Blue Cross of Idaho Logo

Express Sign-on

Thank you for registering with Blue Cross of Idaho

If you are an Individual or Family Member under age 65, please register here.

If you are an Medicare or Medicare Supplement member, please register here.

New Options for Affordable Health Insurance

MP 5.01.95

Xolair (Omalizumab)


Medical Policy

 

 

Section
Prescription Drugs

Original Policy Date
12/01/06

Last Review Status/Date
Local policy/6:2014

Issue
6:2014

 

Return to Medical Policy Index


Disclaimer

Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.


Description

Xolair (Omalizumab) is a recombinant DNA-derived humanized IgG1k monoclonal antibody that selectively binds to human immunoglobulin E (IgE). It is produced by a Chinese hamster ovary cell suspension culture in a nutrient medium containing the antibiotic gentamicin which is not detectable in the final product according to the product insert.

Omalizumab inhibits the binding of IgE to the high-affinity on the surface of mast cells and basophils. Reduction in surface-bound IgE on the receptor (FceRI bearing) cells limits the degree of release of mediators of the allergic response. Treatment also reduces the number of FceRI receptors on basophils of allergic patients.

Omalizumab is indicated for adults and adolescents (12 years of age and above) with moderate to severe persistent asthma who have a positive skin test and for patients with chronic spontaneous urticaria (CSU) (also referred to as chronic idiopathic urticaria or CIU), which cannot be treated with H1-antihistamines. Xolair has been shown to decrease the incidence of asthma exacerbations in these patients. Safety and efficacy have not been established in other allergic conditions.


Background

According to the global strategy for asthma management and prevention of the National Heart, Lung and Blood Institute (NHLBI), patients with moderate persistent asthma exhibit some of the following characteristics:

  • Symptoms daily
  • Exacerbations may affect activity and sleep
  • Daily use of inhaled short-acting beta2-agonist
  • PEF 60 to 80% of personal best
  • Diurnal PEF variation greater than 30%
  • For patients with severe persistent asthma, they have some of the following characteristics:
  • Symptoms daily
  • Frequent exacerbations
  • PEF less than or equal to 60% of personal best
  • Diurnal PEF variation greater than 30%

The preferred therapy for patients with moderate persistent asthma is regular treatment with a combination of inhaled corticosteroids and a long-acting inhaled beta2-agonist twice daily. For patients with severe persistent asthma, the primary therapy includes inhaled corticosteroids at higher doses plus a long-acting inhaled beta2-agonist twice daily. Furthermore, according to the NHBLI guidelines, control of asthma is defined as:

  • Minimal (ideally not) chronic symptoms, including nocturnal symptoms
  • Minimal (infrequent) exacerbations
  • No visits to the emergency room
  • Minimal (ideally no) use of p.r.n. (as needed) beta2-agonist
  • No limitations on activities, including exercise
  • PEF diurnal variation of less than 20%
  • (Near) normal PEF
  • Minimal (or no) adverse effects from medicine.

Appendex A: Estimated Comparative Daily Doseages for Inhaled Corticosteroids

Adults

Drug

Low Dose

Medium Dose

High Dose

Beclomethasone dipropionate

42 mcg/puff

84 mcg/puff

168-504 mcg

(4-12 puffs - 42 mcg)

(2-6 puffs - 84 mcg)

 

504-840 mcg

(12-20 puffs - 42 mcg)

(6-10 puffs - 42 mcg)

 

'>840 mcg

('>20 puffs - 42 mcg)

('10 puffs - 84 mcg)

Budesonide

DPI: 200 mcg/dose

200-400 mcg

(1-2 inhalations)

400-600 mcg

(2-3 inhalations)

'>600 mcg

('>3 inhalations)

Flunisonde

250 mcg/puff

500-1000 mcg

(2-4 puffs)

1000-2000 mcg

(4-8 puffs)

'>2000 mcg

('>8 puffs)

Fluticasone

MDI: 44, 110, 220 mcg/ puff

 

 

DPI: 50, 100, 250 mcg/dose

88-264 mcg

(2-6 puffs - 44 mcg) OR

(2 puffs - 110 mcg)

 

(2-6 inhalations - 50 mcg)

264-660 mcg

(2-6 puffs - 110 mcg)

 

 

(3-6 inhalations - 100 mcg)

/>660 mcg

('>6 puffs - 110 mcg) OR

('>3 puffs - 220 mcg)

 

('>6 inhalations - 100 mcg) OR

('>2 inhalations - 250 mcg)

Triamcinolone acetonide 100 mcg/puff

400-1000 mcg

(4-10 puffs)

1000-2000 mcg

(10-20 puffs)

'>2000 mcg

('>20 puffs)

Children 

Beclomethasone dipropionate

42 mcg/puff

84 mcg/puff

84-336 mcg

(2-8 puffs - 42mcg)

