DUPIXENT, Dupilumab DUPIXENT, Dupilumab (Asthma) Form

Dupilumab (Dupixent®) is an interleukin-4 receptor alpha antagonist. FDA Approved Indication(s) Dupixent is indicated: • For the treatment of adult and pediatric patients aged 6 months and older with moderate-to- severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent can be used with or without topical corticosteroids. • As an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma. • As an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP). • For the treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE). • For the treatment of adult patients with prurigo nodularis (PN). Limitation(s) of use: Not 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 Dupixent is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Atopic Dermatitis (must meet all):

1. Diagnosis of atopic dermatitis affecting one of the following (a or b): a. At least 10% of the member’s body surface area (BSA); b. Hands, feet, face, neck, scalp, genitals/groin, and/or intertriginous areas;

2. Prescribed by or in consultation with a dermatologist or allergist;

   3. Age ≥ 6 months; Page 1 of 20

   CLINICAL POLICY Dupilumab

3. Failure of both of the following (a and b), unless contraindicated or clinically significant adverse effects are experienced: a. Two formulary medium to very high potency topical corticosteroids of different molecular identities, each used for ≥ 2 weeks; b. One non-steroidal topical therapy used for ≥ 4 weeks: topical calcineurin inhibitor (e.g., tacrolimus 0.03% ointment, pimecrolimus 1% cream) or Eucrisa®; These agents may require prior authorization
4. Dupixent is not prescribed concurrently with another biologic immunomodulator (e.g., Adbry™, Cinqair®, Fasenra®, Nucala®, Tezspire™, Xolair®) or a Janus kinase (JAK) inhibitor (e.g., Olumiant®, Rinvoq®, Cibinqo®, Opzelura™);
5. Dose does not exceed one of the following (a, b, or c):
   a. Age 6 months to 5 years and weight 5 to < 15 kg: 200 mg every 4 weeks; b. Age 6 months to 5 years and weight 15 to < 30 kg: 300 mg every 4 weeks; c. Age ≥ 6 years and the following: Initial (one-time) dose:
   1) Age ≥ 18 years, weight ≥ 60 kg, or age 6-17 years and weight 15 to < 30 i. kg: 600 mg;
   2) Age 6-17 years and weight 30 to < 60 kg: 400 mg; ii. Maintenance dose:
   1) Age ≥ 18 years or weight ≥ 60 kg: 300 mg every other week; 2) Age 6-17 years and weight 30 to < 60 kg: 200 mg every other week; 3) Age 6-17 years and weight 15 to < 30 kg: 300 mg every 4 weeks. Approval duration: 6 months B. Asthma (must meet all):
6. Diagnosis of asthma and one of the following (a or b): a. Absolute blood eosinophil count ≥ 150 cells/mcL within the past 3 months; b. Currently receiving maintenance treatment with systemic glucocorticoids and has received treatment for at least 4 weeks;
7. Prescribed by or in consultation with an allergist, immunologist, or pulmonologist;
   3. Age ≥ 6 years;
   4. Member has experienced ≥ 2 exacerbations within 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 beta2 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;
8. Dupixent is prescribed concurrently with an ICS plus either a LABA or LTRA;
   6. Dupixent is not prescribed concurrently with another biologic immunomodulator (e.g., Adbry, Cinqair, Fasenra, Nucala, Tezspire, Xolair) or a JAK inhibitor (e.g., Olumiant, Rinvoq, Cibinqo, Opzelura);

9. Dose does not exceed the following:
   a. Initial (one-time) dose for age ≥ 12 years: 600 mg; b. Maintenance dose:
   Page 2 of 20

   CLINICAL POLICY Dupilumab i. Age ≥ 12 years: 300 mg every other week; ii. Age 6-11 years and weight ≥ 30 kg: 200 mg every other week; iii. Age 6-11 years and weight 15 to < 30 kg: 300 mg every 4 weeks. Approval duration: 6 months C. Chronic Rhinosinusitis with Nasal Polyposis (must meet all):

