Subject: Xolair (Omalizumab)for Allergic Asthma Original Effective Date: 10/26/2011

Policy Number: MCP-001 Revision Date(s):10/26/2011; 12/29/2015;

7/18/2016

Review Date(s): 10/26/2011; 12/29/2015; 7/18/2016, 9/19/2017, 7/10/2018

DISCLAIMER

This Molina Clinical Policy (MCP) is intended to facilitate the Utilization Management process. It expresses Molina's

determination as to whether certain services or supplies are medically necessary, experimental, investigational, or

cosmetic for purposes of determining appropriateness of payment. The conclusion that a particular service or supply is

medically necessary does not constitute a representation or warranty that this service or supply is covered (i.e., will be

paid for by Molina) for a particular member. The member's benefit plan determines coverage. Each benefit plan defines

which services are covered, which are excluded, and which are subject to dollar caps or other limits. Members and their

providers will need to consult the member's benefit plan to determine if there are any exclusion(s) or other benefit

limitations applicable to this service or supply. If there is a discrepancy between this policy and a member's plan of

benefits, the benefits plan will govern. In addition, coverage may be mandated by applicable legal requirements of a

State, the Federal government or CMS for Medicare and Medicaid members. CMS's Coverage Database can be found on

the CMS website. The coverage directive(s) and criteria from an existing National Coverage Determination (NCD) or

Local Coverage Determination (LCD) will supersede the contents of this MCP document and provide the directive for all

Medicare members.

SUMMARY

This policy addresses the coverage of Xolair (Omalizumab) for the treatment of moderate to severe persistent asthma

in adults and adolescents 6 years and older when appropriate criteria are met. The intent of the Xolair (omalizumab)

drug policy is to ensure appropriate selection of patients for therapy based on product labeling, clinical guidelines, and

clinical studies.

*REFER TO MCP-178 for Xolair (Omalizumab) for Chronic Idiopathic Urticaria

∑ Asthma is one of the most common long-term diseases in children1, affecting about 6.3 million people younger than

18 in the U.S or one in 12 children in the U.S.g The American Academy of Pediatrics estimates that between 70 and

80 percent of school-aged children with asthma also have allergies, which are among the most common triggers for

asthma.H

∑ Omalizumab is a monoclonal antibody that reduces the levels of circulating IgE and inhibits binding of IgE to mast

cells, to prevent the activation of the allergic cascade and decrease inflammation. Omalizumab is an adjunct therapy

option for select patients with allergic asthma. It is indicated for patients who have severe allergic asthma with

elevated IgE levels and have not achieved asthma control with other drug therapies.B

∑ Achieving and maintaining asthma control is the goal of treatment. Controller medications suppress the inflammatory

causes of asthma to provide clinical control over the long term, whereas reliever medications relieve

bronchoconstriction quickly (2010 Global Strategy for Asthma Treatment and PreventionB)

∑ There are no available data demonstrating that omalizumab is superior to preferred options recommended in treatment

guidelines for moderate-to-severe persistent asthma.3

Page 1 of 20

∑ For both asthma and chronic urticaria, omalizumab has not been proven to be safer or more effective than preferred

options recommended in treatment guidelines, nor in patients with less severe asthma/urticaria, non-allergic asthma,

or non-idiopathic urticaria (urticaria with a clearly defined underlying cause).

∑ The National Heart, Lung and Blood Institute's Expert Panel Report 3 (EPR3) Guidelines for the Diagnosis and

Management of Asthma recommend Xolair may be considered as adjunct therapy for patients 12 years and older with

allergies and Step 5 or 6 (severe) asthma whose symptoms have not been controlled by ICS and LABAA,F [as defined

by NAEPP Guidelines for the Diagnosis and Treatment of Asthma (Step 5 or Step 6)].

∑ The efficacy of omalizumab in moderate to severe asthma has been further demonstrated by recent meta-analysis and

systematic reviews that considered reductions of steroid use and of asthma exacerbations as the primary outcomes;

secondary outcome measures included lung function, use of rescue medication, asthma symptoms, and health-related

quality of life (Hanania, 2011; Rodrigo, 2011).4,5

CLASSIFICATION: Respiratory Tract Agents, Miscellaneous

FDA INDICATIONS

∑ Asthma: Treatment of moderate to severe persistent asthma in adults and adolescents 6 years and older who have a

positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled

with inhaled corticosteroids.a

Guideline recommendations:

The 2007 National Asthma Education and Prevention Program asthma guidelines recommend use be considered as

adjunctive therapy in patients with severe persistent asthma who have allergies and in patients with severe persistent

asthma that is inadequately controlled with a combination of a high-dose inhaled corticosteroid and a long-acting

beta2-agonist.A

The Global Initiative for Asthma suggests use be considered as adjunctive therapy in patients with moderate or severe

allergic asthma that is uncontrolled with a combination of a medium- to high-dose inhaled corticosteroid and a long-

acting beta2-agonist (GINA 2016).B

∑ Chronic idiopathic urticaria: Treatment of chronic idiopathic urticaria in adults and adolescents 12 years and older

who remain symptomatic despite H1 antihistamine treatment.a --NOT ADDRESSED in this coverage policy.

REFER TO MCP-178 for Xolair (Omalizumab) for Chronic Idiopathic Urticaria

Available as: For injection: Lyophilized, sterile powder in a single-use 5mL vial, 150 mg.

FDA Approved

• June 2003: for use in patients with a positive skin test or in vitro reactivity to a perennial aeroallergen for the

treatment of moderate to severe persistent asthma that is inadequately controlled despite the use of inhaled

corticosteroids

• March 2014: for the treatment of chronic idiopathic urticaria that is symptomatic despite H1 antihistamine treatment.

• July 2016: FDA Approves Xolair (omalizumab) for allergic asthma in children placing Xolair as the only biologic for

children ages six and up with uncontrolled allergic asthma at this time.

Black Box Warnings: Xolair (omalizumab) has a black box warning for anaphylaxis after administration and presents as

bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue. Anaphylaxis has occurred after

the first dose of Xolair but also has occurred beyond 1 year after beginning treatment. Patients should be closely observed

for an appropriate period of time after Xolair administration; professional personnel should be prepared to manage

anaphylaxis that can be life-threatening.

