Pharmacy Prior Authorization Criteria

Cinqair (reslizumab)

Indications for Prior Authorization

Cinqair (reslizumab)

• For diagnosis of Severe Eosinophilic Asthma
  Indicated for the add-on maintenance treatment of patients with severe asthma aged 18 years and older with an eosinophilic phenotype.

  Limitation of Use: Cinqair is not indicated for treatment of other eosinophilic conditions; Cinqair is not indicated for the relief of acute bronchospasm or status asthmaticus.

Criteria

Cinqair

Prior Authorization (Initial Authorization)

Length of Approval: 6 Months [H]

• Diagnosis of severe asthma [1]
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 [1, B, D]
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 [A]
OR
• Prior asthma-related hospitalization within the past 12 months [D]
AND
• Age greater than or equal to 18 years
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 [C, E, F]:
• 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

Cinqair

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• 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

P & T Revisions

2024-05-10, 2023-09-13, 2023-04-24, 2022-04-15, 2022-03-03, 2021-09-27, 2021-05-20, 2021-03-11, 2020-02-06

References

1. Cinqair Prescribing Information. Teva Respiratory, LLC. Frazer, PA. June 2020.
2. Castro M, Zangrilli J, Wechsler ME, et al. Reslizumab for inadequately controlled asthma with elevated blood eosinophil counts: results from two multicentre, parallel, doubleblind, randomised, placebo-controlled, phase 3 trials. Lancet Respir Med. 2015;3(5):355-366.
3. Bjermer L, Lemiere C, Maspero J, et al. A randomized phase 3 study of the efficacy and safety of reslizumab in subjects with asthma with elevated eosinophils. Eur Respir J. 2014;44(Suppl 58):P299. Paper presented at: European Respiratory Society International Congress; September 6-10, 2014; Munich, Germany.
4. 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.
5. 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.
6. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention (2022 update). 2022 www.ginasthma.org. Accessed 9 April, 2024.
7. Per clinical consult with allergist specialist. May 4, 2016.
8. 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 9 April, 2024.

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End Notes

1. In two duplicate 52-week Phase III studies, eligible patients were required to have experienced at least one asthma exacerbation that required a systemic corticosteroid for at least 3 days within the past 12 months. [2, 3]
2. 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. [8]
3. The ERS/ATS guidelines define severe asthma as that which requires treatment with high-dose ICSs plus a second controller (or systemic corticosteroids [CSs]) to prevent progression to uncontrolled disease status or continuing uncontrolled disease status despite this therapy. [4]
4. Recommended per 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.
5. In the pivotal study for Nucala (mepolizumab), another IL-5 antagonist indicated for severe eosinophilic asthma, patients met the inclusion criteria with a well-documented requirement for regular treatment with high dose ICS (i.e., greater than or equal to 880 mcg/day fluticasone propionate or equivalent daily), with or without maintenance oral corticosteroids, in the 12 months prior to Visit 1. [5]
6. 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]
7. 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].
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]

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Revision History

• 2024-05-10: 2024 Annual Review. Background updates. Updated criteria language in line with other drugs in same class.
• 2023-09-13: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-04-24: 2023 UM Annual Review. No criteria changes. Background updates
• 2022-04-15: Annual Review, updated initial auth exacerbation criteria.
• 2022-03-03: Updated criteria/examples to align with asthma mABs class. Updated reauth criteria to req an ICS only.
• 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-20: Addition of EHB formulary to guideline, no changes to criteria
• 2021-03-11: Annual Review; updated criteria and references
• 2020-02-06: Annual Review; updated criteria

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