Nucala (mepolizumab)
Indications for Prior Authorization
Nucala (mepolizumab)
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For diagnosis of Severe Eosinophilic Asthma
Indicated for the add-on maintenance treatment of patients with severe asthma aged 6 years and older, and with an eosinophilic phenotype.Limitations of Use: Nucala is not indicated for the relief of acute bronchospasm or status asthmaticus.
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For diagnosis of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
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. -
For diagnosis of Eosinophilic Granulomatosis with Polyangiitis
Indicated for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). -
For diagnosis of Hypereosinophilic Syndrome
Indicated for the treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for greater than or equal to 6 months without an identifiable non-hematologic secondary cause.
Criteria
Nucala
Prior Authorization (Initial Authorization)
Length of Approval: 6 Months [G]
For diagnosis of Severe Asthma
- Diagnosis of severe asthma [1, A] AND
- Asthma is an eosinophilic phenotype as defined by one of the following [1, 3, B]:
- 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
- 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 [2-4, H] OR
- Prior asthma-related hospitalization within the past 12 months
- One of the following [2-4, D]:
- Both of the following:
- Patient is 6 years of age or older but less than 12 years of age AND
- Patient is currently being treated with one of the following unless there is a contraindication or intolerance to these medications:
- Both of the following [4]:
- Medium-dose inhaled corticosteroid (e.g., greater than 100 – 200 mcg fluticasone propionate equivalent/day)
- Additional asthma controller medication (e.g., leukotriene receptor antagonist [LTRA] [e.g., montelukast], long-acting beta-2 agonist [LABA] [e.g., salmeterol], long-acting muscarinic antagonist [LAMA] [e.g., tiotropium])
- One medium dosed combination ICS/LABA product (e.g., Advair Diskus [fluticasone propionate 100mcg/ salmeterol 50mcg], Symbicort [budesonide 80mcg/ formoterol 4.5mcg] Breo Ellipta [fluticasone furoate 50 mcg/ vilanterol 25 mcg])
- Both of the following:
- Patient is 12 years of age or older AND
- Patient is currently being treated with one of the following unless there is a contraindication or intolerance to these medications:
- Both of the following [4]:
- High-dose inhaled corticosteroid (ICS) (e.g., greater than 500 mcg fluticasone propionate equivalent/day)
- Additional asthma controller medication (e.g., leukotriene receptor antagonist [LTRA] [e.g., montelukast], long-acting beta-2 agonist [LABA] [e.g., salmeterol], long-acting muscarinic antagonist [LAMA] [e.g., tiotropium])
- One maximally-dosed combination ICS/LABA product (e.g., Advair [fluticasone propionate 500mcg/ salmeterol 50mcg], Symbicort [budesonide 160mcg/ formoterol 4.5mcg], Breo Ellipta [fluticasone 200mcg/ vilanterol 25mcg])
- Prescribed by or in consultation with one of the following:
- Pulmonologist
- Allergist/Immunologist
Nucala
Prior Authorization (Reauthorization)
Length of Approval: 12 Months
For diagnosis of Severe Asthma
- Patient demonstrates positive clinical response to therapy (e.g., reduction in exacerbations, improvement in forced expiratory volume in 1 second [FEV1], decreased use of rescue medications) [C] 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 [LTRA] [e.g., montelukast], long-acting beta-2 agonist [LABA] [e.g., salmeterol], long-acting muscarinic antagonist [LAMA] [e.g., tiotropium]) unless there is a contraindication or intolerance to these medications AND
- Prescribed by or in consultation with one of the following:
- Pulmonologist
- Allergist/Immunologist
Nucala
Prior Authorization (Initial Authorization)
Length of Approval: 12 Month(s)
For diagnosis of Chronic rhinosinusitis with nasal polyps (CRSwNP)
- Diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP) AND
- Patient is 18 years of age or older AND
