Subject: Inbrija SGM 2860-A P2024_R

Drug

INBRIJA  (levodopa )

Policy:

Indications

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-approved Indication¹

Inbrija is indicated for the intermittent treatment of OFF episodes in patients with Parkinson’s disease treated with carbidopa/levodopa.

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

Coverage Criteria

Parkinson’s disease^1-4

Authorization of 6 months may be granted for intermittent treatment of “off” episodes in members with Parkinson’s disease when all of the following criteria are met:

• The member experiences at least 2 hours per day of “off” time.
• The 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 therapies was ineffective at managing “off” episodes:
• Dopamine agonist (e.g., pramipexole, ropinirole)
• Monoamine oxidase B (MAO-B) inhibitor (e.g., selegiline, rasagiline)
• Catechol-O-methyltransferase (COMT) inhibitor (e.g., entacapone, tolcapone)

Continuation of Therapy

Authorization of 12 months may be granted for continued intermittent treatment of “off” episodes in members with Parkinson’s disease when both of the following criteria are met:

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

Place of Service:

Outpatient

The above policy is based on the following references:

1. Inbrija [package insert]. Pearl River, NY: Acorda Therapeutics, Inc.; December 2022.
2. National Institute for Health and Care Excellence (NICE) guideline: Parkinson’s disease in adults. Published July 19, 2017. Accessed August 12, 2024. https://www.nice.org.uk/guidance/ng71/resources/parkinsons-disease-in-adults-pdf-1837629189061.
3. Fox SH, Katzenschlager R, Lim SY, et al. International Parkinson and movement disorder society evidence-based medicine review: Update on treatments for the motor symptoms of Parkinson’s disease [published correction appears in Mov Disord. 2018 Dec;33(12):1992]. Mov Disord. 2018;33(8):1248-1266. doi:10.1002/mds.27372
4. LeWitt PA, Hauser RA, Pahwa R, et al. Safety and efficacy of CVT-301 (levodopa inhalation powder) on motor function during off periods in patients with Parkinson's disease: a randomised, double-blind, placebo-controlled phase 3 trial [published correction appears in Lancet Neurol. 2019 Mar;18(3):e2]. Lancet Neurol. 2019;18(2):145-154. doi:10.1016/S1474-4422(18)30405-8

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

February 16, 2025