Subject: Dupixent 1743-A Enhanced SGM P2022c
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
1. Initial requests:
i. Member’s chart notes or medical records showing
affected area(s) and body surface area (see section
IV.A.1).
ii. Member’s chart notes or medical record
documentation and claims history of prerequisite
therapies (including topical calcineurin inhibitors
and topical corticosteroids) (see section IV.A.2)
including dosage, duration, and response to
therapy. If prerequisite therapy is not advisable,
documentation of why topical calcineurin inhibitors
and/or topical corticosteroids are not advisable for
the member.
2. Continuation requests: Documentation (e.g., chart
notes) that the member has experienced a positive
clinical response to therapy as evidenced by low
disease activity or improvement in signs or symptoms
of atopic dermatitis.
B. Asthma
1. 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. Continuation requests: Chart notes or medical record
documentation of positive clinical response.
C. Chronic rhinosinusitis with nasal polyposis
1. Initial requests:
i. Member’s chart or medical record showing nasal
endoscopy, anterior rhinoscopy details, or computed
tomography (CT) (e.g., location, size), or Meltzer
Clinical Score or endoscopic nasal polyps 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. Continuation requests: Chart notes or medical record
documentation of 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. PRESCRIBER SPECIALTIES
This medication must be prescribed by or in consultation with
one of the following:
A. Atopic dermatitis: dermatologist or allergist/immunologist
B. Asthma: allergist/immunologist or pulmonologist
C. Chronic rhinosinusitis with nasal polyposis:
allergist/immunologist or otolaryngologist
D. 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 area is greater than or equal to
10% OR crucial body areas (e.g., hands, feet, face,
neck, scalp, genitals/groin, intertriginous areas) are
affected.
2. Member has had an inadequate treatment response to
both of the following in the past 180 days:
i. A high potency or super-high potency topical
corticosteroid (see Appendix), or the use of topical
corticosteroids is not advisable for the member (e.g.,
due to contraindications, prior intolerances, potency
not appropriate for member’s age)
ii. A topical calcineurin inhibitor, or the use of topical
calcineurin inhibitors is not advisable for the member
(e.g., due to contraindications or prior intolerances).
3. Member’s dose will not exceed the following:
i. Pediatric members (6 months to 5 years of age) 5 kg to
less than 15 kg: 200 mg every 4 weeks
ii. Pediatric members (6 months to 5 years of age) 15 kg
to less than 30 kg: 300 mg every 4 weeks
iii. Pediatric members (6 to 17 years of age) 15 kg to less
than 30 kg: Initial 600 mg dose followed by 300 mg
every 4 weeks
iv. Pediatric members (6 to 17 years of age) 30 kg to less
than 60 kg: Initial 400 mg dose followed by 200 mg
every other week
v. Pediatric members (6 to 17 years of age) 60 kg or
more: Initial 600 mg dose followed by 300 mg every
other week
vi. Adult members: Initial 600 mg dose followed by 300
mg every other week
B. Moderate-to-severe asthma
Authorization of 6 months may be granted for treatment of
moderate-to-severe 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 asthma is
inadequately controlled despite treatment for at
least 3 months with both of the following at
optimized doses:
a. Medium-to-high-dose inhaled corticosteroid
1. Adult and adolescent members (12 years age
and older): greater than 250 microgram total
daily dose of fluticasone propionate or
equivalent
2. Pediatric members (6 to 11 years of age):
greater than 100 microgram total daily dose
of fluticasone propionate or equivalent
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
1. Adult and adolescent members (12 years of
age and older): greater than 500 microgram
total daily dose of fluticasone propionate or
equivalent
2. Pediatric members (6 to 11 years of age):
greater than 200 microgram total daily dose
of fluticasone propionate or equivalent
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)10.
3. Member will continue to use maintenance asthma
treatments (e.g., inhaled corticosteroid, additional
controller) in combination with Dupixent.
4. Member’s dose will not exceed the following:
i. Adult and adolescent members (12 years of age and
older): Initial dose 600 mg followed by 300 mg
every other week or initial dose 400 mg followed by
200 mg every other week
ii. Adult adolescent members (12 years of age and
older) with co-morbid moderate-to-severe atopic
dermatitis: initial dose 600 mg followed by 300 mg
every other week
iii. Pediatric members (6 to 11 years of age) 15 to less
than 30 kg: 100 mg every other week or 300 mg
every four weeks
iv. Pediatric members (6 to 11 years of age) ≥ 30 kg:
200 mg every other week
v. Pediatric members (6 to 11 years of age) with co-
morbid moderate-to-severe atopic dermatitis:
a. 15 kg to less than 30 kg: Initial 600 mg dose
followed by 300 mg every 4 weeks
b. 30 kg to less than 60 kg: Initial 400 mg dose
followed by 200 mg every other week
c. 60 kg or more: Initial 600 mg dose followed by
300 mg every other week
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.