(1-4 puffs - 84 mcg)

336-672 mcg

(8-10 puffs - 42 mcg)

(1-4 puffs - 84 mcg)

'>672 mcg

('>16 puffs - 42 mcg)

('>8 puffs - 84 mcg)

Budesonide

DPI: 200 mcg/dose

100-200 mcg

200-400 mcg

(1-2 inhalations - 200 mcg)

'>400 mcg

('>2 inhalations - 200 mcg)

Flunisonde

250 mcg/puff

500-750 mcg

(2-3 puffs)

1000-1250 mcg

(4-5 puffs)

'>1250 mcg

('>5 puffs)

Fluticasone

MDI: 44, 110, 220 mcg/ puff

 

 

DPI: 50, 100, 250 mcg/dose

88-176 mcg

(2-4 puffs - 44 mcg)

 

 

(2-4 inhalations - 50 mcg)

176-440 mcg (4-10 puffs - 44 mcg) OR (2-4 puffs - 110 mcg)

 

 

(2-4 inhalations - 100 mcg)

'>440 mcg

('>4 puffs - 110mcg)OR('>2 puffs - 220 mcg)

 

 

('>4 inhalations - 100mcg)OR('>2 inhalations - 250 mcg)

Triamcinolone acetonide 100 mcg/puff

400-800 mcg

(4-8 puffs)

800-1200 mcg

(8-12 puffs)

'>1200 mcg

('>12 puffs)

DPI (dry powder inhaler) doses are expressed as the amount of drug in the inhaler following activation.

MDI (metered-dose inhaler) dosages are expressed as the actuater dose (the amount of drug leaving the actuater and delivered to the patient), which is the labeling required in the United States.

Adapted from: National Asthma Educational Prevention Program Expert Panel Report 2: Guidelines for the Diagnosis and Management of Asthma. NIH Publication No 97-4051, July 1997. Available at: http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf.

Appendix B: Dosing Schedule for Subcutaneously Administered Omalizumab

Baseline Serum IgE Level

strong>Body Weight

 

30-60 kg

61-70 kg

71-80 kg

81-90 kg

91-150 kg

IU/ml

Dose in milligrams

30-100

150

150

150

150

300

101-200

300

300

300

300

225

201-300

300

225

225

225

300

301-400

225

225

300

300

401-500

300

300

375

375

501-600

300

375

601-700

375

Adapted from Strunk & Bloomberg, 2006. The recommended dose is 0.016 mg per kilogram of body weight per international unit of IgE every four weeks, administered subcutaneously at either four-week (italic) or two-week (roman) intervals for adults and adolescents (persons 12 years of age or older) with allergic asthma. Dashes indicate that no dose should be prescribed.


Policy

Moderate to Severe Persistent Allergic Asthma

Omalizumab is considered medically necessary when all of the following conditions are met:

  • The request for approval comes from an allergist, immunologist, or pulmonologist who is currently treating the patient.
  • The patient is an adult or adolescent (12 years of age or above).
  • The patient has moderate or severe persistent asthma as defined by the current NAEPP clinical guidelines for the management of asthma.
  • The patient has a positive skin test or in vitro reactivity to a specific perennial aeroallergen.
  • The patient's symptoms are inadequately controlled with appropriate doses of inhaled corticosteroids
  • There is documentation of poor asthma control or recurrent exacerbations such as those that require hospitalizations or treatment with repeated courses of oral corticosteroids.
  • Triggers of asthma to which the patient is exposed are appropriately managed 

Omalizumab is considered not medically necessary when used for the following conditions: 

-allergic rhinitis

-prevention or therapy for peanut or other food allergies

Administration may not exceed 375 mg every 2 weeks. Omalizumab is not a self-injectable medication.

Continued treatment with omalizumab beyond six months is considered medically necessary for members who meet all of the following criteria:

  • Member had met criteria for omalizumab set forth by BCI at initiation of omalizumab therapy; and
  • treatment with omalizumab has resulted in clinical improvement as documented by one or more of the following:
    • Decreased utilization of rescue medications; or
    • Decreased frequency of exacerbations (defined as worsening of asthma that requires increase in inhaled corticosteroid does or treatment with systemic corticosteroids); or
    • Increase in percent predicted FEV-1 from pretreatment baseline; or
    • Reduction in reported symptoms (decrease in asthma symptom score), as evidenced by decreases in frequency or magnitude of one or more of the following symptoms:
      • Sleep disturbances, night wakening, or symptoms upon wakening; or
      • Shortness of breath; or
      • Wheezing/heavy breathing/fighting for air; or
      • Chest tightening or heaviness; or
      • Asthma attacks; or
      • Difficulty taking deep breath or difficulty breathing out; or
      • Coughing or clearing throat; or
      • Tiredness; and
  • Member has not exhibited symptoms of anaphylaxis (bronchospasm, hypotension, syncope, urticara, and/or angioedema) after administration of omalizumab.
Chronic Idiopathic Urticaria
Omalizumab is considered medically necessary when all of the following conditions are met:
  • The request for approval comes from an allergist/immunologist or dermatologist.
  • The patient is an adult or adolescent (12 years of age or above).
  • The patient has an established diagnosis of Chronic Idiopathic Urticaria (CIU). Symptoms are moderate to severe as marked by failure of traditional treatements [described below], and disruption of activities of daily living or sleep.
  • The patient's symptoms persist despite treatment for at least two weeks with two or more anithistimines.
  • The patient has required treatment with at least one course of oral corticosteroids unless contra-indicated.

