Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Omalizumab (Xolair®)
Policy #:MA08.025c

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.

MEDICALLY NECESSARY

ALLERGIC ASTHMA
Omalizumab (Xolair®) is considered medically necessary and, therefore, covered as an adjunctive treatment of moderate-to-severe persistent asthma in individuals who are at least 6 years of age when all of the following criteria and the Dosing and Frequency Requirements listed in Attachment A are met:
  • The individual has a positive skin test or in vitro reactivity to a perennial aeroallergen.
  • The individual has a baseline serum IgE level of between 30 IU/mL and 1500 IU/mL.
  • High-dose inhaled corticosteroids (ICS) taken in combination with a long-acting beta-agonist (LABA) have been tried but failed to adequately control the individual's asthma symptoms.

CHRONIC URTICARIA
Omalizumab (Xolair®) is considered medically necessary and, therefore, covered for the treatment of chronic urticaria in individuals who are at least 12 years of age when all of the following criteria and the Dosing and Frequency Requirements listed in Attachment A are met:
  • Documented failure, contraindication, or intolerance to a four-week trial of one second-generation non-sedating H1 antihistamine at the maximum recommended doses (e.g., cetirizine [Zyrtec®], fexofenadine [Allegra®], loratadine [Claritin®, Alavert®], desloratadine [Clarinex®], levocetirizine [Xyzal®])
  • Documented failure, contraindication, or intolerance to at least a two-week trial of any of the following medications:
    • leukotriene receptor antagonist (e.g., zafirlukast [Accolate®], montelukast [Singulair®], zileuton [Zyflo®]) in addition to the non-sedating H1 antihistamine
    • histamine H2-receptor antagonist (e.g., cimetidine [Tagamet], famotidine [Pepcid®], nizatidine [Axid®], ranitidine [Zantac®]) in addition to the non-sedating H1 antihistamine
    • first-generation (sedating) H1 antihistamine (e.g., chlorpheniramine [Chlor-Trimeton®], cyproheptadine [Periactin®], diphenhydramine [Benadryl®]) in addition to the non-sedating H1 antihistamine
    • systemic glucocorticosteroids administered as a short-term therapy (may treat for less than a two-week trial) in addition to the non-sedating H1 antihistamine
    • substitution to a different second-generation non-sedating H1 antihistamine
    • cyclosporine, in addition to the non-sedating H1 antihistamine

EXPERIMENTAL/INVESTIGATIONAL

All other uses for omalizumab (Xolair®) including, but not limited to, treatment of other allergic conditions, acute bronchospasm, or status asthmaticus are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the medical policy on off-label coverage for prescription drugs and biologics.

DOSING AND FREQUENCY REQUIREMENTS

Refer to Attachment A for the Dosing and Frequency Requirements for omalizumab (Xolair®).

The Company reserves the right to modify the Dosing and Frequency Requirements listed in this policy to ensure consistency with the most recently published recommendations for the use of omalizumab (Xolair®). Changes to these guidelines are based on a consensus of information obtained from resources such as, but not limited to: the US Food and Drug Administration (FDA); Company-recognized authoritative pharmacology compendia; or published peer-reviewed clinical research. The professional provider must supply supporting documentation (i.e., published peer-reviewed literature) in order to request coverage for an amount of omalizumab (Xolair®) outside of the Dosing and Frequency Requirements listed in this policy. For a list of Company-recognized pharmacology compendia, view our policy on off-label coverage for prescription drugs and biologics.

Accurate member information is necessary for the Company to approve the requested dose and frequency of this drug. If the member’s dose, frequency, or regimen changes (based on factors such as changes in member weight or incomplete therapeutic response), the provider must submit those changes to the Company for a new approval based on those changes as part of the precertification process. The Company reserves the right to conduct post-payment review and audit procedures for any claims submitted for omalizumab (Xolair®).

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug.

When coverage of omalizumab (Xolair®) is requested outside of the Dosing and Frequency Requirements listed in this policy, the prescribing professional provider must supply documentation (i.e., published peer-reviewed literature) to the Company that supports this request.
Policy Guidelines

There is no Medicare coverage criteria addressing this service; therefore, the Company policy is applicable.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, omalizumab (Xolair®) is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria and Dosing and Frequency Requirements listed in this medical policy are met.

Omalizumab (Xolair®) is available through either the member's medical benefit (Part B benefit) or pharmacy benefit (Part D benefit), depending on how the drug is prescribed, dispensed, or administered. This medical policy only addresses instances when omalizumab (Xolair®) is covered under a member's medical benefit. It does not address instances when omalizumab (Xolair®) is covered under a member’s pharmacy benefit.

