Subject: Nucala 1655-A SGM P2022a

Drug

NUCALA  (mepolizumab)

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. 

FDA-Approved Indications
A.   Nucala is indicated for add-on maintenance treatment of patients with severe asthma aged 6 years and
      older, and with an eosinophilic phenotype.
B.   Nucala is indicated for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).
C.   Nucala is indicated for the treatment of adult and pediatric patients aged 12 years and older with
      hypereosinophilic syndrome (HES) for ³6 months without an identifiable non-hematologic secondary cause.
D.   Nucala is indicated for add-on maintenance treatment of adult patients 18 years and older with chronic
      rhinosinusitis with nasal polyps (CRSwNP).              

      Limitations of Use:  Not for relief of acute bronchospasm or status asthmaticus 

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.   For initial requests:
            i.   Member’s chart or medical record showing pretreatment blood eosinophil count, dependance
                 on systemic corticosteroids if applicable.
            ii.  Chart notes, medical record documentation, or claims history supporting previous medications
                 tried including drug, dose, frequency, and duration.
      2.   For continuation requests: Chart notes or medical record documentation supporting improvement in
            asthma control.
B.   EGPA:
      1.   For initial requests: Member’s chart or medical record showing pretreatment blood eosinophil count.
      2.   For continuation requests: Chart notes or medical record documentation supporting improvement in
            EGPA control.
C.   HES:
      1.   For initial requests:
            i.   FIP1L1-PDGFRA fusion gene test results.
            ii.  Member’s chart or medical record showing pretreatment blood eosinophil count.
      2.   For continuation requests: Chart notes or medical record documentation supporting improvement in
            HES control.
D.   CRSwNP:
      1.   For initial requests:
            i.   Member’s chart or medical record showing nasal endoscopy, anterior rhinoscopy, or computed
                 tomography details (e.g., location, size), or Meltzer Clinical Score or endoscopic nasal polyps 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.   For continuation requests: Chart notes or medical record documentation supporting positive clinical response. 

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 rhinosinusitis with nasal polyposis: 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 meets either of the following criteria:
            i.   Member has a baseline blood eosinophil count of at least 150 cells per microliter; or
            ii.  Member is dependent on systemic corticosteroids
      3.   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).
      4.   Member has inadequate asthma control despite current treatment with both of the following medications
            at optimized doses:
            i.   High dose inhaled corticosteroid
            ii.  Additional controller (i.e., long acting beta₂-agonist, long acting muscarinic antagonist, leukotriene
                 modifier, or sustained-release theophylline)
      5.   Member will continue to use maintenance asthma treatments (e.g., inhaled corticosteroid, additional
            controller) in combination with Nucala.
      6.   Member will not use Nucala concomitantly with other biologics indicated for asthma (e.g., Cinqair,
            Dupixent, Fasenra, Tezspire, Xolair). 

B.   Eosinophilic granulomatosis with polyangiitis
      Authorization of 12 months may be granted for treatment of eosinophilic granulomatosis with polyangiitis
      when all of the following criteria are met:
      1.   Member is 18 years of age or older.
      2.   Member has a history or the presence of an eosinophil count of more than 1000 cells per microliter or
            a blood eosinophil level of greater than 10%.
      3.   Member has at least two of the following disease characteristics of EGPA:
            i.     Biopsy showing histopathological evidence of eosinophilic vasculitis, perivascular eosinophilic
                   infiltration, or eosinophil-rich granulomatous inflammation
            ii.    Neuropathy, mono or poly (motor deficit or nerve conduction abnormality)
            iii.   Pulmonary infiltrates, non-fixed; sino-nasal abnormality
            iv.   Cardiomyopathy (established by echocardiography or magnetic resonance imaging)
            v.    Glomerulonephritis (hematuria, red cell casts, proteinuria)
            vi.   Alveolar hemorrhage (by bronchoalveolar lavage)
            vii.  Palpable purpura
            viii. Anti-neutrophil cytoplasmic anti-body (ANCA) positive (Myeloperoxidase or proteinease 3)
      4.   Member has had at least one relapse (requiring increase in oral corticosteroids dose, initiation/increased
            dose of immunosuppressive therapy or hospitalization) within 2 years prior to starting treatment with
            Nucala or has a refractory disease. 

C.   Hypereosinophilic syndrome (HES)
      Authorization of 12 months may be granted for treatment of HES when all of the following criteria are met:
      1.   Member is 12 years of age or older.
      2.   Member does not have either of the following:
            i.    HES secondary to a non-hematologic cause (e.g., drug hypersensitivity, parasitic helminth
                  infection, [human immunodeficiency virus] HIV infection, non-hematologic malignancy)
            ii.   FIP1L1-PDGFRA kinase-positive HES
      3.   Member has a history or presence of a blood eosinophil count of at least 1000 cells per microliter.
      4.   Member will not use Nucala as monotherapy.
      5.   Member has been on a stable dose of HES therapy (e.g., oral corticosteroid, immunosuppressive,
            and/or cytotoxic therapy).
      6.   Member has had HES for at least 6 months.
      7.   Member has experienced at least two HES flares within the past 12 months.