Page 2 of 20

On September 26, 2014, the U.S. FDA released a drug safety alert entitled: FDA approves label changes for asthma drug

Xolair (omalizumab), including describing slightly higher risk of heart and brain adverse events. An FDA review of safety

studies suggests a slightly increased risk of problems involving the heart and blood vessels supplying the brain among

patients being treated with the asthma drug Xolair (omalizumab) than in those who were not treated with Xolair. As a

result, FDA has added information about these potential risks to the drug label. Additionally, reviewers found no

difference in the rates of cancer between those patients being treated with Xolair and those who were not being treated

with Xolair. However, due to limitations in the 5-year study, FDA cannot rule out a potential risk of cancer with Xolair, so

this information was added to the Warnings and Precautions section of the drug label.

Reference: FDA Drug Safety Communication. FDA approves label changes for asthma drug Xolair (omalizumab),

including describing slightly higher risk of heart and brain adverse events. Updated September 26, 2014. Available at

http://www.fda.gov/Drugs/DrugSafety/ucm414911.htm.

RECOMMENDATIONS/COVERAGE CRITERIA

Xolair (Omalizumab) may be authorized for members who meet ALL of the following criteria [ALL]

1.� Prescriber specialty [ONE]

¶ Prescribed by, or in consultation with, a board-certified allergy/asthma specialist (allergist, immunologist, or

pulmonologist) or physician experienced in the management of allergy/asthma. Submit consultation notes if

applicable.

NOTE: Consultation notes must be submitted for initial request and for continuation of treatment requests at

least ONCE annually.

2.� Diagnosis/Indication [ALL]

Clinical documented diagnosis of (includes clinical notes from the member’s medical records including any

applicable labs and/or tests, supporting the diagnosis): [ALL]

¶ Diagnosis of moderate persistent to severe persistent asthma as defined by the National Asthma Education

and Prevention Program (NAEPP)* (Step 5 or Step 6) or moderate to severe persistent as defined by the

National Heart, Lung and Blood Institute (NHLBI) criteria asthma

¶ Allergic asthma has been confirmed by skin testing or in vitro reactivity testing as documented by ONE (1)

or more of the following: [ONE]

û Positive skin testing to at least one perennial aeroallergen (i.e. prick/puncture test, intracutaneous test)

û In vitro reactivity to a perennial aeroallergen (i.e. RAST, MAST, FAST, ELISA)

‹ In vitro testing [i.e., a blood test for allergen-specific IgE antibodies such as the

radioallergosorbent test (RAST)] for one or more perennial aeroallergens (e.g., house dust

mite [Dermatophagoides farinae, D. pteronyssinus], animal dander (dog, cat), cockroach,

feathers, mold spores), AND/OR for one or more seasonal aeroallergens (grass, pollen,

weeds)

‹ The four perennial aeroallergens most commonly tested for in the clinical trials were dog

dander, cat dander, cockroach, and house dust mite.

Page 3 of 20

¶ Airflow limitation: Forced expiratory volume in one second (FEV1) or peak expiratory flow (PEF) less than

80% of predicted level (after bronchodilator withhold*)

*Spirometry performed prior to the administration of bronchodilators (pre- and post-bronchodilator

administration)--bronchodilators have been withheld for a period of time.

‹ Based on the National Asthma Education and Prevention Program (NAEPP), moderate persistent

asthma is classified as daily daytime symptoms, night time awakenings of greater than once per week

but not nightly, daily use of short-acting beta2-agonist for symptom control, some limitation of normal

activity, FEV1 >60% but <80% of predicted value and FEV1/FVC reduced up to 5%. Severe

persistent asthma is classified as symptoms throughout the day, nighttime awakenings often 7 times

per week, use of short-acting beta2-agonist for symptom control, extreme limitation of daily activity,

FEV1 <60% of predicted, and FEV1/FVC reduced >5%. (NAEPP Expert Panel Report 3: Guidelines

for the Diagnosis and Management of Asthma, 2007)

‹ Patients in the clinical trials most often were required to have an FEV1 between 40% and 80% of

predicted. No patients were enrolled with an FEV1 greater than 80% of predicted.

‹ Data from omalizumab clinical trials did not support its efficacy in patients who had a baseline FEV1

greater than 80%, or who required oral steroids as maintenance therapy. In all three of the trials, a

reduction of asthma exacerbations was not observed in the Xolair-treated patients who had FEV1 >

80% at the time of randomization. Reductions in exacerbations were not seen in patients who

required oral steroids as maintenance therapy.

Note:�Moderate persistent asthma: FEV1 or PEF 60%-80% of predicted�Severe persistent asthma: FEV1 or PEF ≤ 60% predicted�

3.� Age/Gender/Other restrictions [ALL]

¶ 6 years of age or older ‹ Safety and efficacy in pediatric patients with asthma below 6 years of age have not been established.a

¶ Members age 6 to <12 years: [BOTH]

û Body weight between 20 kg (44 lbs) and 150 kg (330 lbs)

û Pre-treatment serum total IgE levels of 30 to 1300 IU/mL. Documentation (lab results) required. NOTE: Limited clinical information is available regarding Xolair use for pediatric patients between the

ages of 6- 12 years old with IgE levels of > 1300 IU/mL.

¶ Members age ≥12 years : [BOTH]

û Body weight between 30 kg (66 lbs) and 150 kg (330 lbs)

û Pre-treatment serum total IgE levels of 30 to 700 IU/mL. Documentation (lab results) required.

NOTE: Limited clinical information is available regarding Xolair use for patients over the age of 12 with

IgE levels >700 IU/mL.

¶ Member is a non-smoker OR smoking cessation has been at least 6 months

‹ Patients currently smoking were excluded in pivotal trials, thus the safety and efficacy of the drug for

a person who smokes is not known. a

¶ Underlying conditions or triggers for asthma or pulmonary disease are being maximally managed

Page 4 of 20

4.� Step/Conservative Therapy/Other condition Requirements [ALL] NHLBI recommended first-line STEP5 asthma therapies for persistent asthma including use of as-needed short-acting beta-

agonists (SABAs), high-dose inhaled corticosteroids (ICS), and inhaled long-acting beta-agonists (LABAs), along with strict

allergen (environmental) control. Oral corticosteroids are recommended for exacerbations, as well as STEP 6 therapy.F

¶ Omalizumab not being prescribed as monotherapy for asthma (will be used in combination with other

medications for long-term control of asthma)

¶ Asthma symptoms have not been adequately controlled by inhaled corticosteroids after at least 3 months (90

days) of therapy. Inadequate control on inhaled corticosteroids as documented by ONE (1) or more of the

following: [ONE]

