Member has a diagnosis of moderate to severe chronic obstructive pulmonary disease (COPD)

based on label indication

Step requirement

ONE of: History of failure, contraindication, or intolerance to Spiriva Handihaler or Respimat (tiotropium)
Document prior trial or intolerance
ONE of: Patient is unable to use a metered‑dose, dry powder, or slow mist inhaler due to cognitive or physical impairment or inadequate inspiratory force
If inability claimed, document cognitive/physical impairment (e.g., dementia, arthritis) or objective evidence of inadequate inspiratory force (PIFR < 60 L/min)

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Continuation Therapy (Reauthorization) — Reauthorization

Reauthorization: Covered when

Reauthorization: Documentation of positive clinical response to therapy

Positive clinical response must be documented in the medical record; authorization valid for 12 months

No explicit exclusions are listed in this policy document.

The document does not include any explicit statements declaring services or uses as not medically necessary.

Provider Requirements and Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required. Yupelri (revefenacin) will be approved for members with moderate to severe COPD who meet the step and documentation criteria below. Authorization will be issued for 12 months.

Affected medication: Yupelri (revefenacin inhalation solution)
Authorization duration: 12 months

Step Therapy

Step Therapy Requirement

Approval requires a history of failure, contraindication, or intolerance to tiotropium (Spiriva Handihaler or Respimat) OR documented inability to use a metered-dose, dry powder, or slow‑mist inhaler.

Step requirement: Failure, contraindication, or intolerance to Spiriva Handihaler or Spiriva Respimat (tiotropium)
Alternate pathway: Documented inability to use handheld inhalers (see required supporting documentation)

Documentation Required

Required Supporting Documentation

Required supporting documentation must be submitted with the prior authorization request to demonstrate eligibility under the inhaler‑use exception.

Documentation of cognitive or physical impairment limiting coordination of handheld devices (e.g., cognitive decline, arthritis) — provide clinical notes or assessment documenting the impairment
Objective evidence the patient cannot generate adequate inspiratory force (e.g., peak inspiratory flow rate < 60 L/min) — provide PIFR measurement or respiratory therapist documentation
If claiming failure, contraindication, or intolerance to tiotropium, provide clinical documentation of trial and reason for discontinuation (e.g., adverse effects, lack of efficacy, documented contraindication)

Denial Risk

Denial Triggers

Requests missing the required diagnosis, step‑therapy history, or supporting documentation for an inhaler‑use exception may be denied.

Denial triggers: No documentation of moderate to severe COPD diagnosis
Denial triggers: No documentation of trial and failure/contraindication/intolerance to Spiriva Handihaler or Respimat when required
Denial triggers: No documentation of cognitive/physical impairment or insufficient objective evidence of inadequate inspiratory force for inhaler‑use exception
Denial triggers: Lack of documentation of positive clinical response for reauthorization requests

Initial Therapy

Initial Therapy — Initial authorization criteria

Initial authorization criteria

Diagnosis: Moderate to severe COPD

Indication per label

Step or exception: Either history of failure/contraindication/intolerance to tiotropium (Spiriva Handihaler or Respimat) OR inability to use handheld inhalers with documented impairment or PIFR <60 L/min

If inability claimed, must document cognitive/physical impairment or PIFR < 60 L/min

Step Therapy Requirements

Requirement	Details
Prior trial of tiotropium (Spiriva Handihaler or Respimat)	History of failure, contraindication, or intolerance to Spiriva Handihaler or Respimat (tiotropium)
Inability to use handheld inhalers	Patient is unable to use a metered‑dose, dry powder, or slow mist inhaler due to either: a) cognitive or physical impairment limiting coordination of handheld devices (e.g., cognitive decline, arthritis in the hands) — document impairment; or b) inability to generate adequate inspiratory force (e.g., PIFR < 60 L/min)

Definitions

Inability to use handheld inhalers

DefinitionCognitive or physical impairment limiting coordination of handheld devices (e.g., cognitive decline, arthritis in the hands)

Inadequate inspiratory forceUnable to generate adequate inspiratory force (e.g., PIFR < 60 L/min)

Acceptable examplesImpairment that prevents use of metered‑dose, dry powder, or slow‑mist inhalers (e.g., Spiriva Respimat)

DocumentationDocument the specific impairment or provide objective evidence (e.g., PIFR measurement) when claiming inability to use inhalers

Purpose in policyAllows use of nebulized revefenacin (Yupelri) as an exception to step therapy when inhaler use is not feasible

Background

Yupelri (revefenacin) is a nebulized long-acting antimuscarinic agent indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD). It is intended for patients with moderate to severe COPD who are appropriate candidates for long-acting antimuscarinic therapy and either have failed or cannot tolerate tiotropium (Spiriva Handihaler or Respimat) or are unable to effectively use handheld inhaler devices. Prior authorization is required for coverage, and approvals are issued for 12 months when the member meets the documented criteria.