Subject: Duopa 3029-A SGM P2021

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.   EXCLUSIONS

       Coverage will not be provided for 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 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; and
       B.  The member has off periods greater than 3 hours per day despite optimization efforts; and
       C.  The member must have had an inadequate response or intolerable adverse event with oral
            carbidopa-levodopa (IR or CR) and one of the following anti-Parkinson agents: 
            1.  Catechol-O‐methyl transferase (COMT) inhibitor (e.g. entacapone)
            2.  Monoamine oxidase B (MAO)-B inhibitor (e.g. oral selegiline, Azilect)
            3.  Dopamine agonists (e.g. pramipexole, ropinirole, Neupro)
 
IV.   CONTINUATION OF THERAPY   
 
       Authorization of 12 months may be granted for continued treatment in members requesting
       reauthorization for 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; May 2020.
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 14, 2022