û Requirement for systemic (oral, parenteral) corticosteroids to control exacerbations of asthma

û Frequent severe exacerbations that often require emergency room visits, unscheduled office visits

and/or hospitalizations

û Excessive use of rescue medications and/or oral steroids OR increasing need for short-acting inhaled

beta2 agonists for symptoms (not including preventive use for exercise-induced asthma)

û Limitations or impairment in activities of daily living, such as work, school, exercise and/or sleep

û Nocturnal symptoms/awakening

û Lung function (PEF or FEV1) < 80% predicted or personal best (without administration of

bronchodilator or after bronchodilator withhold)

¶ Member's symptoms are inadequately controlled [as documented in above criterion] after a compliant

regimen of at least 3 months of the following COMBINATION THERAPY: [A OR B]

A.� Medium-high dose inhaled corticosteroid (ICS) AND long-acting beta-agonists (LABAs)* [in

addition to leukotriene receptor antagonists, theophyllines, oral corticosteroids and beta-2 agonist

tablets where clinically appropriate] (if a long-acting beta-agonist is contraindicated, a second

controller agent must be used in combination with an inhaled corticosteroid): [BOTH]

¶ Clinical documentation of compliance with medium-high dose inhaled corticosteroids (ICS)

and long-acting inhaled beta-2 agonists (LABA) (Step 5 of the National Asthma Treatment

Guidelines) and use of oral corticosteroids for exacerbation unless contraindicated

û Inhaled Corticosteroids [e.g., Aerospan® (flunisoolide), Alvesco® (ciclesodine),

Arnuity™ Ellipta® (fluticasone furoate inhalation powder), Asmanex® (mometasone furoate),

Flovent® HFA (fluticasone propionate), Pulmicort® (budesonide), QVAR® (beclomethasone

dipropionate HFA)] OR Oral Corticosteroids (e.g., methylprednisolone, prednisone,

prednisolone)

û Long-acting beta-agonists (LABAs) [e.g., Foradil® Aerolizer (formoterol fumarate),

Severent® Diskus (salmeterol xinafoate)]

OR

Leukotriene Modifiers [e.g., Singulair® (montelukast sodium), Accolate® (zafirlukast)]

OR

Theophylline

¶ One combination inhaled corticosteroid/long-acting beta2-agonist product [e.g., fluticasone

propionate/salmeterol (Advair®), mometasone/formoterol (Dulera®), budesonide/formoterol

(Symbicort®)]

NOTE: MOLINA STAFF: Verify pharmacy claims data for compliance and rescue medication use

within the last 90 days, OR for new members to Molina Healthcare, confirm rescue

medications use in medical chart history. Non-compliance, which can be documented

by review of the prescription fill history, would not constitute therapeutic failure.

Page 5 of 20

B.� A documented contraindication or clinical intolerance to the above medications based on adverse

effects from high dose ICS or long term risks of adverse effects from high dose ICS or oral

corticosteroids [including but not limited to: Cataracts in patients > 40 years of age; Glaucoma;

Recurrent thrush; Dysphonia; Growth inhibition, after evaluation by Endocrine Consult; Diagnosis

of osteoporosis, treatment resistant to FDA approved osteoporosis treatment]

*For an estimated Comparative Daily Dosages for Inhaled Corticosteroids of Low, Medium, and Daily Dose

reference the National Asthma Educational Prevention Program Expert Panel Report 3: Guidelines for the

Diagnosis and Management of Asthma. Full Report 2007.

Available at: http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.htm

5.� Contraindications*/Exclusions/Discontinuations

Authorization will not be granted if ANY of the following conditions apply [ANY]

¶ Non-FDA approved indications

¶ Severe hypersensitivity reaction to omalizumab or any component of the formulation�Exclusions [ANY]�

¶ Treatment to relieve acute bronchospasm or status asthmaticusa

‹ Not indicated for acute bronchospasm or status asthmaticus.a Omalizumab has not been shown to

alleviate acute asthma exacerbations and should not be used for the treatment of acute bronchospasm

or status asthmaticus.

6.� Labs/Reports/Documentation required [ALL]

All documentation for determination of medical necessity must be submitted for review. Prescriber to submit medical

records and specific labs, chart notes, and documentation as indicated in the criteria above. Letters of support and/or

explanation are often useful, but are not sufficient documentation unless ALL specific information required by this

MCP is included.

NOTE: Additional documentation, rationale, and/or supporting evidence may be requested for review as deemed

necessary or appropriate by Molina Medical/Pharmacy staff.

Page 6 of 20

CONTINUATION OF THERAPY

Xolair (Omalizumab) may be authorized for continuation of therapy if meet ALL of the following criteria are met: [ALL]

1.� Initial Coverage Criteria

ß Member currently meets ALL initial coverage criteria

ß Consultation notes must be submitted for initial request and for continuation of treatment requests at least

ONCE annually. The prescribing physician should periodically reassess the need for continuation of therapy

based on the member’s disease severity and level of asthma control. Continuation of therapy requires

submission of relevant medical records or chart notes documenting continued efficacy of Xolair.

2. Compliance

ß Adherence to therapy at least 85% of the time as verified by Prescriber and member’s medication fill history

(review Rx history for compliance), including:

û Adherent to the prescribed medication regimen

û Tolerance to therapy

û No severe adverse reactions or drug toxicity

NOTE: Therapy may be discontinued due to poor adherence upon recommendation of the Molina Medical

Director when adherence < 85% has been demonstrated in at least two months during the course of therapy

NOTE: History of non-compliance or non-adherence as verified by member’s medication fill history or

prescription drug profile may result in continuation of therapy request not being authorized. [MOLINA

MEDICAL/PHARMACY REVIEWER TO VERIFY

‹ Optimal clinical response to omalizumab requires strict compliance with dosing, as there is a 6 to 12

week lag before beneficial effects are apparent. (Effects are not immediate and explain the various phases

that are included in study protocols.)

3.� Labs/Reports/Documentation required [ALL]

Documentation of significant reduction in corticosteroid dosage or asthma exacerbations as demonstrated by:

¶ Maintenance therapy with an oral/inhaled corticosteroid (prior to initiation of Xolair) has resulted in the

reduction of oral/inhaled corticosteroid dose

‹ In the pivotal trial, Xolair-treated patients had a statistically significant reduction in the rate of

exacerbations (exacerbation was defined as worsening of asthma that required treatment with

systemic corticosteroids or a doubling of the baseline ICS dose), but other efficacy variables such as

nocturnal symptom scores, beta-agonist use, and measures of airflow (FEV1) were not significantly

different in Xolair-treated patients compared to placebo.

