BlueCross BlueShield of Tennessee Medical Policy Manual

Omalizumab

NDC CODE(S)

50242-0040-XX - Xolair 150mg powder for injection (Genentech, Inc)

DESCRIPTION

Omalizumab is a recombinant DNA-derived humanized IgG1κ monoclonal antibody which selectively binds to immunoglobulin E (IgE).  High serum levels of IgE are found in individuals with allergic disease and asthma.  By binding with omalizumab, circulating IgE is inhibited from binding with high-affinity Fc receptors (FcεRI) on the surfaces of mast cells and basophils, key participants in allergic inflammation. This has been shown to diminish the release of mediators of the allergic response, decrease asthma exacerbations in individuals reactive to perennial aeroallergens and reduce the number of FcεRI receptors on basophils in atopic allergic hypersensitive individuals.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

*Components of severity for classifying asthma as moderate may include any of the following (not all inclusive):

Daily symptoms

Nighttime awakenings > 1x/week but not nightly

SABA use for symptom control occurs daily

Some limitation to normal activities

Lung function (percent predicted FEV1) >60%, but <80%

Exacerbations requiring oral systemic corticosteroids are generally more frequent and intense relative to mild asthma

*Components of severity for classifying asthma as severe may include any of the following (not all inclusive):

Symptoms throughout the day

Nighttime awakenings, often 7x/week

SABA use for symptom control occurs several times daily

Extremely limited in normal activities

Lung function (percent predicted FEV1) <60%

Exacerbations requiring oral systemic corticosteroids are generally more frequent and intense relative to moderate asthma      

**H1 Antihistamine Products (not all inclusive)

fexofenadine

loratadine

desloratadine

cetirizine

levocetirizine

clemastine

diphenhydramine

chlorpheniramine

hydroxyzine

cyproheptadine

brompheniramine

triprolidine

dexchlorpheniramine

carbinoxamine

Daily symptoms

Nighttime awakenings > 1x/week but not nightly

SABA use for symptom control occurs daily

Some limitation to normal activities

Lung function (percent predicted FEV1) >60%, but <80%

Exacerbations requiring oral systemic corticosteroids are generally more frequent and intense relative to mild asthma

**Components of severity for classifying asthma as severe may include any of the following (not all inclusive):

Symptoms throughout the day

Nighttime awakenings, often 7x/week

SABA use for symptom control occurs several times daily

Extremely limited in normal activities

Lung function (percent predicted FEV1) <60%

Exacerbations requiring oral systemic corticosteroids are generally more frequent and intense relative to moderate asthma      

**H1 Antihistamine Products (not all inclusive)

fexofenadine

loratadine

desloratadine

cetirizine

levocetirizine

clemastine

diphenhydramine

chlorpheniramine

hydroxyzine

cyproheptadine

brompheniramine

triprolidine

dexchlorpheniramine

carbinoxamine

 

RENEWAL CRITERIA

 

INDICATION(S)

DOSAGE & ADMINISTRATION

Allergic Asthma

75 to 375 mg administered subcutaneously by a health care provider every 2 or 4 weeks. Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). See tables below

Chronic idiopathic urticaria

150 or 300 mg administered subcutaneously by a health care provider every 4 weeks. Dosing is not dependent on serum IgE (free or total) level or body weight.

*NHLBI Asthma Guidelines 2007 Symptoms of Moderate Asthma


Omalizumab Doses Administered Every 4 Weeks (mg) in patients ≥ 12 years

Pre-treatment serum IgE (IU/mL)

Body weight (kg)

30 to 60

> 60 to 70

> 70 to 90

> 90 to 150

≥ 30 to 100

150

150

150

300

> 100 to 200

300

300

300

See the following table.

> 200 to 300

300

See the following table.

See the following table.

See the following table.

               

 

Omalizumab Doses Administered Every 2 Weeks (mg) in patients ≥ 12 years

Pre-treatment serum IgE (IU/mL)

Body weight (kg)

30 to 60

> 60 to 70

> 70 to 90

> 90 to 150

> 100 to 200

See previous table.

See previous table.

See previous table.

225

> 200 to 300

See previous table.

225

225

300

> 300 to 400

225

225

300

Do not dose.

> 400 to 500

300

300

375

Do not dose.

> 500 to 600

300

375

Do not dose.

Do not dose.

> 600 to 700

375

Do not dose.

Do not dose.

Do not dose

               

 

 

 

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION 

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

SOURCES

Diakow, Marla N, <D, James William D. MD et al Medscape Chronic Urticaria Guidelines 2017, May  https://emedicine.medscape.com/article/1050052-guidelines

Global Initiative for Asthma (GINA).Global Strategy for Asthma Management and Prevention. 20178 Update. Available from: http://www.ginasthma.org. Accessed October April 2018.

Lexi-Comp Online. (2018). AHFS DI. Omalizumab. Retrieved July 3, 2018 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2018, June). Omalizumab. Retrieved July 3, 2018 from MICROMEDEX Healthcare Series.

National Asthma Education and Prevention Program (NAEPP). Guidelines for the diagnosis and management of asthma. Expert Panel Report 3. Bethesda, MD: National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI); August 2007.

U. S. Food and Drug Administration. (2016, July). Center for Drug Evaluation and Research. Xolair® (omalizumab). Retrieved July 3, 2018 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103976s5225lbl.pdf.

Zuberbier T, Aberer W, Asero R, Bindslev-Jensen C, et al. EAACI/GA (2) LEN/EDF/WAO guideline for the Definition, Classification, Diagnosis and Management of Urticaria. The 2017 Revision and Update.: management of urticaria. Allergy. 2018 Jan 15. doi: 10.1111/all.13397.2009 Oct;64(10):1427-43. doi: 10.1111/j.1398-9995.2009.02178.x. 

ORIGINAL EFFECTIVE DATE:  4/14/2004

MOST RECENT REVIEW DATE:  3/2/2019

ID_MRx

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

This document has been classified as public information.

 

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit  1 billable unit = 5 mg

DIAGNOSIS

MAXIMUM UNITS

Allergic Asthma 90 billable units every 14 days
Chronic idiopathic urticaria 60 billable units every 28 days