Pharmacy Prior Authorization Criteria

Topical Retinoid Agents

Indications for Prior Authorization

Atralin (tretinoin), Avita (tretinoin) cream and gel, Retin-A (tretinoin) cream and gel, Retin-A Micro (tretinoin) gel

• For diagnosis of Acne vulgaris
  Indicated for the topical treatment of acne vulgaris.

• For diagnosis of Wound healing (mild) [9]
  Tretinoin 0.05% cream has been shown to decrease would healing time in patients receiving electroepilation. Enhanced healing of epidermal wounds in patients undergoing dermabrasion when pretreated with tretinoin 0.05% cream has been reported. DRUGDEX Recommendation: Adult, Class IIb, Evidence favors efficacy.

• Actinic keratosis [9]
  

• Hyperkeratosis [9]
  

• Keloid scar [9]
  

Aklief (trifarotene) cream, Arazlo (tazarotene) lotion

• For diagnosis of Acne vulgaris
  Indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.

Altreno (tretinoin) lotion

• For diagnosis of Acne vulgaris
  Indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.

• For diagnosis of Wound healing (mild) [9]
  Tretinoin 0.05% cream has been shown to decrease would healing time in patients receiving electroepilation. Enhanced healing of epidermal wounds in patients undergoing dermabrasion when pretreated with tretinoin 0.05% cream has been reported. DRUGDEX Recommendation: Adult, Class IIb, Evidence favors efficacy.

• Actinic keratosis [9]
  

• Hyperkeratosis [9]
  

• Keloid scar [9]
  

Differin (adapalene) cream/lotion/gel/solution/pads

• For diagnosis of Acne vulgaris
  Indicated for the topical treatment of acne vulgaris.

Tazorac (tazarotene) cream 0.1%

• For diagnosis of Acne Vulgaris
  Indicated for the topical treatment of patients with acne vulgaris.

• For diagnosis of Plaque Psoriasis
  Indicated for the topical treatment of patients with plaque psoriasis.

Tazorac (tazarotene) cream 0.05%

• For diagnosis of Plaque Psoriasis
  Indicated for the topical treatment of patients with plaque psoriasis.

Tazorac (tazarotene) gel 0.1%

• For diagnosis of Acne Vulgaris
  Indicated for the topical treatment of patients with facial acne vulgaris of mild to moderate severity.

• For diagnosis of Plaque Psoriasis
  Indicated for the topical treatment of patients with plaque psoriasis of up to 20% body surface area involvement.

Tazorac (tazarotene) gel 0.05%

• For diagnosis of Plaque Psoriasis
  Indicated for the topical treatment of patients with plaque psoriasis of up to 20% body surface area involvement.

Fabior (tazarotene) foam

• For diagnosis of Acne Vulgaris
  Indicated for the topical treatment of acne vulgaris in patients 12 years of age or older.

Criteria

Avita, Brand Retin A Micro (0.06%, 0.08%)

Treatment for cosmetic purposes (i.e., wrinkles, senile lentigo, solar elastosis, dyschromia, melasma or chloasma, hyperpigmentation of skin, facial mottling) is a benefit exclusion. [A]

Prior Authorization

Length of Approval: 12 Month(s)
For diagnosis of Acne Vulgaris

• One of the following:
• Patient is 25 years of age or younger
OR
• Both of the following:
• Patient is older than 25 years of age
• Diagnosis of acne vulgaris (i.e., acne)

Avita, Brand Retin A Micro (0.06%, 0.08%)

Treatment for cosmetic purposes (i.e., wrinkles, senile lentigo, solar elastosis, dyschromia, melasma or chloasma, hyperpigmentation of skin, facial mottling) is a benefit exclusion. [A]

Prior Authorization

Length of Approval: 12 Month(s)
For diagnosis of Other Medical Uses (Off-Label)

• One of the following diagnoses: [A, 9]
• Actinic keratosis
• Hyperkeratosis
• Keloid scar
• Wound healing (mild)

Aklief

Treatment for cosmetic purposes (i.e., wrinkles, senile lentigo, solar elastosis, dyschromia, melasma or chloasma, hyperpigmentation of skin, facial mottling) is a benefit exclusion. [A]