¶ Xolair (omalizumab) has resulted in clinical improvement as documented by ONE (1) or more of the

following from pre-Xolair baseline. Documentation required: [ONE]

û Improvement in lung function (increase in percent predicted FEV1 or PEF) from pre-treatment

baseline

û Decreased utilization of rescue medications

û Decreased frequency of exacerbations (defined as worsening of asthma that requires increase in

inhaled corticosteroid dose or treatment with systemic corticosteroids)

û Decreased frequency of unscheduled clinic, urgent care or emergency department visits

Page 7 of 20

û Reduction in reported symptoms: chest tightness, coughing, shortness of breath, nocturnal wakening

wheezing, sustained improvement in ACT scores

û Reduction use of ICS, leukotriene or beta agonist therapy

û 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:

o Asthma attacks

o Chest tightness or heaviness

o Coughing or clearing throat

o Difficulty taking deep breath or difficulty breathing out

o Shortness of breath

o Sleep disturbance, night wakening, or symptoms upon awakening

o Tiredness

o Wheezing/heavy breathing

NOTE: In Xolair clinical trials, subjects had a reduced number of asthma exacerbations, reduced duration of

asthma exacerbations, reduced corticosteroids usage, reduced number of rescue medications, improvements in

pulmonary function tests, reduced number of hospitalizations/emergency room visits.

4.� Discontinuation of Treatment [ANY]

Discontinue treatment if ANY of the following conditions applies: [ANY]

ß Intolerable adverse effects or absence of unacceptable toxicity from the drug

‹ Examples of unacceptable toxicity include the following: symptoms of anaphylaxis (bronchospasm,

hypotension, syncope, urticara, 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

corticosteroids

ß Persistent and uncorrectable problems with adherence to treatment

ß Poor response to treatment as evidenced by physical findings and/or clinical symptoms

ß Contraindications/Exclusions to therapy

û Non-FDA approved indications

û Severe hypersensitivity reaction to omalizumab or any component of the formulation

Exclusions [ANY]

û Treatment to relieve acute bronchospasm or status asthmaticusa

‹ Not indicated for acute bronchospasm or status asthmaticus.a Omalizumab has not been

shown to alleviate acute asthma exacerbations and should not be used for the treatment of

acute bronchospasm or status asthmaticus.

Page 8 of 20

ADMINISTRATION, QUANTITY LIMITATIONS, AND AUTHORIZATION PERIOD

1.� Recommended Dosage [ALL]

¶ Dose requested is consistent with corresponding weight and IgE level per manufacturer’s dosing chart

¶ For subcutaneous (SC) administration only. Divide doses of more than 150 mg among more than one

injection site to limit injections to not more than 150 mg per site.

¶ Asthma: Xolair 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). Omalizumab dosage

and dosing frequency are determined based on total serum IgE concentrations and body weight measured

before the start of treatment. Dosage should be adjusted accordingly if the patient's body weight change

substantially since apparent clearance of the drug is proportional to body weight.

¶ Adults and Adolescents (12 Years of Age and Older): Table 1 and Table 2 (per FDA-approved labeling)

¶ Pediatric patients 6 to <12 years of age: Table 3 (per FDA-approved labeling)

Table 1. ADMINISTRATION EVERY 4 WEEKS

Every 4 Weeks for Adults and Adolescents (12 Years of Age and Older) with Asthma

Pre-treatment

Serum IgE

(IU/mL)

Body Weight (kg)

30-60 >60-70 >70-90 >90-150

> 30-100 150 150 150 300

>100-200 300 300 300

>200-300 300

>300-400 See Table 2

>400-500 Below

>500-600

Table 2. ADMINISTRATION EVERY 2 WEEKS

Every 2 Weeks for Adults and Adolescents (12 Years of Age and Older) with Asthma

Pre-treatment

Serum IgE

(IU/mL)

Body Weight (kg)

30-60 >60-70 >70-90 >90-150

> 30-100 See Table 1

>100-200 Above 225

>200-300 225 225 300

>300-400 225 225 300

>400-500 300 300 375

>500-600 300 375

>600-700 375 Do Not Dose

Efficacy and dosing of omalizumab in asthma patients whose weight is outside the range provided in the

standard dosing table for omalizumab has not been established (weight-IgE level combinations yielding doses

greater than 750 mg every 4 weeks were excluded from clinical trials).

Page 9 of 20

Table 3. Pediatric Patients with Asthma Who Begin Xolair Between the Ages of 6 to < 12 years old�Omalizumab Doses (mg) Administered by Subcutaneous Injection Every 2 or 4 Weeks*�

Pre-

treatment

Serum IgE

(IU/mL)

Dosing

Freq.

(Weeks)

Body Weight (kg)

20-25 >25-30 >30-40 >40-50 >50-60 >60-70 >70-80 >80-90 >90-125 >125-150

30-100

4

75 75 75 150 150 150 150 150 300 300

>100-200 150 150 150 300 300 300 300 300 225 300

>200-300 150 150 225 300 300 225 225 225 300 375

>300-400 225 225 300 225 225 225 300 300

>400-500 225 300 225 225 300 300 375 375

>500-600 300 300 225 300 300 375

>600-700 300 225 225 300 375

>700-800 225 225 300 375

>800-900 225 225 300 375 Do Not Dose

>900-1000 225 300 375

>1000-1100 2 225 300 375

>1100-1200 300 300

>1200-1300 300 375

2.� Authorization Limit [ALL]

¶ Quantity limit: [ALL]

û The number of vials authorized will be determined based on the indication and dosing table provided

in the manufacturer product labeling. For asthma, patient-specific doses are determined based on pre-

treatment serum IgE levels, body weight in kg, and dosing frequency (every 2 weeks or every 4

weeks) [for chronic idiopathic urticaria, the quantity limit is 300mg every 4 weeks]

û Maximum of 6 vials per 30 days or maximum of 375mg every 2 weeks for up to 6 months

¶ Dispensing limit: Only a 1-month supply may be dispensed at a timea-e

¶ Duration of initial authorization: 6 months

¶ Continuation of treatment: Re-authorization for continuation of treatment is required every 6 months to

determine continued need based on documented positive clinical response. Subsequent renewals will be

authorized upon verification of marked clinical improvement demonstrated by a reduction in asthma related

exacerbations

¶ Duration of continuation of treatment: May be authorized up to 6 months at a time ‹ The optimal duration of therapy in patients who experience clinical benefit has not been determined. Patients

who respond are generally continued on the drug long-term. Long-term dosing should be adjusted for changes

in body weight. There are no data exploring whether patients may require more or less omalizumab to control

symptoms over time. Reductions in the omalizumab dose below the recommended formula (0.016 mg/kg per

international units/mL of IgE per month) are likely to result in a loss of efficacy.7

Page 10 of 20

3.� Route of Administration [ALL]

¶ Xolair (Omalizumab) is considered a provider-administered medication and requires supervision of therapy

by a physician specializing in Allergy or Pulmonary Medicine. Omalizumab is not considered a self-injectable

medication for safety reasons. Medical observation for hypersensitivity reactions is necessary following

omalizumab administration.

