Reslizumab (Cinqair) Form

Reslizumab (Cinqair®) is a humanized interleukin-5 antagonist monoclonal antibody (IgG4 kappa). FDA Approved Indication(s) Cinqair is indicated for add-on maintenance treatment of patients with severe asthma aged 18 years and older, and with an eosinophilic phenotype. Limitation(s) 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. 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 Cinqair is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Severe Asthma (must meet all):

1. Diagnosis of asthma;
   2. Member has an absolute blood eosinophil count ≥ 400 cells/mcL within the past 3 months;
2. Prescribed by or in consultation with an allergist, immunologist, or pulmonologist;
   4. Age ≥ 18 years;
   5. Member has experienced ≥ 2 exacerbations within 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;

3. Cinqair is prescribed concurrently with an ICS plus either a LABA or LTRA;

   7. Cinqair is not prescribed concurrently with Fasenra®, Nucala®, Dupixent®, Xolair®, or Tezspire®; Page 1 of 8

   CLINICAL POLICY Reslizumab

4. Dose does not exceed 3 mg/kg once every 4 weeks. Approval duration: 6 months B. Other diagnoses/indications (must meet 1 or 2):
5. 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
6. 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):
7. 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);
8. Demonstrated adherence to asthma controller therapy (an ICS plus either an 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);
9. 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);
10. Cinqair is not prescribed concurrently with Fasenra, Nucala, Dupixent, Xolair, or Tezspire;

11. If request is for a dose increase, new dose does not exceed 3 mg/kg once every 4 weeks.
    Approval duration:
    Medicaid/HIM – 12 months
    Commercial – 6 months or member’s renewal period, whichever is longer Page 2 of 8

    CLINICAL POLICY Reslizumab B. Other diagnoses/indications (must meet 1 or 2):

12. 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

13. 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 GINA: Global Initiative for Asthma
    ICS: inhaled corticosteroid FDA: Food and Drug Administration
    LABA: long-acting beta-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 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) 90 mcg, 180 mcg per actuation 2-4 actuations BID

    160 mcg/day 80 mcg, 160 mcg per actuation 2 actuations BID Page 3 of 8

    Dose Limit/ Maximum Dose 2 actuations BID 1 actuation QD 2 inhalations BID 1 inhalation BID 4 actuations per day 1 actuation QD 1 actuation BID 1 actuation BID 2 actuations BID 10 mg per day 40 mg per day 2,400 mg per day 2,400 mg per day CLINICAL POLICY Reslizumab Drug Name Dosing Regimen Flovent (fluticasone propionate) 1-2 actuations BID

    250 mcg/day 44-250 mcg per actuation 2-4 actuations BID 200 mcg/day
    100 mcg, 200 mcg per actuation 1 actuation QD Asmanex (mometasone) > 200 mcg/day Arnuity Ellipta (fluticasone furoate) 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)
    10 to 20 mg PO BID 1,200 mg PO BID 600 mg PO QID 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) 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 Varies 40 to 80 mg PO in 1 to 2 divided doses Varies Page 4 of 8

    CLINICAL POLICY Reslizumab Drug Name Dosing Regimen Dose Limit/ Maximum Dose prednisone (Deltasonec) 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. 40 to 80 mg PO in 1 to 2 divided doses Varies Appendix C: Contraindications/Boxed Warnings • Contraindication(s): hypersensitivity • Boxed warning(s): anaphylaxis Appendix D: General Information • Asthma exacerbations (primary endpoint) was defined as 1) use of systemic steroid, or ≥ 2-fold increase in the use of ICS for 3 or more days; 2) asthma related emergency treatment by nebulizer, a visit to the emergency department, or asthma related hospitalization.
    • The Global Initiative for Asthma (GINA) guidelines recommend Cinqair be considered as adjunct therapy for patients 18 years of age and older with exacerbations or poor symptom control despite taking at least high dose ICS/LABA and who have eosinophilic biomarkers or need maintenance oral corticosteroids.
    • Patients could potentially meet asthma criteria for both Xolair and Cinqair, though there is insufficient data to support the combination use of multiple asthma biologics. The combination has not been studied. Approximately 30% of patients in the Nucala MENSA study also were candidates for therapy with Xolair.
    • Lab results for blood eosinophil counts can be converted into cells/mcL using the following unit conversion calculator: https://www.gsksource.com/pharma/content/micro- sites/nucala-eos-calc/index.html • 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 Severe asthma
    Dosing Regimen 3 mg/kg IV every 4 weeks
    Maximum Dose 3 mg/kg every 4 weeks Cinqair should be administered in a healthcare setting by a healthcare professional prepared to manage anaphylaxis. VI. Product Availability
    Single-use vial: 100 mg/10 mL solution
    VII.