Subject: Apokyn-Kynmobi 2258-A SGM P2022
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APOKYN
(apomorphine hydrochloride injection)
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KYNMOBI®
(apomorphine hydrochloride)
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apomorphine hydrochloride
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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 Indications
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:
- Apokyn [package insert]. Louisville, KY: US WorldMeds, LLC; April 2020.
- Kynmobi [package insert]. Marlborough, MA: Sunovion Pharmaceuticals Inc.; May 2022.
- 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.
- 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 16, 2022.
- 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.
- Apomorphine hydrochloride [package insert]. Lee, MA: Berkshire Sterile Manufacturing, Inc. February 2022.
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