10. Diagnosis of CRSwNP with documentation of all of the following (a, b, and c): a. Presence of nasal polyps; b. Disease is bilateral; c. Member has experienced signs and symptoms (e.g., nasal congestion/blockage/ obstruction, loss of smell, rhinorrhea) for ≥ 12 weeks;
11. Prescribed by or in consultation with an allergist, immunologist, or otolaryngologist;
    3. Age ≥ 18 years;
    4. Member has required the use of systemic corticosteroids for symptom control within the last 2 years, unless contraindicated or clinically significant adverse effects are experienced (see Appendix B for examples);
12. Failure of maintenance therapy with at least two intranasal corticosteroids, one of which must be Xhance™, each used for ≥ 4 weeks, unless contraindicated or clinically significant adverse effects are experienced (see Appendix B for examples);
    6. Dupixent is prescribed concurrently with an intranasal corticosteroid, unless contraindicated or clinically significant adverse effects are experienced (see Appendix B for examples);
13. Dupixent is not prescribed concurrently with another biologic immunomodulator (e.g., Adbry, Cinqair, Fasenra, Nucala, Tezspire, Xolair) or a JAK inhibitor (e.g., Olumiant, Rinvoq, Cibinqo, Opzelura);
14. Dose does not exceed 300 mg every other week. Approval duration: 6 months D. Eosinophilic Esophagitis (must meet all):
15. Diagnosis of EoE confirmed by ≥ 15 intraepithelial eosinophils per high-power field (eos/hpf) on endoscopic biopsy;
16. Prescribed by or in consultation with an allergist, immunologist, or gastroenterologist;
    3. Age ≥ 1 year;
    4. Weight ≥ 15 kg;
    5. Member does not have hypereosinophilic syndrome or eosinophilic granulomatosis with polyangiitis (formerly Churg-Strauss syndrome);
17. Failure of one of the following (a or b), unless clinically significant adverse effects are experienced or both are contraindicated: a. Proton pump inhibitor (see Appendix B for examples); b. Corticosteroid (see Appendix B for examples);
18. Dupixent is not prescribed concurrently with another biologic immunomodulator (e.g., Adbry, Cinqair, Fasenra, Nucala, Tezspire, Xolair) or a JAK inhibitor (e.g., Olumiant, Rinvoq, Cibinqo, Opzelura);

19. Dose does not exceed the following: a. Weight 15 to < 30 kg: 200 mg every other week; b. Weight 30 to < 40 kg: 300 mg every other week; Page 3 of 20

    CLINICAL POLICY Dupilumab c. Weight ≥ 40 kg: 300 mg every week. Approval duration: 6 months E. Prurigo Nodularis (must meet all):

20. Diagnosis of PN with documentation of both of the following (a and b): a. Worst Itch-Numeric Rating Scale (WI-NRS) ≥ 7 on a scale of 0 (“no itch”) to 10 (“worst imaginable itch”); b. ≥ 20 nodular lesions total on both legs, and/or both arms and/or trunk;
21. Prescribed by or in consultation with a dermatologist;
    3. Age ≥ 18 years;
    4. Failure of a ≥ 2-week course of a medium to very high potency topical corticosteroid, unless contraindicated or clinically significant adverse effects are experienced;
    5. Dupixent is not prescribed concurrently with another biologic immunomodulator (e.g., Adbry, Cinqair, Fasenra, Nucala, Tezspire, Xolair) or a JAK inhibitor (e.g., Olumiant, Rinvoq, Cibinqo, Opzelura);
22. Dose does not exceed the following: a. Initial (one-time) dose: 600 mg; b. Maintenance dose: 300 mg every other week. Approval duration: 6 months F. Immunotherapy-related Pruritus (off-label) (must meet all):
23. Diagnosis of immune checkpoint inhibitor-related severe (G3) pruritus that is refractory (see Appendix E);
24. Member has an increased IgE level;
    3. Prescribed by or in consultation with an oncologist;
    4. Dupixent is not prescribed concurrently with Cinqair, Fasenra, Nucala, Xolair, or Tezspire;
25. Dose is within FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).Prescribed regimen must be FDA-approved or recommended by NCCN
    Approval duration: 6 months G. Other diagnoses/indications (must meet 1 or 2):

