NUCALA (mepolizumab)

NUCALA (mepolizumab)

Autoinjector or Syringe:
Self-Administration – injectable

Vial for reconstitution:
Medical Administration – injectable

Diagnosis considered for coverage:

• Maintenance Treatment of Severe Asthma: indicated for the 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: Nucala is not indicated for the relief of acute bronchospasm or status asthmaticus.
• Maintenance Treatment of Chronic Rhinosinusitis with Nasal Polyps: indicated for the 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
• Eosinophilic Granulomatosis with Polyangiitis: indicated for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).
• Hypereosinophilic Syndrome: indicated for the treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for ≥6 months without an identifiable non-hematologic secondary cause.

Coverage Criteria:

For diagnosis of Severe Asthma:

• Dose does not exceed:
  • For 12 years and older: 100 mg administered once every 4 weeks
  • For 6 years to 11 years old: 40 mg administered once every 4 weeks, AND
• Patient is 6 years of age or older, AND
• Prescribed by or in consultation with a pulmonologist or allergist/immunologist, AND 
• Documented diagnosis of severe asthma, AND
• Asthma is an eosinophilic phenotype as defined by one of the following:
  • Baseline (pre-treatment) peripheral blood eosinophil level is greater than or equal to 150 cells/microliter 
  • Peripheral blood eosinophil levels were greater than or equal to 300 cells/microliter within the past 12 months, AND
• Patient meets one of the following:
  • Patient has had at least two or more asthma exacerbations requiring systemic corticosteroids (e.g., prednisone) within the past 12 months
  • Prior asthma-related hospitalization within the past 12 months, AND
• Patient has paid claims or is currently being treated with ONE of the following unless there is a contraindication or intolerance to these medications (A or B):
  • A) Both of the following:
    • High-dose inhaled corticosteroid (ICS) (e.g., greater than 500 mcg fluticasone propionate equivalent/day) 
    • Additional asthma controller medication (e.g., leukotriene receptor antagonist [e.g., montelukast], long-acting beta-2 agonist [LABA] [e.g., salmeterol], tiotropium)
  • B) One maximally-dosed combination ICS/LABA product (e.g., Advair [fluticasone propionate/salmeterol], Symbicort [budesonide/formoterol], Breo Ellipta [fluticasone/vilanterol]), AND
• Will not be used in combination with other biologic medications for severe asthma (e.g., Cinqair (reslizumab), Fasenra (benralizumab), Dupixent (dupilumab), or Xolair (omalizumab))

For diagnosis of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP):

• Dose does not exceed 100 mg administered once every 4 weeks, AND
• Patient is 18 years of age or older, AND
• Prescribed by or in consultation with an allergist/immunologist, otolaryngologist or pulmonologist, AND
• Diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP) confirmed by chart note documentation, AND
• Unless contraindicated, the patient has had an inadequate response to 2 months of treatment with an intranasal corticosteroid (e.g., fluticasone, mometasone), AND
• Will use an intranasal corticosteroid in combination with Nucala, AND
• Will not be used in combination with Cinqair, Fasenra, Dupixent, or Xolair

For diagnosis of Eosinophilic Granulomatosis with Polyangiitis (Churg-Strauss, abbreviated EGPA):

• Dose does not exceed 300 mg administered once every 4 weeks (given as 3 separate 100-mg injections), AND
• Patient is 18 years of age or older, AND
• Prescribed by or in consultation with a pulmonologist, rheumatologist or allergist/immunologist, AND
• Diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA) confirmed by chart note documentation, AND
• Patient's disease has relapsed or is refractory to standard of care therapy (i.e., oral corticosteroid treatment with or without immunosuppressive therapy), AND 
• Patient is currently receiving oral corticosteroid therapy (e.g., prednisolone, prednisone), AND
• Will not be used in combination with Cinqair, Fasenra, Dupixent, or Xolair

