Medical Policies - Prescription Drugs


Xolair (Omalizumab)

Number:RX501.058

Effective Date:10-15-2017

Coverage:

Medical policies are a set of written guidelines that support current standards of practice. They are based on current peer-reviewed scientific literature. A requested therapy must be proven effective for the relevant diagnosis or procedure. For drug therapy, the proposed dose, frequency and duration of therapy must be consistent with recommendations in at least one authoritative source. This medical policy is supported by FDA-approved labeling and nationally recognized authoritative references. These references include, but are not limited to: MCG care guidelines, Hayes, DrugDex (IIb level of evidence or higher), NCCN Guidelines (IIb level of evidence or higher), NCCN Compendia (IIb level of evidence or higher), professional society guidelines, and CMS coverage policy.

Xolair® (Omalizumab) may be considered medically necessary for the treatment of allergic asthma when ALL the following criteria are met:

It is prescribed by an asthma specialist (pulmonologist, allergist/immunologist); AND

The patient is at least 6 years of age or older; AND

The patient has moderate to severe persistent allergic asthma with forced expiratory volume in one second (FEV1) <80% predicted; AND

There is documentation that the patient is compliant with Step Four of the National Heart, Lung and Blood Institute (NHLBI) guidelines for asthma treatment, which includes:

1. Documented current use of an inhaled corticosteroid for at least three consecutive months; and

2. Documented current use of a long-acting beta agonist or leukotriene inhibitor for at least three consecutive months; AND

There is documentation that compliance with Step Four treatment for at least three months either:

1. Has not been effective, as evidenced by continued exacerbations, acute attacks, frequent ER visits, hospitalizations or chronic oral corticosteroid use; or

2. Is not tolerated; AND

The patient's baseline serum total IgE >30IU/ml and <700IU/ml (Exception: patients from 6 years of age to <12 can have baseline total IgE up to 1300 IU/mL); AND

Body weight is 150 kg or less; AND

There is written documentation of at least one perennial aeroallergen by a positive skin prick test or an in-vitro specific IgE test, which correlated with the patient’s clinical history.

Authorization Limits for Allergic Asthma:

Initial certification therapy that does not exceed administration of > 375 mg of Xolair (Omalizumab) every two weeks, may be authorized for up to 6 months.

Recertification will be authorized for 12 months and annually thereafter if the patient demonstrates documented reduction or discontinuation of oral or inhaled steroids.

Xolair may be considered medically necessary for the treatment of adults and adolescents (12 years of age and above) with chronic idiopathic urticaria (urticaria lasting > 6 weeks) who remain symptomatic despite treatment with:

Two or more H1 antihistamines, or

One H1 antihistamine and one or more of the following:

o -H2 antihistamines, OR

o leukotriene modifiers

Xolair (Omalizumab) is considered not medically necessary for the off -label use of allergic rhinitis as clinical outcomes have not demonstrated Xolair as superior to established, less costly treatment options.

Xolair (Omalizumab) is considered experimental, investigational and/or unproven for other allergies, acute bronchospasm, status asthmaticus, eosinophilic gastroenteritis, eosinophilic esophagitis, and other forms of urticaria not addressed above.

Description:

Xolair is a recombinant DNA-derived humanized IgG1κ monoclonal antibody that selectively binds to human immunoglobulin E (IgE).

Allergic Asthma

Asthma is a common condition in which the airways in the lungs become narrowed, making it difficult to breathe. Asthma caused by allergies results from the immune system's over-reaction to inhaled allergen, and this immune system reaction prompts inflammation that causes the airway narrowing and other symptoms (i.e., wheezing, chest tightness, and cough). Xolair, which blocks this immune response, received U.S. Food and Drug Administration (FDA) approval in June 2003 and is the first anti-IgE agent for the treatment of patients at high risk from their allergy related asthma.

The severity of asthma varies from mild intermittent to severe persistent. Most asthma is effectively treated based on the National Heart, Lung and Blood Institute (NHLBI) clinical guidelines. Xolair can be beneficial as adjunctive therapy in patients whose symptoms are inadequately controlled despite the regular use of maximum dose inhaled corticosteroids.

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

Xolair is administered subcutaneously once or twice a month, and in some cases more than one injection at a time.

Recommended FDA labeled dosing:

In the treatment of allergic asthma, Xolair is administered 150 to 375 mg subcutaneous 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).

Chronic Idiopathic Urticaria (CIU)

In the treatment of CIU, Xolair binds to IgE and lowers free IgE levels. Subsequently, IgE receptors (FcεRI) on cells down-regulate. The mechanism by which these effects of omalizumab result in an improvement of CIU symptoms is unknown.

Recommended Food and Drug Administration (FDA) labeled dosing:

Xolair for CIU is usually administered 150 or 300 mg by subcutaneous injection every 4 weeks.

Dosing of Xolair in CIU patients is not dependent on serum IgE (free or total) level or body weight.