BLACK BOX WARNINGS

Refer to the specific manufacturer's prescribing information for any applicable Black Box Warnings.

DEFINITIONS

Moderate persistent asthma is defined by the National Heart, Lung, and Blood Institute (NHLBI) for treatment purposes as any of the below:
  • Daily symptoms
  • Nocturnal symptoms that occur more than 1 time a week but not nightly
  • Daily use of inhaled, short-acting, beta2-agonist for symptom control
  • Some limitation with normal activity
  • FEV1 or PEF is greater than 60 percent and less than 80 percent predicted
  • FEV1/FVC (forced vital capacity) is reduced 5 percent

Severe persistent asthma is defined by the NHLBI for treatment purposes as any of the below:
  • Symptoms throughout the day
  • Nocturnal symptoms are frequent (often 7 times per week)
  • Extreme limitation with normal activity
  • FEV1 or PEF less than 60 percent predicted
  • Daily use of an inhaled, short-acting, beta2-agonist for symptom control (can be several times/day)
  • FEV1/FVC (forced vital capacity) is reduced more than 5 percent

The NHLBI also recommends that individuals who have had two or more asthma exacerbations requiring oral systemic corticosteroid in the past year be considered the same for treatment purposes as individuals who have persistent asthma.

OTHER INFORMATION REGARDING TREATMENT

Omalizumab (Xolair®) treatment should be initiated by a professional provider within one of the following specialties: Allergy, Dermatology, or Pulmonology. Maintenance treatment should be administered by a professional provider within the areas of Primary Care (e.g., Family Medicine, Internal Medicine, Pediatrics) or any of the aforementioned specialties.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Omalizumab (Xolair®) was approved by the FDA on June 24, 2003. Supplemental approvals for Xolair® (Omalizumab) have since been issued by the FDA.

PEDIATRIC USE
According to the Drug Manufacturer's Prescribing Information:

The safety and effectiveness of omalizumab (Xolair®) in pediatric individuals age 6 to less than 12 years of age with allergic asthma have been established. The safety and effectiveness of omalizumab (Xolair®) in pediatric individuals younger than six years of age with allergic asthma have not been established.

The safety and effectiveness of omalizumab (Xolair®) in adolescent individuals ages 12 to 17 years old with chronic idiopathic urticaria have been established. The safety and effectiveness of omalizumab (Xolair®) in pediatric individuals younger than 12 years of age with chronic idiopathic urticaria have not been established.

Description

Omalizumab (Xolair®) is a monoclonal antibody that binds to naturally occurring human immunoglobulin E (IgE). It inhibits the binding of IgE to the high-affinity IgE receptor on the surface of mast cells and basophils. A reduction in the number of surface-bound IgE on the high-affinity IgE receptor-bearing cells limits the release of mediators of the allergic response. Treatment with omalizumab (Xolair®) also reduces the number of high-affinity IgE receptors on basophils in individuals with atopic asthma.

ALLERGIC ASTHMA

Omalizumab (Xolair®) was approved by the US Food and Drug Administration (FDA) on June 24, 2003, for treatment of moderate-to-severe persistent allergic asthma in individuals who are at least 12 years of age. The safety and efficacy of omalizumab (Xolair®) were evaluated in three randomized, double-blind, placebo-controlled multicenter trials. The trials consisted of individuals between the ages of 12 and 76 who had experienced moderate-to-severe persistent asthma, as defined by the National Heart, Lung, and Blood Institute (NHLBI) criteria, for at least 1 year, had a baseline IgE between 30 and 700 IU/mL, and who exhibited a positive skin test reaction to a perennial aeroallergen.

Results from the first two studies demonstrated that the number of exacerbations per individual was reduced in those who were treated with omalizumab (Xolair®) compared with a placebo. In the third study, results illustrated that the number of exacerbations experienced by individuals treated with omalizumab (Xolair®) was similar to the number of exacerbations experienced by individuals treated with the placebo. The absence of an observed treatment effect in the third study may be related to differences in patient population, study sample size, and/or other factors that existed, in comparison to the first two studies.

In all three studies, the majority of exacerbations were managed in the outpatient setting and were treated with systemic steroids. Hospitalization rates were not significantly different between the individuals who were treated with omalizumab (Xolair®) and the patients who were treated with the placebo; however, the overall hospitalization rate was low. Among those individuals who experienced an exacerbation, the distribution of exacerbation severity was similar between treatment groups.

