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Specialty Pharmacy Clinical Policy Bulletins
Aetna Non-Medicare Prescription Drug Plan
Subject: Specialty Quantity Limit Wakix 3755-H P2023

Drug
WAKIX  (pitolisant)


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

   Medication

   Standard Limit

   FDA-recommended dosing

Wakix 4.45 mg tablet

60 tablets per 30 days

 Titration schedule:
 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.

 Moderate hepatic impairment:
 Initiate at 8.9 mg once daily and
 increase to a maximum of 17.8
 mg once daily after 14 days.

 Moderate or severe renal
 impairment: Initiate at 8.9 mg
 once daily and increase to a
 maximum of 17.8 mg once daily
 after 7 days.

Wakix 17.8 mg tablet

60 tablets per 30 days

 


Place of Service:

Outpatient

The above policy is based on the following references:
  1. Wakix [package insert]. Plymouth Meeting, PA: Harmony Biosciences, LLC; December 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.

October 15, 2023
Aetna
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