The appropriate duration of therapy for CIU has not been evaluated and should be periodically reassessed for the need for continued therapy.

Rationale:

Allergic Asthma

The current indication for Xolair for allergic asthma is based principally on data from three multicenter, randomized, double-blind, placebo-controlled studies in over 1400 patients 12 years of age and older with moderate to severe persistent asthma for at least one year and a positive skin test reaction to a perennial aeroallergen.

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 Xolair or placebo for 16 weeks (stable corticosteroid phase); patients then entered a corticosteroid reduction phase for an additional 12 (studies 1 and 2) or 16 weeks (study 3) during which therapy with Xolair or placebo was continued while corticosteroid therapy was gradually tapered. In 2 of the 3 studies (studies 1 and 2), treatment with Xolair 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. No reduction in the incidence of asthma exacerbations was observed in patients with a baseline forced expiratory volume in one second (FEV) greater than 80% or in patients who required oral corticosteroids as maintenance therapy.

These clinical trials have evaluated the ability of Xolair to reduce the number of significant asthma exacerbations and reduce the need for inhaled corticosteroids. This reduces the need for rescue therapy, decreases hospitalizations and emergency visits and improves patient's quality of life.

The safety and efficacy of Xolair in the management of other allergic conditions has not been established.

A search and review of scientific literature conducted through July 2007 did not identify any published peer-reviewed literature that would alter the indications and/or limitations noted in the above discussion.

2009 Update

A search of peer reviewed literature through December 2009 identified no significant clinical trial publications or any additional information that would change the coverage position of this medical policy.

2012 Update

This medical policy has been updated with a literature review through May 2012.

FDA labeled indications remains unchanged from previous updates. The prescribing information on the manufacturer’s web site notes: “Patients whose pretreatment serum IgE level or body weight is outside the limits of the dosing table (<30 or >700 IU/mL and <30 or >150 kg, respectively) should not be dosed” (Xolair® Prescribing Information).

Therapies, such as use of Xolair, for treatment of eosinophilic disorders (eosinophilic gastroenteritis and eosinophilic esophagitis) are directed at reducing the production of eosinophils, and the stimuli that attract them. Clinical trials using Xolair are currently ongoing for these conditions. Studies for use of Xolair for urticaria are ongoing (Thomson – DRUGDEX Evaluations).

2014 Update

Allergic Asthma

A search of peer reviewed literature through March 2014 identified no additional published studies that would prompt reconsideration of the coverage statement for allergic asthma which remains unchanged.

Chronic Idiopathic Urticaria (CIU)

In March 2014 the US Food and Drug Administration (FDA) approved Xolair (omalizumab) for the treatment of chronic idiopathic urticaria (CIU). Xolair is indicated for CIU in adults and adolescents (12 years of age and above) who remain symptomatic despite H1-antihistamine treatment. The safety of Xolair for the treatment of CIU was assessed in three placebo-controlled, multiple-dose clinical studies of 12 weeks’ (CIU Study 2) and 24 weeks’ duration (CIU Studies 1 and 3). In CIU Studies 1 and 2, patients received Xolair 75, 150, or 300 mg or placebo every 4 weeks in addition to their baseline level of H1-antihistamine therapy throughout the treatment period. In CIU Study 3 patients were randomized to Xolair 300 mg or placebo every 4 weeks in addition to their baseline level of H1-antihistamine therapy. The data described below reflect Xolair exposure for 733 patients enrolled and receiving at least one dose of Xolair in the three clinical trials, including 684 patients exposed for 12 weeks and 427 exposed for 24 weeks. The mean age of patients receiving Xolair 300 mg was 43 years, 75% were women, and 89% were white. The demographic profiles for patients receiving Xolair 150 mg and 75 mg were similar.

The safety and effectiveness of Xolair for adolescent patients with CIU were evaluated in 39 patients 12 to 17 years of age (Xolair 29, placebo 10) included in three randomized, placebo-controlled CIU studies. A numerical decrease in weekly itch score was observed and adverse reactions were similar to those reported in patients 18 years and older.

Clinical studies with Xolair have not been conducted in CIU patients below the age of 12 years. Considering the risk of anaphylaxis and malignancy seen in Xolair-treated patients ≥ 12 years old, the risk-benefit assessment does not support the use of Xolair in patients <12 years of age. Therefore, the use of Xolair in this patient population is not recommended.

Update 2016

A search of the peer reviewed literature through March 2016, including review of most current FDA label, identified no new clinical trial publications or any additional information that would change the coverage position of this medical policy.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

None

HCPCS Codes

J2357

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does have a national Medicare coverage position.

A national coverage position for Medicare may have been changed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov.

References:

1. Guidelines for the Diagnosis and Management of Asthma National Institutes of Health, Expert Panel Report 2, National Heart, Lung, and Blood Institute, NIH Publication 97-4051(1997 July).

2. Guidelines for the Diagnosis and Management of Asthma, Update on Selected Topics (2002), NIH Publication No. 02-5075.

3. Buhl R, Omalizumab (Xolair) improves quality of life in adult patients with allergic asthma: a review. Respir Med (2003 Feb) 97(2):123-9.

