CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Inbrija (levodopa inhalation powder) — Coverage Criteria for OFF Episodes in Parkinson's Disease

Covers authorization criteria for Inbrija when used to treat intermittent OFF episodes in members with Parkinson's disease who are already on carbidopa/levodopa.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyInbrija (levodopa inhalation powder) — Coverage Criteria for OFF Episodes in Parkinson's Disease

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documentation of baseline daily OFF time, current oral carbidopa/levodopa use, prior adjunct therapy trials, and response to Inbrija for continuation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moInitial authorization duration

12 moContinuation authorization duration

≥2 hrsRequired daily OFF time

Coverage Criteria

inv-01: COVERAGE CRITERIA — Initial authorization (6 months)

Covered when ALL of the following are met:

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Initial authorization criteria

A: Member experiences at least 2 hours per day of 'off' time>=2 hours/day
B: Member is currently being treated with oral carbidopa/levodopa
C: Attempts to manage 'off' episodes by adjusting the dosing or formulation of carbidopa/levodopa were ineffective
D: Treatment with carbidopa/levodopa plus one of the following therapies was ineffective at managing 'off' episodes: 1) Dopamine agonist (e.g., pramipexole, ropinirole); 2) Monoamine oxidase B (MAO-B) inhibitor (e.g., selegiline, rasagiline); 3) Catechol-O-methyl transferase (COMT) inhibitor (e.g., entacapone, tolcapone)

inv-02: COVERAGE CRITERIA — Continuation authorization (12 months)

Covered when ALL of the following are met:

Continuation criteria

A: Member is currently being treated with oral carbidopa/levodopa
B: Member is experiencing improvement on Inbrija therapy (e.g., reduction in daily off time, improvement in motor function post-administration)

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Initial authorization: Authorizations for up to 6 months require documentation that the member has Parkinson's disease with clinically significant OFF episodes and that less invasive/adjunct strategies were tried and ineffective.

Prior authorization required for initial 6‑month course
Submit baseline daily OFF time (hours) and current carbidopa/levodopa regimen

Documentation Required

Documentation Required for Continuation

Continuation authorizations may be approved for up to 12 months only if the member is maintained on oral carbidopa/levodopa and the prescriber documents clinical improvement on Inbrija (examples: reduction in daily OFF time or better motor function after dosing).

Provide objective or clinician-assessed evidence of improvement compared with baseline
Include current medication list and any dose changes since initiation

Step Therapy

Adjunct Therapy Trial Required

Adjunct therapy trial requirement: Before initial approval, document that one of the following adjunct therapies added to carbidopa/levodopa was tried and found ineffective for managing OFF episodes: a dopamine agonist (e.g., pramipexole, ropinirole), an MAO‑B inhibitor (e.g., selegiline, rasagiline), or a COMT inhibitor (e.g., entacapone, tolcapone).

List the specific agent(s) tried, dates of trial, reason for discontinuation or documented lack of benefit
If trials were not possible, provide clinical justification

Documentation Required

Clinical Documentation Checklist

Required clinical documentation to support prior authorization: provide baseline OFF time (hours/day), current carbidopa/levodopa regimen, documentation of unsuccessful carbidopa/levodopa dose/formulation adjustments, records of adjunct therapy trials (agents, dates, outcomes), and follow‑up evidence of clinical benefit for continuation requests.

Baseline OFF time (minimum 2 hours per day)
Current oral carbidopa/levodopa dose and schedule
Details of dosing/formulation adjustments attempted and outcomes
Specific adjunct agents tried (dopamine agonist, MAO‑B inhibitor, COMT inhibitor) with dates and outcomes
For continuation: objective or clinician‑documented improvement on Inbrija

Denial Risk

Use Outside FDA‑Approved Indication Not Covered

Non‑FDA indications: Inbrija is FDA‑approved only for intermittent OFF episodes in Parkinson's disease; use for other indications is considered experimental/investigational and will be denied.

Do not submit requests for non‑Parkinson's indications without strong evidence — these requests are likely to be denied