Subject: Dupixent 1690-A SGM P2022c

Drug

DUPIXENT  (dupilumab)

Policy:

       I.  INDICATIONS

            The indications below including FDA-approved indications and
            compendial uses are considered a covered benefit provided
            that all the approval criteria are met and the member has no
            exclusions to the prescribed therapy.

            FDA-Approved Indications
            A.  Dupixent is indicated for the treatment of 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.
            B.  Dupixent is indicated as an add-on maintenance treatment
                 in patients with moderate-to-severe asthma aged 6 years
                 and older with an eosinophilic phenotype or with oral
                 corticosteroid dependent asthma.
            C.  Dupixent is indicated as an add-on maintenance treatment
                 in adult patients with inadequately controlled chronic
                 rhinosinusitis with nasal polyposis (CRSwNP).
            D.  Dupixent is indicated for the treatment of adult and
                 pediatric patients aged 12 years and older, weighing at
                 least 40 kg, with eosinophilic esophagitis (EoE).

                 Limitation of Use: Dupixent is not indicated for the relief of
                 acute bronchospasm or status asthmaticus

             All other indications are considered
             experimental/investigational and not medically necessary.

 
      II.  DOCUMENTATION

            Submission of the following information is necessary to initiate
            the prior authorization review:
            A.  Atopic dermatitis (for initial requests): Member’s chart or
                 medical record showing prerequisite therapies (see section
                 IV.A.2). If therapy is not advisable, documentation of
                 clinical reason to avoid therapy.

            B.  Asthma
                 1.  For initial requests:
                      i.    Member’s chart or medical record showing
                            pretreatment blood eosinophil count (where
                            applicable)
                      ii.   Chart notes, medical record documentation, or
                            claims history supporting previous medications tried
                            including drug, dose, frequency, and duration.
                 2.  For continuation requests: Chart notes or medical record
                      documentation supporting improvement in asthma
                      control.

             C.  Chronic rhinosinusitis with nasal polyposis
                  1.  For initial requests:
                       i.    Member’s chart or medical record showing nasal
                             endoscopy, anterior rhinoscopy, or computed
                             tomography (CT) details (e.g., location, size), or
                             Meltzer Clinical Score or endoscopic nasal polyp
                             score (NPS) (where applicable).
                       ii.   Chart notes, medical record documentation, or
                             claims history supporting previous medications
                             tried. If therapy is not advisable, documentation of
                             clinical reason to avoid therapy.
                  2.  For continuation requests: Chart notes or medical
                       record documentation supporting positive clinical
                       response.

             D.  Eosinophilic esophagitis
                  1.  For initial requests:
                       i.    Member’s chart or medical record showing
                             endoscopic biopsy details including intraepithelial
                             esophageal eosinophil count.
                       ii.   Chart notes, medical record documentation, or
                             claims history supporting previous medications
                             tried. If therapy is not advisable, documentation of
                             clinical reason to avoid therapy.
                   2.  For continuation requests: Chart notes or medical
                        record documentation supporting positive clinical
                        response.

 
     III.  PRESCIBER SPECIALTIES

             This medication must be prescribed by or in consultation with
             one of the following:
             A.  Asthma: allergist/immunologist or pulmonologist
             B.  Chronic rhinosinusitis with nasal polyposis:
                  allergist/immunologist or otolaryngologist|
             C.  Eosinophilic esophagitis: gastroenterologist or
                  allergist/immunologist

 
      IV.  CRITERIA FOR INITIAL APPROVAL

             A. Moderate-to-severe atopic dermatitis
                 Authorization of 4 months may be granted for treatment of
                 moderate-to-severe atopic dermatitis in members 6 months
                 of age or older when all of the following criteria are met:
                 1.  Affected body surface is greater than or equal to 10%
                      body surface area OR crucial body areas (e.g., hands,
                      feet, face, neck, scalp, genitals/groin, intertriginous
                      areas) are affected.
                 2.  Member meets one of the following:
                      i.    Member has had an inadequate treatment response
                            to one of the following in the past 180 days:
                            a.  A high potency or super-high potency topical
                                 corticosteroid (see Appendix)
                            b.  A topical calcineurin inhibitor
                      ii.   The use of high potency or super-high potency
                            topical corticosteroids and topical calcineurin
                            inhibitors are not advisable for the member (e.g.,
                            due to contraindications, prior intolerances, potency
                            not appropriate for member’s age)