- Unless contraindicated, the patient has had an inadequate response to 2 months of treatment with an intranasal corticosteroid (e.g., fluticasone, mometasone) [10, 11] AND
- Used in combination with another agent for CRSwNP [J] AND
- Prescribed by or in consultation with one of the following:
- Allergist/Immunologist
- Otolaryngologist
- Pulmonologist
Nucala
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of Chronic rhinosinusitis with nasal polyps (CRSwNP)
- Patient demonstrates positive clinical response to therapy (e.g., reduction in nasal polyps score [NPS; 0-8 scale], improvement in nasal obstruction symptoms via visual analog scale [VAS; 0-10 scale]) AND
- Used in combination with another agent for CRSwNP [J] AND
- Prescribed by or in consultation with one of the following:
- Allergist/Immunologist
- Otolaryngologist
- Pulmonologist
Nucala
Prior Authorization (Initial Authorization)
Length of Approval: 12 Months
For diagnosis of Eosinophilic Granulomatosis with Polyangiitis (EGPA)
- Diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA) AND
- Patient's disease has relapsed or is refractory to standard of care therapy (i.e., corticosteroid treatment with or without immunosuppressive therapy) [F, 7] AND
- Patient is currently receiving corticosteroid therapy (e.g., prednisolone, prednisone) unless there is a contraindication or intolerance to corticosteroid therapy [F, 7] AND
- Prescribed by or in consultation with one of the following:
- Pulmonologist
- Rheumatologist
- Allergist/Immunologist
Nucala
Prior Authorization (Reauthorization)
Length of Approval: 12 Months
For diagnosis of Eosinophilic Granulomatosis with Polyangiitis (EGPA)
- Patient demonstrates positive clinical response to therapy (e.g., increase in remission time)
Nucala
Prior Authorization (Initial Authorization)
Length of Approval: 12 Months
For diagnosis of Hypereosinophilic Syndrome (HES)
- Diagnosis of hypereosinophilic syndrome (HES) AND
- Patient is 12 years of age or older 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:
- History of 2 or more flares within the past 12 months [I]
- Pre-treatment blood eosinophil count greater than or equal to 1000 cells/microliter
- Trial and failure, contraindication, or intolerance to one of the following:
- Corticosteroid therapy (e.g., prednisone)
- Cytotoxic/immunosuppressive therapy (e.g., hydroxyurea, cyclosporine, imatinib)
- Prescribed by or in consultation with one of the following:
- Allergist/Immunologist
- Hematologist
Nucala
Prior Authorization (Reauthorization)
Length of Approval: 12 Months
For diagnosis of Hypereosinophilic Syndrome (HES)
- Patient demonstrates positive clinical response to therapy (e.g., reduction in flares, decreased blood eosinophil count, reduction in corticosteroid dose)
P & T Revisions
2024-11-07, 2024-10-01, 2024-05-21, 2023-10-03, 2023-04-24, 2022-07-27, 2022-07-04, 2022-03-03, 2021-09-16, 2021-05-21, 2021-03-12, 2020-12-01, 2020-02-07, 2019-10-30, 2019-07-29
References
- Nucala prescribing information. GlaxoSmithKline LLC. Philadelphia, PA. March 2023.
- 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.
- Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention (2023 update). 2023 www.ginasthma.org. Accessed April 20234
- 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.
End Notes
- Patients included across the 3 pivotal studies (DREAM, MENSA, and SIRIUS) [2-4] were characterized with clinical features of severe refractory asthma per American Thoracic Society (ATS) criteria [5]. Per the ATS: "Severe asthma is defined as asthma which requires treatment with high dose inhaled corticosteroids (ICS) plus a second controller (and/or systemic corticosteroids) to prevent it from becoming ‘uncontrolled’ or which remains ‘uncontrolled’ despite this therapy.’’ This definition includes patients who received an adequate trial of these therapies in whom treatment was stopped due to lack of response. In patients greater than 6 years of age, ‘‘Gold Standard/International Guidelines treatment’’ is high dose ICS plus a long-acting beta 2-agonist (LABA), leukotriene modifier or theophylline and/or continuous or near continuous systemic corticosteroids as background therapy."
