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Specialty Pharmacy Clinical Policy Bulletins
Aetna Non-Medicare Prescription Drug Plan
Subject: Specialty Quantity Limit Xolair 2544-H P2023a

Drug
XOLAIR  (omalizumab)


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

  Xolair 150 mg vial

  8 per 28 days

  Asthma: 75 mg to 375 mg subcutaneously every 2 or 4 weeks. 
  Determine dose (mg) and dosing frequency by serum total IgE (IU/mL)
  and body weight.

 

  Chronic rhinosinusitis with nasal polyps (CRSwNP): 75 mg to 600 mg
  subcutaneously every 2 or 4 weeks. Determine dose (mg) and dosing
  frequency by serum total IgE (IU/mL) and body weight.

 

  IgE-mediated food allergy: 75 mg to 600 mg subcutaneously every 2 or
  4 weeks. Determine dose (mg) and dosing frequency by serum total
  IgE (IU/mL) and body weight.

 

  Chronic spontaneous urticaria: 150 mg or 300 mg subcutaneously
  every 4 weeks. Dosing in CSU is not dependent on serum IgE level or
  body weight.

  Xolair 75 mg/0.5 mL single-dose prefilled syringe/autoinjector

  2 per 28 days

  Xolair 150 mg/1 mL single-dose prefilled syringe/autoinjector

  8 per 28 days

  Xolair 300 mg/2 mL single-dose prefilled syringe/autoinjector

  4 per 28 days

 


Place of Service:

Outpatient

The above policy is based on the following references:
  1. Xolair [package insert]. South San Francisco, CA: Genentech, Inc.; February 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 09, 2024
Aetna
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