26. 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 Page 4 of 20

    CLINICAL POLICY Dupilumab

27. 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. Atopic Dermatitis (must meet all):
28. 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);
29. Member is responding positively to therapy as evidenced by, including but not limited to, reduction in itching and scratching;
30. Dupixent is not prescribed concurrently with another biologic immunomodulator (e.g., Adbry, Cinqair, Fasenra, Nucala, Tezspire, Xolair) or a JAK inhibitor (e.g., Olumiant, Rinvoq, Cibinqo, Opzelura);
31. If request is for a dose increase, new dose does not exceed: a. Age ≥ 18 years or weight ≥ 60 kg: 300 mg every other week; b. Age 6-17 years and weight 30 to < 60 kg: 200 mg every other week; c. Age 6-17 years and weight 15 to < 30 kg: 300 mg every 4 weeks; d. Age 6 months to 5 years and weight 5 to < 15 kg: 200 mg every 4 weeks; e. Age 6 months to 5 years and weight 15 to < 30 kg: 300 mg every 4 weeks. Approval duration:
    Medicaid/HIM – 12 months Commercial – 6 months or to the member’s renewal date, whichever is longer B. Asthma (must meet all):
32. 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);
33. 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);

34. 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);
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    CLINICAL POLICY Dupilumab

35. Dupixent is not prescribed concurrently with another biologic immunomodulator (e.g., Adbry, Cinqair, Fasenra, Nucala, Tezspire, Xolair) or a JAK inhibitor (e.g., Olumiant, Rinvoq, Cibinqo, Opzelura);
36. If request is for a dose increase, new dose does not exceed: a. Age ≥ 12 years: 300 mg every other week; b. Age 6-11 years and weight ≥ 30 kg: 200 mg every other week; c. Age 6-11 years and weight 15 to < 30 kg: 300 mg every 4 weeks. Approval duration:
    Medicaid/HIM – 12 months Commercial – 6 months or to the member’s renewal date, whichever is longer C. Chronic Rhinosinusitis with Nasal Polyposis (must meet all):
37. 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);
38. Demonstrated adherence to an intranasal corticosteroid, unless contraindicated or clinically significant adverse effects are experienced;
39. Member is responding positively to therapy (examples may include but are not limited to: reduced nasal polyp size, reduced need for systemic corticosteroids, improved sense of smell, improved quality of life);
40. Dupixent is not prescribed concurrently with another biologic immunomodulator (e.g., Adbry, Cinqair, Fasenra, Nucala, Tezspire, Xolair) or a JAK inhibitor (e.g., Olumiant, Rinvoq, Cibinqo, Opzelura);
41. If request is for a dose increase, new dose does not exceed 300 mg every other week. Approval duration:
    Medicaid/HIM – 12 months Commercial – 6 months or to the member’s renewal date, whichever is longer D. Eosinophilic Esophagitis (must meet all):
42. Currently 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);
43. Member is responding positively to therapy (examples may include but are not limited to: reduced eos/hpf count, improvement in dysphagia symptoms);
44. Dupixent is not prescribed concurrently with another biologic immunomodulator (e.g., Adbry, Cinqair, Fasenra, Nucala, Tezspire, Xolair) or a JAK inhibitor (e.g., Olumiant, Rinvoq, Cibinqo, Opzelura);

45. If request is for a dose increase, new dose does not exceed the following: a. Weight 15 to < 30 kg: 200 mg every other week; b. Weight 30 to < 40 kg: 300 mg every other week; Page 6 of 20

    CLINICAL POLICY Dupilumab c. Weight ≥ 40 kg: 300 mg every week. Approval duration:
    Medicaid/HIM – 12 months Commercial – 6 months or to the member’s renewal date, whichever is longer E. Prurigo Nodularis (must meet all):

46. Currently 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);
47. Member is responding positively to therapy (examples may include but are not limited to: improvement in itching or skin pain, reduction in number of nodules);
    
    3. Dupixent is not prescribed concurrently with another biologic immunomodulator (e.g., Adbry, Cinqair, Fasenra, Nucala, Tezspire, Xolair) or a JAK inhibitor (e.g., Olumiant, Rinvoq, Cibinqo, Opzelura);
48. If request is for a dose increase, new dose does not exceed 300 mg every other week. Approval duration:
    Medicaid/HIM – 12 months Commercial – 6 months or to the member’s renewal date, whichever is longer F. Immunotherapy-related Pruritus (off-label) (must meet all):
49. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Dupixent for a covered indication and has received this medication for at least 30 days;
50. Member is responding positively to therapy;
    3. If request is for a dose increase, new dose is within FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).Prescribed regimen must be FDA-approved or recommended by NCCN.
       Approval duration: 6 months G. Other diagnoses/indications (must meet 1 or 2):