‹ Administer only in a healthcare setting prepared to manage anaphylaxis that can be life-threatening

and observe patients for an appropriate period of time after administration.a-dAnaphylaxis, presenting

as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has

been reported to occur after administration of Xolair.

¶ Molina Healthcare supports administering injectable medications in various settings, provided that those

services are furnished in the most appropriate and cost-effective setting that are supportive of the member’s

medical condition and unique needs. The decision on the most appropriate setting for administration is based

on the member’s current medical condition and any required monitoring or additional services that may

coincide with the delivery of the specific medication.

Page 11 of 20

COVERAGE EXCLUSIONS

This policy only addresses the indication of Xolair (Omalizumab) for the treatment of moderate to severe persistent

asthma when appropriate criteria are met.

All other uses of Xolair (Omalizumab) that are not an FDA-approved indication or not included in the ‘Coverage Criteria’

section of this policy are considered experimental/investigational or not a covered benefit of this policy. This subject to

change based on research and medical literature, or at the discretion of Molina Healthcare.

¶ Acute Bronchospasm or Status Asthmaticus

The US Food and Drug Administration (FDA) has required the manufacturer of omalizumab to state in its

labeling that Xolair cannot be used to treat acute bronchospasm or status asthmaticus.a-d

¶ Baseline IgE serum levels above 700 IU/mL

‹ Data for use in patients with baseline IgE serum levels up to 1500 IU/mL are available (considered off-

label in the US). Omalizumab (Xolair) is only indicated in patients with elevated IgE levels and is dosed

according to IgE levels between 30 to 700 IU/ml. There is no established dose or benefit for IgE levels

outside of this range.

‹ Efficacy and dosing of omalizumab in asthma patients with IgE levels less than 30 or greater than 700

have not been established.a-d

‹ The majority of data on the use of omalizumab (Xolair) in patients with baseline IgE <30 or >700 IU/ml

are limited to case reports with inconsistent results of effectiveness.

‹ Monitoring IgE levels after administration of omalizumab are problematic, as IgE levels post-

administration measure both bound and unbound (free) IgE.

¶ Smokers

There is limited information on the efficacy and safety of omalizumab in patients who smoke. The decision to use

omalizumab in patients who have had unsuccessful attempts at smoking cessation should be made on a case-by-

case basis.

¶ Off-label Indications

Per DrugPointsc (DrugPoints, 2014), the ratings for all non-FDA labeled (off-label) indications for the use of

omalizumab are unchanged as follows:

• Allergic rhinitis, Prophylaxis- Recommendation for Adult & Pediatric Class llb, Strength of Evidence

Category B;

• Allergy to peanuts- Recommendation for Adult Class llb, Strength of Evidence Category B;

• Latex allergy- Recommendation for Adult Class llb, Strength of Evidence Category B;

• Subcutaneous immunotherapy, Adjunct- Recommendation for Adult & Pediatric Class IIb, Strength of

Evidence Category B

Page 12 of 20

SUMMARY

Asthma is a chronic inflammatory disorder of the airways in which many cells and cellular elements (multiple cytokines

and mediators, as well as potentially IgE-mediated events involving mast cells and basophils) play a role (in particular,

mast cells, eosinophils, T lymphocytes, macrophages, neutrophils and epithelial cells). Asthma is a chronic inflammatory

disorder of the airways in which many cells and cellular elements play a role: in particular, mast cells, eosinophils,

neutrophils (especially in sudden onset, fatal exacerbations, occupational asthma, and patients who smoke), T

lymphocytes, macrophages, and epithelial cells. In susceptible individuals, this inflammation causes recurrent episodes of

coughing (particularly at night or early in the morning), wheezing, breathlessness, and chest tightness. These episodes are

usually associated with widespread but variable airflow obstruction that is often reversible either spontaneously or with

treatment (NAEPP, 2007).

Drugs for asthma may be categorized as relievers (e.g., bronchodilators taken as needed for acute symptoms) or

controllers (principally inhaled corticosteroids or other anti-inflammatory agents taken regularly to achieve long-term

control of asthma).A,C

Omalizumab is a recombinant DNA-derived humanized IgG1к monoclonal antibody that selectively binds to human

immunoglobulin E (IgE). IgE is the antibody responsible for activation of allergic reactions and is important to the

pathogenesis of allergic diseases and the development and persistence of inflammation. Omalizumab is administered by

subcutaneous injection.

Omalizumab is indicated for the management of moderate to severe persistent asthma in patients who have a positive skin

test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled

corticosteroids.a, C However, some experts recommend use of omalizumab mainly for management of patients with severe

allergic asthma.C,A Safety and efficacy of omalizumab in the management of other allergic conditions have not been

established.a

Mechanism of Action

Asthma: Omalizumab is an IgG monoclonal antibody (recombinant DNA derived) that inhibits IgE binding to the high-

affinity IgE receptor on mast cells and basophils. By decreasing bound IgE, the activation and release of mediators in the

allergic response (early and late phase) is limited. Serum free IgE levels and the number of high-affinity IgE receptors are

decreased. Long-term treatment in patients with allergic asthma showed a decrease in asthma exacerbations and

corticosteroid usage.a-d

Chronic idiopathic urticaria: Omalizumab binds to IgE and lowers free IgE levels. Subsequently, IgE receptors (FceRI)

on cells down-regulate. The mechanism by which these effects of omalizumab result in an improvement of chronic

idiopathic urticaria symptoms is unknown.a-d

Safety and efficacy in other allergic conditions have not been established. Doses and dosing frequency are determined by

serum total IgE level (which is measured before the start of therapy) and the patient’s body weight. The drug is given

subcutaneously (SC).

