Subject: Inbrija 2860-A SGM P2021

Drug

INBRIJA  (levodopa inhalation powder)

Policy:

I.    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 Indication
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. 

II.  EXCLUSIONS 

Coverage will not be provided for members with any of the following exclusions:
A.   Asthma
B.   Chronic obstructive pulmonary disease (COPD)
C.   Other chronic underlying lung disease
D.   Members who are receiving concomitant treatment with nonselective monoamine oxidase (MAO)
      inhibitors (e.g. phenelzine, tranylcypromine)

III. CRITERIA FOR INITIAL APPROVAL 

Parkinson’s disease
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:
A.   The member experiences at least 2 hours per day of off time
B.   The 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)

IV.  CONTINUATION OF THERAPY 

Authorization of 12 months may be granted for intermittent treatment of “off” episodes in members with Parkinson’s disease when all of the following criteria are met:
A.   The member is currently being treated with oral carbidopa/levodopa
B.   The member is experiencing improvement on Inbrija therapy (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]. Ardsley, NY: Acorda Therapeutics, Inc.; August 2020.
2. Miyasaki JM, Martin W, Suchowersky O, et al. Practice parameter: Initiation of treatment for Parkinson’s disease: An evidence-based review. Neurology Jan 2002, 58 (1) 11-17.
3. National Institute for Clinical Excellence: Parkinson’s disease in adults. July 2017. https://www.nice.org.uk/guidance/ng71/resources/parkinsons-disease-in-adults-pdf-1837629189061. Accessed August 1, 2021.
4. 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. Mov Disord. 2018; 33(8):1248-1266.

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 14, 2022