              B.  Asthma
                   Authorization of 6 months may be granted for treatment
                   of asthma in members 6 years of age or older when all of
                   the following criteria are met:
                   1.  Member as uncontrolled asthma as demonstrated by
                        experiencing at least one of the following within the
                        past year:
                        i.    Two or more asthma exacerbations requiring oral
                              or injectable corticosteroid treatment.
                        ii.   One or more asthma exacerbation resulting in
                              hospitalization or emergency medical care visit.
                        iii.  Poor symptom control (frequent symptoms or
                              reliever use, activity limited by asthma, night
                              waking due to asthma).
                   2.  Member meets one of the following criteria:
                        i.    Member has a baseline blood eosinophil count of at
                              least 150 cells per microliter and inadequate
                              asthma control despite current treatment with
                              both of the following medications at optimized
                              doses:
                              a.  Medium-to-high-dose inhaled corticosteroid
                              b.  Additional controller (i.e., long acting beta2-
                                   agonist, long acting muscarinic antagonist,
                                   leukotriene modifier, or sustained-release
                                   theophylline)
                        ii.  Member has inadequate asthma control despite
                             current treatment with all of the following
                             medications at optimized doses*:
                             a.  High-dose inhaled corticosteroid
                             b.  Additional controller (i.e., long acting beta2-
                                  agonist, long acting muscarinic antagonist,
                                  leukotriene modifier, or sustained-release
                                  theophylline)
                             c.  Oral glucocorticoids (at least 5 mg per day of
                                  prednisone/prednisolone or equivalent)
                             *Members should be receiving treatment with
                              inhaled corticosteroid and additional controller for
                              at least the previous 3 months, and oral
                              glucocorticoids for most days during the previous
                              6 months (e.g. 50% of days, 3 steroid bursts in
                              the previous 6 months).⁶
                    3.  Member will continue to use maintenance asthma
                         treatments (e.g., inhaled corticosteroid, additional
                         controller) in combination with Dupixent.

              C.  Chronic rhinosinusitis with nasal polyposis
                   (CRSwNP)
                  Authorization of 6 months may be granted for treatment of
                  CRSwNP in members 18 years of age or older when all of
                  the following criteria are met:
                  1.  Member has bilateral nasal polyposis and chronic
                       symptoms of sinusitis despite intranasal corticosteroid
                       treatment for at least 2 months unless contraindicated
                       or not tolerated; and
                  2.  The member has CRSwNP despite one of the following:
                        i.    Prior sino-nasal surgery; or
                        ii.   Prior treatment with systemic corticosteroids
                              within the last two years was ineffective, unless
                              contraindicated or not tolerated; and
                  3.  Member has one of the following:
                       i.    A bilateral nasal endoscopy, anterior rhinoscopy, or
                             computed tomography (CT) showing polyps
                             reaching below the lower border of the middle
                             turbinate or beyond in each nostril
                       ii.   Meltzer Clinical Score of 2 or higher in both nostrils
                       iii.  A total endoscopic nasal polyp score (NPS) of at
                             least 5 with a minimum score of 2 for each nostril
                  4.  Member has nasal blockage plus one additional
                       symptom:
                       i.    Rhinorrhea (anterior/posterior); or
                       ii.   Reduction or loss of smell; or
                       iii.  Facial pain or pressure
                  5.  Member will continue to use a daily intranasal
                       corticosteroid while being treated with Dupixent, unless
                       contraindicated or not tolerated.

               D.  Eosinophilic esophagitis (EoE)
                    Authorization of 6 months may be granted for treatment
                    of EoE in members 12 years of age or older, weighing at
                    least 40 kg, when all of the following criteria are met:
                    1.  Member has history of an average of at least 2
                         episodes of dysphagia (with intake of solids) per week
                    2.  Diagnosis has been confirmed by esophageal biopsy
                         as characterized by 15 or more intraepithelial
                         esophageal eosinophils per high power field
                    3.  Member has had an inadequate treatment response to
                         both of the following:
                         i.    Proton pump inhibitor
                         ii.   Systemic corticosteroid or local therapies (e.g.,
                               budesonide, fluticasone [powder or suspension for
                               inhalation] swallowed), unless contraindicated or
                               not tolerated.

 
      V.  CONTINUATION OF THERAPY

           A.  Moderate-to-severe atopic dermatitis
                Authorization of 12 months may be granted for members 6
                months of age or older who are using the requested
                medication for moderate-to-severe atopic dermatitis when
                the member has achieved or maintained positive clinical
                response with Dupixent therapy as evidenced by low disease
                activity (i.e., clear or almost clear skin), or improvement in
                signs and symptoms of atopic dermatitis (e.g., redness,
                itching, oozing/crusting).

