Subject: Adapalene PA with Limit 351-C 08-2022

Drug

RETINOIDS (TOPICAL)

adapalene

DIFFERIN  (adapalene)

Policy:

FDA-approved Indications
Differin Cream 0.1%, Adapalene Gel 0.1%, Adapalene Topical Solution 0.1% (swab), Adapalene Topical Solution 0.1%
Differin Cream 0.1%, Adapalene Gel 0.1%, Adapalene Topical Solution 0.1% (swab), and Adapalene Topical Solution 0.1% are indicated for the topical treatment of acne vulgaris.

Differin Gel 0.3%, Differin Lotion 0.1%
Differin Gel 0.3% and Differin Lotion 0.1% are indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

 

COVERAGE CRITERIA
The requested drug will be covered with prior authorization when the following criteria are met:
      •     The patient has a diagnosis of acne vulgaris
             AND
                  º     If additional quantities are being requested, then the
                         requested drug is being prescribed to treat a body
                         surface area that requires additional quantities

Quantity Limits apply.

QUANTITY LIMIT   PLEASE NOTE: Since manufacturer package sizes may vary, it is the discretion of the dispensing   pharmacy to fill quantities per package size up to these quantity limits. In such cases the filling limit   and day supply may be less than what is indicated.
Medication	COLUMN A   (Lower Limit)	COLUMN B   (Lower Limit)	COLUMN C   (Upper Limit)	COLUMN D   (Upper Limit)
	4 Week Limit*	12 Week Limit*	4 Week Limit*	12 Week Limit*
Adapalene topical   solution	120 mL / 21 days	360 mL / 63 days	240 mL / 21 days	720 mL / 63 days
Adapalene topical  solution (swab)	28 swabs /   21 days	84 swabs /   63 days	56 swabs /   21 days	168 swabs /   63 days
Differin cream  0.1%  (adapalene cream)	45 grams /   21 days	135 grams /   63 days	90 grams /   21 days	270 grams /   63 days
Adapalene gel   0.1%	45 grams /   21 days	135 grams /   63 days	90 grams /   21 days	270 grams /   63 days
Differin gel 0.3%   (adapalene gel)	45 grams /   21 days	135 grams /   63 days	90 grams /   21 days	270 grams /   63 days
Differin lotion   0.1%   (adapalene lotion)	59 mL / 21 days	177 mL / 63 days	118 mL / 21 days	354 mL / 63 days
* The duration of 21 days is used for a 28-day fill period and 63 days is used for an 84-day fill period to allow time for refill processing.

 

RATIONALE
The intent of the criteria is to provide coverage consistent with product labeling, FDA guidance, standards of medical practice, evidence-based drug information, and/or published guidelines. Adapalene is indicated for the topical treatment of acne vulgaris.^1-8

The American Academy of Dermatology (AAD) guidelines state that the topical therapy of acne vulgaris includes the usage of agents that are available over the counter or via prescription. Therapy choice may be influenced by age of the patient, site of involvement, extent and severity of disease, and patient preference. Topical therapies may be used as monotherapy, in combination with other topical agents or in combination with oral agents in both initial control and maintenance. Commonly used topical acne therapies include benzoyl peroxide, salicylic acid, antibiotics, combination antibiotics with benzoyl peroxide, retinoids, retinoid with benzoyl peroxide, retinoid with antibiotic, azelaic acid, and sulfone agents. A topical retinoid alone is a first-line treatment option for mild acne vulgaris. Topical retinoids are also considered to be a first-line treatment option for mild, moderate or severe acne vulgaris when used as combination therapy with benzoyl peroxide, oral antibiotics, and/or topical antibiotics. Topical retinoids are important in addressing the development and maintenance of acne and are recommended as monotherapy in primarily comedonal acne, or in combination with topical or oral antimicrobials in patients with mixed or primarily inflammatory acne lesions. Using multiple topical agents that affect different aspects of acne pathogenesis can be useful; combination therapy should be used in the majority of patients with acne.⁹

The safety and effectiveness of adapalene in pediatric patients below the age of 12 have not been established.^1-6

Per AAD guidelines, topical adapalene, tretinoin, and benzoyl peroxide can be safely used in the management of preadolescent acne in children. Current data show that retinoids in younger patients are effective and are not associated with increased irritation or risk.⁹

These criteria do not provide approval for cosmetic uses of this drug.

Adapalene Topical Solution 0.1%
Adapalene Topical Solution 0.1% should be applied once a day to affected areas. Adapalene Topical Solution 0.1% is available in a 120 mL glass bottle.

