Subject: Specialty Quantity Limit Xolair-Omlyclo 2544-H P2026a

Drug

Xolair-Omlyclo

XOLAIR  (omalizumab)

OMLYCLO  (omalizumab-igec)

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
Xolair (omalizumab) 150 mg single-dose vial	8 vials per 28 days
Xolair (omalizumab) 75 mg/0.5 mL single-dose prefilled syringe/autoinjector	2 syringes/autoinjectors per 28 days
Xolair (omalizumab) 150 mg/1 mL single-dose prefilled syringe/autoinjector	8 syringes/autoinjectors per 28 days
Xolair (omalizumab) 300 mg/2 mL single-dose prefilled syringe/autoinjector	4 syringes/autoinjectors per 28 days
Omlyclo (omalizumab-igec) 75 mg/0.5 mL single-dose prefilled syringe	2 syringes per 28 days
Omlyclo (omalizumab-igec) 150 mg/1 mL single-dose prefilled syringe	8 syringes per 28 days
Omlyclo (omalizumab-igec) 300 mg/2 mL single-dose prefilled syringe	4 syringes per 28 days

FDA-Recommended Dosing

Asthma

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

Chronic Spontaneous Urticaria (CSU)

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

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.

2.      Omlyclo [package insert]. Jersey City, NJ: Celltrion USA Inc.; December 2025.

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.

May 16, 2026