Pharmacy Prior Authorization Criteria

Fasenra (benralizumab)

Indications for Prior Authorization

Fasenra (benralizumab)

• For diagnosis of Severe 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: Fasenra is not indicated for treatment of other eosinophilic conditions. Fasenra is not indicated for the relief of acute bronchospasm or status asthmaticus.

• For diagnosis of Eosinophilic Granulomatosis with Polyangiitis:
  Indicated for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).

Criteria

Fasenra

Prior Authorization (Initial Authorization)

Length of Approval: 6 Months [F]
For diagnosis of Severe Asthma

• Diagnosis of severe asthma
AND
• Asthma is an eosinophilic phenotype as defined by a baseline (pre-treatment) peripheral blood eosinophil level greater than or equal to 150 cells per microliter [5, B, F]
AND
• 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, 3, B]
OR
• Prior asthma-related hospitalization within the past 12 months [C]
AND
• One of the following:
• 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 [A, 4, 5]:
• 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])
OR
• 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])
OR
• 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, 5, A]:
• 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])
OR
• 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])
AND
• Prescribed by or in consultation with one of the following:
• Pulmonologist
• Allergist/Immunologist

Fasenra

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)
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

Fasenra

Prior Authorization (Initial Authorization)

Length of Approval: 12 Months
For diagnosis of Eosinophilic Granulomatosis with Polyangiitis

• 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)
AND
• Patient is currently receiving corticosteroid therapy (e.g., prednisolone, prednisone) unless there is a contraindication or intolerance to corticosteroid therapy 
AND
• Prescribed by or in consultation with one of the following:
• Pulmonologist
• Rheumatologist
• Allergist/Immunologist

Fasenra

Prior Authorization (Reauthorization)

Length of Approval: 12 Months
For diagnosis of Eosinophilic Granulomatosis with Polyangiitis

• Patient demonstrates positive clinical response to therapy (e.g., increase in remission time)

P & T Revisions

2024-11-07, 2024-06-04, 2024-05-10, 2023-08-22, 2023-04-24, 2022-06-28, 2022-05-04, 2022-03-03, 2021-03-12, 2020-02-06, 2019-11-25

References

1. Fasenra Prescribing Information. AstraZeneca Pharmaceuticals LP. Wilmington, DE. April 2024.
2. FitzGerald JM, Bleecker ER, Nair P, et al. Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016 Oct 29;388(10056):2128-2141.
3. Bleecker ER, FitzGerald JM, Chanez P, et al. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting Beta two agonist (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016 Oct 29;388(10056):2115-2127.
4. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention (2023 update). 2023 www.ginasthma.org. Accessed April 2024.
5. Nair P, Wenzel S, Rabe KF, et al. ZONDA Trial Investigators. Oral glucocorticoid-sparing effect of benralizumab in severe asthma. N Engl J Med. 2017;376(25):2448-2458.
6. Institute for Clinical and Economic Review (ICER). Biologic therapies for treatment of asthma associated with type 2 inflammation: effectiveness, value, and value-based price benchmarks. https://icer.org/wp-content/uploads/2020/10/ICER_Asthma-Final-Report_Unredacted_08122020.pdf. Published December 20, 2018. Accessed April 15, 2022.
7. Wedner HJ, Fujisawa T, Guilbert TW, Ikeda M, Mehta V, Tam JS, Lukka PB, Asimus S, Durżyński T, Johnston J, White WI, Shah M, Werkström V, Jison ML; all TATE investigators. Benralizumab in children with severe eosinophilic asthma: Pharmacokinetics and long-term safety (TATE study). Pediatr Allergy Immunol. 2024 Mar;35(3):e14092.

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End Notes

1. 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). [5]
2. The SIROCCO and CALIMA trials evaluated the effect of benralizumab 30mg administered in 4 week and 8 week regimens as add on therapy to standard of care medicine. The trials enrolled patients 12 to 75 years of age with severe asthma defined as a history of two or more exacerbations in the previous year which needed systemic corticosteroids or a temporary increase in the patient's usual maintenance dose of oral corticosteroids. Patients were also required to have received treatment with a medium dose or high dose ICS plus LABA for at least one year before enrollment. Both trials confirmed benralizumab significantly reduced the annual exacerbation rates and was generally well tolerated in patients who were uncontrolled on high dose ICS plus LABA and had a baseline blood eosinophil count of 300 cells per microliter or greater [2, 3]. The baseline eosinophil level requirement of greater than or equal to 150 cells per microliter and the requirement for a history of one or more exacerbations listed in the criteria comes from the inclusion criteria allowed in the ZONDA trial. The ZONDA trial was a 28-week, Phase 3, randomized, double blind, placebo controlled, multicenter, oral corticosteroid reduction trial [6].
3. Recommendation inferred from the national P&T committee meeting, December 2015, regarding similar agent first-in-class IL-5 antagonist Nucala (mepolizumab) in the use of severe eosinophilic asthma.
4. 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 [5].
5. 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. [5]
6. The Institute for Clinical and Economic Review (ICER) defines eosinophilic inflammation as a blood eosinophil level greater than or equal to 150 cells per microliter at initiation of therapy. This is the lowest measured threshold for eosinophilic asthma in pivotal trials. [7]

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Revision History

• 2024-11-07: Addition of PA criteria for new indication EPGA.
• 2024-06-04: Addition of new 10 mg/0.5mL prefilled syringe.
• 2024-05-10: 2024 annual review. Background changes. Updated guideline to align with approved age expansion to 6 years plus. 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.
• 2023-08-22: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-04-24: 2023 UM Annual Review. No criteria changes. Background updates
• 2022-06-28: Annual Review, updated initial auth exacerbation criteria.
• 2022-05-04: Annual Review, updated initial auth exacerbation criteria.
• 2022-03-03: Updated criteria/examples to align all asthma mABs class criteria. Updated reauth criteria to req an ICS only.
• 2021-03-12: Annual Review; updated criteria and references
• 2020-02-06: Annual review; updated criteria
• 2019-11-25: Updated guideline to include new autoinjector pen.

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