CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Inbrija (levodopa inhalation powder) for intermittent treatment of OFF episodes in Parkinson's disease

Defines coverage criteria for Inbrija (levodopa inhalation powder) for intermittent treatment of OFF episodes in members with Parkinson's disease, including initial authorization (6 months) and continuation criteria (12 months). Other indications are considered experimental/investigational and not medically necessary.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyInbrija (levodopa inhalation powder) for intermittent treatment of OFF episodes in Parkinson's disease

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionDocument baseline treatment with oral carbidopa/levodopa, attempts to adjust dosing/formulation, prior adjunctive therapies tried, and clinical improvement to support authorization.

POLICY UPDATE CHANGES

No material clinical or coverage changes.

1Covered Indication (Parkinson's OFF episodes)

>=2 hrs/dayRequired daily OFF time

6 moInitial authorization duration

12 moContinuation authorization duration

Coverage Summary

Defines coverage criteria for Inbrija (levodopa inhalation powder) for the intermittent treatment of OFF episodes in members with Parkinson's disease. Initial authorization may be granted for up to 6 months when all specified criteria are met (including ≥ 2 hours per day of OFF time, current treatment with oral carbidopa/levodopa, unsuccessful attempts to manage OFF episodes by adjusting carbidopa/levodopa, and failure of at least one adjunctive therapy such as a MAO-B inhibitor or a dopamine agonist). Continuation authorization may be granted for up to 12 months when the member remains on oral carbidopa/levodopa and is experiencing improvement with Inbrija (for example, reduction in daily OFF time or improved motor function after dosing). All other indications are considered experimental/investigational and not medically necessary.

Quick Facts and Thresholds

Covered Indication (Parkinson's OFF episodes)1

Required daily OFF time>= 2 hrs/day

Initial authorization duration6 months

Continuation authorization duration12 months

Initial Therapy Criteria

Initial Authorization (up to 6 months)

Authorization of 6 months may be granted for intermittent treatment of OFF episodes when ALL of the following are met:

ALL of the following

Member experiences at least 2 hours per day of 'off' time>= 2 hours per day
Member is currently being treated with oral carbidopa/levodopa
Attempts to manage 'off' episodes by adjusting the dosing or formulation of carbidopa/levodopa were ineffective
At least one of the following adjunctive therapies tried and were ineffective
- Monoamine oxidase B (MAO-B) inhibitor (e.g., selegiline, rasagiline) tried and ineffective
- Dopamine agonist (e.g., pramipexole, ropinirole) tried and ineffective

Continuation Therapy Criteria

Continuation of Therapy (up to 12 months)

Authorization of 12 months may be granted for continued intermittent treatment when BOTH of the following are met:

ALL of the following

Member is currently being treated with oral carbidopa/levodopa
Member is experiencing improvement with the requested medication (e.g., reduction in daily 'off' time, improvement in motor function post-administration)

Unproven / Exclusions

Indications Not Covered

All other indications are considered experimental/investigational and not medically necessary.

Any indication for Inbrija other than intermittent treatment of OFF episodes in patients with Parkinson's disease treated with carbidopa/levodopa

Provider Actions

Prior Authorization

Prior authorization required for Inbrija

Initial authorization may be granted for up to 6 months and continuation up to 12 months when the clinical criteria are documented. For initial approval, the member must be currently treated with oral carbidopa/levodopa, experience at least 2 hours per day of "off" time, have tried adjusting carbidopa/levodopa dosing or formulation without adequate control, and have had prior adjunctive therapies tried and ineffective. For continuation, the member must remain on oral carbidopa/levodopa and demonstrate clinical improvement with the requested medication (for example, reduction in daily "off" time or improved motor function after administration).

Baseline treatment with oral carbidopa/levodopa
Attempts to adjust carbidopa/levodopa dosing or formulation
Prior adjunctive therapies tried and ineffective (e.g., MAO-B inhibitor such as selegiline or rasagiline; dopamine agonist such as pramipexole or ropinirole)
Documentation of clinical improvement on therapy for continuation (e.g., reduction in daily "off" time or improved motor function post-administration)

Documentation Required

Documentation of therapeutic failures

Provider must document that attempts to manage "off" episodes by adjusting the dosing or formulation of carbidopa/levodopa were ineffective and must specify which adjunctive therapies were tried and found ineffective.

Which adjustments to carbidopa/levodopa dosing or formulation were tried and response
Which adjunctive therapies were attempted and failed (e.g., MAO-B inhibitor such as selegiline or rasagiline; dopamine agonist such as pramipexole or ropinirole)

Clinical Evidence

Evidence includes the Inbrija package insert: Inbrija [package insert], Acorda Therapeutics, Inc.; December 2022, and guideline/review sources: NICE Parkinson's disease in adults, July 2017 and the Movement Disorders evidence review (Fox et al., 2018). Other uses of Inbrija beyond the FDA‑approved intermittent treatment of OFF episodes are considered experimental/investigational; see the package insert and guideline reviews for background and supporting information.

Background

Background: Inbrija (levodopa inhalation powder) is FDA‑approved for the intermittent treatment of OFF episodes in patients with Parkinson's disease who are treated with carbidopa/levodopa. Other uses are considered experimental/investigational and not medically necessary. The package insert and relevant Parkinson's disease treatment reviews/guidelines are cited as background evidence.