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.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

 

INDICATION(S)

DOSAGE & ADMINISTRATION

Allergic Asthma

75 to 375 mg SC 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 by subcutaneous injection 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).

No controlled studies were found in the published literature that validate the use of omalizumab for the treatment of other conditions or diseases.

SOURCES

Lexi-Comp Online. (2016). AHFS DI. Omalizumab. Retrieved November 4, 2016 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2016, August). Omalizumab. Retrieved November 4, 2016 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 November 4, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103976s5225lbl.pdf.

ORIGINAL EFFECTIVE DATE:  4/14/2004

MOST RECENT REVIEW DATE:  3/14/2017

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. 

Pharmaceutical Decision Support Tree

Omalizumab (Xolair ®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #10

  1. Does the individual have a diagnosis of moderate to severe persistent asthma as defined by the NHLBI’s 2007 Asthma Guidelines*?

If yes, go to question #3

If no, go to question #5

  1. Does the individual have a positive skin test or in vitro reactivity to a perennial aeroallergen with serum IgE levels are ANY ONE of the following?

If yes, go to question #4

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Are symptoms inadequately controlled with minimum 3 month trial of previous combination therapy including medium- or high-dose inhaled corticosteroids PLUS another controller medication (e.g., long-acting beta-2 agonist, leukotriene receptor antagonist, theophylline, etc.)?

If yes, go to question #5

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the individual 12 years of age or older with a diagnosis of urticaria?

If yes, go to question #6

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the condition refractory to a 3 month trial of ANY ONE of the following?

If yes, go to question #7

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the disease diagnosed as moderate-to-severe chronic idiopathic urticaria and no other allergic condition or other form or urticaria with a documented baseline score from an objective clinical evaluation tool, such as: urticaria activity score (UAS7), Dermatology Life Quality Index (DLQI), or Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) (NOTE: Renewal will require submission of score from an objective clinical evaluation tool (e.g., UAS7, DLQI or CU-Q2oL) completed within 30 days of request)?

If yes, go to question #8

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for no more than 90 billable units every 14 days for a diagnosis of allergic asthma OR for 60 billable units every 28 days for a diagnosis of chronic idiopathic urticaria?

If yes, go to question #9

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is dosage requested for allergic asthma 75 to 375 mg SC every 2 or 4 weeks as determined by total IgE level (IU/ML) as measured before start of treatment and body weight (kg) as per tables below OR for a diagnosis of chronic idiopathic urticaria, is dosage requested 150 or 300 mg by subcutaneous injection every 4 weeks for an authorization period of 6 months?

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

               

 

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual continue to meet initial approval criteria in questions 2 through 9?

If yes, go to question #11

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of Moderate-to-severe persistent allergic asthma  with ALL of the following?

If yes, go to question #13

If no, go to question #12

  1. Does the individual have a diagnosis of Chronic Idiopathic Urticaria (CIU) with ALL of the following?

If yes, go to question #13

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is there absence of unacceptable toxicity from the agent such as symptoms of anaphylaxis (bronchospasm, hypotension, syncope, urticaria, and/or angioedema); malignancy; symptoms similar to serum sickness (fever, arthralgia, and rash); eosinophilic conditions, including vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy, especially upon reduction of oral corticosteroid, etc.?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

 

  *Components of moderate asthma severity

This document has been classified as public information.