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Specialty Pharmacy Clinical Policy Bulletins
Aetna Non-Medicare Prescription Drug Plan
Subject: Specialty Quantity Limit Orladeyo 4401-H P2023

Drug
ORLADEYO  (berotralstat)


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

  Orladeyo (berotralstat)
  110 mg capsules

  1 carton (28 capsules)
  per 28 days

  Recommended dose:150 mg orally
  once daily

 

  Dose Reduction: 110 mg orally
  once daily

  Orladeyo (berotralstat)
  150 mg capsules

  1 carton (28 capsules) per
  28 days

 


Place of Service:

Outpatient

The above policy is based on the following references:
  1. Orladeyo [package insert]. Durham, NC: BioCryst Pharmaceuticals, Inc.; March 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 22, 2023
Aetna
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