CurrentColorado Rocky Mountain Health PlansPolicy 2026 P 2164-9

Inbrija® (levodopa inhalation powder) - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plans

Prior authorization and medical necessity criteria for Inbrija (levodopa inhalation powder) for intermittent treatment of OFF episodes in patients with Parkinson's disease for UnitedHealthcare Commercial Plans (Colorado Rocky Mountain Health Plans). Specifies initial and reauthorization clinical criteria, prescriber requirements, concomitant therapy requirements, and authorization duration.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyInbrija® (levodopa inhalation powder) - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plans

Policy CodePolicy 2026 P 2164-9

Change TypeClarifiedRevised

Effective Date5/1/2026

Next Review Date

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

SourceLink

POLICY UPDATE CHANGES

Effective Date set to 5/1/2026 and annual reviews through 2/2026 had no change in clinical criteria.

Initial authorization duration revised to 12 months (noted in 2/2024 change control).

12 monthsAuthorization duration (initial and reauth)

>=2Hours OFF time required per day

2Adjunctive medication classes required to have failed

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Coverage Summary

Coverage stance: covered_with_criteria. Scope: Prior authorization and medical necessity criteria for Inbrija (levodopa inhalation powder) for intermittent treatment of OFF episodes in patients with Parkinson's disease for UnitedHealthcare Commercial Plans (Colorado Rocky Mountain Health Plans). Indication: Inbrija is indicated for the intermittent treatment of OFF episodes in Parkinson's disease when used with the Inbrija inhaler. Policy effective date: 5/1/2026. Policy number: 2026 P 2164-9. Key thresholds: Daily OFF time threshold: ≥ 2 hours of OFF time per day; Authorization duration (initial and reauthorization): 12 months.

Initial Therapy Criteria

Initial Authorization

Inbrija will be approved based on all of the following criteria:

ALL of the following

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
OFF time
- Optimal management includes both: 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
Adjunctive therapy trials
- Adjunctive classes (pick two different classes)
  - Dopamine agonists (e.g., pramipexole, ropinirole)
  - Catechol-O-methyl transferase (COMT) inhibitors (e.g., entacapone)
  - Monoamine oxidase (MAO) B inhibitors (e.g., rasagiline, selegiline)

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Initial Authorization

Prior Authorization

Prior authorization required

Prior authorization is required; approval will be issued for 12 months for initial authorization and 12 months for reauthorization when criteria are met.

Documentation Required

Prescriber specialty and concomitant therapy documentation

Prescriber must be a neurologist or specialist in the treatment of Parkinson's disease or prescribed in consultation with one; document a stable carbidopa/levodopa regimen and that the patient will continue carbidopa/levodopa while on Inbrija.

Continuation / Reauthorization Criteria

Reauthorization

Inbrija will be approved based on the following criteria:

ALL of the following

Documentation of positive clinical response to Inbrija therapy
Patient will continue to receive treatment with a carbidopa/levodopa-containing medication

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Provider Actions & Documentation Requirements

Documentation Required

Document OFF time and optimization attempts

Document that the patient experiences ≥ 2 hours of OFF time per day despite optimal carbidopa/levodopa management. Specifically document at least 2 hours daily OFF time and attempts to optimize therapy, including timing carbidopa/levodopa on an empty stomach or at least one half-hour before or one hour after a meal (or avoidance of high protein diet) and dose and dosing-interval optimization.

Documentation Required

Adjunctive therapy trial requirements

Document failure, contraindication, or intolerance to two anti-Parkinson's therapies from two different classes. The adjunctive classes specified are dopamine agonists, COMT inhibitors, and MAO-B inhibitors (a trial must include therapies from two different classes).

Dopamine agonists (e.g., pramipexole, ropinirole)
Catechol-O-methyl transferase (COMT) inhibitors (e.g., entacapone)
Monoamine oxidase (MAO) B inhibitors (e.g., rasagiline, selegiline)

Applicable Codes

ICD-10 Diagnosis Codes (referenced)ICD-10

No codes listed

Clinical Evidence

Evidence sources cited by the policy: Inbrija [package insert], Merz Pharmaceuticals, March 2025; and the Phase 3 trial: LeWitt P et al., Lancet Neurology 2019 (safety and efficacy of CVT-301/levodopa inhalation powder).

Background & Definitions

Background: Inbrija (levodopa inhalation powder) is indicated for the intermittent treatment of OFF episodes in patients with Parkinson's disease treated with carbidopa/levodopa and must be administered with the Inbrija inhaler. Coverage is contingent on continued carbidopa/levodopa therapy: the patient must be on a stable dose of a carbidopa/levodopa-containing medication and will continue receiving carbidopa/levodopa while on Inbrija. The policy is intended for payers/plans and outlines prior authorization and medical necessity criteria including prescriber requirements and clinical thresholds. Definition: OFF episodes are "periods of worsened motor function in Parkinson's disease when effect of levodopa wanes."

Key thresholds and policy stats

Daily OFF time threshold≥ 2 hours of OFF time per day

Authorization duration12 months (initial and reauthorization)

Adjunctive medication classes failedFailure/contraindication/intolerance to 2 different classes (dopamine agonist, COMT inhibitor, MAO-B inhibitor)

Policy effective date5/1/2026

Revision History

2026-02annual_reviewLatest

Annual review with no change in clinical criteria; effective date set to 5/1/2026.

2024-02policy_change

Annual review revised initial authorization duration to 12 months.