51. 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 Page 7 of 20

    CLINICAL POLICY Dupilumab

52. 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 CRSwNP: chronic rhinosinusitis with nasal polyposis EoE: eosinophilic esophagitis eos/hpf: eosinophils per high-power field
    FDA: Food and Drug Administration GINA: Global Initiative for Asthma ICS: inhaled corticosteroid JAK: Janus kinase LABA: long-acting beta2 agonist
    LTRA: leukotriene modifier PDC: proportion of days covered PN: prurigo nodularis WI-NRS: Worst Itch-Numeric Rating Scale 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 Apply topically to the affected area(s) BID ATOPIC DERMATITIS, PN Very High Potency Topical Corticosteroids augmented betamethasone 0.05% (Diprolene AF) cream, ointment, gel, lotion clobetasol propionate 0.05% (Temovate ) cream, ointment, gel, solution diflorasone diacetate 0.05% (Maxiflor, Psorcon E) cream, ointment fluocinonide 0.1% cream flurandrenolide 4 mcg/cm2 tape halobetasol propionate 0.05% (Ultravate) cream, ointment High Potency Topical Corticosteroids amcinonide 0.1% ointment, lotion Varies
    Varies Page 8 of 20

    CLINICAL POLICY Dupilumab Drug Name Dosing Regimen
    Dose Limit/ Maximum Dose Apply topically to the affected area(s) BID augmented betamethasone 0.05% (Diprolene AF) cream, ointment, gel, lotion betamethasone valerate 0.1%, 0.12% (Luxiq®) ointment, foam clobetasol propionate 0.025% (Impoyz ) cream diflorasone 0.05% (Florone, Florone E, Maxiflor,Psorcon E) cream fluocinonide acetonide 0.05% (Lidex, Lidex E) cream, ointment, gel, solution fluticasone propionate 0.005% cream, ointment halcinonide 0.1% cream, ointment, solution (Halog®) halobetasol propionate 0.01% lotion (Bryhali®) mometasone furoate 0.1% ointment triamcinolone acetonide 0.5% (Aristocort, Kenalog) cream, ointment Medium Potency Topical Corticosteroids clocortolone pivalate 0.1% cream Apply topically to the affected desoximetasone 0.05%, 0.25%
    (Topicort ) cream, ointment, gel, spray fluocinolone acetonide 0.025% (Synalar) cream, ointment flurandrenolide 0.05% lotion, ointment (Cordran®) hydrocortisone valerate 0.2% cream mometasone 0.1% (Elocon) cream, ointment, lotion triamcinolone acetonide 0.025%, 0.1% (Aristocort, Kenalog) cream, ointment Other Classes of Agents Protopic (tacrolimus), Elidel (pimecrolimus) Children ≥ 2 years and adults: Apply a thin layer topically to area(s) BID Page 9 of 20 Varies Varies

    CLINICAL POLICY Dupilumab Drug Name Dosing Regimen
    Dose Limit/ Maximum Dose Eucrisa® (crisaborole) cyclosporine
    azathioprine methotrexate mycophenolate mofetil ASTHMA ICS (medium – high dose) Qvar (beclomethasone) budesonide (Pulmicort) Alvesco (ciclesonide) affected skin BID. Treatment should be discontinued if resolution of disease occurs. Apply to the affected areas BID Varies 3-6 mg/kg/day PO BID 1-3 mg/kg/day PO QD 7.5-25 mg/wk PO once weekly 1-1.5 g PO BID 300 mg/day Weight-based 25 mg/week 3 g/day

    100 mcg/day 40 mcg, 80 mcg per actuation 1-4 actuations BID 200 mcg/day 90 mcg, 180 mcg per actuation 2-4 actuations BID 80 mcg/day 80 mcg, 160 mcg per actuation 1-2 actuations BID 4 actuations BID 2 actuations BID 2 actuations BID Flovent (fluticasone propionate) > 100 mcg/day 2 actuations BID Arnuity Ellipta (fluticasone furoate) Asmanex (mometasone) LABA Serevent (salmeterol) 44-250 mcg per actuation 2-4 actuations BID ≥ 50 mcg/day
    100 mcg, 200 mcg per actuation 1 actuation QD 100 mcg/day HFA: 100 mcg, 200 mcg per actuation Twisthaler: 110 mcg, 220 mcg per actuation 1-2 actuations QD to BID 50 mcg per dose 1 inhalation BID Combination Products (ICS + LABA) Dulera (mometasone/ formoterol) Breo Ellipta (fluticasone/vilanterol) 100/5 mcg, 200/5 mcg per actuation 2 actuations BID 100/25 mcg, 200/25 mcg per actuation 1 actuation QD 1 actuation QD 2 inhalations BID 1 inhalation BID 4 actuations per day 1 actuation QD Advair (fluticasone/ salmeterol) Diskus: 100/50 mcg, 250/50 1 actuation BID mcg, 500/50 mcg per actuation Page 10 of 20

