Subject: Xolair 1656-A SGM P2022a

Drug

XOLAIR  (omalizumab)

Policy:

I.    INDICATIONS 

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

A.   FDA-Approved Indications
      1.   Allergic asthma
            Xolair is indicated for patients 6 years of age and older with moderate to severe persistent asthma
            who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms
            are inadequately controlled with inhaled corticosteroids. 

                    Limitations of use: Xolair is not indicated for the relief of acute bronchospasm or status asthmaticus,
                    or for treatment of other allergic conditions.

            2.   Chronic spontaneous urticaria (CSU)
                  Xolair is indicated for the treatment of adults and adolescents 12 years of age and older with chronic
                  spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment.

                   Limitations of use: Xolair is not indicated for treatment of other forms of urticaria.

            3.   Nasal polyps
                  Xolair is indicated for add-on maintenance treatment of nasal polyps in adult patients 18 years of age
                  and older with inadequate response to nasal corticosteroids. 

B.   Compendial Uses
      1.   Immune checkpoint inhibitor-related toxicities
      2.   Systemic mastocytosis 

All other indications are considered experimental/investigational and not medically necessary. 

II.  DOCUMENTATION 

Submission of the following information is necessary to initiate the prior authorization review:
A.   Asthma:
      1.   Initial Requests:
            i.    Member’s chart or medical record showing pre-treatment IgE level
            ii.   Chart notes, medical record documentation, or claims history supporting previous medications tried
      2.   Continuation requests: Chart notes or medical record documentation supporting improvement in
            asthma control.
B.   CSU:
      1.   Initial Requests: Member’s chart or medical record documentation, or claims history supporting previous
            medications tried showing an inadequate treatment response to a second-generation H1 antihistamine
      2.   Continuation Requests: Chart notes or medical record documentation supporting response to therapy
C.   Nasal polyps:
      1.   Initial Requests:
            i.   Member’s chart or medical record showing nasal endoscopy, anterior rhinoscopy, or computed
                 tomography (CT) details (e.g., location, size), or Meltzer Clinical Score or endoscopic nasal
                 polyp score (NPS) (where applicable).
            ii.  Chart notes, medical record documentation, or claims history supporting previous medications tried.
                 If therapy is not advisable, documentation of clinical reason to avoid therapy.
      2.   Continuation Requests: Chart notes or medical record documentation supporting response to therapy
D.   Immune checkpoint inhibitor-related toxicity (initial requests): Member’s chart or medical record showing
      pre-treatment IgE level
E.   Systemic mastocytosis (initial requests):
      1.   Chart notes or medical record documentation supporting diagnosis of systemic mastocytosis
      2.   Chart notes, medical record documentation, or claims history of prerequisite therapies (if applicable)

III. PRESCRIBER SPECIALTIES 

This medication must be prescribed by or in consultation with one of the following:
A.   Asthma: allergist/immunologist or pulmonologist
B.   Chronic spontaneous urticaria: allergist/immunologist or dermatologist
C.   Nasal polyps: allergist/immunologist or otolaryngologist

IV. CRITERIA FOR INITIAL APPROVAL

A.   Asthma
      Authorization of 6 months may be granted for treatment of asthma when all of the following criteria are met:
      1.   Member is 6 years of age or older.
      2.   Member has a positive skin test or in vitro reactivity to at least one perennial aeroallergen.
      3.   Member has a pre-treatment IgE level greater than or equal to 30 IU/mL.
      4.   Member has uncontrolled asthma as demonstrated by experiencing at least one of the following within
            the past year:
            i.    Two or more asthma exacerbations requiring oral or injectable corticosteroid treatment.
            ii.   One or more asthma exacerbation resulting in hospitalization or emergency medical care visit.
            iii.  Poor symptom control (frequent symptoms or reliever use, activity limited by asthma, night
                  waking due to asthma).
      5.   Member has inadequate asthma control despite current treatment with both of the following medications
            at optimized doses:
            i.    Medium-to-high-dose inhaled corticosteroid
            ii.   Additional controller (i.e., long acting beta₂-agonist, long acting muscarinic antagonist, leukotriene
                  modifier, or sustained-release theophylline)
      6.   Member will continue to use maintenance asthma treatments (e.g., inhaled corticosteroid, additional
            controller) in combination with Xolair.
      7.   Member will not use Xolair concomitantly with other biologics indicated for asthma (e.g., Cinqair, Dupixent,
            Fasenra, Nucala, Tezspire). 

