Subject: Inbrija 2860-A SGM P2023

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.  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)


  III.  CONTINUATION OF THERAPY

          Authorization of 12 months may be granted for continued
          treatment of intermittent treatment of “off” episodes in
          members with Parkinson’s disease when both of the following
          criteria are met:
          A.  The member is currently being treated with oral
               carbidopa/levodopa.
          B.  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. Miyasaki JM, Martin W, Suchowersky O, et al. Practice parameter: Initiation of treatment for Parkinson’s disease: An evidence-based review: report of the Quality Standards Subcommittee of the American Academy of Neurology. Jan 2002, 58 (1) 11-17. doi:10.1212/wnl.58.1.11
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, 2023.
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 [published correction appears in Mov Disord. 2018 Dec;33(12):1992]. Mov Disord. 2018; 33(8):1248-1266. doi:10.1002/mds.27372

 

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 11, 2024