Omalizumab (Xolair) (ARCHIVED)

Policy ID: I-9053-005

Section: Injections

Effective Date: January 01, 2022

Revised Date: October 20, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Applies To: Commercial Only

**This policy has been Archived effective December 08, 2024. Click the Archive tab above for more information.**

Policy ID: I-9053-005

Section: Injections

Effective Date: January 01, 2022

Revised Date: October 20, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Archived Date: December 08, 2024

Applies To: Commercial Only

Description

Omalizumab (Xolair®) is a recombinant DNA-derived humanized IgG1k murine monoclonal antibody that selectively binds to human immunoglobulin E (IgE). Omalizumab (Xolair) inhibits the binding of IgE to the high-affinity IgE receptor on the surface of mast cells and basophils, which limits the degree of release of mediators of the allergic response.

Omalizumab (Xolair) vial may be covered on the medical benefit. Omalizumab (Xolair) prefilled syringe may be covered on the pharmacy benefit.

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Omalizumab (Xolair) vial may be considered medically necessary when ALL of the following are met:

If the individual has a Food and Drug Administration (FDA) approved indication, then ONE of the following:
- The individual's age is within FDA labeling for the requested indication for omalizumab (Xolair); or
- The prescriber has provided information in support of using omalizumab (Xolair) for the individual's age for the requested indication; and
ONE of the following:
- The individual has a diagnosis of moderate to severe persistent asthma AND ALL of the following:
  1. ONE of the following:
    1. The individual is six (6) to less than 12 years of age AND BOTH of the following:
      1. The pretreatment IgE level is 30 IU/mL to 1300 IU/mL; and
      2. The individual's weight is 20 kg to 150 kg; or
    2. The individual is 12 years of age or over AND BOTH of the following:
      1. The pretreatment IgE level is 30 IU/mL to 700 IU/mL; and
      2. The individual's weight is 30 kg to 150 kg; and
  2. Allergic asthma has been confirmed by a positive skin test or in vitro reactivity test (RAST) to a perennial aeroallergen; and
  3. The individual has a history of uncontrolled asthma while on asthma control therapy as demonstrated by ONE of the following:
    1. Frequent severe asthma exacerbations requiring two or more courses of systemic corticosteroids (steroid burst) within the past 12 months; or
    2. Serious asthma exacerbations requiring hospitalization, mechanical ventilation, or visit to the emergency room or urgent care within the past 12 months; or
    3. Controlled asthma that worsens when the doses of inhaled and/or systemic corticosteroids are tapered; or
    4. The individual has baseline Forced Expiratory Volume (FEV1) that is less than 80% of predicted; and
  4. ONE of the following:
    1. The individual is NOT currently being treated with omalizumab (Xolair) AND is currently treated with a maximally tolerated inhaled corticosteroid for at least three (3) months; or
    2. The individual is currently being treated with omalizumab (Xolair) AND ONE of the following:
      1. Is currently treated with an inhaled corticosteroid for at least three (3) months that is adequately dosed to control symptoms; or
      2. Is currently treated with a maximally tolerated inhaled corticosteroid for at least three (3) months; or
    3. The individual has an intolerance or hypersensitivity to inhaled corticosteroid therapy; or
    4. The individual has an FDA labeled contraindication to ALL inhaled corticosteroids; and
  5. ONE of the following:
    1. The individual is currently being treated for at least three (3) months with ONE of the following:
      1. A long-acting beta-2 agonist (LABA); or
      2. A Leukotriene receptor antagonist (LTRA); or
      3. Long-acting muscarinic antagonist (LAMA); or
      4. Theophylline; or
    2. The individual has an intolerance or hypersensitivity to therapy with long-acting beta-2 agonists (LABA), leukotriene receptor antagonists (LTRA), long-acting muscarinic antagonists (LAMA), or theophylline; or
    3. The individual has an FDA labeled contraindication to ALL long-acting beta-2 agonists (LABA), leukotriene receptor antagonists (LTRA), long-acting muscarinic antagonists (LAMA), AND theophylline; and
  6. The individual will continue asthma control therapy (e.g., ICS, ICS/LABA, LTRA, LAMA, theophylline) in combination with omalizumab (Xolair); and
  7. The requested dose is based on pre-treatment serum IgE level and the individual's body weight as defined in FDA approved labeling AND does NOT exceed 375 mg every 2 weeks; or
- The individual has a diagnosis of chronic idiopathic urticaria (CIU) AND ALL of the following:
  1. The individual has had over six (6) weeks of hives and itching; and
  2. If the individual is currently being treated with medications known to cause or worsen urticaria, then ONE of the following:
    1. The prescriber has reduced the dose or discontinued any medications known to cause or worsen urticaria (e.g., NSAIDs); or
    2. The prescriber has provided information indicating that a reduced dose or discontinuation of any medications known to cause or worsen urticaria is not appropriate; and
  3. ONE of the following:
    1. The individual has tried and had an inadequate response to the FDA max dose of a second-generation H-1 antihistamine (e.g., cetirizine, levocetirizine, fexofenadine, loratadine, desloratadine) after at least a two (2)-week trial AND ONE of the following:
      1. The individual has tried and had an inadequate response to a dose titrated up to four (4) times the FDA labeled maximum dose of a second-generation H-1 antihistamine; or
      2. The prescriber has provided information indicating the patient cannot be treated with a dose titrated up to four (4) times the FDA labeled maximum dose of a second-generation H-1 antihistamine; or
    2. The individual has an intolerance or hypersensitivity to second-generation H-1 antihistamine therapy; or
    3. The individual has an FDA labeled contraindication to ALL second-generation H-1 antihistamines; and
  4. The requested dose is within the FDA labeled dose AND does NOT exceed 300 mg every four (4) weeks; or
- The individual has a diagnosis of chronic rhinosinusitis with nasal polys (CRSwNP) AND ALL of the following:
  - The individual has at least TWO of the following symptoms consistent with chronic rhinosinusitis (CRS):
    1. Nasal discharge (rhinorrhea or post-nasal drainage); or
    2. Nasal obstruction or congestion; or
    3. Loss or decreased sense of smell (hyposmia); or
    4. Facial pressure or pain; and
  - The patient has had symptoms consistent with chronic rhinosinusitis (CRS) for at least 12 consecutive weeks AND
  - There is information indicating the individual's diagnosis was confirmed by ONE of the following:
    1. Anterior rhinoscopy or endoscopy; or
    2. Computed tomography (CT) of the sinuses; and
  - ONE of the following:
    1. The individual has tried and had an inadequate response to intranasal corticosteroids (e.g., fluticasone, Sinuva) used for at least a three (3)-month trial; or
    2. The individual has an intolerance or hypersensitivity to therapy with intranasal corticosteroids (e.g., fluticasone, Sinuva); or
    3. The individual has an FDA labeled contraindication to ALL intranasal corticosteroids; and
  - BOTH of the following:
    1. The individual is currently treated with standard nasal polyp maintenance therapy (e.g., nasal saline irrigation, intranasal corticosteroids); and
    2. The individual will continue standard nasal polyp maintenance therapy (e.g., nasal saline irrigation, intranasal corticosteroids) in combination with omalizumab (Xolair); and
  - The requested dose is based on the individual's pretreatment serum IgE level and body weight as defined in FDA labeling AND does NOT exceed 600 mg every two (2) weeks; or
- The individual has a diagnosis of IgE-mediated food allergy AND ALL of the following:
  - The individual has a confirmed IgE-mediated food allergy confirmed by an allergy diagnostic test (e.g., skin prick test, serum specific IgE test, oral food challenge); and
  - The patient will avoid known food allergens while treated with omalizumab (Xolair); and
  - The requested agent will NOT be used for the emergency treatment of allergic reactions, including anaphylaxis; or
- The individual has another FDA approved indication for omalizumab (Xolair) AND the requested dose is within FDA labeled dosing for the requested indication; or
- The individual has another indication that is supported in compendia for omalizumab (Xolair) AND the requested dose is supported in compendia for the requested indication; and
ONE of the following:
- The individual has tried a self-administered Xolair product (i.e., Xolair prefilled syringe); or
- The individual has NOT yet received three (3) doses of Xolair in the healthcare setting; or
- The prescriber has provided information that self-administration is not appropriate for the individual based on careful assessment of risk for anaphylaxis and mitigation strategies; and
The prescriber is a specialist in the area of the individual's diagnosis (e.g., allergist, immunologist, otolaryngologist, pulmonologist) or the prescriber has consulted with a specialist in the area of the individual's diagnosis; and
ONE of the following:
- The individual will NOT be using omalizumab (Xolair) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using omalizumab (Xolair) in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for omalizumab (Xolair) does NOT limit the use with another immunomodulatory agent; and
  - The prescriber has provided information in support of combination therapy (submitted copy required, e.g., clinical trials, phase III studies, guidelines required).

