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ph-0273

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Cinqair® (reslizumab)

Policy Number: PH-0273

Intravenous

 

Last Review Date: 10/03/2023

Date of Origin: 05/31/2016

Dates Reviewed: 05/2016, 06/2017, 09/2017, 12/2017, 03/2018, 06/2018, 10/2018, 10/2019, 10/2020, 10/2021, 10/2022, 10/2023

FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.

  1. Length of Authorization

Coverage is provided for 6 months and may be renewed.

  1. Dosing Limits

A. Quantity Limit (max daily dose) [NDC unit]:

  • Cinqair 100 mg single-use vial: 4 vials every 28 days

B. Max Units (per dose and over time) [HCPCS Unit]:

  • 400 billable units every 4 weeks
  1. Initial Approval Criteria 1

For PEEHIP Members ONLY:

  • Nucala is the preferred interleukin-5 receptor product. Cinqair is a non-covered product for new to therapy members and will be non-covered for current patients after precertification expires. Patients currently on Cinqair may complete their current course of treatment for the duration of the current precertification period; upon precertification renewal or restarting therapy, transition to the preferred product is required.

Coverage is provided in the following conditions:

  • Patient is at least 18 years of age; AND

Universal Criteria 1

  • Will not be used in combination with other anti-IgE, anti-IL4, anti-IL5, or IgG2 lambda monoclonal antibody agents (e.g., omalizumab, mepolizumab, benralizumab, dupilumab, tezepelumab, etc.); AND
  • Must NOT be used for either of the following:
    • Treatment of other eosinophilic conditions (e.g., allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome, etc.)
    • Relief of acute bronchospasm or status asthmaticus; AND

Severe Asthma † 1,2,5-7,9,10

  • Patient must have severe* disease; AND
  • Patient must have asthma with an eosinophilic phenotype indicated by blood eosinophils ≥ 400 cells/μL within 4 weeks of dosing; AND
  • Must be used for add-on maintenance treatment in patients regularly receiving BOTH of the following:
    • Medium to high-dose inhaled corticosteroids; AND
    • An additional controller medication (e.g., long acting beta agonist, leukotriene modifiers, etc.); AND
  • Patient must have two or more exacerbations in the previous year requiring daily oral corticosteroids for at least 3 days (in addition to the regular maintenance therapy defined above); AND
  • Baseline measurement of at least one of the following for assessment of clinical status:
    • Use of systemic corticosteroids
    • Use of inhaled corticosteroids
    • Number of hospitalizations, ER visits, or unscheduled visits to healthcare provider due to condition
    • Forced expiratory volume in 1 second (FEV1)

*Components of severity for classifying asthma as severe may include any of the following (not all inclusive):2,7

  • Symptoms throughout the day
  • Nighttime awakenings, often 7x/week
  • SABA use for symptom control occurs several times per day
  • Extremely limited normal activities
  • Lung function (percent predicted FEV1) <60%
  • Exacerbations requiring oral systemic corticosteroids are generally more frequent and intense relative to moderate asthma

FDA approved Indication(s); Compendia Recommended Indication(s); Ф Orphan Drug

  1. Renewal Criteria 1,5,6
  • Patient continues to meet the universal and other indication-specific relevant criteria identified in section III; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: malignancy, parasitic (helminth) infection, and anaphylaxis (e.g., dyspnea, decreased oxygen saturation, wheezing, vomiting, skin and mucosal involvement, urticaria), etc.; AND
    • Improvement in asthma symptoms or asthma exacerbations as evidenced by a decrease in one or more of the following:
      • Use of systemic corticosteroids
      • Two-fold or greater decrease in inhaled corticosteroid use for at least 3 days
      • Hospitalizations
      • ER visits
      • Unscheduled visits to healthcare provider; OR
  • Improvement from baseline in forced expiratory volume in 1 second (FEV1)
  1. Dosage/Administration 1

Indication

Dose

Severe Asthma with an eosinophilic phenotype

Administer 3 mg/kg via intravenous infusion every 4 weeks

  1. Billing Code/Availability Information

HCPCS code:

  • J2786 - Injection, reslizumab, 1 mg: 1 billable unit = 1 mg

NDC:

  • Cinqair 100 mg/10 mL single-use vial: 59310-0610-xx
  1. References
  1. Cinqair [package insert]. West Chester, PA; Teva Respiratory, LLC; June 2020. Accessed September 2023.
  2. National Asthma Education and Prevention Program (NAEPP). Guidelines for the diagnosis and management of asthma. Expert Panel Report 3. Bethesda, MD: National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI); August 2007.
  3. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. 2020 Update. Available from: http://www.ginasthma.org. Accessed September 2020.
  1. Castro M, Zangrilli J, Wechsler ME, et al. Reslizumab for inadequately controlled asthma with elevated blood eosinophil counts: results from two multicentre, parallel, double blind, randomised, placebo-controlled, phase 3 trials. Lancet Respir Med 2015;3:355-66.
  2. 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.
  3. Holguin F, Cardet JC, Chung KF, et al. Management of severe asthma: a European

Respiratory Society/American Thoracic Society guideline. Eur Respir J 2020; 55: 1900588 [https://doi.org/10.1183/13993003.00588-2019].

  1. National Asthma Education and Prevention Program (NAEPP). 2020 Focused Updates to the Asthma Management Guidelines: A Report from the National Asthma Education and Prevention Program Coordinating Committee Expert Panel Working Group. Bethesda, MD: National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI); December 2020.
  2. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. 2021 Update. Available from: http://www.ginasthma.org. Accessed August 2021.
  3. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. 2022 Update. Available from: http://www.ginasthma.org. Accessed September 2023.
  4. Global Initiative for Asthma (GINA) Report: Global Strategy for Asthma Management and Prevention. 2023 Update. Available from: http://www.ginasthma.org/2023-gina-main-report. Accessed September 2023.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

J45.50

Severe persistent asthma, uncomplicated

J82.81

Eosinophilic pneumonia, NOS

J82.82

Acute eosinophilic pneumonia

J82.83

Eosinophilic asthma

J82.89

Other pulmonary eosinophilia, not elsewhere classified

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC

 

 

 

CINQAIR® (reslizumab) Prior Auth Criteria
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