Notification



Notification Issue Date:



Policy Attachment

Attachment to Policy # MA08.025c


Attachment:A

Policy #:MA08.025c

Description:Dosing and Frequency Requirements for Omalizumab (XolairŽ)

Title:Omalizumab (XolairŽ)

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.


DOSING AND FREQUENCY REQUIREMENTS

Refer to Attachment A for the Dosing and Frequency Requirements for omalizumab (XolairŽ).

The Company reserves the right to modify the Dosing and Frequency Requirements listed in this policy to ensure consistency with the most recently published recommendations for the use of omalizumab (XolairŽ). Changes to these guidelines are based on a consensus of information obtained from resources such as, but not limited to: the US Food and Drug Administration (FDA); Company-recognized authoritative pharmacology compendia; or published peer-reviewed clinical research. The professional provider must supply supporting documentation (i.e., published peer-reviewed literature) in order to request coverage for an amount of omalizumab (XolairŽ) outside of the Dosing and Frequency Requirements listed in this policy. For a list of Company-recognized pharmacology compendia, view our policy on off-label coverage for prescription drugs and biologics.

Accurate member information is necessary for the Company to approve the requested dose and frequency of this drug. If the member’s dose, frequency, or regimen changes (based on factors such as changes in member weight or incomplete therapeutic response), the provider must submit those changes to the Company for a new approval based on those changes as part of the precertification process. The Company reserves the right to conduct post-payment review and audit procedures for any claims submitted for omalizumab (XolairŽ).

ALLERGIC ASTHMA

Dosing for Allergic Asthma: Dosing and frequency is determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Doses may need to be adjusted for significant changes in body weight. See dosing information below:

Peer-reviewed literature and clinical trials recommend a minimum dose of 0.016 mg/kg/IgE (units/mL) subcutaneously per 4 weeks.

Dosing and Frequency for Individuals 6 Years of Age and Older:

Pretreat- ment Serum IgE (IU/mL)Dosing Freq.Body Weight
20-25
kg
>25-30
kg
>30-40
kg
>40-50
kg
>50-60
kg
>60-70
kg
>70-80
kg
>80-90
kg
>90-125
kg
>125-150
kg
Dose (mg)
30-100Every 4
weeks
7575+75 *150150150150150150300300
>100-200150150+150 *300300300300300300225+300 *225
>200-300150150+225 *300300300225225225300+375 *300
>300-400225225+300 225225225300300450525
*225
>400-500225300+225 *300+225 *300300300375375525600
>500-600300300+225 *300300300375450450600
>600-700300225+225 *375+300 *375375450450525
>700-800Every 2
weeks
225225300375450450525600
>800-900225225300375450525600
>900-1000225300375450525600
>1000-1100225300375450600DO NOT DOSE
>1100-1200300300450525600
>1200-1300300375450525
>1300-1500300375525600
Sources: U.S. Prescribing Information, European Prescribing Information, Kornmann 2014, Zielen 2013, Lowe 2015.

Note: There are some dosing differences between age groups that are identified by the following symbols:
    + Individuals 6 – 12 years of age
    * Individuals 12 years of age and older

CHRONIC IDIOPATHIC URTICARIA

Dosing and Frequency for Individuals 12 Years of Age and Older: Omalizumab (XolairŽ) 150 or 300 mg by subcutaneous injection every 4 weeks. Dosing is not dependent on serum IgE levels or body weight.



Version Effective Date: 12/13/2017
Version Issued Date: 12/13/2017
Version Reissued Date: 05/22/2019

Connect with Us        


Š 2017 Independence Blue Cross.
Independence Blue Cross is an independent licensee of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.