Subject: Specialty Quantity Limit Wakix 3755-H P2025

Drug

WAKIX  (pitolisant)

Policy:

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.

Covered Quantities

Medication	Standard Limit
Wakix (pitolisant) 4.45 mg tablet	60 tablets per 30 days
Wakix (pitolisant) 17.8 mg tablet	60 tablets per 30 days

FDA-recommended Dosing

Titration schedule

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.

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 less than 40kg).
• Week 4: For patient weighing greater than or equal to 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 greater than or equal to 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 greater than or equal to 40 kg, may increase to 17.8 mg once daily after another 7 days.

Place of Service:

Outpatient

The above policy is based on the following references:

1. 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.

June 07, 2025