Subject: Cibinqo 5142-A SGM P2023
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 Indication
Cibinqo is indicated for the treatment of adults and pediatric
patients 12 years of age and older with refractory, moderate-to-
severe atopic dermatitis whose disease is not adequately
controlled with other systemic drug products, including biologics,
or when use of those therapies is inadvisable.
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. Initial requests:
1. Chart notes or medical records showing affected area(s)
and affected body surface area (where applicable).
2. Chart notes, medical record documentation, or claims
history of prerequisite therapies including response to
therapy. If prerequisite therapies are not advisable,
documentation of why therapies are not advisable for the
member.
B. 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.
III. PRESCRIBER SPECIALTIES
This medication must be prescribed by or in consultation with a
dermatologist or allergist/immunologist.
IV. CRITERIA FOR INITIAL APPROVAL
Atopic dermatitis
Authorization of 4 months may be granted for treatment of
moderate-to-severe atopic dermatitis in members 12 years of
age or older when all of the following criteria are met:
A. 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.
B. Member meets one of the following:
1. Member has had an inadequate treatment response with
one of the following in the past year:
i. A medium potency to super-high potency topical
corticosteroid (see Appendix)
ii. A topical calcineurin inhibitor
2. The use of medium potency to super-high potency topical
corticosteroid and topical calcineurin inhibitor are not
advisable for the member (e.g., due to contraindications,
prior intolerances).
C. Member has had an inadequate response to treatment with a
systemic drug product (e.g., oral cyclosporine, azathioprine,
methotrexate, mycophenolate mofetil) or a biologic (e.g.,
Dupixent, Adbry) indicated for the treatment of atopic
dermatitis, or use of these therapies are not advisable for the
member.
V. CONTINUATION OF THERAPY
Atopic dermatitis
Authorization of 12 months may be granted for members 12
years of age or older (including new members) who are using
the requested medication for moderate-to-severe atopic
dermatitis when the member has achieved or maintained a
positive clinical response 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).
VI. OTHER
For all indications: Member has had a documented negative
tuberculosis (TB) test (which can include a tuberculosis skin test
[PPD], an interferon-release assay [IGRA], or a chest x-ray)*
within 6 months of initiating therapy for persons who are naïve
to biologic drugs or targeted synthetic drugs associated with an
increased risk of TB.
* If the screening testing for TB is positive, there must be
further testing to confirm there is no active disease. Do not
administer the requested medication to members with active TB
infection. If there is latent disease, TB treatment must be
started before initiation of the requested medication.
Member cannot use the requested medication concomitantly
with any other biologic drug, targeted synthetic drug, or potent
immunosuppressant such as azathioprine or cyclosporine.
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,
greater than or equal
to 2%)
|
Cream, Ointment,
Solution
|
2.5%
|
|
Lotion
|
2%
|
|
Hydrocortisone (base,
less than 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:
- Cibinqo [package insert]. New York, NY: Pfizer Inc.; February 2023.
- Simpson EL, Sinclair R, Forman S, et al. Efficacy and safety of abrocitinib in adults and adolescents with moderate-to-severe atopic dermatitis (JADE MONO-1): a multicentre, double-blind, randomised, placebo-controlled, phase 3 clinical trial. Lancet. 2020;396:255-266.
- Eichenfield LF, Tom WL, Chamlin SL, et. al. Guidelines of care for the management of atopic dermatitis: Section Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol. 2014;70:338-51.
- 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;71:116-132.
- Testing for TB Infection. Centers for Disease Control and Prevention. Retrieved on November 15, 2022 from: https://www.cdc.gov/tb/topic/testing/tbtesttypes.htm.
- Topical Corticosteroids. Drug Facts and Comparisons. Facts & Comparisons [database online]. St. Louis, MO: Wolters Kluwer Health Inc; December 1, 2021. Accessed November 7, 2022.
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.
May 26, 2023