For diagnosis of Hypereosinophilic Syndrome (HES):

• Dose does not exceed 300 mg administered once every 4 weeks (given as 3 separate 100-mg injections), AND
• Patient is 12 years of age or older, AND
• Prescribed by or in consultation with an allergist/immunologist, hematologist or dermatologist, AND
• Diagnosis of hypereosinophilic syndrome (HES) confirmed by chart note documentation, AND
• Patient has been diagnosed for at least 6 months, AND
• Verification that other non-hematologic secondary causes have been ruled out (e.g., drug hypersensitivity, parasitic helminth infection, HIV infection, non-hematologic malignancy), AND
• Patient is Fip1-like1-platelet-derived growth factor receptor alpha (FIP1L1-PDGFRA)-negative, AND
• Patient has uncontrolled HES defined as BOTH of the following (A AND B):
  • A) History of 2 or more flares within the past 12 months, AND
  • B) Pre-treatment blood eosinophil count greater than or equal to 1000 cells/microliter, AND
• Trial and failure, contraindication, or intolerance to ONE of the following (i OR ii):
  • i) Oral corticosteroid therapy (e.g., prednisone), OR
  • ii) Cytotoxic/immunosuppressive therapy (e.g., hydroxyurea, cyclosporine, imatinib), AND
• Nucala is prescribed in combination with baseline HES therapy (e.g., oral corticosteroids, immunosuppressive therapy), AND
• Will not be used in combination with Cinqair, Fasenra, Dupixent, or Xolair
   

Reauthorization Criteria:

For diagnosis of Severe Asthma:

• Dose does not exceed:
  • For 12 years and older: 100 mg administered once every 4 weeks
  • For 6 years to 11 years old: 40 mg administered once every 4 weeks, AND
• Prescribed by or in consultation with a pulmonologist or allergist/immunologist, AND
• Documentation of positive clinical response to therapy (e.g., reduction in exacerbations, improvement in forced expiratory volume in 1 second [FEV1], decreased use of rescue medications), AND
• Patient continues to be treated with an inhaled corticosteroid (ICS) (e.g., fluticasone, budesonide) with or without additional asthma controller medication (e.g., leukotriene receptor antagonist [e.g., montelukast], long-acting beta-2 agonist [LABA] [e.g., salmeterol], tiotropium) unless there is a contraindication or intolerance to these medications, AND
• Will not be used in combination with other biologic medications for severe asthma (e.g., Cinqair (reslizumab), Fasenra (benralizumab), Dupixent (dupilumab), or Xolair (omalizumab))

For diagnosis of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP):

• Dose does not exceed 100 mg administered once every 4 weeks, AND
• Prescribed by or in consultation with an allergist/immunologist, otolaryngologist or pulmonologist, AND
• Documentation of positive clinical response to therapy (e.g., reduced nasal polyp size, reduced need for systemic corticosteroids, improved sense of smell, improved quality of life), AND
• Will use an intranasal corticosteroid in combination with Nucala, AND
• Will not be used in combination with Cinqair, Fasenra, Dupixent, or Xolair

For diagnosis of Eosinophilic Granulomatosis with Polyangiitis (Churg-Strauss, abbreviated EGPA):

• Dose does not exceed 300 mg administered once every 4 weeks (given as 3 separate 100-mg injections), AND
• Prescribed by or in consultation with a pulmonologist, rheumatologist or allergist/immunologist, AND
• Documentation of positive clinical response to therapy (e.g., increase in remission time, reduction in glucocorticoid dose), AND
• Will not be used in combination with Cinqair, Fasenra, Dupixent, or Xolair

For diagnosis of Hypereosinophilic Syndrome (HES):

