CurrentNeighborhood Health Plan of Rhode IslandPolicy Inbrija 2860 A Sgm P2023

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

Policy governs coverage and authorization criteria for Inbrija (levodopa inhalation powder) for intermittent treatment of 'OFF' episodes in members with Parkinson's disease, including initial (6-month) authorization and continuation (12-month) criteria. Non-FDA indications are considered experimental/investigational and not covered.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

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

Policy CodePolicy Inbrija 2860 A Sgm P2023

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization documenting daily 'off' time, current oral carbidopa/levodopa use, failed dosing adjustments and adjunct therapies, and for continuation document clinical improvement.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes.

1Covered Indication (Parkinson's disease OFF episodes)

3Required prior adjunct therapy classes

6/12Authorization durations (months) initial/continuation

Coverage Summary

Policy governs coverage and authorization criteria for Inbrija (levodopa inhalation powder) for intermittent treatment of OFF episodes in members with Parkinson's disease, including initial (6-month) authorization and continuation (12-month) criteria. Coverage is limited to the FDA-approved indication: intermittent treatment of OFF episodes in patients treated with carbidopa/levodopa. Any use for non-FDA indications is considered experimental/investigational and is not covered.

Initial Therapy Criteria (Parkinson's disease)

Initial Authorization (Parkinson's disease)

Authorization of 6 months may be granted 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
Treatment with carbidopa/levodopa plus one of the following was ineffective
- Dopamine agonist (e.g., pramipexole, ropinirole)
- Monoamine oxidase B (MAO-B) inhibitor (e.g., selegiline, rasagiline)
- Catechol-O-methyl transferase (COMT) inhibitor (e.g., entacapone, tolcapone)

Continuation Therapy Criteria (Parkinson's disease)

Continuation of Therapy (Parkinson's disease)

Authorization of 12 months may be granted for continued 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 Indications / Exclusions

Indications Not Covered

All other indications

Any indication other than intermittent treatment of 'off' episodes in patients with Parkinson's disease treated with carbidopa/levodopa is considered experimental/investigational and not medically necessary

Provider Actions / Authorization Requirements

Prior Authorization

Prior authorization required for initial and continuation

Prior authorization is required for initial (6-month) and continuation (12-month) authorization. For initial authorization, document that the member experiences at least 2 hours per day of "off" time, is currently treated with oral carbidopa/levodopa, that attempts to manage "off" episodes by adjusting carbidopa/levodopa dosing or formulation were ineffective, and that treatment with carbidopa/levodopa plus one of the adjunct therapies below was ineffective.

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

Documentation Required

Clinical improvement documentation for continuation

For continuation authorization (12 months), the provider must document that the member is currently treated with oral carbidopa/levodopa and is experiencing improvement with the requested medication. Examples of improvement include reduction in daily "off" time and improvement in motor function following administration.

Clinical Evidence & References

Evidence includes the Inbrija package insert: Inbrija [package insert], Acorda Therapeutics, Inc.; December 2022.

Supporting guideline evidence cited: Practice parameter: Initiation of treatment for Parkinson's disease, Neurology Jan 2002.

Background

Inbrija is FDA indicated for the intermittent treatment of OFF episodes in patients with Parkinson's disease who are treated with carbidopa/levodopa. The policy limits coverage to this indication and requires documentation that oral carbidopa/levodopa has been optimized and that adjustments in dosing or formulation and trials of adjunct therapies (dopamine agonist, MAO-B inhibitor, or COMT inhibitor) were ineffective prior to authorization.