Subject: Wakix 3176-A SGM P2021a
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
Treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy.
All other indications are considered experimental/investigational and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review:
A. For initial requests, all of the following (if applicable):
1. Documentation of a sleep lab evaluation
2. Chart notes, medical record documentation, or claims history supporting previous medications
tried (if applicable), including response to therapy. If therapy is not advisable, documentation of
clinical reason to avoid therapy
B. For continuation requests, chart notes or medical record documentation supporting a beneficial response
to therapy (e.g., decrease in daytime sleepiness, decrease in cataplexy episodes from baseline)
III. CRITERIA FOR INITIAL APPROVAL
A. Excessive Daytime Sleepiness with Narcolepsy
Authorization of 12 months may be granted for treatment of excessive daytime sleepiness (EDS) in
adult patients with narcolepsy when all of the following criteria are met:
1. The diagnosis of narcolepsy is confirmed by a sleep lab evaluation
2. The member has experienced an inadequate treatment response, intolerance or contraindication to
a central nervous system (CNS) stimulant (i.e., amphetamine, dextroamphetamine, methylphenidate)
3. The member has experienced an inadequate treatment response, intolerance to armodafinil or modafinil OR
the member has a contraindication to both armodafinil and modafinil
B. Cataplexy with Narcolepsy
Authorization of 12 months may be granted for the treatment of cataplexy in adult patients with narcolepsy
when all of the following criteria are met:
1. The diagnosis of narcolepsy is confirmed by a sleep lab evaluation
2. The member experiences at least 3 cataplexy attacks per week
IV. CONTINUATION OF THERAPY
A. Excessive Daytime Sleepiness with Narcolepsy
Authorization of 12 months may be granted for continued treatment of excessive daytime sleepiness (EDS)
with narcolepsy when the member has demonstrated beneficial response to treatment as defined by a
decrease in symptoms of daytime sleepiness from baseline.
B. Cataplexy with Narcolepsy
Authorization of 12 months may be granted for continued treatment of cataplexy with narcolepsy when the
member has demonstrated beneficial response to treatment as defined by a decrease in cataplexy episodes
from baseline.
Place of Service:
Outpatient
The above policy is based on the following references:
1. Wakix [package insert]. Plymouth Meeting, PA: Harmony Biosciences, LLC; October 2020.
2. Dauvilliers Y, Bassetti C, Lammers GJ, Arnulf I, Mayer G, Rodenbeck A, Lehert P, Ding CL, Lecomte JM,
Schwartz JC; HARMONY I study group. Pitolisant versus placebo or modafinil in patients with narcolepsy: a double-blind,
randomised trial. Lancet Neurol. 2013 Nov;12(11):1068-75. doi: 10.1016/S1474-4422(13)70225-4. Epub 2013
Oct 7. Accessed March 10, 2020.
3. Fronczek R, Middelkoop HA, van Dijk JG, Lammers GJ. Focusing on vigilance instead of sleepiness in the assessment
of narcolepsy: high sensitivity of the Sustained Attention to Response Task (SART). Sleep. 2006 Feb;29(2):187-91.
Accessed March 10, 2020
4. Morgenthaler TI, Vishesh KK, Brown T, et al. Practice Parameters for the Treatment of Narcolepsy and other
Hypersomnias of Central Origin. Sleep 2007;30(12):1705-11.
5. Micromedex (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA.
http://www.micromedexsolutions.com/. Accessed March 2021.
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.
May 14, 2022
