Department of Origin: Integrated Healthcare Services

Effective Date: 01/01/21

Approved by: Pharmacy and Therapeutics Quality Management Subcommittee

Date Approved: 12/09/20

Pharmacy Clinical Policy Document: Dupixent Prior Authorization

Replaces Effective Clinical Policy Dated: N/A

Reference #: PC/D006

Page: 1 of 4

PURPOSE: The intent of the Dupixent Prior Authorization Pharmacy Clinical Policy is to ensure services are medically necessary Please refer to the member’s benefit document for specific information. To the extent there is any inconsistency between this policy and the terms of the member’s benefit plan or certificate of coverage, the terms of the member’s benefit plan document will govern. POLICY: Benefits must be available for health care services. Health care services must be ordered by a provider. Health care services must be medically necessary, applicable conservative treatments must have been tried, and the most cost-effective alternative must be requested for coverage consideration. GUIDELINES: Medical Necessity Criteria – Must satisfy any the following: I or II (approval for up to 12 months) I. Initial request for Dupixent (dupilumab) - must satisfy any the following: A - C

A. Diagnosis of moderate to severe atopic dermatitis – must satisfy all of the following: 1 - 4

1. Equal to or greater than 6 years of age; and

2. Prescribed by or in consultation with a dermatologist or allergist/immunologist; and 3. A history of failure, contraindication, or intolerance to ONE medium to high potency topical

corticosteroid (see Table 1); and 4. A history of failure, contraindication, or intolerance to ONE of the following: a - b

a. Pimecrolimus topical cream (Elidel) b. Tacrolimus topical ointment (Protopic)

B. Diagnosis of moderate to severe asthma – must satisfy all of the following: 1 – 4

1. Equal to or greater than 12 years of age; and

2. Prescribed by or in consultation with a pulmonologist or allergist/immunologist; and 3. One of the following: a – e

a. Asthma with an eosinophilic phenotype as defined by a baseline (pre-treatment) peripheral blood eosinophil level greater than or equal to 150 cells per microliter; or

b. Member is considered dependent on oral corticosteroids for the treatment of asthma; or c. Member has required treatment with 3 or more courses of oral corticosteroids for the

treatment of asthma in the last year; or d. Member has had a prior intubation for an asthma exacerbation; or e. Member has had an asthma-related hospitalization within the past 12 months.

4. Currently treated with or has a contraindication or intolerance to one of the following: a or b

a. High-dose inhaled corticosteroid (ICS) (eg, greater than 500mcg fluticasone propionate equivalent/day) AND an additional asthma controller medication (eg, leukotriene receptor antagonist, long-acting beta-2 agonist [LABA], theophylline); or

Department of Origin: Integrated Healthcare Services

Effective Date: 01/01/21

Approved by: Pharmacy and Therapeutics Quality Management Subcommittee

Date Approved: 12/09/20

Pharmacy Clinical Policy Document: Dupixent Prior Authorization

Replaces Effective Clinical Policy Dated: N/A

Reference #: PC/D006

Page: 2 of 4

b. One maximally-dosed combination ICS/LABA product (eg, Advair [fluticasone

propionate/salmeterol], Dulera [mometasone/formoterol], Symbicort [budesonide/formoterol]) or an ICS/LABA/LAMA product (eg, Trelegy Ellipta [fluticasone furoate/umeclidinium/vilanterol])

C. Diagnosis of chronic rhinosinusitis with nasal polyposis (CRSwNP) – must satisfy all of the following: 1 - 4 1. Equal to or greater than 8 years of age; and

2. Prescribed by or in consultation with an allergist or immunologist; and 3. A history of failure, contraindication, or intolerance to treatment with 2 different intranasal

corticosteroids (minimum 6 months of treatment) (eg, fluticasone, mometasone); and 4. Will be used in combination with another agent for CRSwNP (eg, intranasal corticosteroid)

Table 1: Medium to Very-high Potency Topical Corticosteroids* Class Drug Dosage Form Strength (%)

Very high potency

Augmented betamethasone dipropionate

Ointment, gel 0.05

Clobetasol propionate Cream, foam, ointment 0.05 Diflorasone diacetate Ointment 0.05 Halobetasol propionate Cream, ointment 0.05

High Potency Amcinonide Cream, lotion, ointment 0.1 Augmented betamethasone dipropionate

Cream, lotion 0.05

Betamethasone dipropionate Cream, foam, ointment, solution 0.05 Desoximetasone Cream, ointment 0.25 Desoximetasone Gel 0.05 Diflorasone diacetate Cream 0.05 Fluocinonide Cream, gel, ointment, solution 0.05 Halcinonide Cream, ointment 0.1 Mometasone furoate Ointment 0.1 Triamcinolone acetonide Cream, ointment 0.5

Medium potency

Betamethasone valerate Cream, foam, lotion, ointment 0.1 Clocortolone pivalate Cream 0.1 Desoximetasone Cream 0.05 Fluocinolone acetonide Cream, ointment 0.025 Flurandrenolide Cream, ointment, lotion 0.05 Fluticasone propionate Cream 0.05 Fluticasone propionate Ointment 0.005 Mometasone furoate Cream, lotion 0.1 Triamcinolone acetonide Cream, ointment, lotion 0.1

* Listing of drugs in table above does not ensure coverage. Please check member’s prescription benefit.