- Inclusion criteria was modified from the DREAM study to the MENSA study to be limited to patients with eosinophils greater than or equal to 150 cells/mcL in the peripheral blood at screening or greater than or equal to 300 cells/mcL at some time during the previous year [3].
- The primary endpoint for the DREAM and MENSA studies was the annual rate of clinically significant asthma exacerbations as a composite of the required use of systemic corticosteroids for at least 3 days, admission, or ED visit. Both studies showed mepolizumab-treated patients experienced a significant improvement in exacerbation rates compared with baseline and compared with placebo. [2, 3]
- The Global Initiative for Asthma (GINA) Global Strategy for Asthma Management and Prevention update lists anti-interleukin- 5 treatment or anti-interleukin 5 receptor treatment as an add on option for patients with severe eosinophilic asthma that is uncontrolled on two or more controllers plus as-needed reliever medication (Step 4-5 treatment). [6]
- Asthma treatment can often be reduced, once good asthma control has been achieved and maintained for three months and lung function has hit a plateau. However the approach to stepping down will depend on patient specific factors (e.g., current medications, risk factors). At this time evidence for optimal timing, sequence and magnitude of treatment reductions is limited. It is feasible and safe for most patients to reduce the ICS dose by 25-50% at three month intervals, but complete cessation of ICS is associated with a significant risk of exacerbations [6].
- Nucala was approved for Eosinophilic Granulomatosis with Polyangiitis (EGPA) based on the results from the pivotal, 52-week, Phase III MIRRA study. MIRRA looked at the efficacy and safety of 300 mg of mepolizumab administered SQ every four weeks versus placebo as add-on therapy to standard of care (corticosteroids plus or minus immunosuppressants) in 136 patients with relapsing and/or refractory EGPA. MIRRA reported statistically significant outcomes with both co-primary endpoints (i.e., accrued time in remission and proportion of patients achieving remission) in favor of the treatment group [7, 8].
- The GINA Global Strategy for Asthma Management and Prevention update recommends that patients with asthma should be reviewed regularly to monitor their symptom control, risk factors and occurrence of exacerbations, as well as to document the response to any treatment changes. Ideally, response to Type 2-targeted therapy should be re-evaluated every 3-6 months, including re-evaluation of the need for ongoing biologic therapy for patients with good response to Type 2 targeted therapy. [6]
- Per P&T Committee, February 2019, revised exacerbation requirement to mirror other IL-5 antagonists.
- Historical flares were defined as a worsening of HES-related clinical symptoms or a blood eosinophil count requiring an escalation in therapy. [1]
- Other agents used for CRSwNP include intranasal corticosteroids and nasal saline.
Revision History
- 2024-11-07: EPGA: addition of bypass for C/I to corticosteroid therapy in line with fasenra criteria.
- 2024-10-01: Addition of age criterion for CRSwNP & HES.
- 2024-05-21: 2024 annual review. Background changes. Updated criteria language and formatting for asthma indication to align with other drugs within the class, including splitting the age criterion into two: a) 6-11 yrs old b)12 yrs plus, to allow for differences in optimal treatment.
- 2023-10-03: Program update to standard reauthorization language. No changes to clinical intent
- 2023-04-24: 2023 UM Annual Review. No criteria changes. Background updates
- 2022-07-27: Updated severe asthma criteria.
- 2022-07-04: Addition of 40 mg strength for asthma
- 2022-03-03: Updated criteria/examples to align all asthma mABs class criteria. Updated reauth criteria to req an ICS only.
- 2021-09-16: Added criteria for new CRSwNP indication
- 2021-05-21: Addition of EHB formulary to guideline, no changes to criteria
- 2021-03-12: Annual review; updated criteria
- 2020-12-01: Added criteria for new Hypereosinophilic Syndrome (HES) indication
- 2020-02-07: Annual review; updated criteria
- 2019-10-30: Revised guideline to add new expanded age indication.
- 2019-07-29: August P&T auto-update to add new self-injectable GPIs: 4460405500D530, 4460405500E530 to existing criteria. No changes to criteria. Updated background and references. AJL 7/29/19
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