Omalizumab is considered not medically necessary when all of the above criteria are not met.

Omalizumab is considered investigational when used for all other conditions.


Policy Guidelines

Omalizumab is considered medically necessary as a second line treatment for moderate to severe persistent allergic asthma, when all of the following conditions are met:

  • The request for approval comes from an allergist, immunologist, or pulmonologist who is currently treating the patient.
  • The patient is an adult or adolescent (12 years of age or above).
  • The patient has moderate or severe persistent asthma as defined by the current NAEPP clinical guidelines for the management of asthma.
  • The patient has a positive skin test or in vitro reactivity to a specific perennial aeroallergen.
  • The patient’s symptoms are inadequately controlled with appropriate doses of inhaled corticosteroids.
  • There is documentation of poor asthma control or recurrent exacerbations such as those that require hospitalizations or treatment with repeated courses of oral corticosteroids.
  • Triggers of asthma to which the patient is exposed are appropriately managed
  • Moderate persistent asthma has daily daytime symptoms and nighttime symptoms >1 night/week and a PEF or FEV1 of greater than 60% - less than 80% and PEF variability if greater than 30%.
  • Since clinical trials involved patients 12 to 76 years of age, administration is limited to those age groups.
  • Clinical trials did not involve patients who weighed more than 150 kg and there is no evidence of efficacy for patients above that weight.
  • Total serum IgE levels should be between 30 and 700 international units/mL, but no higher than 700 international units.
  • Dosage is to be determined by pre-treatment IgE level as noted in the product insert.
  • Omalizumab is not indicated for conditions other than asthma.
  • Cost effectiveness is unlikely unless the patient has severe persistent asthma with frequent exacerbations requiring hospitalization.

 

Authorization for Omalizumab in the treatment of CIU will be provided for a period of only 6 months at a time so that the need for continued therapy can be periodically reassessed.

Symptoms for CIU are considered moderate to severe when:

  • Other specific causes have been considered and ruled out and possible triggers have been considered and managed without improvement.
  • Patients must have hives on most days of the week for six weeks or longer.
  • Disruption of activities of daily living or sleep

 

References:

  1. Xolair (Omalizumab) product insert – Genentech, Inc./ Novartis Pharmaceuticals Corporation   April 2006
  2. NAEPP Stepwise Approach for Managing Asthma in Adults and Children Older than 5 Years of Age: Treatment   May 2003
  3. The Allergy Report' American Academy of Allergy, Asthma and Immunology. http://www.theallergyreport.org/reportindex.html.
  4. Easthope, S and Garvis, B 'Omalizumab' Drugs 2001;61(2):253-60.
  5. Prenner, BM 'Asthma 2008: targeting immunoglobulin E to achieve disease control.' J Asthma. 2008 Aug;45(6):429-36.
  6. 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.
  7. National Institute for Health and Clinical Excellence (NICE). Omalizumab for severe persistent allergic asthma. Technology Appraisal Guidance No 133. London, UK: NICE; November 2007.
  8. Strunk RC, Bloomberg GR. Omalizumab for asthma. N Engl J Med. 2006;354(25):2689-2695
  9. J Dermatol Sci. 2014 Jan;73(1):57-62. doi: 10.1016/j.jdermsci.2013.08.011. Epub 2013 Sep 3

 


Codes

 Codes

 Number

 Description

 HCPCS

J2357

 Injection, Omalizumab, 5 mg

ICD-9 diagnosis

493.00

 Asthma, exogenous

  708.1 Idiopathic urticaria
ICD-10-CM (effective 10/1/2015) J45.20-J45.50 Persistent asthma code range
  L50.1 Idiopathic urticaria

Policy History

 12/01/06

Policy added to Prescription Drug section

 New Policy

08/27/08 Replace policy  policy updated; background section added; policy statement revised to include additional criteria, and not medically necessary indications; local policy
10/06/09 Updated policy number only Policy re-numbered to 5.01.95
6/03/14 Replace policy Added statement regarding use for Chronic Idiopathic Urticaria