II. Continuation request – Must satisfy any of the following: A – C A. Diagnosis of moderate to severe atopic dermatitis - member has demonstrated a positive clinical

response to Dupixent therapy; or

Department of Origin: Integrated Healthcare Services

Effective Date: 01/01/21

Approved by: Pharmacy and Therapeutics Quality Management Subcommittee

Date Approved: 12/09/20

Pharmacy Clinical Policy Document: Dupixent Prior Authorization

Replaces Effective Clinical Policy Dated: N/A

Reference #: PC/D006

Page: 3 of 4

B. Diagnosis of moderate to severe asthma – member is currently treated with, or has a

contraindication or intolerance to, either of the following: 1 or 2 1. High-dose inhaled corticosteroid (ICS) (eg, greater than 500mcg fluticasone propionate

equivalent/day) AND an additional asthma controller medication (eg, leukotriene receptor antagonist, long-acting beta-2 agonist [LABA], theophylline); or

2. One maximally-dosed combination ICS/LABA product (eg, Advair [fluticasone propionate/salmeterol], Dulera [mometasone/formoterol], Symbicort [budesonide/formoterol] or ICS/LABA/LAMA product [eg, Trelegy Ellipta [fluticasone furoate/umeclidinium/vilanterol]).

C. Diagnosis of chronic rhinosinusitis with nasal polyposis (CRSwNP) – member continues to use

Dupixent with another agent for CRSwNP (eg, intranasal corticosteroid).

EXCLUSIONS (not limited to): Refer to member’s Certificate of Coverage or Summary Plan Description

DEFINITIONS: Moderate to Severe Atopic Dermatitis: Eczema Area and Severity Index (EASI) equal to or greater than 7.1 or a SCORAD index equal to or greater than 15

Department of Origin: Integrated Healthcare Services

Effective Date: 01/01/21

Approved by: Pharmacy and Therapeutics Quality Management Subcommittee

Date Approved: 12/09/20

Pharmacy Clinical Policy Document: Dupixent Prior Authorization

Replaces Effective Clinical Policy Dated: N/A

Reference #: PC/D006

Page: 4 of 4

Prior Authorization: Yes, per network provider agreement REFERENCES: 1. Integrated Healthcare Services Process Manual: UR015 Use of Medical Policy and Criteria 2. Clinical Policy: MP/C009 Coverage Determination Guidelines 3. Dupixent [package insert]. Bridgewater, NJ: sanofi-aventis U.S. LLC; 2020. 4. Simpson EL, Bieber T, Guttman-Yassky E, et al. Two phase 3 trials of dupilumab versus placebo in

atopic dermatitis. N Engl J Med. 2016; [Epub ahead of print]. 5. Eichenfield LF, Tom WL, Berger TG, et al. Guidelines of care for the management of atopic

dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014; 71(1):116-32.

6. Elidel [package insert]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; 2014. 7. Lee M. The role of corticosteroids in dermatology. Aust Prescr 1998;21:9-11. 8. Ellsworth A, Smith RE. Dermatotherapy and Drug Induced Skin Disorders. In: Koda-Kimble MA, et al,

eds. Applied Therapeutics: The Clinical Use of Drugs. Philadelphia, PA: Lippincott, Willliams, & Wilkins; 2005:38-1-38-19.

9. Wenzel S, Castro M, Corren J, et al. Dupilumab efficacy and safety in adults with uncontrolled persistent asthma despite use of medium-to-high dose inhaled corticosteroids plus a long-acting B2 agonist: a randomized double-blind placebo-controlled pivotal phase 2b dose-ranging trial. Lancet. 2016;388:31-44.

10. Castro M, Corren J, Pavord ID, et al. Dupilumab efficacy and safety in moderate-to-severe uncontrolled asthma. N Engl J Med. 2018; 378(26):2486-96.

11. Rabe KF, Nair P, Brusselle G, et al. Efficacy and safety of dupilumab in glucocorticoid-dependent severe asthma. N Engl J Med. 2018; 378(26):2475-85.

12. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention (2018 update). 2018 Retrieve from: https://ginasthma.org/ Accessed 12-04-20.

13. 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.

14. Peters AT, Spector S, Hsu J, et al. Diagnosis and management of rhinosinusitis: a practice parameter update. Ann Allergy Asthma Immunol. 2014;113(4):347-85.

15. Orlandi RR, Kingdom TT, Hwang PH, et al. International consensus statement on allergy and rhinology: rhinosinusitis. Int Forum Allergy Rhinol. 2016 Feb; Suppl 1:S22-209

DOCUMENT HISTORY: Created Date: 12/4/2020 Reviewed Date: Revised Date:

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