Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Tezspire (Tezepelumab) requires prior authorization.

2)      Tezspire is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.

Initial Approval Criteria A. Severe Asthma (must meet all):

1. Diagnosis of asthma;

2. Prescribed by or in consultation with an allergist, immunologist, or pulmonologist;

3. Age ≥ 12 years;

4. Member has experienced ≥ 2 exacerbations with in the last 12 months, requiring any of the following despite adherent use of controller therapy (i.e., medium- to high-dose inhaled corticosteroid [ICS] plus either a long acting beta-2 agonist [LABA] or leukotriene modifier [LTRA] if LABA contraindication/intolerance):

a. Oral/systemic corticosteroid treatment (or increase in dose if already on oral corticosteroid);

b. Urgent care visit or hospital admission;

c. Intubation;

5. Tezspire is prescribed concurrently with an ICS plus either a LABA or LTRA;

6. Tezspire is not prescribed concurrently with Cinqair®, Dupixent®, Fasenra®, Nucala®, or Xolair®;

7. Dose does not exceed 210 mg every 4 weeks.

Approval duration: 6 months

Continued Therapy

A. Severe Asthma (must meet all):

1. Currently receiving medication via Centene benefit or member has previously met initial approval criteria;

2. Demonstrated adherence to asthma controller therapy (an ICS plus either a LABA or LTRA) as evidenced by proportion of days covered (PDC) of 0.8 in the last 6 months (i.e., member has received asthma controller therapy for at least 5 of the last 6 months);

3. Member is responding positively to therapy (examples may include but are not limited to: reduction in exacerbations or corticosteroid dose, improvement in forced expiratory volume over one second since baseline, reduction in the use of rescue therapy);

4. Tezspire is not prescribed concurrently with Cinqair, Dupixent, Fasenra, Nucala, or Xolair;

5. If request is for a dose increase, new dose does not exceed 210 mg every 4 weeks.

Approval duration: 6 months or member’s renewal period, whichever is longer

Codes Used In This BI:

1)    J2356 – Injection, Tezepelumab-ekko, 1mg

1. Tezspire Prescribing Information. Thousand Oaks, CA: Amgen; December 2021. Available at: https://www.pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-com/tezspire/tezspire_pi_hcp_english.ashx. Accessed January 10, 2022.

2. Corren J, Parnes JR, Wang L, et al. Tezepelumab in Adults with Uncontrolled Asthma. N Engl J Med 2017;377:936-46.

3. Menzies-Gow A, Corren J, Bourdin A, et al. Tezepelumab in Adults and Adolescents with Severe, Uncontrolled Asthma. N Engl J Med 2021;384:1800-9.

4. National Asthma Education and Prevention Program: Expert panel report III: Guidelines for the diagnosis and management of asthma. Bethesda, MD: National Heart, Lung, and Blood Institute, 2007. (NIH publication no. 08-4051). Available at http://www.nhlbi.nih.gov/health-pro/guidelines/current/asthma-guidelines. Accessed September 21, 2021.

5. Cloutler MM, Dixon AE, Krishnan JA, et al. Managing asthma in adolescents and adults 2020: asthma guideline update from the National Asthma Education and Prevention Program. JAMA. 2020; 324: 2301-2317.

6. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2021. Available at: http://www.clinicalpharmacology.com. Accessed September 24, 2021.

7. Global Initiative for Asthma. Global strategy for asthma management and prevention (2021 report). Available from: www.ginasthma.org. Accessed September 21, 2021.