    CLINICAL POLICY Dupilumab Drug Name Dosing Regimen
    fluticasone/salmeterol (Airduo RespiClick®) Symbicort (budesonide/ formoterol)
    LTRA montelukast (Singulair) zafirlukast (Accolate) zileuton ER (Zyflo CR) Zyflo (zileuton) Oral Corticosteroids dexamethasone (Decadron) methylprednisolone (Medrol) prednisolone (Millipred, Orapred ODT) prednisone (Deltasone) 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 Dose Limit/ Maximum Dose 1 actuation BID 2 actuations BID 4 to 10 mg PO QD 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 0.75 to 9 mg/day PO in 2 to 4 divided doses 40 to 80 mg PO in 1 to 2 divided doses 40 to 80 mg PO in 1 to 2 divided doses 40 to 80 mg PO in 1 to 2 divided doses Varies Varies Varies Varies 1-2 sprays IN BID CRSwNP Intranasal Corticosteroids beclomethasone (Beconase AQ, Qnasl) budesonide (Rhinocort Aqua, Rhinocort) flunisolide fluticasone propionate (Flonase) 1-2 sprays IN BID mometasone (Nasonex) Omnaris, Zetonna (ciclesonide) Omnaris: 2 sprays IN QD Zetonna: 1 spray IN QD 128 mcg IN QD or 200 mcg IN BID 2 sprays IN BID 2 sprays IN BID triamcinolone (Nasacort) Xhance™ (fluticasone propionate) 1 to 2 sprays (93 mcg/spray) to 2 sprays IN QD nostril IN BID
    2 sprays/nostril BID 1-2 inhalations/ nostril/day 2 sprays/nostril TID 2 sprays/nostril BID 2 sprays/nostril BID Omnaris: 2 sprays/ nostril/day Zetonna: 2 sprays/ nostril/day 2 sprays/ nostril/day 744 mcg/day Oral Corticosteroids dexamethasone (Decadron) 0.75 to 9 mg/day PO in 2 to 4 divided doses Varies Page 11 of 20

    CLINICAL POLICY Dupilumab Drug Name Dosing Regimen
    methylprednisolone (Medrol) prednisolone (Millipred, Orapred ODT) prednisone (Deltasone) 4 to 48 mg PO in 1 to 2 divided doses 5 to 60 mg PO in 1 to 2 divided doses 5 to 60 mg PO in 1 to 2 divided doses EoE Corticosteroids: examples –
    • Topical: Varies
    Dose Limit/ Maximum Dose Varies Varies Varies Varies o Budesonide administered as an oral viscous slurry of budesonide inhalation suspension [Pulmicort Respules] with sucralose or similar carrier vehicle o Fluticasone propionate administered using a metered dose inhaler • Oral:
    o Prednisone Varies Varies Varies
    Proton pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, rabeprazole, pantoprazole) Immunotherapy-related pruritus H1 blockers: examples – diphenhydramine, chlorpheniramine, hydroxyzine, cetirizine, loratadine, fexofenadine antihistamines, H2 blockers:
    examples –
    cimetidine, famotidine corticosteroids: examples – methylprednisolone, prednisolone
    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. Varies
    Varies Varies Appendix C: Contraindications/Boxed Warnings • Contraindication(s): known hypersensitivity to Dupixent or any of its excipients • Boxed warning(s): none reported Appendix D: General Information • Atopic dermatitis Page 12 of 20

