Subject: Apokyn-Kynmobi 2258-A SGM P2021

Drug

APOKYN  (apomorphine hydrochloride injection)

KYNMOBI  (apomorphine hydrochloride)

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
       Apokyn is indicated for the acute, intermittent treatment of hypomobility, “off” episodes
       (“end-of-dose wearing off” and unpredictable “on/off” episodes) in patients with advanced
       Parkinson’s disease.

       Kynmobi is indicated for the acute, intermittent treatment of “off” episodes in patients with
       Parkinson’s disease (PD).

       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 the treatment of acute,
       intermittent treatment of “off” episodes for members with Parkinson’s
       disease when all of the following criteria are met:
       A.  The member experiences at least 1 hour per day of off time
       B.  The member is currently being treated with 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 acute, intermittent
        treatment of “off” episodes for members with Parkinson’s disease when both of the following
        criteria are met:
        A.  The member is currently being treated with 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. Apokyn [package insert]. Louisville, KY: US WorldMeds, LLC; April 2020.
2. Kynmobi [package insert]. Marlborough, MA: Sunovion Pharmaceuticals Inc.; May 2020.
3. Miyasaki JM, Martin W, Suchowersky O, et al. Practice parameter: Initiation of treatment for Parkinson’s disease: An evidence-based review. Neurology Jan 2002, 58 (1) 11-17.
4. 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, 2021.
5. 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. Mov Disord. 2018; 33(8):1248-1266.

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