Subject: Duopa 3029-A SGM P2023

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 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 in members requesting reauthorization for advanced
          Parkinson’s disease who have demonstrated a positive clinical
          response with the requested medication.

 

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. Olanow CW, Keiburtz K, Odin P, 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. doi:10.1016/S1474-4422(13)70293-X

 

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