B.   Chronic spontaneous urticaria
      Authorization of 6 months may be granted for treatment of chronic spontaneous urticaria when all of the
      following criteria are met:
      1.   Member is 12 years of age or older.
      2.   Member remains symptomatic despite treatment with up-dosing (in accordance with
            EAACI/GA²LEN/EDF/WAO guidelines) of a second-generation H₁ antihistamine (e.g., cetirizine,
            fexofenadine, levocetirizine, loratadine) for at least 2 weeks.
      3.   Member has been evaluated for other causes of urticaria, including bradykinin-related angioedema
            and interleukin-1-associated urticarial syndromes (auto-inflammatory disorders, urticarial vasculitis).
      4.   Member has experienced a spontaneous onset of wheals, angioedema, or both, for at least 6 weeks.

      C.   Nasal polyps
            Authorization of 6 months may be granted for treatment of nasal polyps when all of the following
            criteria are met:
            1.   Member is 18 years of age or older.
            2.   Member has bilateral nasal polyps and chronic symptoms of sinusitis despite intranasal corticosteroid
                  treatment for at least 2 months unless contraindicated or not tolerated.
            3.   Member has one of the following:
                  i.    A bilateral nasal endoscopy, anterior rhinoscopy, or computed tomography (CT) showing polyps
                        reaching below the lower border of the middle turbinate or beyond in each nostril
                  ii.    Meltzer Clinical Score of 2 or higher in both nostrils
                  iii.   A total endoscopic nasal polyp score (NPS) of at least 5 with a minimum score of 2 for each nostril
            4.   Member has nasal blockage plus one additional symptom:
                  i.    Rhinorrhea (anterior/posterior); or
                  ii.   Reduction or loss of smell; or
                  iii.  Facial pain or pressure
            5.   Member will continue to use a daily intranasal corticosteroid while being treated with Xolair,
                  unless contraindicated or not tolerated.
            6.   Member will not use Xolair concomitantly with other biologics indicated for nasal polyps
                  (e.g., Dupixent, Nucala). 

D.   Immune checkpoint inhibitor-related toxicity
      Authorization of 1 month may be granted for treatment of immune checkpoint inhibitor-related toxicity
      when both of the following are met:
      1.   The member has a refractory case of immune-therapy related severe (G3) pruritus
      2.   The member has elevated IgE levels

E.   Systemic mastocytosis
      Authorization of 12 months may be granted for the treatment of systemic mastocytosis when both
      of the following are met:
      1.   The major and at least one minor diagnostic criterion for systemic mastocytosis are present or
            three or more minor diagnostic criteria are present (see Appendix)
      2.   Xolair will be used in any of the following treatment settings:
            i.    Used as stepwise prophylactic treatment for chronic mast cell mediator-related cardiovascular
                  and pulmonary symptoms when the member has tried both of the following:
                  a.   H1 blockers and H2 blockers
                  b.   Corticosteroids
            ii.   Used for prevention of recurrent unprovoked anaphylaxis
            iii.  Used for prevention of hymenoptera or food-induced anaphylaxis, with negative specific
                  IgE or negative skin test
            iv.   Used to improve tolerability of venom immunotherapy

V.   CONTINUATION OF THERAPY 

A.   Asthma
      Authorization of 12 months may be granted for continuation of treatment of asthma when all of the
      following criteria are met:
      1.   Member is 6 years of age or older.
      2.   Asthma control has improved on Xolair treatment as demonstrated by at least one of the following:
            i.   A reduction in the frequency and/or severity of symptoms and exacerbations
            ii.  A reduction in the daily maintenance oral corticosteroid dose⁹
      3.   Member will continue to use maintenance asthma treatments (e.g., inhaled corticosteroid, additional
            controller) in combination with Xolair.
      4.   Member will not use Xolair concomitantly with other biologics indicated for asthma (e.g., Cinqair,
            Dupixent, Fasenra, Tezspire, Nucala). 

B.   Chronic spontaneous urticaria
      Authorization of 12 months may be granted for continuation of treatment of chronic spontaneous urticaria
      when all of the following criteria are met:
      1.   Member is 12 years of age or older.
      2.   Member has experienced a response (e.g., improved symptoms, decrease in weekly urticaria
            activity score [UAS7]) since initiation of therapy. 

C.   Nasal polyps
      Authorization of 12 months may be granted for continuation of treatment of nasal polyps when all of the
      following criteria are met:
      1.   Member is 18 years of age or older.
      2.   Member has experienced a response as evidenced by improvement in signs and symptoms
            (e.g., improvement in nasal congestion, nasal polyp size, loss of smell, anterior or posterior rhinorrhea,
            sinonasal inflammation, hyposmia and/or facial pressure or pain or reduction in corticosteroid use).
      3.   Member will not use Xolair concomitantly with other biologics indicated for nasal polyps (e.g., Dupixent, Nucala).

D.   Immune checkpoint inhibitor-related toxicities and systemic mastocytosis
      All members (including new members) requesting authorization for continuation of therapy must meet all
      initial authorization criteria.