• Dose does not exceed 300 mg administered once every 4 weeks (given as 3 separate 100-mg injections), AND
• Prescribed by or in consultation with an allergist/immunologist or hematologist, AND
• Documentation of positive clinical response to therapy (e.g., reduction in flares, decreased blood eosinophil count, reduction in corticosteroid dose or other baseline HES therapy), AND
• Used in combination with baseline HES therapy (e.g., oral corticosteroids, immunosuppressive therapy), AND
• Will not be used in combination with Cinqair, Fasenra, Dupixent, or Xolair

Dosing:

For Asthma:

• Adults and Adolescents Aged 12 Years and Older: 100 mg every 4 weeks
• Pediatric Patients Aged 6 to 11 Years: 40 mg every 4 weeks

For CRSwNP:

• 100 mg every 4 weeks

For EGPA:

• 300 mg (3 separate 100-mg injections) every 4 weeks

For HES:

• 300 mg (3 separate 100-mg injections) every 4 weeks

Coverage Duration:

For Asthma:

• Initial: 6 months
• Reauthorization: 1 year

For CRSwNP, EGPA, or HES:

• Initial: 1 year 
• Reauthorization: 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• Nucala Injection Vial: Should be reconstituted and administered by a healthcare professional.  
• Nucala Prefilled Autoinjector and Prefilled Syringe: 
  • The 100-mg/mL prefilled autoinjector and 100-mg/mL prefilled syringe are only for use in adults and adolescents aged 12 years and older
  • The 40-mg/0.4-mL prefilled syringe is only for use in children aged 6 to 11 years and must be administered by the healthcare provider or the patient caregiver
  • Intended for use under the guidance of a healthcare provider.  A patient may self-inject or the patient caregiver may administer Nucala injection subcutaneously after the healthcare provider determines it is appropriate.
• Warnings and precautions include:
  • Hypersensitivity reactions
  • Acute asthma symptoms or deteriorating disease
  • Opportunistic infections: herpes zoster
  • Reduction of corticosteroid dosage
  • Parasitic (helminth) infection

Policy Updates:

• 7/31/2016 – New policy approved by P&T.
• 3/7/2022 – Updates to severe asthma criteria.  Criteria created for CRSwNP, EGPA, and HES indications.
• 6/1/2023 – Criteria updated as a part of a class review for severe asthma medications

References:

• Nucala prescribing information. GlaxoSmithKline LLC. Philadelphia, PA. July 2021. 
• Pavord ID, Korn S, Howarth P, et al. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet. 2012;380: 651-59. 
• 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. 
• Bel EH, Wenzel SE, Thompson PJ, et al. Oral Glucocorticoid-Sparing Effect of Mepolizumab in Eosinophilic Asthma. N Engl J Med. 2014;371:1189-1197. 
• Chung KF, Wenzel SE, Brozek JL, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014;43:343-373. 
• Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention (2020 update). 2020 www.ginasthma.org. Accessed March 2021. 
• Wechsler ME, Akuthota P, Jayne D, et al. Mepolizumab or Placebo for Eosinophilic Granulomatosis with Polyangiitis. N Engl J Med. 2017;376(20):1921-1932. 
• GlaxoSmithKline Press Release. GSK achieves approval for Nucala (mepolizumab) for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA) for adults in the US. Website. Available from: https://www.gsk.com/en-gb/media/press-releases/gsk-achieves-approval-for-nucala-mepolizumab-for-the-treatment-of-eosinophilic-granulomatosis-with-polyangiitis-egpa-for-adults-in-the-us/. Accessed March 11, 2021. 
• ClinicalTrials.gov Web site. https://clinicaltrials.gov/ct2/show/NCT03085797. Accessed August 15, 2021. 
• Peters AT, Spector S, Hsu J, et al. Diagnosis and management of rhinosinusitis: a practice parameter update. Ann Allergy Asthma Immunol. 2014;113(4):347-85. 
• Orlandi RR, Kingdom TT, Hwang PH, et al. International consensus statement on allergy and rhinology: rhinosinusitis. Int Forum Allergy Rhinol. 2016 Feb; Suppl 1:S22-209.