Subject: Duopa 3029-A SGM P2022

Drug

DUOPA  (carbidopa and levodopa enteral suspension)

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
            Duopa is indicated for the treatment of motor fluctuations in
            patients with advanced Parkinson’s disease.

            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 treatment of
           motor fluctuations in members with advanced Parkinson’s
           disease when all of the following criteria are met:
           A.  Member is levodopa responsive with clearly defined “on”
                periods 
           B.  The member has “off” periods greater than 3 hours per day
                despite optimization efforts
           C.  The member must have had an inadequate response or
                intolerable adverse event with oral carbidopa-levodopa and
                one of the following anti-Parkinson agents:
                1.  Dopamine agonists (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 in members requesting reauthorization for advanced
           Parkinson’s disease who have demonstrated a positive clinical
           response to Duopa therapy.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Duopa [package insert]. North Chicago, IL: AbbVie, Inc; March 2022.
2. Warren Olanow, Karl Keiburtz, Per Odin, et al. Double blind, double dummy, randomized study of continuous intrajejunal infusion of levodopa-carbidopa intestinal gel in advanced Parkinson’s disease, Lancet Neurol. 2014 February; 13 (2): 141-149.

 

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 12, 2023