Prior Authorization

Length of Approval: 12 Month(s)
For diagnosis of Acne Vulgaris

• One of the following:
• Both of the following:
• Patient is 25 years of age or younger
AND
• Trial and failure (of a minimum 30-day supply) within the past 180 days, contraindication, or intolerance to one of the following generics:
• Adapalene (cream, gel)
• Topical tretinoin or tretinoin microsphere
OR
• All of the following:
• Patient is older than 25 years of age
AND
• Diagnosis of acne vulgaris (i.e., acne)
AND
• Trial and failure (of a minimum 30-day supply) within the past 180 days, contraindication, or intolerance to one of the following generics:
• Adapalene (cream, gel)
• Topical tretinoin or tretinoin microsphere

Altreno, Atralin, Brand Retin-A, Brand Retin-A Micro (0.1% 0.04%), Brand Adapalene 0.1% Soln, Brand Adapalene 0.1% Pads

Treatment for cosmetic purposes (i.e., wrinkles, senile lentigo, solar elastosis, dyschromia, melasma or chloasma, hyperpigmentation of skin, facial mottling) is a benefit exclusion. [A]

Prior Authorization

Length of Approval: 12 Month(s)
For diagnosis of Acne Vulgaris

• One of the following:
• Both of the following:
• Patient is 25 years of age or younger
AND
• Trial and failure (of a minimum 30-day supply) within the past 180 days, contraindication, or intolerance to BOTH of the following generics:
• Adapalene (cream, gel)
• Topical tretinoin or tretinoin microsphere
OR
• All of the following:
• Patient is older than 25 years of age
AND
• Diagnosis of acne vulgaris (i.e., acne)
AND
• Trial and failure (of a minimum 30-day supply) within the past 180 days, contraindication, or intolerance to BOTH of the following generics:
• Adapalene (cream, gel)
• Topical tretinoin or tretinoin microsphere

Altreno, Atralin, Brand Retin-A, Brand Retin-A Micro (0.04%, 0.1%)

Treatment for cosmetic purposes (i.e., wrinkles, senile lentigo, solar elastosis, dyschromia, melasma or chloasma, hyperpigmentation of skin, facial mottling) is a benefit exclusion. [A]

Prior Authorization

Length of Approval: 12 Month(s)
For diagnosis of Other Medical Uses (Off-Label)

• One of the following diagnoses: [A, 9]
• Actinic keratosis
• Hyperkeratosis
• Keloid Scar
• Wound healing (mild)
AND
• Trial and failure (of a minimum 30-day supply) within the past 180 days, contraindication, or intolerance to any generic topical tretinoin product

Brand Differin

Treatment for cosmetic purposes (i.e., wrinkles, senile lentigo, solar elastosis, dyschromia, melasma or chloasma, hyperpigmentation of skin, facial mottling) is a benefit exclusion. [A]

Prior Authorization

Length of Approval: 12 Month(s)
For diagnosis of Acne Vulgaris

• One of the following:
• Both of the following:
• Patient is 25 years of age or younger
AND
• Trial and failure (of a minimum 30-day supply) within the past 180 days, contraindication, or intolerance to BOTH of the following generics:
• adapalene (cream, gel)
• Topical tretinoin or tretinoin microsphere
OR
• All of the following:
• Patient is older than 25 years of age
AND
• Diagnosis of acne vulgaris (i.e., acne)
AND
• Trial and failure (of a minimum 30-day supply) within the past 180 days, contraindication, or intolerance to BOTH of the following generics:
• adapalene (cream, gel)
• Topical tretinoin or tretinoin microsphere

Arazlo, Fabior, Brand Tazarotene 0.1% foam, Brand Tazorac 0.1% cream and gel

Treatment for cosmetic purposes (i.e., wrinkles, senile lentigo, solar elastosis, dyschromia, melasma or chloasma, hyperpigmentation of skin, facial mottling) is a benefit exclusion. [A]

Prior Authorization

Length of Approval: 12 Month(s)
For diagnosis of Acne Vulgaris

• One of the following:
• Both of the following:
• Patient is 25 years of age or younger
AND
• Trial and failure (of a minimum 30-day supply) within the past 180 days, contraindication or intolerance to BOTH of the following:
• generic tazarotene
AND
• One of the following:
• generic adapalene
• generic topical tretinoin or tretinoin microsphere
OR
• All of the following:
• Patient is older than 25 years of age
AND
• Diagnosis of acne vulgaris (i.e., acne)
AND
• Trial and failure (of a minimum 30-day supply) within the past 180 days, contraindication or intolerance to BOTH of the following:
• generic tazarotene
AND
• One of the following:
• generic adapalene
• generic topical tretinoin or tretinoin microsphere

