Asset Publisher

ph-90650

print Print Back Back

Tezspire™ (tezepelumab-ekko)

Policy Number: PH-90650

Subcutaneous

Last Review Date: 10/03/2024

Date of Origin: 02/01/2022

Dates Reviewed: 02/2022, 07/2022, 10/2022, 03/2023, 10/2023, 10/2024

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

Initial coverage will be provided for 6 months and may be renewed annually thereafter.

  1. Dosing Limits

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

  • Tezspire 210 mg single-dose prefilled pen: 1 pen every 4 weeks
  • Tezspire 210 mg single-dose prefilled syringe: 1 syringe every 4 weeks
  • Tezspire 210 mg single-dose vial: 1 vial every 4 weeks

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

  • 210 billable units (210 mg) every 4 weeks
  1. Initial Approval Criteria 1

Coverage is provided in the following conditions:

  • Patient is at least 12 years of age; AND

Universal Criteria 1

  • Will not be used in combination with other anti-IgE, anti-IL4, or anti-IL5 monoclonal antibody agents (e.g., benralizumab, omalizumab, mepolizumab, reslizumab, dupilumab, etc.); AND
  • Will not be administered concurrently with live vaccines; AND
  • Will NOT be used for the relief of acute bronchospasm or status asthmaticus; AND

Severe Asthma † 1-5,8-11

For PEEHIP Member Only:

            1. If the patient has a diagnosis of allergic type asthma:
              1. The patient must have tried and had an inadequate response to Xolair used for a minimum of 4 months for the treatment of allergic asthma; OR
              2. The patient has an intolerance or hypersensitivity, or an FDA labeled contraindication to Xolair; OR
            2. If the patient has a diagnosis of oral corticosteroid dependent type asthma:
              1. The patient has tried and had an inadequate response to Dupixent used for a minimum of 4 months for the treatment of asthma; OR
              2. The patient has an intolerance or hypersensitivity, or an FDA labeled contraindication to Dupixent; OR
            3. If the patient has a diagnosis of eosinophilic type asthma:
              1. The patient has tried and had an inadequate response to Dupixent AND an IL-5 inhibitor (e.g., Fasenra, Nucala) used for a minimum of 4 months for the treatment of asthma; OR
              2. The patient has an intolerance or hypersensitivity, or FDA labeled contraindication to Dupixent AND an IL-5 inhibitor; AND

  • Patient has severe* disease; AND
  • Will 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, long-acting muscarinic agent, leukotriene modifiers, etc.); AND
  • Patient must have had two or more exacerbations in the previous year requiring oral or injectable corticosteroid treatment (in addition to the regular maintenance therapy defined above) OR one exacerbation resulting in a hospitalization; 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):4,5

  • 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 1-3,8

Coverage may be renewed based upon the following criteria:

  • 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: parasitic (helminth) infection, severe hypersensitivity reactions (e.g., rash and allergic conjunctivitis), etc.; AND
  • Improvement in asthma symptoms or asthma exacerbations as evidenced by 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

Administer 210 mg subcutaneously once every 4 weeks.

NOTE:

  • Tezspire single-dose vial and pre-filled syringe are intended for administration by a healthcare provider.
  • Tezspire single-dose pre-filled pen can be administered by patients or caregivers after proper training in subcutaneous injection technique and after the healthcare provider determines it is appropriate.
  1. Billing Code/Availability Information

HCPCS Code:

  • J2356 – Injection, tezepelumab-ekko, 1 mg; 1 billable unit = 1 mg

 

NDC:

  • Tezspire 210 mg/1.91 mL single-dose prefilled pen: 55513-0123-xx
  • Tezspire 210 mg/1.91 mL single-dose prefilled syringe: 55513-0112-xx
  • Tezspire 210 mg/1.91 mL single-dose vial: 55513-0100-xx
  1. References
  1. Tezspire [package insert]. Sodertalje, Sweden; AstraZeneca AB; May 2023. Accessed August 2024.
  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). 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.
  2. 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.
  3. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. 2021 Update. Available from: http://www.ginasthma.org. Accessed December 2021.
  4. Menzies-Gow A, Corren J, Bourdin A, et al. Tezepelumab in Adults and Adolescents with Severe, Uncontrolled Asthma. N Engl J Med. 2021 May 13;384(19):1800-1809. doi: 10.1056/NEJMoa2034975.
  5. Menzies-Gow A, Colice G, Griffiths JM, et al. NAVIGATOR: a phase 3 multicentre, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma. Respir Res. 2020 Oct 13;21(1):266. doi: 10.1186/s12931-020-01526-6.
  6. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. 2022 Update. Available from: http://www.ginasthma.org. Accessed September 2023.
  7. 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
  8. Global Initiative for Asthma (GINA) Report: Global Strategy for Asthma Management and Prevention. 2024 Update. Available from: http://www.ginasthma.org. Accessed August 2024.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

J45.50

Severe persistent asthma, uncomplicated

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

The preceding information is intended for non-Medicare coverage determinations. 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 Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied 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

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA

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