BlueCross BlueShield of Tennessee Medical Policy Manual

Mepolizumab (Nucala®)

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.

POLICY

1. 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

1. Nucala is indicated for add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma, and with an eosinophilic phenotype.

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

2. Nucala is indicated for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).
3. 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.
4. Nucala is indicated for add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.

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

2. DOCUMENTATION

Submission of the following information is necessary to initiate the prior authorization review:

1. Asthma:
   1. For initial requests:
      1. baselinedocumentation Chart notes or medical record showing blood eosinophil count, or dependance on systemic corticosteroids, if applicable.
      2. 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. 

2. EGPA:

1. For initial requests:
   1. Chart notes or medical record documentation showing pretreatment blood eosinophil count. 
   2. Chart notes, medical record documentation, or claims history supporting previous medications tried including drug, dose, frequency, and duration. If therapy is not advisable, documentation of clinical reason to avoid therapy.

2. For continuation requests: Chart notes or medical record documentation supporting improvement in EGPA control. 

3. HES:
   1. For initial requests:
      1. FIP1L1-PDGFRA fusion gene test results.

1. 1. 2. Chart notes or medical record documentation showing pretreatment blood eosinophil count. 
   2. For continuation requests:
      1. FIP1L1-PDGFRA fusion gene test results.
      2. Chart notes or medical record documentation supporting improvement in HES control.

4. CRSwNP:
   1. For initial requests:
      1. Chart notes or medical record documentation showing nasal endoscopy, anterior rhinoscopy, or computed tomography details (e.g., polyps location, size), or Meltzer Clinical Score or endoscopic nasal polyps score (NPS) (where applicable).
      2. Chart notes, medical record documentation, or claims history supporting previous medications tried including drug, dose, frequency and duration. 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. 

3. EXCLUSIONS

Coverage will not be provided for treatment of HES for members with any of the following exclusions:

1. HES secondary to a non-hematologic cause (e.g., drug hypersensitivity, parasitic helminth infection, [human immunodeficiency virus] HIV infection, non-hematologic malignancy).
2. FIP1L1-PDGFRA kinase-positive HES.

4. PRESCRIBER SPECIALTIES

This medication must be prescribed by or in consultation with one of the following:

1. Asthma: allergist/immunologist or pulmonologist
2. Chronic rhinosinusitis with nasal polyposis: allergist/immunologist or otolaryngologist

5. CRITERIA FOR INITIAL APPROVAL

1. Asthma

1. Authorization of 6 months may be granted for members 6 years of age or older who have previously received a biologic drug (e.g., Dupixent, Cinqair) indicated for asthma in the past year.

2. Authorization of 6 months may be granted for treatment of severe 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:
   1. Member has a baseline blood eosinophil count of at least 150 cells per microliter
   2. 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:
   1. Two or more asthma exacerbations requiring oral or injectable corticosteroid treatment.
   2. One or more asthma exacerbation(s) resulting in hospitalization or emergency medical care visit(s).
   3. 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:

1. High-dose inhaled corticosteroid
2. 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 the requested medication.

2. Eosinophilic granulomatosis with polyangiitis (EGPA)

Authorization of 12 months may be granted for treatment of EGPA 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 is currently taking oral corticosteroids, unless contraindicated or not tolerated.

4. Member has at least two of the following disease characteristics of EGPA^:
   1. Biopsy showing histopathological evidence of eosinophilic vasculitis, perivascular eosinophilic infiltration, or eosinophil-rich granulomatous inflammation
   2. Neuropathy, mono or poly (motor deficit or nerve conduction abnormality)
   3. Pulmonary infiltrates, non-fixed
   4. Sino-nasal abnormality
   5. Cardiomyopathy (established by echocardiography or magnetic resonance imaging)
   6. Glomerulonephritis (hematuria, red cell casts, proteinuria)
   7. Alveolar hemorrhage (by bronchoalveolar lavage)
   8. Palpable purpura
   9. Anti-neutrophil cytoplasmic anti-body (ANCA) positive (Myeloperoxidase or proteinase 3)
5. Member has had at least one relapse (i.e., requiring increase in oral corticosteroids dose, initiation/increased dose of immunosuppressive therapy or hospitalization) within 2 years prior to starting treatment with the requested medication or has a refractory disease.

