CurrentNeighborhood Health Plan of Rhode IslandPolicy 2860-A

Inbrija (levodopa inhalation) — coverage criteria for OFF episodes in Parkinson's disease

Defines prior authorization criteria and coverage for Inbrija (levodopa inhalation) as intermittent treatment of OFF episodes in members with Parkinson's disease for Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyInbrija (levodopa inhalation) coverage criteria for OFF episodes in Parkinson's disease

Policy CodePolicy 2860-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization (up to 12 months) with documentation of ≥2 hours/day OFF time, current oral carbidopa/levodopa use, and trial of one other anti‑Parkinson agent class.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration (initial and continuation)

>=2 hrs/dayminimum daily OFF time required

on carbidopa/levodopaconcomitant therapy requirement

try 1 classprior trial required

Coverage Criteria for Inbrija (levodopa inhalation)

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyInbrija (levodopa inhalation) coverage criteria for OFF episodes in Parkinson's disease

Policy CodePolicy 2860-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization (up to 12 months) with documentation of ≥2 hours/day OFF time, current oral carbidopa/levodopa use, and trial of one other anti‑Parkinson agent class.

SourceLink

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Initial Authorization (12 months)

Covered when ALL of the following are met:

Initial criteria: Member experiences at least 2 hours per day of 'off' time>= 2 hours/day

Initial criteria: Member is currently being treated with oral carbidopa/levodopa

Initial criteria: Attempts to manage 'off' episodes by adjusting the dosing or formulation of carbidopa/levodopa were ineffective

Initial criteria

ONE of: Dopamine agonist (e.g., pramipexole, ropinirole)
ONE of: MAO-B inhibitor (e.g., selegiline, rasagiline)
ONE of: COMT inhibitor (e.g., entacapone, tolcapone)

Authorization of up to 12 months may be granted when criteria are met

Continuation of Therapy (12 months)

Covered when ALL of the following are met:

Continuation criteria: Member is currently being treated with oral carbidopa/levodopa

Continuation criteria: Member is experiencing improvement with the requested medication (e.g., reduction in daily 'off' time, improvement in motor function post-administration)

Authorization of up to 12 months may be granted when criteria are met

Requests for use of Inbrija outside the FDA-approved indication are not supported. All indications other than intermittent treatment of OFF episodes in Parkinson's disease treated with carbidopa/levodopa are considered experimental/investigational and not medically necessary, and may be denied.

Use of Inbrija is limited to the FDA-approved population. Indications other than intermittent treatment of OFF episodes in patients with Parkinson's disease on carbidopa/levodopa are not covered and will be evaluated as experimental/investigational and not medically necessary.

Drug and Coding Information

Covered drugNDCCovered

Inbrija

levodopa inhalation powder (brand and generic listed in document)

inv-06: Minimum daily OFF time

Minimum daily OFF timeAt least 2 hours per day

Concomitant therapy requirementMember must be currently treated with oral carbidopa/levodopa

Prior optimization of levodopaAttempts to manage OFF episodes by adjusting dosing or formulation of carbidopa/levodopa were ineffective

Required prior trialsInadequate response or intolerable adverse event with one agent from dopamine agonist, MAO‑B inhibitor, or COMT inhibitor classes

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Inbrija for the intermittent treatment of OFF episodes in Parkinson's disease. Approval may be granted for up to 12 months.

Authorization duration: up to 12 months
Indication: intermittent treatment of OFF episodes only

Documentation Required

Required Documentation

Initial prior authorization requests must include documentation supporting the diagnosis and prior medication history. Submit chart notes, relevant medical record documentation, or claims history that documents previous medications tried and the member’s response or intolerance.

Required documentation for initial requests: chart notes, medical record documentation, or claims history documenting prior medications and response/intolerance

Step Therapy

Required Prior Trials

Prior to approval, the member must have had an inadequate response or intolerable adverse event with at least one agent from the following classes: dopamine agonists, MAO‑B inhibitors, or COMT inhibitors.

Required prior trial: one agent from a dopamine agonist (e.g., pramipexole, ropinirole), MAO‑B inhibitor (e.g., selegiline, rasagiline), or COMT inhibitor (e.g., entacapone, tolcapone)

Documentation Required

Prescriber Specialty Requirement

Prescriptions must be written by, or in consultation with, a neurologist or a specialist in the treatment of Parkinson's disease.

Prescriber specialty: neurologist or Parkinson's disease specialist

Denial Risk

Indication Restricted to OFF Episodes

Inbrija is approved only for intermittent treatment of OFF episodes in Parkinson's disease. Requests for other indications are considered experimental/investigational and will be denied.

Indication restriction: OFF episodes only; all other indications experimental/investigational

Background

Inbrija (levodopa inhalation) is indicated for the intermittent treatment of OFF episodes in patients with Parkinson's disease treated with carbidopa/levodopa. This specific FDA-approved indication is the basis for coverage; uses outside this indication are considered experimental/investigational and not medically necessary.

Definitions

inv-13: OFF episode

DefinitionEpisodes of reduced motor function in Parkinson's disease for which intermittent inhaled levodopa (Inbrija) is indicated

Regulatory contextFDA‑approved indication: intermittent treatment of OFF episodes in patients treated with carbidopa/levodopa

Coverage limitationRequests for indications other than OFF episodes are considered experimental/investigational and not medically necessary