Adapalene Topical Solution 0.1% (swab)
Adapalene solution should be applied once a day to affected areas. Adapalene Topical Solution, 0.1% is available in 14-count unit-of-use 1.2 gram swabs.

Differin Cream 0.1%
Differin Cream 0.1% should be applied once daily to the affected area. Differin Cream 0.1% is available in a 45 gram tube.

 
Adapalene Gel 0.1%
Differin Gel 0.1% should be applied once a day to the affected area. Differin Gel 0.1% is available in a 45 gram tube.

Differin Gel 0.3%
Differin Gel 0.3% should be applied once daily to the entire face and other affected areas. Differin Gel 0.3% is available in a 45 gram tube.

Differin Lotion 0.1%
Differin Lotion 0.1% should be applied once daily to the entire face and other affected areas. Differin Lotion 0.1% is available in a 2 oz (59 mL) pump bottle.

The quantity limits take into consideration available packages sizes, including at least the smallest package size, and quantity sufficient for FDA-approved dosage for approximate body surface area (BSA) treated. The quantity for an application and the percent BSA were chosen based on estimations of the areas that may be affected following the fingertip method and rule of nines. Gels, creams, lotions, and solutions, will follow this approximation for determining the quantity limits. The dosing and duration of use for the target drugs varies. Since manufacturer package sizes may also vary, it is the discretion of the dispensing pharmacy to fill quantities per package size up to these quantity limits. In such cases the filling limit and day supply may be less than what is indicated.

No universal standard exists for quantity of application, although suggested methods include use of the adult fingertip unit (the amount from the distal interphalangeal joint to the fingertip, or approximately 0.5 grams (gm), being applied over an area equal to 2 adult palms), following the rule of 9’s that measures the percent of affected area, and use of charts that propose amounts based on patient age and body site.¹⁰ It is calculated by using the area from the wrist to the fingers and thumb of the hand closed together to represent 1% of the patient’s BSA.¹¹
In adults, the rule of nines is used as a rough indicator of % BSA. Palmar hand surface is approximately 1% BSA.¹²

Anatomic Surface	% of Body Surface
head and neck	9%
anterior trunk	18%
posterior trunk	18%
arms, including hands	9% each
legs, including feet	18% each
genitalia	1%

Quantity for 1% BSA, suggested AAD estimation
º     Grams per application
       0.5 gm per application over 2 palms (1% BSA per palm) = 0.25gm
       per application over 1% BSA
Limit
º     45 gm / 0.25 gm per 1% BSA / 1 application per day / 28 days =
       6.4% BSA
º     59 mL / 0.25 mL per 1% BSA / 1 application per day / 28 days =
       8.4% BSA

Place of Service:

Outpatient

The above policy is based on the following references:

1. Adapalene Gel 0.1% [package insert]. Mahwah, NJ: Glenmark Pharmaceuticals Inc., USA; October 2021.
2. Adapalene Topical Solution 0.1% [package insert]. Doylestown, PA: Rochester Pharmaceuticals; July 2021.
3. Adapalene Topical Solution 0.1% Swab [package insert]. Doylestown, PA: Rochester Pharmaceuticals; November 2020.
4. Differin Cream 0.1% [package insert]. Fort Worth, TX: Galderma Laboratories, L.P.; November 2011.
5. Differin Gel 0.3% [package insert]. Fort Worth, TX: Galderma Laboratories, L.P.; February 2018.
6. Differin Lotion 0.1% [package insert]. Fort Worth, TX: Galderma Laboratories, L.P.; February 2018.
7. Lexicomp Online, AHFS DI (Adult and Pediatric) Online, Hudson, Ohio: UpToDate, Inc.; 2022; Accessed July 1, 2022.
8. Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com. Accessed July 1, 2022.
9. Zaenglein AL, Pathy AL, Schlosser BJ, et al. Guidelines of Care for the Management of Acne Vulgaris. J Am Acad Dermatol. 2016;74(5):945-973.
10. 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):116-132.
11. Elmets CA, Korman NJ, Prater EF, et al. Joint AAD–NPF Guidelines of Care for the Management and Treatment of Psoriasis with Topical Therapy and Alternative Medicine Modalities for Psoriasis Severity Measures. J Am Acad Dermatol. 2021;84(2):432-470.
12. Burn Triage and Treatment - Thermal Injuries. Available at: https://chemm.hhs.gov/burns.htm. Accessed July 1, 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.

December 10, 2022