Subject: Specialty Quantity Limit Wakix 3755-H P2024a
Policy:
I. PROGRAM DESCRIPTION
The standard limit is designed to allow a quantity sufficient for the most common uses of the medication. The recommended dosing parameters for all FDA-approved indications fall within the standard limits. Coverage of an additional quantity may be reviewed on a case-by-case basis upon request.
II. COVERED QUANTITIES
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Medication
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Standard Limit
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FDA-recommended dosing
|
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Wakix 4.45 mg tablet
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60 tablets per 30 days
|
Titration schedule for Adults:
Week 1: Initiate with 8.9 mg once daily.
Week 2: Increase to 17.8 mg once daily.
Week 3: May increase to the maximum recommended dosage of 35.6 mg once daily.
Titration schedule for Pediatric Patients (6 years and older):
Week 1: Initiate with 4.45 mg once daily.
Week 2: Increase to 8.9 mg once daily.
Week 3: Increase to 17.8 mg once daily (maximum recommended dose for patients
weighing <40kg)
Week 4: For patient weighing ≥40 kg, may increase to the maximum recommended dosage
of 35.6 mg once daily.
Moderate hepatic impairment:
Adults: Initiate at 8.9 mg once daily and increase to a maximum of 17.8 mg once daily after
14 days.
Pediatric: Initiate at 4.45 mg once daily and increase to 8.9 mg once daily after 14 days; for
patients weighing ≥40 kg, may increase to 17.8 mg once daily after another 14 days.
Moderate or severe renal impairment:
Adults: Initiate at 8.9 mg once daily and increase to a maximum of 17.8 mg once daily after
7 days.
Pediatric: Initiate at 4.45 mg once daily and increase to 8.9 mg once daily after 7 days; for
patients weighing ≥40 kg, may increase to 17.8 mg once daily after another 7 days.
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Wakix 17.8 mg tablet
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60 tablets per 30 days
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Place of Service:
Outpatient
The above policy is based on the following references:
- Wakix [package insert]. Plymouth Meeting, PA: Harmony Biosciences, LLC; June 2024.
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.
September 08, 2024