Reauthorization Criteria

Omalizumab (Xolair) vial may be approved when ALL of the following are met:

The individual has been previously approved for omalizumab (Xolair) through the Blue Cross Blue Shield of North Dakota precertification process; and
ONE of the following:
- The individual has a diagnosis of moderate to severe persistent asthma AND ALL of the following
  - The individual has had improvements or stabilization with omalizumab (Xolair) from baseline (prior to therapy with omalizumab (Xolair)) as indicated by ONE of the following:
    - Increase in percent predicted Forced Expiratory Volume (FEV ₁ ) from baseline; or
    - Decrease in the dose of inhaled corticosteroid required to control the individual's asthma; or
    - Decrease in need for treatment with systemic corticosteroids due to exacerbations of asthma; or
    - Decrease in the number of hospitalizations, need for mechanical ventilation, or visits to the emergency room or urgent care due to exacerbations of asthma; and
  - The individual is currently treated and is compliant with standard therapy [i.e., inhaled corticosteroids (ICS), ICS/long acting beta-2 agonists (ICS/LABA), leukotriene receptor antagonists (LTRA), long-acting muscarinic antagonist (LAMA), theophylline]; and
  - The requested dose is based on the individual's pre-treatment serum IgE level and body weight as defined in FDA approved labeling AND does not exceed 375 mg every two (2) weeks; or
- The individual has a diagnosis of chronic idiopathic urticaria AND BOTH of the following:
  - The individual has had clinical benefit with omalizumab (Xolair) ;and
  - The requested dose is within the FDA labeled dose AND does NOT exceed 300 mg every four (4) weeks; or
- The individual has a diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP) AND ALL of the following:
  - The individual has had clinical benefit with omalizumab (Xolair); and
  - The individual will continue standard nasal polyp maintenance therapy (e.g., nasal saline irrigation, intranasal corticosteroids) in combination with omalizumab (Xolair); and
  - The requested dose is based on the individual's pretreatment serum IgE level and body weight as defined in FDA labeling AND does NOT exceed 600 mg every two (2) weeks; or
- The individual has a diagnosis of IgE-mediated food allergy, AND the requested dose is based on the patient's pretreatment serum IgE level and body weight as defined in FDA labeling AND does NOT exceed 600 mg every 2 weeks; or
- The individual has another FDA approved indication for omalizumab (Xolair) AND BOTH of the following:
  - The individual has had clinical benefit with omalizumab (Xolair); and
  - The requested dose is within the FDA labeled dosing for the requested indication; or
- The individual has another indication that is supported in compendia for omalizumab (Xolair) AND BOTH of the following:
  - The individual has had clinical benefit with omalizumab (Xolair); and
  - The requested dose is within the FDA labeled dosing for the requested indication; and
ONE of the following:
- The individual has tried a self-administered Xolair product (i.e., Xolair prefilled syringe); or
- The individual has NOT yet received three (3) doses of Xolair in the healthcare setting; or
- The prescriber has provided information that self-administration is not appropriate for the individual based on careful assessment of risk for anaphylaxis and mitigation strategies; and
The prescriber is a specialist in the area of the individual's diagnosis (e.g., allergist, immunologist, otolaryngologist, pulmonologist) or the prescriber has consulted with a specialist in the area of the individual's diagnosis; and
ONE of the following:
- The individual will NOT be using omalizumab (Xolair) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using omalizumab (Xolair) in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for omalizumab (Xolair) does NOT limit the use with another immunomodulatory agent; and
  - The prescriber has provided information in support of combination therapy (submitted copy required, e.g., clinical trials, phase III studies, guidelines required).