           B.  Asthma
                Authorization of 12 months may be granted for continuation
                of treatment of asthma in members 6 years of age or older
                when all of the following criteria are met:
                1.  Asthma control has improved on Dupixent treatment as
                     demonstrated by at least one of the following:
                     i.    A reduction in the frequency and/or severity of
                           symptoms and exacerbations
                     ii.   A reduction in the daily maintenance oral
                           corticosteroid dose
                2.  Member will continue to use maintenance asthma
                     treatments (e.g., inhaled corticosteroid, additional
                     controller) in combination with Dupixent.

           C.  Chronic rhinosinusitis with nasal polyposis (CRSwNP)
                Authorization of 12 months may be granted for continuation
                of treatment of chronic rhinosinusitis with nasal polyposis
                when all of the following are met:
                1.  Member is 18 years of age or older.
                2.  Member has achieved or maintained positive
                     clinical response to Dupixent therapy as evidenced by
                     improvement in signs and symptoms of CRSwNP (e.g.,
                     improvement in nasal congestion, nasal polyp size, loss
                     of smell, anterior or posterior rhinorrhea, sinonasal
                     inflammation, hyposmia, and/or facial pressure or pain
                     or reduction in corticosteroid use).

            D.  Eosinophilic Esophagitis
                 Authorization of 12 months may be granted for continuation
                 of treatment of eosinophilic esophagitis in members 12
                 years of age or older, weighing at least 40 kg, when
                 member has achieved or maintained positive clinical
                 response with Dupixent therapy as evidenced by
                 improvement in signs and symptoms of eosinophilic
                 esophagitis (e.g., dysphagia, heartburn, chest pain,
                 emesis).

 
     VI.  OTHER
            For all indications: Member cannot use Dupixent concomitantly
            with any other biologic drug or targeted synthetic drug.

            Note: If the member is a current smoker or vaper, they should
            be counseled on the harmful effects of smoking and vaping on
            pulmonary conditions and available smoking and vaping
            cessation options.

 
   VII.  APPENDIX

 

Table. Relative potency of select topical corticosteroid products

Potency	Drug	Dosage form	Strength
I. Super-high potency (group 1)	Augmented betamethasone   dipropionate	Ointment, Lotion, Gel	0.05%
	Clobetasol propionate	Cream, Gel, Ointment,   Solution, Cream   (emollient), Lotion,   Shampoo, Foam, Spray	0.05%
	Fluocinonide	Cream	0.1%
	Flurandrenolide	Tape	4 mcg/cm2
	Halobetasol propionate	Cream, Lotion,   Ointment, Foam	0.05%
II. High potency     (group 2)	Amcinonide	Ointment	0.1%
	Augmented betamethasone   dipropionate	Cream	0.05%
	Betamethasone     dipropionate	Ointment	0.05%
	Clobetasol propionate	Cream	0.025%
	Desoximetasone	Cream, Ointment, Spray	0.25%
		Gel	0.05%
	Diflorasone diacetate	Ointment, Cream   (emollient)	0.05%
	Fluocinonide	Cream, Ointment, Gel,   Solution	0.05%
	Halcinonide	Cream, Ointment	0.1%
	Halobetasol propionate	Lotion	0.01%
Potency	Drug	Dosage form	Strength
III. High potency   (group 3)	Amcinonide	Cream, Lotion	0.1%
	Betamethasone   dipropionate	Cream, hydrophilic   emollient	0.05%
	Betamethasone valerate	Ointment	0.1%
		Foam	0.12%
	Desoximetasone	Cream, Ointment	0.05%
	Diflorasone diacetate	Cream	0.05%
	Fluocinonide	Cream, aqueous   emollient	0.05%
	Fluticasone propionate	Ointment	0.005%
	Mometasone furoate	Ointment	0.1%
	Triamcinolone acetonide	Cream, Ointment	0.5%
IV. Medium        potency (group 4)	Betamethasone   dipropionate	Spray	0.05%
	Clocortolone pivalate	Cream	0.1%
	Fluocinolone acetonide	Ointment	0.025%
	Flurandrenolide	Ointment	0.05%
	Hydrocortisone valerate	Ointment	0.2%
	Mometasone furoate	Cream, Lotion, Solution	0.1%
	Triamcinolone acetonide	Cream	0.1%
		Ointment	0.05% and 0.1%
		Aerosol Spray	0.2 mg per 2-second   spray
V. Lower-mid   potency   (group 5)	Betamethasone   dipropionate	Lotion	0.05%
	Betamethasone valerate	Cream	0.1%
	Desonide	Ointment, Gel	0.05%
	Fluocinolone acetonide	Cream	0.025%
	Flurandrenolide	Cream, Lotion	0.05%
	Fluticasone propionate	Cream, Lotion	0.05%
	Hydrocortisone butyrate	Cream, Lotion,   Ointment, Solution	0.1%
	Hydrocortisone probutate	Cream	0.1%
	Hydrocortisone valerate	Cream	0.2%
	Prednicarbate	Cream (emollient),   Ointment	0.1%
	Triamcinolone acetonide	Lotion	0.1%
		Ointment	0.025%
VI. Low potency    (group 6)	Alclometasone dipropionate	Cream, Ointment	0.05%
	Betamethasone valerate	Lotion	0.1%
	Desonide	Cream, Lotion, Foam	0.05%
	Fluocinolone acetonide	Cream, Solution,   Shampoo, Oil	0.01%
	Triamcinolone acetonide	Cream, lotion	0.025%
VII. Least potent   (group 7)	Hydrocortisone (base, less   than 2%)	Cream, Ointment,   Solution	2.5%
		Lotion	2%
		Cream, Ointment, Gel,   Lotion, Spray, Solution	1%
		Cream, Ointment	0.5%
	Hydrocortisone acetate	Cream	2.5%
		Lotion	2%
		Cream	1%