3. Hypereosinophilic syndrome (HES)

Authorization of 12 months may be granted for treatment of HES when all of the following criteria are met:

1. 1. 1. 1. 1. 1. 1. Member is 12 years of age or older.
                  2. Member has a history or presence of a blood eosinophil count of at least 1000 cells per microliter.
                  3. Member will not use the requested medication as monotherapy.
                  4. Member has been on a stable dose of HES therapy (e.g., oral corticosteroid, immunosuppressive, and/or cytotoxic therapy).
                  5. Member has had HES for at least 6 months.
                  6. Member has experienced at least two HES flares within the past 12 months.

4. Chronic rhinosinusitis with nasal polyps (CRSwNP)
   1. Authorization of 6 months may be granted for adult members who have previously received a biologic drug (e.g., Dupixent, Xolair) indicated for CRSwNP in the past year.

0. 2. Authorization of 6 months may be granted for treatment of CRSwNP when all of the following criteria are met:
1. Member is 18 years of age or older.
2. Member has bilateral nasal polyposis and chronic symptoms of sinusitis despite intranasal corticosteroid treatment for at least 2 months unless contraindicated or not tolerated
3. The member has CRSwNP despite one of the following:
   1. Prior sino-nasal surgery
   2. Prior treatment with systemic corticosteroids within the last two years was ineffective, unless contraindicated or not tolerated
4. Member has one of the following:
   1. 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
   2. Meltzer Clinical Score of 2 or higher in both nostrils
   3. A total endoscopic nasal polyp score (NPS) of at least 5 with a minimum score of 2 for each nostril
5. Member has symptoms of nasal blockage, congestion, or obstruction plus one of the following additional symptoms:
   1. Rhinorrhea (anterior/posterior)
   2. Reduction or loss of smell
   3. Facial pain or pressure
6. Member will continue to use a daily intranasal corticosteroid while being treated with the requested medication, unless contraindicated or not tolerated.

6. CONTINUATION OF THERAPY

1. Asthma

Authorization of 12 months may be granted for continuation of treatment of severe asthma when all of the following criteria are met:

1. Member is 6 years of age or older.
2. Asthma control has improved on the requested medication as demonstrated by at least one of the following:

1. A reduction in the frequency and/or severity of symptoms and exacerbations
2. 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 the requested medication.

2. Eosinophilic granulomatosis with polyangiitis (EGPA)

Authorization of 12 months may be granted for continuation of treatment of EGPA 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 the requested medication as demonstrated by any of the following:

1. A reduction in the frequency of relapses
2. A reduction or discontinuance of daily oral corticosteroid dose
3. No active vasculitis

3. 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. 1. 1. 1. 1. 1. 1. Member is 12 years of age or older.
                  2. Member has experienced a reduction in HES flares since starting treatment with the requested medication.
                  3. Member will not use the requested medication as monotherapy.

4. Chronic rhinosinusitis with nasal polyps (CRSwNP)

Authorization of 12 months may be granted for continuation of treatment of CRSwNP when all of the following are met:

2. 1. 1. 1. 1. 1. 1. Member is 18 years of age or older.
                  2. Member has achieved or maintained a positive clinical response with the requested medication 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 continue to use a daily intranasal corticosteroid while being treated with the requested medication, unless contraindicated or not tolerated.

7. OTHER

For all indications: Member cannot use the requested medication concomitantly with any other biologic drug or targeted synthetic drug for the same indication.

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.        

MEDICATION QUANTITY LIMITS

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

ADDITIONAL INFORMATION 

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

REFERENCES

1. Nucala [package insert]. Research Triangle Park, NC: GlaxoSmithKline; March 2023.
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: Asthma Management Guidelines: Focused Updates 2020. Bethesda, MD: National Heart Lung and Blood Institute; December 2020. Available at: https://www.nhlbi.nih.gov/sites/default/files/publications/AsthmaManagementGuidelinesReport-2-4-21.pdf. Accessed March 12, 2024.
5. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. 2022 update. Available at: https://ginasthma.org/wp-content/uploads/2022/07/GINA-Main-Report-2022-FINAL-22-07-01-WMS.pdf. Accessed March 12, 2024.
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 12, 2024.
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. GlaxoSmithKline. 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, 2024.
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: 2022 update on diagnosis, risk stratification, and management.  Am J Hematol. 2022;97(1):129-148.
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. JAMA. 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, 2024.
18. WJ Fokkens, VJ Lund, C Hopkins, et al. European Position Paper on Rhinosinusitis and Nasal Polyps 2020. Rhinology. 2020;58(Suppl S29):1-464.
19. Hopkins C. Chronic Rhinosinusitis with Nasal Polyps. N Engl J Med. 2019;381(1):55-63.

ORIGINAL EFFECTIVE DATE: 12/1/2015

MOST RECENT REVIEW DATE: 12/3/2024

ID_CHS

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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