Tezepelumab-ekko (Tezspire) Form

Tezepelumab-ekko (Tezspire™) is human monoclonal antibody (IgG2λ) that functions as a thymic stromal lymphopoietin blocker. FDA Approved Indication(s) Tezspire is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. Limitation(s) of use: Tezspire is not indicated for the relief of acute bronchospasm or status asthmaticus. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Tezspire is medically necessary when the following criteria are met:
I. 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;
2. 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®;

3. Dose does not exceed 210 mg every 4 weeks. Approval duration: 6 months
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   CLINICAL POLICY Tezepelumab-ekko B. Other diagnoses/indications (must meet 1 or 2):

4. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
5. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Severe Asthma (must meet all):
6. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
7. 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);
8. 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);
9. Tezspire is not prescribed concurrently with Cinqair, Dupixent, Fasenra, Nucala, or Xolair;
10. If request is for a dose increase, new dose does not exceed 210 mg every 4 weeks. Approval duration:
    Medicaid/HIM – 12 months
    Commercial – 6 months or member’s renewal period, whichever is longer B. Other diagnoses/indications (must meet 1 or 2):

11. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): Page 2 of 8

    CLINICAL POLICY Tezepelumab-ekko a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

12. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
    III. Diagnoses/Indications for which coverage is NOT authorized:
    A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid or evidence of coverage documents; B. Acute bronchospasm or status asthmaticus. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration GINA: Global Initiative for Asthma ICS: inhaled corticosteroid LABA: long-acting beta2 agonist
    LTRA: leukotriene modifier
    PDC: proportion of days covered Appendix B: Therapeutic Alternatives
    This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
    Drug Name Dosing Regimen Dose Limit/ Maximum Dose ICS (medium – high dose) Qvar (beclomethasone) > 200 mcg/day 4 actuations BID 40 mcg, 80 mcg per actuation 1-4 actuations BID budesonide (Pulmicort) > 400 mcg/day 2 actuations BID Alvesco (ciclesonide) Flovent (fluticasone propionate) 90 mcg, 180 mcg per actuation 2-4 actuations BID

    160 mcg/day 80 mcg, 160 mcg per actuation 1-2 actuations BID 250 mcg/day 44-250 mcg per actuation 2-4 actuations BID 2 actuations BID 2 actuations BID Page 3 of 8

    CLINICAL POLICY Tezepelumab-ekko Drug Name Dosing Regimen Arnuity Ellipta (fluticasone furoate) 200 mcg/day
    100 mcg, 200 mcg per actuation 1 actuation QD Asmanex (mometasone) > 200 mcg/day Dose Limit/ Maximum Dose 1 actuation QD 2 inhalations BID HFA: 100 mcg, 200 mcg per actuation Twisthaler: 110 mcg, 220 mcg per actuation 1-2 actuations QD to BID LABA Serevent (salmeterol) 50 mcg per dose 1 inhalation BID Combination products (ICS + LABA) Dulera (mometasone/ formoterol) Breo Ellipta (fluticasone/vilanterol) Advair (fluticasone/ salmeterol) 100/5 mcg, 200/5 mcg per actuation 2 actuations BID 100/25 mcg, 200/25 mcg per actuation 1 actuation QD Diskus: 100/50 mcg, 250/50 mcg, 500/50 mcg per actuation HFA: 45/21 mcg, 115/21 mcg, 230/21 mcg per actuation 1 actuation BID 55/13 mcg, 113/14 mcg, 232/14 mcg per actuation 1 actuation BID 80 mcg/4.5 mcg, 160 mcg/4.5 mcg per actuation 2 actuations BID fluticasone/salmeterol (Airduo RespiClick®) Symbicort (budesonide/ formoterol)
    1 inhalation BID 4 actuations per day 1 actuation QD 1 actuation BID 1 actuation BID 2 actuations BID 10 to 20 mg PO BID 1,200 mg PO BID 600 mg PO QID 10 mg per day 40 mg per day 2,400 mg per day 2,400 mg per day LTRA montelukast (Singulair) 4 to 10 mg PO QD zafirlukast (Accolate) zileuton ER (Zyflo CR) Zyflo (zileuton) Oral corticosteroids dexamethasone (Decadron) methylprednisolone (Medrol) prednisolone (Millipred, Orapred ODT) prednisone (Deltasone) Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. 0.75 to 9 mg/day PO in 2 to 4 divided doses 40 to 80 mg PO in 1 to 2 divided doses Varies 40 to 80 mg PO in 1 to 2 divided doses Varies 40 to 80 mg PO in 1 to 2 divided doses Varies Varies Page 4 of 8

    CLINICAL POLICY Tezepelumab-ekko Appendix C: Contraindications/Boxed Warnings • Contraindication(s): known hypersensitivity to tezepelumab-ekko or excipients • Boxed warning(s): none Appendix D: General Information
    • The phase 3 pivotal study for Tezspire, NAVIGATOR, required a history of 2 or more asthma exacerbations requiring oral or injectable corticosteroid treatment or resulting in hospitalization in the past 12 months. The primary endpoint of reduction in the annualized asthma exacerbation rate at 52 weeks was met, with a 56% decrease compared with placebo. Patients were required to have been on regular treatment with medium or high-dose ICS and at least one additional asthma controller, with or without oral corticosteroids. Patients continued background asthma therapy throughout the duration of the trial. • The definition of the primary endpoint marker of clinically significant asthma exacerbation was defined as worsening of asthma requiring the use of or increase in oral or injectable corticosteroids for at least 3 days, or a single depo-injection of corticosteroids, and/or emergency department visits requiring use of oral or injectable corticosteroids and/or hospitalization. • The Global Initiative for Asthma (GINA) guidelines recommend Tezspire be considered as adjunct therapy for patients 12 years of age and older with uncontrolled severe asthma despite optimized maximal therapy.
    • PDC is a measure of adherence. PDC is calculated as the sum of days covered in a time frame divided by the number of days in the time frame. To achieve a PDC of 0.8, a member must have received their asthma controller therapy for 144 days out of the last 180 days, or approximately 5 months of the last 6 months. V. Dosage and Administration
    Indication Dosing Regimen Asthma 210 mg SC once every 4 weeks Maximum Dose 210 mg/4 weeks Note: The vial and pre-filled syringe are intended for administration by a healthcare provider. The pre-filled pen can be administered by patients/caregivers or healthcare providers. VI. Product Availability
    • Single-dose vial: 210 mg/1.91 mL (110 mg/mL) • Single-dose pre-filled syringe: 210 mg/1.91 mL (110 mg/mL) • Single-dose pre-filled pen: 210 mg/1.91 mL (110 mg/mL) VII.