GUIDELINES

∑ 2014 International European Respiratory Society/American Thoracic Society guidelines recommend a therapeutic

trial of omalizumab in adults and children with severe allergic asthma for improvement in asthma control and quality

of life and reduction in exacerbations and unscheduled health care utilization.D

∑ Current guidelines universally support omalizumab as an adjunctive treatment option in patients 12 years of age and

older who have severe persistent allergic (IgE-mediated) asthma that is inadequately controlled with the combination

of inhaled high-dose corticosteroids (ICS) and long-acting beta-agonists (LABAs).B Omalizumab has demonstrated

efficacy in pediatric patients 6 to 12 years of age with moderate-to-persistent allergic asthma and in patients requiring

medium-to-high ICS dosages; however, limited information on safety in children has resulted in its approval only for

Page 13 of 20

patients 12 years and older.B,a Omalizumab is associated with anaphylactic reactions, which are described in a black

box warning, as well as malignancies, joint pain, rash, fever, lymphadenopathy, injection-site pain, and bruising.a

Also, in a small number of patients in whom the anti-IgE therapy has facilitated steroid withdrawal, unmasking of

Churg-Strauss syndrome has been observed.B Omalizumab is not approved for use in patients younger than 12 years.

It is not available generically.a

∑ National Institute for Health and Clinical Excellence (NICE)

‹ NICE guidelines support the use of leukotriene receptor antagonists (LTRAs), theophylline, and oral

corticosteroids as adjunctive therapy in combination with ICS and LABA prior to initiating therapy with

omalizumab.E

‹ NICE guidelines (2010) recommended the use of omalizumab as add-on therapy to optimized standard

therapy only in patients 12 years of age and older with severe persistent (IgE mediated) asthma who have

been identified as having severe unstable disease. Optimized standard therapy is defined as a full trial of, and

documented compliance with, inhaled high dose corticosteroids and long acting beta2 agonists in addition to

leukotriene receptor antagonists, theophyllines, oral corticosteroids and beta-2 agonist tablets and smoking

cessation where clinically appropriate. Furthermore, in the clinical studies submitted to the FDA for approval

of omalizumab (Xolair), patients currently smoking were excluded.G

PIVOTAL TRIALS

The current indication for omalizumab is based principally on data from 3 multicenter, randomized, double-blind,

placebo-controlled studies in over 1400 patients 12 years of age or older with symptomatic moderate to severe persistent

asthma for at least 1 year and a positive skin test reaction to a perennial aeroallergen.a

Adult and Adolescent Patients 12 Years of Age and Older�The safety and efficacy of Xolair were evaluated in three randomized, double-blind, placebo-controlled, multicenter trials.�

The trials enrolled patients 12 to 76 years old, with moderate to severe persistent (NHLBI criteria) asthma for at least one

year, and a positive skin test reaction to a perennial aeroallergen. In all trials, Xolair dosing was based on body weight and

baseline serum total IgE concentration. All patients were required to have a baseline IgE between 30 and 700 IU/mL and

body weight not more than 150 kg. Patients were treated according to a dosing table to administer at least 0.016 mg/kg/IU

(IgE/mL) of Xolair or a matching volume of placebo over each 4-week period. The maximum Xolair dose per 4 weeks

was 750 mg.

In all three trials an exacerbation was defined as a worsening of asthma that required treatment with systemic

corticosteroids or a doubling of the baseline ICS dose. Most exacerbations were managed in the out-patient setting and the

majority was treated with systemic steroids. Hospitalization rates were not significantly different between Xolair and

placebo-treated patients; however, the overall hospitalization rate was small. Among those patients who experienced an

exacerbation, the distribution of exacerbation severity was similar between treatment groups.

Asthma Trials 1 and 2

At screening, patients in Asthma Trials 1 and 2 had a forced expiratory volume in one second (FEV1) between 40% and

80% predicted. All patients had a FEV1 improvement of at least 12% following beta2-agonist administration. All patients

were symptomatic and were being treated with inhaled corticosteroids (ICS) and short acting beta2-agonists. Patients

receiving other concomitant controller medications were excluded, and initiation of additional controller medications

while on study was prohibited. Patients currently smoking were excluded.

Each trial was comprised of a run-in period to achieve a stable conversion to a common ICS (beclomethasone

dipropionate), followed by randomization to Xolair or placebo. Patients received Xolair for 16 weeks with an unchanged

corticosteroid dose unless an acute exacerbation necessitated an increase. Patients then entered an ICS reduction phase of

12 weeks during which ICS dose reduction was attempted in a step-wise manner. The distribution of the number of

asthma exacerbations per patient in each group during a study was analyzed separately for the stable steroid and steroid-

reduction periods.

Page 14 of 20

In both Asthma Trials 1 and 2 the number of exacerbations per patient was reduced in patients treated with Xolair

compared with placebo.

Asthma Trial 3

In Asthma Trial 3, there was no restriction on screening FEV1, and unlike Asthma Trials 1 and 2, long-acting beta2-

agonists were allowed. Patients were receiving at least 1000 µg/day fluticasone propionate and a subset was also receiving

oral corticosteroids. Patients receiving other concomitant controller medications were excluded, and initiation of

additional controller medications while on study was prohibited. Patients currently smoking were excluded.

The trial was comprised of a run-in period to achieve a stable conversion to a common ICS (fluticasone propionate),

followed by randomization to Xolair or placebo. Patients were stratified by use of ICS-only or ICS with concomitant use

of oral steroids. Patients received Xolair for 16 weeks with an unchanged corticosteroid dose unless an acute exacerbation

necessitated an increase. Patients then entered an ICS reduction phase of 16 weeks during which ICS or oral steroid dose

reduction was attempted in a step-wise manner.

The number of exacerbations in patients treated with Xolair was similar to that in placebo-treated patients.