4. U.S. Food and Drug Administration, FDA Talk Paper, June 20, 2003, FDA Approves First Biologic for Allergy-Related Asthma.

5. Lanier BQ, Corren J, et al. Omalizumab is effective in the long-term control of severe allergic asthma, Ann Allergy Asthma Immunol (2003 Aug) 91 (2):154-9.

6. Food and Drug Administration (FDA) – Xolair® Omalizumab Label -– BLA 103976/5102(1994). Available at < http://www.fda.gov> (accessed – 2006 August 8).

7. McEvoy GK, ed. AHFS 2009 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists, Inc; 2009.

8. Micromedex ® Healthcare Series, DRUGDEX Evaluations – Omalixumab (December 2009). < http://www.thomsonhc.com>.

9. Molimard, M., Buhl, R., et al. Omalizumab reduces oral corticosteroid use in patients with severe allergic asthma: Real-life data. Respiratory Medicine Volume 104, Issue 9, Pages 1381-5, September 2010.

10. Xolair® (omalizumab) Prescribing Information– Genentech, Inc. July 2010 Available at <http://www.genentech-access.com> (accessed March 2016).

11. Costello, R.W., Long, D. A., et al. Therapy with omalizumab for patients with severe allergic asthma improves asthma control and reduces overall healthcare costs. Ir J Med Sci. 2011 Sep; 180(3):637-41.

12. Domingo, C., Moreno, A, et al. Omalizumab in the management of oral corticosteroid-dependent IGE-mediated asthma patients. Curr Med Res Opin. 2011 Jan; 27(1):45-53.

13. Thomson – DRUGDEX Evaluations (MICROMEDEX 2.0 [Health Care Series]) Drug Information for the Health Care Professional (25th Edition). Xolair. Available at <http://www.thomsonhc.com> (accessed March 2014).

14. Food and Drug Administration (FDA) – Xolair® Omalizumab Label -– Available at < http://www.fda.gov> (last accessed – 2016 March 23).

Policy History:

Date Reason
10/15/2017 Reviewed. No changes.
8/1/2016 Document updated with revised age requirement for Xolair for allergic asthma per the Food and Drug Administration (FDA) label. Specific coverage criterion changed from 12 years of age and older, to 6 years of age and older.
4/15/2016 Document updated with literature review. Coverage unchanged.
10/1/2015 Reviewed. No changes.
10/15/2014 Document updated with literature review. Idiopathic urticaria was removed as an experimental, investigational and/or unproven indication and replaced with the following medically necessary coverage statement: "Xolair may be considered medically necessary for the treatment of adults and adolescents (12 years of age and above) with chronic idiopathic urticaria (urticaria lasting > 6 weeks) who remain symptomatic despite treatment with: 1) two or more H1 antihistamines, or 2) one H1 antihistamine and one or more of the following: H2 antihistamines, OR leukotriene modifiers. The NMN statement was clarified for allergic rhinitis to include the following: “clinical outcomes have not demonstrated Xolair as superior to established, less costly treatment options’. Experimental, investigational and/or unproven statement clarified to add the following indications: other allergies, acute bronchospasm, status asthmaticus and other forms of urticaria not addressed in the MN statement.
11/1/2012 Document updated with literature review. The following was added to criteria for coverage: “Body weight is 150 kg or less”. The following was added to authorization limits: “Recertification will be authorized for 12 months and annually thereafter if the patient demonstrates documented reduction or discontinuation of oral or inhaled steroids”. The following was added to the listing of experimental, investigational and unproven indications: “urticaria, eosinophilic gastroenteritis, and eosinophilic esophagitis.”
2/15/2010 Medical document updated with literature review. Coverage unchanged. Medically necessary when meeting coverage criteria based on FDA approved indications and considered experimental, investigational and unproven for all other indications.
3/1/2009 Coverage Revised
2/1/2009 Coverage Revised
9/15/2007 Revised/Updated Entire Document
10/1/2004 New Medical Document

Archived Document(s):

Title:Effective Date:End Date:
Omalizumab02-15-202106-14-2021
Omalizumab10-01-202002-14-2021
Xolair (Omalizumab)06-01-201909-30-2020
Xolair (Omalizumab)10-15-201705-31-2019
Xolair (Omalizumab)08-01-201610-14-2017
Xolair (Omalizumab)04-15-201607-31-2016
Xolair (Omalizumab)10-01-201504-14-2016
Xolair (Omalizumab)10-15-201409-30-2015
Xolair (Omalizumab)11-01-201210-14-2014
Xolair (Omalizumab)02-15-201010-31-2012
Xolair (Omalizumab)03-01-200902-14-2010
Xolair (Omalizumab)02-01-200902-28-2009
Xolair (Omalizumab)09-15-200701-31-2009
Xolair (Omalizumab)10-01-200409-14-2007
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