6. Member’s dose will not exceed the following:
i. 300 mg every other week
ii. Members with co-morbid moderate-to-severe
asthma: initial dose of 600 mg followed by 300
mg every other week
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.
4. Member’s dose will not exceed 300 mg every week
V. CONTINUATION OF THERAPY
A. Moderate-to-severe atopic dermatitis
Authorization of 6 months may be granted for members 6
months of age or older when all of the following criteria is
met:
1. Member has achieved or maintained positive clinical
response with Dupixent therapy for moderate-to-severe
atopic dermatitis 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).
2. Member’s dose will not exceed the following:
i. Pediatric members (6 months to 5 years of age) 5
kg to less than 15 kg: 200 mg every 4 weeks
ii. Pediatric members (6 months to 5 years of age) 15
kg to less than 30 kg: 300 mg every 4 weeks
iii. Pediatric members (6 to 17 years of age) 15 kg to
less than 30 kg: Initial 600 mg dose followed by
300 mg every 4 weeks
iv. Pediatric members (6 to 17 years of age) 30 kg to
less than 60 kg: Initial 400 mg dose followed by
200 mg every other week.
v. Pediatric members (6 to 17 years of age) 60 kg or
more: Initial 600 mg dose followed by 300 mg every
other week
vi. Adult members: Initial 600 mg dose followed by 300
mg every other week
B. Moderate-to-severe asthma
Authorization of 12 months may be granted for continuation
of treatment of moderate-to-severe asthma in members 6
years of age or older when all of the following criteria are
met:
1. Member has achieved and maintained positive clinical
response with Dupixent therapy for asthma as
evidenced 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.
3. Member’s dose will not exceed the following:
i. Adult and adolescent members (12 years of age and
older): Initial dose of 600 mg followed by 300 mg
every other week or initial dose of 400 mg followed
by 200 mg every other week
ii. Adult and adolescent members (12 years of age and
older) with co-morbid moderate-to-severe atopic
dermatitis: initial dose 600 mg followed by 300 mg
every other week
iii. Pediatric members (6 to 11 years of age) 15 to less
than 30 kg: 100 mg every other week or 300 mg
every four weeks
iv. Pediatric members (6 to 11 years of age): ≥ 30 kg:
200 mg every other week
v. Pediatric members (6 to 11 years of age) with co-
morbid moderate-to-severe atopic dermatitis
a. 15 kg to less than 30 kg: Initial 600 mg dose
followed by 300 mg every 4 weeks
b. 30 kg to less than 60 kg: Initial 400 mg dose
followed by 200 mg every other week
c. 60 kg or more: Initial 600 mg dose followed by
300 mg every other week
C. Chronic rhinosinusitis with nasal polyposis (CRSwNP)
Authorization of 12 months may be granted for continuation
of treatment of chronic rhinosinusitis with nasal polyposis in
members 18 years of age or older when all of the following
are met:
1. 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)
2. Member’s dose will not exceed the following:
i. 300 mg every other week
ii. Members with co-morbid moderate-to-severe
asthma: initial dose 600 mg followed by 300 mg
every other week
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 all of
the following are met:
1. 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).
2. Member will not exceed 300 mg every week
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:
- Dupixent [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc.; June 2022.
- 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.
- Simpson E.L., et al. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med. 2016 [Epub ahead of print].
- Protopic [package insert]. Madison, NJ:LEO Pharmac Inc.; February 2019.
- Topical Corticosteroids. Drug Facts and Comparisons. Facts & Comparisons [database online]. St. Louis, MO: Wolters Kluwer Health Inc; January 15, 2020. Accessed January 27, 2022.
- Castro M, Corren J, Pavord ID, et al. Dupilumab Efficacy and Safety in Moderate-to-Severe Uncontrolled Asthma. The New England Journal Of Medicine. 2018;378(26):2486-2496.
- Rabe KF, Nair P, Brusselle G, et al. Efficacy and Safety of Dupilumab in Glucocorticoid-Dependent Severe Asthma. The New England Journal Of Medicine. 2018;378(26):2475-2485.
- 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.
- 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.
- 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.
- National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. doi: 10.1016/j.jaci.2007.09.043. Erratum in: J Allergy Clin Immunol. 2008 Jun;121(6):1330.
- 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.
- 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.
- 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.
- 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.
- Gonsalves NP, Aceves S. Diagnosis and treatment of eosinophilic esophagitis. J Allergy Clin Immunol. 2020;145(1):1-7.
- 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.
- 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.
- WJ Fokkens, VJ Lund, C Hopkins, et al. European Position Paper on Rhinosinusitis and Nasal Polyps 2020. 2020;58(Suppl S29):1-464.
- 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