    CLINICAL POLICY Dupilumab o The Phase III pivotal studies (SOLO 1 and SOLO 2) of Dupixent showed no significant difference in clinical outcomes between dosing of Dupixent every week and every other week for the treatment of atopic dermatitis. • Asthma o During clinical trials (LIBERTY ASTHMA QUEST), among patients with a baseline blood eosinophil count of < 150 per cubic millimeter, the exacerbation rate was similar with dupilumab and with placebo: 0.47 (95% CI, 0.36 to 0.62) with lower- dose dupilumab and 0.51 (95% CI, 0.35 to 0.76) with matched placebo, and 0.74 (95% CI, 0.58 to 0.95) with higher-dose dupilumab and 0.64 (95% CI, 0.44 to 0.93) with matched placebo. o The Global Initiative for Asthma (GINA) guidelines for difficult-to-treat and severe asthma recommend Dupixent be considered as adjunct therapy for patients 6 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.
    o Patients could potentially meet asthma criteria for both Xolair and Dupixent, 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. o Lab results for blood eosinophil counts can be converted into cells/mcL using the following unit conversion calculator: https://www.fasenrahcp.com/eosinophil- calculator o 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. Appendix E: Immunotherapy-related Pruritus
    • Immunotherapy refers to immune checkpoint inhibitors. Immune checkpoint inhibitors comprise a class of agents that target immune cell checkpoints, such as programmed cell death-1 (PD-1; e.g., Opdivo®, Keytruda®) and PD-1 ligand (PD-L1; e.g., Tecentriq®, Bavencio®, Imfinzi®), as well as cytotoxic T-lymphocyte–associated antigen 4 (e.g., Yervoy®, Imjudo®). • NCCN grading of pruritus o G1: Mild or localized o G2: Moderate. Intense or widespread; intermittent; skin changes from scratching (e.g., edema, papulation, excoriations, lichenification, oozing/crusts); limiting instrumental ADLs o G3: Severe. Intense or widespread; constant; limiting self-care ADLs or sleep V. Dosage and Administration
    Indication Moderate-to-severe atopic dermatitis Dosing Regimen Adults: Initial dose of 600 mg SC followed by 300 mg SC every other week Maximum Dose See regimen
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    CLINICAL POLICY Dupilumab Indication Moderate-to-severe asthma Maximum Dose See regimen Dosing Regimen Adolescents 6-17 years of age:
    • Body weight 15 to < 30 kg: Initial dose of 600 mg SC followed by 300 mg SC every 4 weeks • Body weight 30 kg to < 60 kg: Initial dose of 400 mg SC followed by 200 mg SC every other week • Body weight ≥ 60 kg: Initial dose of 600 mg SC followed by 300 mg SC every other week Pediatrics 6 months - 5 years of age:
    • Body weight 5 to < 15 kg: 200 mg SC every 4 weeks • Body weight 15 to < 30 kg: 300 mg SC every 4 weeks Adults and adolescents (12 years and older):
    Initial dose of 400 mg SC followed by 200 mg SC every other week; or Initial dose of 600 mg SC followed by 300 mg SC every other week For patients requiring concomitant oral corticosteroids or with co-morbid moderate-to- severe atopic dermatitis for which Dupixent is indicated, start with an initial dose of 600 mg SC followed by 300 mg SC every other week Adolescents 6-11 years of age:
    • Body weight 15 to < 30 kg: Initial dose and subsequent dose of 300 mg every four weeks • Body weight ≥ 30 kg: Initial dose and subsequent dose of 200 mg SC every other week
    For pediatric patients (6 to 11 years old) with asthma and co-morbid moderate-to-severe atopic dermatitis, follow the recommended adolescent atopic dermatitis dosing, which includes an initial loading dose CRSwNP 300 mg SC every other week EoE Adult and pediatric patients ≥ 1 year of age, weight ≥ 15 kg:
    300 mg every other week 300 mg/week Page 14 of 20

    CLINICAL POLICY Dupilumab Indication Maximum Dose Dosing Regimen • Body weight 15 to < 30 kg: 200 mg SC every other week • Body weight 30 to < 40 kg: 300 mg SC every other week • Body weight ≥ 40 kg: 300 mg SC every week PN Initial dose of 600 mg SC followed by 300 mg SC every other week See regimen VI. Product Availability
    • Pre-filled syringes with needle shield for injection: 100 mg/0.67 mL, 200 mg/1.14 mL, 300 mg/2 mL • Pre-filled pen: 200 mg/1.14 mL, 300 mg/2 mL The pre-filled pen is for use in adult and pediatric patients aged 2 years and older, while the pre-filled syringe is for use in adult and pediatric patients aged 6 months and older. In pediatric patients 12 to 17 years of age, Dupixent should be administered under the supervision of an adult. In pediatric patients 6 months to less than 12 years of age, Dupixent should be administered by a caregiver.
    VII.