CurrentUnitedHealthcarePolicy N/A

Inbrija (levodopa inhalation powder) prior authorization

Defines UnitedHealthcare prior authorization and medical necessity criteria for Inbrija (levodopa inhalation powder) for treatment of OFF episodes in Parkinson's disease; applies to providers requesting coverage for members under this payer.

Policy Summary

PayerUnitedHealthcare

PolicyInbrija (levodopa inhalation powder) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMay 1, 2025

Next Review DateFeb 1, 2025

Key ActionPrior authorization is required and will be issued for 12 months when all initial authorization criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

≥2 hrs/dayminimum OFF time

2 classesadjunctive therapy trials

specialist requiredprescriber requirement

Coverage Criteria for Inbrija (levodopa inhalation powder)

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Initial Authorization

Covered when ALL of the following are met

Diagnosis of Parkinson's disease.
Inbrija will be used as intermittent treatment for OFF episodes.
Prescribed by or in consultation with a neurologist or specialist in the treatment of Parkinson's disease.
Patient is currently on a stable dose of a carbidopa/levodopa-containing medication and will continue receiving treatment with a carbidopa/levodopa-containing medication while on therapy.
ALL of the following
- Taking carbidopa/levodopa on an empty stomach or at least one half-hour or more before or one hour after a meal or avoidance of high protein diet.
- Dose and dosing interval optimization.
History of failure, contraindication, or intolerance to two anti-Parkinson's disease therapies from two different adjunctive pharmacotherapy classes (examples: dopamine agonists, COMT inhibitors, MAO-B inhibitors).

Provider Requirements and Authorization Actions

Prior Authorization

Prior Authorization Required

Prior authorization required. When initial criteria are met, prior authorization will be issued for 12 months. Reauthorization requires documentation of a positive clinical response and continued use of a carbidopa/levodopa-containing medication. UnitedHealthcare may use previous claim/medication history, diagnosis codes, and/or claim logic to approve initial or reauthorization requests per program rules.

Authorization duration: 12 months for initial approval when criteria met
Reauthorization requirement: documentation of positive clinical response and continued carbidopa/levodopa therapy
Automated/claims-based approvals may be used per program/therapeutic class

Step Therapy

Step Therapy and Supply Limits

Supply limits and/or step therapy may apply per UnitedHealthcare program rules. Prior to prescribing, verify applicable quantity limits or step requirements through plan-specific formulary or program guidance.

Supply limits and Step Therapy may be enforced depending on program
Use plan formulary/program resources to confirm any supply or step requirements

Documentation Required

Required Documentation

Document the diagnosis and clinical rationale for intermittent treatment of OFF episodes. Include evidence of current stable carbidopa/levodopa therapy, details of OFF time despite optimized levodopa management, and prior trials of adjunctive therapies.

Diagnosis: Parkinson's disease (ICD-10 code(s) on claim)
Indication: intermittent treatment for OFF episodes with documentation of ≥ 2 hours OFF time per day
Evidence of optimization: documentation of levodopa dosing optimization and dietary measures (empty stomach or timing around meals)
Current therapy: patient on a stable dose of carbidopa/levodopa and will continue it while on Inbrija
Prior trials: failure, contraindication, or intolerance to two anti-Parkinson adjunctive therapies from two different classes (dopamine agonist, COMT inhibitor, MAO-B inhibitor)

Denial Risk

Triggers for Denial

Denial may occur if required criteria or documentation are not provided, or if the medication is used outside the approved intermittent OFF-episode indication. Common triggers for denial are listed below.

Failure to document a diagnosis of Parkinson's disease
No documentation that Inbrija is prescribed for intermittent OFF episodes or lack of evidence of ≥ 2 hours OFF time per day
Absence of documentation showing patient is on a stable carbidopa/levodopa-containing medication and will continue it
Lack of documentation of optimization of carbidopa/levodopa therapy (timing/diet and dose/dosing interval optimization)
No evidence of prior trials (or intolerance/contraindication) of two adjunctive anti-Parkinson therapies from two different classes
Prescriber is not a neurologist or specialist and no documented consultation with such a specialist
Use for an unapproved indication or continuous (non-intermittent) use

Background on Inbrija and Clinical Context

Inbrija (levodopa inhalation powder) is indicated for the intermittent treatment of OFF episodes in patients with Parkinson’s disease who are being treated with carbidopa/levodopa and is administered using the Inbrija inhaler.

Per policy, Inbrija is approved when specified clinical criteria are met: a documented diagnosis of Parkinson’s disease; use as an intermittent treatment for OFF episodes; prescription by or in consultation with a neurologist or Parkinson’s specialist; the patient is on and will continue a carbidopa/levodopa-containing medication; and the patient continues to experience ≥ 2 hours of OFF time per day despite optimized carbidopa/levodopa therapy, plus prior trials of two adjunctive anti-Parkinson’s therapies from different classes.

Prior authorization is required and will be issued for 12 months when initial criteria are met, with reauthorization contingent on documentation of a positive clinical response and continued carbidopa/levodopa therapy.

Definitions

Inbrija

ProductInbrija (levodopa inhalation powder)

IndicationIntermittent treatment of OFF episodes in patients with Parkinson's disease who are treated with carbidopa/levodopa

Administration requirementMust be administered using the Inbrija inhaler

Concomitant therapyPatient must be on and continue a carbidopa/levodopa-containing medication while receiving Inbrija

OFF time

DefinitionOFF episodes are periods of reduced mobility and symptom control experienced by patients with Parkinson's disease

Policy thresholdPolicy requires the patient to continue to experience ≥ 2 hours of OFF time per day despite optimal management of carbidopa/levodopa therapy

Optimal management examplesIncludes taking carbidopa/levodopa on an empty stomach or ≥30 minutes before or ≥1 hour after a meal (or avoiding a high‑protein diet) and dose/dosing-interval optimization

OpenPayer

Inbrija (levodopa inhalation powder) prior authorization

Coverage Criteria for Inbrija (levodopa inhalation powder)

Key Coding & Thresholds

Provider Requirements and Authorization Actions

Background on Inbrija and Clinical Context

Definitions