Subject: Duopa SGM 3029-A P2024_R

Drug

DUOPA  (carbidopa/levodopa enteral suspension)

Policy:

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 Indications

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.

Coverage Criteria

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:

• Member is levodopa responsive with clearly defined “on” periods.
• The member has “off” periods of at least 3 hours per day despite optimization efforts.
• The member must have had an inadequate response or intolerable adverse event with oral carbidopa/levodopa and one of the following anti-Parkinson agents:
  • Dopamine agonist (e.g., pramipexole, ropinirole)
  • Monoamine oxidase-B (MAO-B) inhibitor (e.g., selegiline, rasagiline)
  • Catechol-O‐methyltransferase (COMT) inhibitor (e.g., entacapone, tolcapone)

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. Continuous intrajejunal infusion of levodopa-carbidopa intestinal gel for patients with advanced Parkinson’s disease: a randomized, controlled, double-blind, double-dummy study. Lancet Neurol. 2014;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 16, 2025