The initial clinical trials that supported the approval of omalizumab (Xolair®) found a higher incidence in malignancies. To assess the long-term safety in those with moderate to severe persistent asthma and a positive skin test or in vitro reactivity to a perennial aeroallergen, a five-year follow-up observational cohort study of 5,007 individuals treated with omalizumab (Xolair®) and a control group of 2,829 individuals treated without omalizumab (Xolair®) was performed. The study reported similar rates of primary malignancies among both groups of individuals. The study also found that individuals treated with omalizumab (Xolair®) had a disproportionate increase in cardiovascular and cerebrovascular events (i.e., transient ischemic attacks, myocardial infarction, pulmonary embolism/venous thrombosis, unstable angina, and pulmonary hypertension.) Since there was selection bias and a high rate of discontinuation in this study, a pooled analysis of 25 randomized double-blind, placebo-controlled clinical trials was conducted to confirm the incidence of these cardiovascular and cerebrovascular events. A total of 3,342 individuals were treated with omalizumab (Xolair®) and 2,895 treated without omalizumab (Xolair®). This study reported no differences in the rates of cardiovascular and cerebrovascular events. Conclusions about the validity of the previous observational study cannot be made since the pooled analysis were based on a low number of events, a younger population, and a shorter duration of follow-up compared to the observational cohort study.

Omalizumab (Xolair®) was approved by the US Food and Drug Administration (FDA) on July 6, 2017 for the treatment of moderate-to-severe persistent allergic asthma in pediatric individuals 6 to less than 12 years of age. One of studies included 628 individuals with moderate-to-severe persistent uncontrolled allergic asthma for at least 1 year, who exhibited a positive skin test reaction to a perennial aeroallergen. After both endpoints of 24 weeks and 52 weeks, there was a statistically significant lower rate of asthma exacerbations in those treated with omalizumab (Xolair®), when compared to placebo. Another study of 334 pediatrics (298 were 6 to less than 12 years of age) with moderate-to-severe asthma who were well-controlled on inhaled corticosteroids resulted in lower rate of asthma exacerbations at 16 weeks and 28 weeks in those treated with omalizumab (Xolair®), when compared to placebo.

Clinical studies with various strengths and weaknesses in study design have been performed in adults and children with baseline IgE levels above 700 IU/mL; most of the studies in the pediatric population had an upper limit of 1300 IU/mL. While there have been studies with IgE levels as high as 2000 IU/mL, the sample size in these trials are sparse, and oftentimes, the outcomes of the subgroup with high IgE levels are not differentiated from the rest of the study population. Omalizumab (Xolair®) has been approved for use in Europe and Australia in individuals with a baseline IgE level of 30-1500 IU/mL.

CHRONIC URTICARIA

Chronic urticaria is a condition characterized by the presence of hives on most days of the week, for a period of over six weeks. In addition, the symptoms of angioedema may occur in 40-50% of all cases. This disease has a 1-2% prevalence among the U.S. population and demonstrated in clinical trials that chronic urticaria can cause interruption of daily living and may decrease an individual's quality of life.

Omalizumab (Xolair®) was approved by the US Food and Drug Administration (FDA) on March 21, 2014, for the treatment of chronic idiopathic urticaria in individuals who were at least 12 years of age and remained symptomatic despite having used an H1 antihistamine.

According to FDA labeling information, the safety and efficacy of omalizumab (Xolair®) was evaluated in two placebo-controlled, multiple-dose trials. In addition to H1 antihistamines, injections of omalizumab (Xolair®) or placebo were administered every 4 weeks for a period of 12-weeks (n=319) or 24-weeks (n=322) in duration plus a 16-week washout observation period. These studies demonstrated a significant decrease in weekly urticaria activity score (UAS), which combines pruritus intensity and number of hives, when omalizumab (Xolair®) was compared to placebo in individuals who had chronic idiopathic urticaria that was resistant to antihistamines.

In addition to chronic idiopathic urticaria, omalizumab (Xolair®) has been studied in other types of chronic urticaria, e.g., cholinergic urticaria, chronic autoimmune urticaria, solar urticaria, etc. The published peer-reviewed literature includes a few randomized, placebo-controlled studies, several small case series, and many case reports. These studies have demonstrated a significant decrease in UAS, with minimal adverse events when omalizumab (Xolair®) was compared to placebo in individuals who had chronic urticaria that was resistant to antihistamines. Several other small clinical trials are currently underway and are in various stages of development. There have also been Guidelines published summarizing the available data and offering algorithms for the treatment of chronic urticaria.