D.  Chronic rhinosinusitis with nasal polyps
     Authorization of 6 months may be granted for treatment of chronic rhinosinusitis with nasal polyps in
     members 18 years of age or older when all of the following criteria are met:
     1.   Member has bilateral nasal polyposis and chronic symptoms of sinusitis despite intranasal
           corticosteroid treatment for at least 2 months unless contraindicated or not tolerated; and
     2.   The member has CRSwNP despite one of the following:
           i.    Prior sino-nasal surgery; or
           ii.   Prior treatment with systemic corticosteroids within the last two years was ineffective, 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 Nucala, unless
           contraindicated or not tolerated.
     6.   Member will not use Nucala concomitantly with other biologics indicated for chronic rhinosinusitis with
           nasal polyps (e.g., Dupixent, Xolair).

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 Nucala 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 dose
     3.   Member will continue to use maintenance asthma treatments (e.g., inhaled corticosteroid, additional
           controller) in combination with Nucala.
     4.   Member will not use Nucala concomitantly with other biologics indicated for asthma (e.g., Cinqair,
           Dupixent, Fasenra, Tezspire, Xolair).

B.  Eosinophilic granulomatosis with polyangiitis
     Authorization of 12 months may be granted for continuation of treatment of eosinophilic granulomatosis
     with polyangiitis when all of the following criteria are met:
     1.   Member is 18 years of age or older.
     2.   Member has beneficial response to treatment with Nucala as demonstrated by any of the following:
           i.    A reduction in the frequency of relapses, or
           ii.   A reduction in the daily oral corticosteroid dose, or
           iii.  No active vasculitis 

C.  Hypereosinophilic syndrome (HES)
     Authorization of 12 months may be granted for continuation of treatment of HES when all of the following
     criteria are met:
     1.   Member is 12 years of age or older.
     2.   Member has experienced a reduction in HES flares since starting treatment with Nucala.
     3.   Member will not use Nucala as monotherapy.

D.  Chronic rhinosinusitis with nasal polyps
     Authorization of 12 months may be granted for continuation of treatment of chronic rhinosinusitis with
     nasal polyposis when all of the following are met:
     1.   Member is 18 years of age or older.
     2.   Member has achieved or maintained a positive clinical response to Nucala therapy as evidenced by
           improvement in signs and symptoms of CRSwNP (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 Nucala concomitantly with other biologics indicated for chronic rhinosinusitis with
           nasal polyps (e.g., Dupixent, Xolair). 

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.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Nucala [package insert]. Research Triangle Park, NC: GlaxoSmithKline; January 2022.
2. Ortega HG, Liu MC, Pavord ID, et al. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014;371(13):1198-1207.
3. Bel EH, Wenzel SE, Thompson PJ, et al. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med. 2014;371(13):1189-1197.
4. 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.
5. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. 2021 update. Available at: https://ginasthma.org/gina-reports/. Accessed March 11, 2022.
6. 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.
7. American Academy of Allergy, Asthma & Immunology (AAAAI) 2020 Virtual Annual Meeting. Available at: https://annualmeeting.aaaai.org/. Accessed March 14, 2022.
8. Wechsler ME, Akuthota P, Jayne D, et al. Mepolizumab or placebo for eosinophilic granulomatosis with polyangiitis. N Engl J Med. 2017:18;376(20):1921-1932.
9. A Study to Investigate Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis. Available from https://clinicaltrials.gov/ct2/show/record/NCT02020889. NLM identifier: NCT02020889. Accessed March 14, 2022.
10. Groh M, Pagnoux C, Baldini C, et al. Eosinophilic granulomatosis with polyangiitis (Churg–Strauss) (EGPA) Consensus Task Force Recommendations for evaluation and management. Eur J Intern Med. 2015;26(7):545-553.
11. Yates M, Watts RA, Bajema M, et al. EULAR/ERA-EDTA recommendations for the management of ANCA-associated vasculitis. Ann Rheum Dis. 2016;75(9):1583-1594.
12. Shomali W, Gotlib J. World Health Organization-defined eosinophilic disorders: 2019 update on diagnosis, risk stratification, and management. Am J Hematol. 2019;94(10):1149-1167.
13. Butt NM, Lambert J, Ali S, et al. Guideline for the investigation and management of eosinophilia. Br J Haematol. 2017;176(4):553-572.
14. Han JK, Bachert C, Fokkens W, Desrosiers M, Wagenmann M, Lee SE, Smith SG, Martin N, Mayer B, Yancey SW, Sousa AR, Chan R, Hopkins C; SYNAPSE study investigators. Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med. 2021 Apr 16.
15. 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.
16. 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.
17. American College of Rheumatology. 2021 American college of rheumatology/vasculitis foundation guideline for the management of antineutrophil cytoplasmic antibody-associated vasculitis. Arthritis & Rheumatology. Https://www.vasculitisfoundation.org/wp-content/uploads/2021/07/2021-ACR-VF-Guideline-for-Management-of-ANCA-Associated-Vasculitis.pdf. Accessed March 14, 2022.
18. WJ Fokkens, VJ Lund, C Hopkins, et al. European Position Paper on Rhinosinusitis and Nasal Polyps 2020. 2020;58(Suppl S29):1-464.
19. 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