VI. OTHER 

Note: If the member is a current smoker or vaper, they should be counseled on the harmful effects of smoking and vaping on pulmonary conditions and available smoking and vaping cessation options.

Special Notes:

VII. APPENDIX

2017 WHO Diagnostic Criteria for Systemic Mastocytosis
A.   Major Criteria: multifocal, dense infiltrates of mast cells (at least 15 mast cells in aggregates) detected in sections of bone marrow and/or other extracutaneous organs
B.   Minor Criteria
      1.   In biopsy sections of bone marrow or other extracutaneous organs, greater than 25% of mast cells in the
            infiltrate are spindle-shaped or have atypical morphology, or greater than 25% of all mast cells in bone
            marrow aspirate smears are immature or atypical
      2.   Detection of an activating point mutation at codon 816 of KIT in the bone marrow, blood, or another
            extracutaneous organ
      3.   Mast cells in bone marrow, blood, or other extracutaneous organs express CD25, with or without CD2,
            in addition to normal mast cell markers
      4.   Serum total tryptase persistently greater than 20 ng/mL (unless there is an associated myeloid neoplasm,
            in which case this parameter is not valid)

Place of Service:

Outpatient

The above policy is based on the following references:

1. Xolair [package insert]. South San Francisco, CA: Genentech, Inc.; July 2021.
2. National Institutes of Health. National Asthma Education and Prevention Program Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma - Full Report 2007. Bethesda, MD: National Heart Lung and Blood Institute; August 2007. Available at https://www.ncbi.nlm.nih.gov/books/NBK7232/pdf/Bookshel_NBK7232.pdf. Accessed March 11, 2022.
3. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. 2021 update. Available at: https://ginasthma.org/wp-content/uploads/2021/05/GINA-Main-Report-2021-V2-WMS.pdf. Accessed March 11, 2022.
4. Strunk RC, Bloomberg GR. Omalizumab for asthma. N Engl J Med. 2006;354(25):2689-2695.
5. Kew KM, Karner C, Mindus SM. Combination formoterol and budesonide as maintenance and reliever therapy versus combination inhaler maintenance for chronic asthma in adults and children (review). Cochrane Database Syst Rev. 2013;12:CD009019.
6. Zuberbier T, Aberer W, Asero R, et al. The EAACI/GA²LEN/EDF/WAO guideline for the definition, classification, diagnosis, and management of urticaria. 2018;73(7):1393-1414. doi: 10.1111/all.13397.
7. Bernstein DI, Blessing-Moore J, Cox L, et al. The diagnosis and management of acute and chronic urticaria: 2014 update. American Academy of Allergy, Asthma & Immunology Practice Parameter. http://www.aaaai.org/practice-resources/statements-and-practice-parameters/practice-parameter-guidelines.aspx. Accessed March 16, 2022.
8. Maurer M, Rosen K, Hsieh HJ, et al. Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria. N Engl J Med. 2013;368(10):924-935.
9. gov. National Library of Medicine (US). Identifier NCT03280550, A Clinical Trial of Omalizumab in Participants with Chronic Rhinosinusitis with Nasal Polyps (POLYP 1) 2017 Sep 12. Available from: https://clinicaltrials.gov/ct2/show/NCT03280550.
10. gov. National Library of Medicine (US). Identifier NCT03280537, A Clinical Trial of Omalizumab in Participants with Chronic Rhinosinusitis with Nasal Polyps (POLYP 2) 2017 Sep 12. Available from: https://clinicaltrials.gov/ct2/show/NCT03280537.
11. The NCCN Drugs & Biologics Compendium^® © 2022 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed March 16, 2022.
12. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Systemic Mastocytosis. Version 3.2021. https://www.nccn.org/professionals/physician_gls/pdf/mastocytosis.pdf. Accessed March 16, 2022.
13. Cloutier MM, Dixon AE, Krishnan JA, et al. Managing asthma in adolescents and adults: 2020 asthma guideline update from the National Asthma Education and Prevention Program. 2020;324(22): 2301-2317.
14. Bachert C, Han JK, Wagenmann M, et al, EUFOREA expert board meeting on uncontrolled severe chronic rhinosinusitis with nasal polyps (CRSwNP) and biologics: Definitions and management. J Allergy Clin Immunol. 2021;147(1):29-36.
15. WJ Fokkens, VJ Lund, C Hopkins, et al. European Position Paper on Rhinosinusitis and Nasal Polyps 2020. 2020;58(Suppl S29):1-464.
16. Hopkins C. Chronic Rhinosinusitis with Nasal Polyps. N Engl J Med. 2019;381(1):55-63.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

October 01, 2022