Although there are several types of chronic urticaria, the treatment of each is similar. Routine management usually begins with a second-generation (non-sedating) H1 antihistamine (e.g., cetirizine [Zyrtec®], fexofenadine [Allegra®], loratadine [Claritin®, Alavert®], desloratadine [Clarinex®], levocetirizine [Xyzal®]), followed by dose escalations that exceed the recommended dose. For those individuals requiring further treatment, adjunctive medications are added or substituted to control signs and symptoms of chronic urticaria. Examples of these adjunctive medications may include:
  • first-generation (sedating) H1 antihistamine (e.g., chlorpheniramine [Chlor-Trimeton®], cyproheptadine [Periactin®], diphenhydramine [Benadryl®])
  • H2 blockers (e.g., cimetidine [Tagamet®], famotidine [Pepcid®], nizatidine [Axid®], ranitidine [Zantac®])
  • leukotriene modifiers (e.g., zafirlukast [Accolate®], montelukast [Singulair®], zileuton [Zyflo®])
  • systemic glucocorticosteroids (for short periods of time) and other anti-inflammatory agents (e.g., dapsone, sulfasalazine, hydroxychloroquine)
  • immunosuppressants (e.g., cyclosporine, tacrolimus)
  • immunomodulatory agents (e.g., immune globulin, methotrexate)

OFF-LABEL INDICATIONS

There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company’s off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.
References

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Lowe PJ, Georgiou P, Canvin J. Revision of omalizumab dosing table for dosing every 4 instead of 2 weeks for specific ranges of bodyweight and baseline IgE. Regul Toxicol Pharmacol. 2015 Feb;71(1):68-77.

Maurer M, Altrichter S, Bieber, T, et al. Efficacy and safety of omalizumab in patients with chronic urticaria who exhibit IgE against thyroperoxidase. J Allergy Clin Immunol. 2011;128(1):202-209.

Maurer M, Metz M, Brehler R, et al. Omalizumab treatment in patients with chronic inducible urticaria: A systematic review of published evidence. J Allergy Clin Immunol. 2018 Feb;141(2):638-649.

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Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

J45.40 Moderate persistent asthma, uncomplicated

J45.41 Moderate persistent asthma with (acute) exacerbation

J45.50 Severe persistent asthma, uncomplicated

J45.51 Severe persistent asthma with (acute) exacerbation

J45.901 Unspecified asthma with (acute) exacerbation

J45.909 Unspecified asthma, uncomplicated

L50.0 Allergic urticaria

L50.1 Idiopathic urticaria

L50.2 Urticaria due to cold and heat

L50.3 Dermatographic urticaria

L50.5 Cholinergic urticaria

L50.6 Contact urticaria

L50.8 Other urticaria

L50.9 Urticaria, unspecified

L56.3 Solar urticaria



HCPCS Level II Code Number(s)

J2357 Injection, omalizumab, 5 mg


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References

Attachment A: Omalizumab (Xolair®)
Description: Dosing and Frequency Requirements for Omalizumab (Xolair®)






Policy History

MA08.025c
05/20/2020The policy has been reviewed and reissued to communicate the Company’s continuing position on omalizumab (Xolair®).
05/22/2019The policy has been reviewed and reissued to communicate the Company’s continuing position on omalizumab (Xolair®).
11/21/2018This policy has been reissued in accordance with the Company's annual review process.
12/13/2017This Policy has undergone a routine review, and the medical necessity criteria have been revised as follows:
  • The Policy Section was updated to communicate the modified Dosing and Frequency information.
  • The Policy Section was also updated to communicate the expanded baseline serum IgE level criteria for the treatment of Allergic Asthma:
    • FROM: between 30 IU/mL and 700 IU/mL
    • TO: between 30 IU/mL and 1500 IU/mL

MA08.025b
06/29/2016This policy was updated to clarify the dosing and frequency of omalizumab (Xolair®). Information regarding use in pediatrics was also added.

MA08.025a
10/21/2015This policy has been updated to communicate the Company's position on omalizumab (Xolair®). Criteria for cyclosporine as a prior agent for the treatment of chronic urticaria; information regarding the safety trials of omalizumab (Xolair®); and the dosing and frequency for the FDA-approved indications have been added to the policy.

MA08.025
01/01/2015This is a new policy.






Version Effective Date: 12/13/2017
Version Issued Date: 12/13/2017
Version Reissued Date: 05/20/2020