LCD/NCD MedicationsL29240

LCD/NCD Portal

Automated World Health

L29240

OMALIZUMAB (XOLAIR®)

02/02/2009

Indications and Limitations of Coverage and/or Medical Necessity

Indications

• Xolair is indicated for adults and children (12 years of age and older) with moderate to severe persistent asthma

o who have a positive skin test or in vitro reactivity to a perennial aeroallergen

And

o Whose symptoms are inadequately controlled with inhaled corticosteroids.

• Xolair has been shown to decrease the incidence of asthma exacerbations in these patients.

o Moderate persistent asthma

 Moderate persistent asthma is defined by the National Heart, Lung, and Blood Institute (NHLBI) as:

• Daily symptoms

• Daily use of inhaled short-acting beta2-agonist

• Exacerbations affect activity

• Exacerbations greater than or equal to 2 times a week; may last days

• Nighttime symptoms greater than 1 time a week

o Severe persistent asthma

 Severe persistent asthma is defined by the National Heart, Lung, and Blood Institute (NHLBI) as:

• Continual symptoms

• Limited physical symptoms

• Frequent exacerbations

• Nighttime symptoms are frequent

• The presence of one of these features of severity (moderate or severe) is sufficient to place a patient in that category.

o These clinical features are based on pre-treatment symptoms and measurements.

Limitations

• Anaphylaxis has occurred within 2 hours of the first or subsequent administration of Xolair.

o Patients should be observed after injection of Xolair, and medications for the treatment of severe hypersensitivity reactions should be available.

o If severe hypersensitivity reaction to Xolair occurs, then therapy should be discontinued.

• Xolair should NOT be administered to patients

o who have a body weight greater than 150 kg and

o Who do not have a baseline IgE level between 30 and 700 IU/mL. (See dosing charts under Utilization guidelines of this LCD.)

• Xoliar has not been shown to alleviate asthma exacerbations acutely and should not be used for the treatment of acute bronchospasm or status asthmaticus.

• Systemic or inhaled corticosteroids should not be abruptly discontinued upon initiation of Xolair therapy.

CPT/HCPCS Codes

J2357 INJECTION, OMALIZUMAB, 5 MG

ICD-9 Codes that Support Medical Necessity

493.00 EXTRINSIC ASTHMA UNSPECIFIED

493.10 INTRINSIC ASTHMA UNSPECIFIED

493.20 CHRONIC OBSTRUCTIVE ASTHMA UNSPECIFIED

Diagnoses that Support Medical Necessity

Any diagnosis not listed under ICD-9 CM codes that support medical necessity

Documentation Requirements

• The medical record documentation should support the indications and limitations outlined in this LCD.

o The medical record should include:

 a history and physical that supports the patient has moderate to severe persistent asthma as defined in this LCD;

 documentation indicating that

• the patient has been on inhaled corticosteroids for asthma before initiation of Xolair

And

• What the patients response to inhaled corticosteroids has been; patients weight.

 documentation supporting a positive skin test or in vitro reactivity (RAST test) to a perennial aeroallergen;

 Documented IgE level prior to treatment that is between 30 and 700 IU/ml.

• If the medical record documents that the patient has not shown any response to Xolair after 16 weeks of therapy, then further use of Xolair will be considered medically unnecessary.

Utilization Guidelines

• The CMS Manual System, Pub. 100-8, Program Integrity Manual, Chapter 13, Section 5.1.C outlines that “reasonable and necessary” services are “ordered and/or furnished by qualified personnel.”

o The use of this drug will be limited to specialty 03 (Allergy/Immunology) and Specialty 29 (Pulmonary Disease), or other physicians (MD/DO)/NPPS who have special expertise in evaluation and treatment of asthma.

• Dosing

o The dosing for Xolair is based on body weight and baseline serum total IgE concentration.

o Xolair should not be administered to patients who have a body weight greater than 150 kg and who do not have a baseline IgE level between 30 and 700 IU/mL. (See dosing charts below.)

o Xolair 150-375 mg is administered subcutaneously (SC) every two (2) or 4 (four) weeks.

o Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).

o Doses of more than 150 mg are divided among more than one injection site to limit injections to not more than 150 mg per site.

o Total IgE levels are elevated during treatment and remain elevated for up to one year after the discontinuation of treatment.

o Therefore, re-testing of IgE levels during Xolair treatment cannot be used as a guide for dose determination.

o Dose determination after treatment interruptions lasting less than 1 year should be based on serum IgE levels obtained at the initial dose determination.

o Total serum IgE levels may be re-tested for dose determination if treatment with Xolair has been interrupted for one year or more.

o Doses should be adjusted for significant changes in body weight.

• Every 4 week administration of Xolair

o Pretreatment serum IgE (units/mL):≥ 30 to 100

 Body weight (kg) 30-60: 150 mg

 Body weight (kg) >60 to 70: 150 mg

 Body weight (kg) >70-90: 150 mg

 Body weight (kg) >90-150: 300 mg

o Pretreatment serum IgE (units/mL):>100 to 200

 Body weight (kg) 30-60: 300 mg

 Body weight (kg) >60 to 70: 300 mg

 Body weight (kg) >70-90: 300mg