Summary

In these studies, patients stabilized on corticosteroid therapy (inhaled beclomethasone dipropionate in studies 1 and 2;

inhaled fluticasone propionate with or without oral corticosteroids in study 3) were randomized to receive either

subcutaneous omalizumab or placebo for 16 weeks (stable corticosteroid phase).a Dosage was based on body weight and

baseline serum total IgE concentration; patients received at least 0.016 mg/kg of omalizumab per IU of serum IgE

concentration (IgE/mL) every 4 weeks (maximum dosage: 750 mg every 4 weeks).a Patients then entered a corticosteroid

reduction phase for an additional 12 (studies 1 and 2) or 16 weeks (study 3) during which therapy with omalizumab or

placebo was continued while corticosteroid therapy was gradually tapered.a In 2 of the 3 studies (studies 1 and 2),

treatment with omalizumab was associated with a lower incidence of asthma exacerbations (defined as a worsening of

asthma that required treatment with systemic corticosteroids or a doubling of the baseline inhaled corticosteroid dosage)

compared with placebo; the incidence of asthma exacerbations was similar between omalizumab and placebo in study 3.a

Results:

‹ No reduction in the incidence of asthma exacerbations was observed in patients with a baseline forced expiratory

volume in 1 second (FEV1) exceeding 80% or in patients who required oral corticosteroids as maintenance therapy in

any of the studies.a

FDA expands use of Xolair (omalizumab) to children 6 to 11 years of age with moderate to severe persistent

asthma, [July 2016]a

The FDA expanded the indication to treat moderate to severe persistent asthma in children 6 to 11 years of age is

supported by multi-center, randomized, double-blind, placebo-controlled Phase III studies that assessed the efficacy and

safety of Xolair in children from six to 11 years old with moderate to severe persistent uncontrolled allergic asthma. The

primary study was a 52-week trial, with the primary endpoint measured at 24 weeks.a Supportive safety and efficacy data

come from a 28-week study4. Additional safety data come from a five-year non-randomized observational post-marketing

study to evaluate the long-term safety of Xolair in patients 12 years and older.6

The 52-week study evaluated the safety and efficacy of Xolair as an add-on therapy in children from six to 11 years old

with moderate to severe allergic asthma who was inadequately controlled despite the use of inhaled corticosteroids with or

without the use of other controller asthma medications. During the first 24 weeks of treatment, steroid doses remained

constant from baseline. This was followed by a 28-week period during which inhaled corticosteroid adjustment was

allowed. The primary efficacy variable in this study was the rate of asthma exacerbations during the 24-week, fixed

steroid treatment phase. An asthma exacerbation was defined as a worsening of asthma symptoms as judged clinically by

the investigator, requiring doubling of the baseline inhaled corticosteroid dose for at least three days and/or treatment with

rescue systemic corticosteroids for at least three days.a

Page 15 of 20

At 24 weeks, the Xolair treatment group had a statistically significantly lower rate of asthma exacerbations compared to

the placebo treatment group (0.45 vs. 0.64, respectively), representing a 31 percent relative rate reduction (rate ratio 0.69,

95 percent CI (0.53, 0.90) p=0.007)4. During the entire 52-week treatment period, the difference in asthma exacerbation

rates between the Xolair and placebo treatment groups (0.78 vs. 1.36, respectively) represented a 43 percent relative rate

reduction (rate ratio 0.57, 95 percent CI (0.45, 0.72) p<0.001).a

In clinical studies with pediatric patients six to 11 years old, the most common side effects (≥3 percent in Xolair-treated

patients and more frequent than placebo) were common cold symptoms (nasopharyngitis), headache, fever (pyrexia),

upper abdominal pain, sore throat (pharyngitis streptococcal), ear discomfort (otitis media), intestinal infection causing

abdominal pain, nausea and vomiting (viral gastroenteritis), insect bites (arthropod bites) and nose bleeding (epistaxis).a

Hayes

A Medical Technology Directory report for Xolair for Allergic Asthma was not available or located at the time of this

writing in July 2016 (to include the FDA expanded indication expanded the indication to treat moderate to severe

persistent asthma in children 6 to 11 years).

There was an Outlook report for “Xolair™ (omalizumab) for moderate-to-severe allergic asthma (humanized anti-

immunoglobulin E [anti-IgE] monoclonal antibody)” however this report was noted as “ARCHIVED: Graduated; Report

Archived On: Jan 31, 2009”

The Global Initiative for Asthma (GINA, 2012) guidelines state that omalizumab has proven efficacy in children ages 6

to 12 years with moderate to severe and severe persistent allergic (IgE mediated) asthma. The GINA guidelines note that

trials involving these children have shown similar efficacy to adolescents and adults. European Medicines Agency

(EMEA) labeling for Xolair indicates omalizumab for children ages 6 years older, as well as for adolescents and adults,

with IgE mediated asthma.

DEFINITIONS

∑ Controller medications

° Controller medications suppress the inflammatory causes of asthma to provide clinical control over the long

term, whereas reliever medications relieve bronchoconstriction quickly.

° Controller medications for the treatment of childhood asthma include ICSs and systemic glucocorticoids,

leukotriene modifiers, LABAs, theophylline, and cromolyn.

∑ Inhaled corticosteroid(s) (ICS or ICSs): A class of medications also referred to as inhaled steroids; used for the

treatment of asthma and COPD. A potent anti-inflammatory medication that improves asthma control more

effectively than any other agent used as a single treatment; helps to prevent chronic asthma symptoms such as

wheezing, chest tightness, shortness of breath, and chronic cough.

∑ Long-acting beta-agonist(s) (LABA or LABAs): Also referred to as long-acting beta2-adrenergic agonists. A type of

bronchodilator whose effects last for 12 hours or more when used as adjunctive treatment for the prevention of asthma

symptoms such as wheezing, chest tightness, shortness of breath, and cough; improves asthma symptoms by

increasing airflow through the lungs.

∑ Eosinophilic granulomatosis with polyangiitis (EGPA): Previously called Churg-Strauss syndrome (CSS) or allergic

granulomatosis and angiitis, is a multisystem disorder characterized by allergic rhinitis, asthma, and prominent

peripheral blood eosinophilia. CSS is classified as a vasculitis of the small and medium sized arteries, although the

vasculitis is often not apparent in the initial phases of the disease.

Page 16 of 20

∑ Hypereosinophilia (HE): An absolute eosinophil count (AEC) in the peripheral blood of greater than 1.5 x 109/L (or

greater than 1500 cells/microL) on 2 examinations separated in time by at least 1 month and/or pathologic

confirmation of tissue HE.

∑ Hypereosinophilic syndrome (HES): The association of HE with eosinophil-mediated organ damage, with or without

dysfunction, provided other potential causes for the damage have been excluded.

∑ FEV1 (forced expiratory volume in 1 second): A measure of airway obstruction determined using spirometry.

Individual FEV1 values are compared to predicted values based on age, height, sex and race.

∑ PEF (peak expiratory flow): PEF is often described as a percent of personal best measurement. Personal best PEF is

the highest PEF value attained after 2 to 3 weeks of testing when asthma is in good control.