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Dupixent [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc.; June 2022.
2. Eichenfield LF, Tom WL, 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;71:116-32.
3. 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;375:2335-2348.
4. 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):2486-2496.
5. 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):2475-2485.
6. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. 2021 update. Available at: https://ginasthma.org/wp-content/uploads/2021/05/GINA-Main-Report-2021-V2-WMS.pdf. Accessed March 11, 2022.
7. Topical Corticosteroids. Drug Facts and Comparisons.  Facts & Comparisons [database online]. St. Louis, MO:  Wolters Kluwer Health Inc; January 15, 2020.  Accessed January 27, 2022. 
8. gov. National Library of Medicine (US). Identifier NCT02912468, A Controlled Clinical Study of Dupilumab in Patients with Nasal Polyps (SINUS-24) 2016 Sep 23. Available from: https://clinicaltrials.gov/ct2/show/NCT02912468.
9. gov. National Library of Medicine (US). Identifier NCT02898454, A Controlled Clinical Study of Dupilumab in Patients with Nasal Polyps (SINUS-52) 2016 Sep 13. Available from: https://clinicaltrials.gov/ct2/show/NCT02898454.
10. Fishbein AB, Silverberg, JI, Wilson EJ, et al. Update on atopic dermatitis: Diagnosis, severity assessment, and treatment selection. J Allergy Clin Immunol Pract. 2020;8(1): 91-101.
11. Cloutier 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. 2020;324(22): 2301-2317.
12. Bachert C, Han JK, Wagenmann M, et al, EUFOREA expert board meeting on uncontrolled severe chronic rhinosinusitis with nasal polyps (CRSwNP) and biologics: Definitions and management. J Allergy Clin Immunol. 2021;147(1):29-36.
13. Lucendo AJ, Molina-Infante J, Arias A, et al. Guidelines on eosinophilic esophagitis: evidence-based statements and recommendations for diagnosis and management in children and adults. United European Gastroenterol J. 2017;5(3):355-358.
14. Gonsalves NP, Aceves S. Diagnosis and treatment of eosinophilic esophagitis. J Allergy Clin Immunol. 2020;145(1):1-7.
15. gov. National Library of Medicine (US). Identifier NCT03633617. Study to determine the efficacy and safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) 2022 May 27. Available from: https://clinicaltrials.gov/ct2/show/NCT03633617.
16. gov. National Library of Medicine (US). Identifier NCT03346434, Safety, Pharmacokinetics and Efficacy of Dupilumab in Patients ≥6 months to <6 years with Moderate-to-Severe Atopic Dermatitis (Liberty AD PRESCHOOL) 2022 Jun 10. Available from: https://clinicaltrials.gov/ct2/show/NCT03346434.
17. WJ Fokkens, VJ Lund, C Hopkins, et al. European Position Paper on Rhinosinusitis and Nasal Polyps 2020. 2020;58(Suppl S29):1-464.
18. Hopkins C. Chronic Rhinosinusitis with Nasal Polyps. N Engl J Med. 2019;381(1):55-63.  

 

 

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

July 16, 2022