The use of omalizumab (Xolair) vial for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Code

J2357

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

J33.0

J33.1

J33.8

J33.9

J44.0

J44.1

J44.9

J45.40

J45.41

J45.42

J45.50

J45.51

J45.52

J45.901

J45.902

J45.909

J45.990

J45.991

J45.998

L50.1

Z91.010

Z91.011

Z91.012

Z91.013

Z91.018

Professional Statements and Societal Positions Guidelines

Agents NOT to be used Concomitantly (subject to change)

Abrilada (adalimumab-afzb)

Actemra (tocilizumab)

Adalimumab

Adbry (tralokinumab-ldrm)

Amjevita (adalimumab-atto)

Arcalyst (rilonacept)

Avsola (infliximab-axxq)

Benlysta (belimumab)

Cibinqo (abrocitinib)

Cimzia (certolizumab)

Cinqair (reslizumab)

Cosentyx (secukinumab)

Cyltezo (adalimumab-adbm)

Dupixent (dupilumab)

Enbrel (etanercept)

Entyvio (vedolizumab)

Fasenra (benralizumab)

Hadlima (adalimumab-bwwd)

Hulio (adalimumab-fkjp)

Humira (adalimumab)

Hyrimoz (adalimumab-adaz)

Idacio (adalimumab-aacf)

Ilaris (canakinumab)

Ilumya (tildrakizumab-asmn)

Inflectra (infliximab-dyyb)

Infliximab

Kevzara (sarilumab)

Kineret (anakinra)

Nucala (mepolizumab)

Olumiant (baricitinib)

Opzelura (ruxolitinib)

Orencia (abatacept)

Otezla (apremilast)

Remicade (infliximab)

Renflexis (infliximab-abda)

Riabni (rituximab-arrx)

Rinvoq (upadacitinib)

Rituxan (rituximab)

Rituxan Hycela (rituximab/hyaluronidase human)

Ruxience (rituximab-pvvr)

Siliq (brodalumab)

Simponi (golimumab)

Simponi ARIA (golimumab)

Skyrizi (risankizumab-rzaa)

Sotyktu (deucravacitinib)

Stelara (ustekinumab)

Taltz (ixekizumab)

Tezspire (tezepelumab-ekko)

Tremfya (guselkumab)

Truxima (rituximab-abbs)

Tysabri (natalizumab)

Xeljanz (tofacitinib)

Xeljanz XR (tofacitinib extended release)

Xolair (omalizumab)

Yuflyma (adalimumab-aaty)

Yusimry (adalimumab-aqvh)

ND Committee Review

Internal Medical Policy Committee 11-23-2021 Effective January 01, 2022

Adopted new policy to replace I-53-021 omalizumab (Xolair) ,
New policy is for omalizumab (Xolair) vial as the prefilled syringe will be reviewed as a pharmacy benefit.

Internal Medical Policy Committee 11-29-2022 - Effective January 01, 2023

Updated combination therapy criteria, and
Updated CIU H-1 antihistamine criteria, and
Updated CRSwNP criteria, and
Updated FDA approved and compendia supported criteria, and
Removed FDA labeled contraindications criteria from the policy; and
Added Agents NOT to be used Concomitantly list, and
Updated experimental/investigational statement

Internal Medical Policy Committee 9-12-2023 Effective October 01, 2023

Updated CRSwNP initial criteria
Updated Agents NOT to be used Concomitantly list

Internal Medical Policy Committee 9-17-2024 Effective November 01, 2024

Added criteria for IgE-mediated food allergy indication

Internal Medical Policy Committee 11-19-2024 Effective December 08, 2024

Archived policy

Links

INSERT REFERENCE LINK

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

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