APPENDIX

Appendix 1: Moderate Persistent Asthma and Severe Persistent Asthma

National Asthma Education and Prevention Program (NAEPP)A defines severe persistent as Continual daytime

symptoms, frequent nighttime symptoms, PEF or FEV1 < 60%, PEF variability > 30% OR Moderate Persistent: Daily

symptoms, nighttime symptoms >1 time/wk, PEF or FEV1 of 60 to 80%, PEF variability >30%

National Heart, Lung and Blood Institute (NHLBI)C,F

Measures of Asthma Assessment and Monitoring of the U.S. Department of Health and Human Services National

Institutes of Health National Heart, Lung, and Blood Institute (NHLBI) 2007 Guidelines for the Diagnosis and

Management of Asthma provides information on classifying asthma severity.F These guidelines recommend that

omalizumab may be considered as adjunctive therapy for patients ages 12 and older who have allergies and severe

persistent asthma that is inadequately controlled with the combination of high-dose inhaled corticosteroid and long-acting

beta-agonist. The Expert Panel also states that the beneficial effects of long-acting beta-agonist (LABAs) in combination

therapy for the great majority of patients who require more therapy than low-dose inhaled corticosteroid alone to control

asthma (i.e., require step 3 care or higher) should be weighed against the increased risk of severe exacerbations, although

uncommon, associated with the daily use of LABAs. Figure 1 shows how to establish asthma severity classification for

children >/= 12 years of age and adults, and recommends a step for initiating therapy. Figure 3 details how to assess

asthma control in children>/= 12 years and adults.

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:

• Daily use of inhaled short-acting beta2-agonist

• Diurnal PEF variation greater than 30%

• Exacerbations may affect activity and sleep

• PEF 60 to 80% of personal best

• Symptoms daily

For patients with severe persistent asthma, they have some of the following characteristics:

• Diurnal PEF variation greater than 30%

• Frequent exacerbations

• PEF less than or equal to 60 % of personal best

• Symptoms daily

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 corticosteroid at higher doses plus a long-acting inhaled beta2-agonist twice-daily. Furthermore,

according to the NHLBI guidelines, control of asthma is defined as:

° (Near) normal PEF

° Minimal (ideally no) chronic symptoms, including nocturnal symptoms

Page 17 of 20

° Minimal (ideally no) use of p.r.n. (as needed) beta2-agonist

° Minimal (infrequent) exacerbations

° Minimal (or no) adverse effects from medicine

° No limitations on activities, including exercise

° No visit to the emergency room

° PEF diurnal variation of less than 20%

Reference:

NIH, National Heart Lung, and Blood Institute. Expert Panel Report 3: Guidelines for the Diagnosis and Management of

Asthma (EPR3 2007) http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf

NIH, National Heart Lung, and Blood Institute. Expert Panel Report 3: Guidelines for the Diagnosis and Management of

Asthma (EPR3 2007) http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf

Allergic Asthma

The GINA guidelines (updated 2015) for adults and adolescents > 12 years of age note that omalizumab is a treatment

option limited to patients with elevated serum levels of IgE.B Improved asthma control is reflected by fewer symptoms,

less need for reliever medications, and fewer exacerbations, although this has not been confirmed in all studies.5 Evidence

of efficacy in children 6-12 years of age with moderate-to-severe and severe persistent allergic asthma has been shown.

For asthma patients aged 5-12 omalizumab treatment recommendations are similar to patients aged > 12 years of age.B

The Global Initiative for Asthma (GINA, 2016) recommends that adults, adolescents, and children 6 years and older may

be treated with omalizumab as follows (Evidence A: Randomized controlled trials and meta-analyses)B

• Suggested for patients with moderate or severe allergic asthma that is uncontrolled on Step 4 treatment

• Severe allergic asthma with elevated IgE levels may benefit from anti-IgE therapy (Evidence A)

National Institute for Health and Care Excellence (NICE) [2013]

Omalizumab for treating severe persistent allergic asthma: review of technology appraisal guidance 133 and 201

(Technology appraisal guidance; no. 278)

NICE published a technology appraisal guidance addressing use of omalizumab in children aged 6 to 11 years with

severe, persistent asthma (April 2013).I In the assessment, NICE noted the ‘life-changing’ effect of omalizumab reported

by patients and concluded that omalizumab as an add-on to optimized standard therapy is more clinically effective in

treating severe persistent allergic asthma than optimized standard therapy alone, leading to a reduction in total emergency

visits (including hospital admissions, A&E visits and unscheduled general physician visits) in adults, reduced hospital

admissions in children, improved lung function in adults and a reduction in the frequency and use of rescue medication

and oral corticosteroids. The committee recommended that omalizumab be used as follows:

• Omalizumab is recommended as an option for treating severe persistent confirmed allergic IgE-mediated asthma

as an add-on to optimized standard therapy [defined - as a full trial of (and, if tolerated, documented compliance

with) inhaled high-dose corticosteroids, long-acting ß2-agonists, leukotriene receptor antagonists, theophylline,

oral corticosteroids and smoking cessation if clinically appropriate].

• In people aged 6 years and older who need continuous or frequent treatment with oral corticosteroids (defined as 4

or more courses in the previous year):

‹ Optimized standard therapy is defined as a full trial of and, if tolerated, documented compliance with

inhaled high-dose corticosteroids, long-acting beta2 agonists, leukotriene receptor antagonists,

theophyllines, oral corticosteroids, and smoking cessation if clinically appropriate.

Page 18 of 20

Appendix 2

NHBLI Estimated Comparative Daily Dosages for Inhaled Corticosteroids (ICS) in Adults

*For an estimated Comparative Daily Dosages for Inhaled Corticosteroids of Low, Medium, and Daily Dose reference

the National Asthma Educational Prevention Program Expert Panel Report 3: Guidelines for the Diagnosis and

Management of Asthma. Full Report 2007. Available at: http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.htm

CODING INFORMATION: THE CODES LISTED IN THIS POLICY ARE FOR REFERENCE PURPOSES ONLY. LISTING OF A SERVICE OR

DEVICE CODE IN THIS POLICY DOES NOT IMPLY THAT THE SERVICE DESCRIBED BY THIS CODE IS A COVERED OR NON-COVERED.

COVERAGE IS DETERMINED BY THE BENEFIT DOCUMENT. THIS LIST OF CODES MAY NOT BE ALL INCLUSIVE.

HCPCS Description J2357 Injection, omalizumab, 5 mg

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