Brand Tazorac

Treatment for cosmetic purposes (i.e., wrinkles, senile lentigo, solar elastosis, dyschromia, melasma or chloasma, hyperpigmentation of skin, facial mottling) is a benefit exclusion. [A]

Prior Authorization

Length of Approval: 12 Month(s)
For diagnosis of Plaque Psoriasis

• Diagnosis of plaque psoriasis
AND
• Both of the following:
• Trial and failure (of a minimum 30-day supply) within the past 180 days, or intolerance to generic tazarotene
AND
• Trial and failure (of a minimum 30-day supply) within the past 180 days, contraindication, or intolerance to one medium to high potency topical corticosteroid (e.g., triamcinolone, fluocinonide)

Generic tazarotene 0.1% cream, Generic tazarotene 0.05% cream, generic tazarotene 0.1% gel, generic tazarotene 0.05% gel

Treatment for cosmetic purposes (i.e., wrinkles, senile lentigo, solar elastosis, dyschromia, melasma or chloasma, hyperpigmentation of skin, facial mottling) is a benefit exclusion. [A]

Prior Authorization

Length of Approval: 12 Month(s)
For diagnosis of Plaque Psoriasis

• Diagnosis of plaque psoriasis
AND
• Trial and failure (of a minimum 30-day supply) within the past 180 days, contraindication, or intolerance to one medium to high potency topical corticosteroid (e.g., triamcinolone, fluocinonide)

Generic tazarotene 0.1% cream, generic tazarotene 0.1% gel

Treatment for cosmetic purposes (i.e., wrinkles, senile lentigo, solar elastosis, dyschromia, melasma or chloasma, hyperpigmentation of skin, facial mottling) is a benefit exclusion. [A]

Prior Authorization

Length of Approval: 12 Month(s)
For diagnosis of Acne Vulgaris

• One of the following:
• Patient is 25 years of age or younger
OR
• Both of the following:
• Patient is older than 25 years of age
• Diagnosis of acne vulgaris (i.e., acne)

P & T Revisions

2024-10-09, 2023-10-24, 2023-08-28, 2023-06-29, 2023-05-26, 2023-01-31, 2022-10-04, 2021-12-17, 2021-09-28, 2021-06-04, 2021-05-17, 2021-02-04, 2020-10-21, 2020-09-18, 2020-04-01, 2019-10-30, 2019-07-26

References

1. Adapalene Topical Solution 0.1% Prescribing Information. Allegis Holdings LLC. Canton, MS. December 2020.
2. Aklief Prescribing Information. Galderma Laboratories, L.P. Fort Worth, Texas. October 2023.
3. Altreno Prescribing Information. Bausch Health US, LLC. Bridgewater, NJ. March 2020.
4. Atralin Prescribing Information. Bausch Health US, LLC.. Bridgewater, NJ. February 2024.
5. Avita Prescribing Information. Mylan Pharmaceuticals Inc. Morgantown, WV. January 2018.
6. Differin Prescribing Information. Galderma Laboratories, L.P. Fort Worth, TX. October 2022.
7. Retin-A Prescribing Information. Bausch Health US, LLC. Bridgewater, NJ. May 2024.
8. Retin-A Micro Prescribing Information. Bausch Health US, LLC. Bridgewater, NJ. October 2023.
9. DRUGDEX System [Internet database]. Greenwood Village (CO): IBM Corporation; Updated periodically. Available by subscription at: www.micromedexsolutions.com. Accessed September 14, 2022.
10. Per clinical consult with dermatologist, June 7, 2012.
11. Fabior Prescribing Information. Mayne Pharma. Greenville, NC. June 2018.
12. Tazorac Prescribing Information. Allergan, Inc. Irvine, CA. July 2017.
13. Arazlo Prescribing Information. Bausch Health US, LLC. Bridgewater, NJ. August 2023.
14. Menter A, Korman N, Elmets C, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 3. Guidelines of care for the management and treatment of psoriasis with topical therapies. J Amer. Acad. of Derm. 2009;60:643-59.
15. UptoDate Online [internet database]. Waltham, MA. UptoDate, Inc. Updated periodically. Available by subscription at: www.uptodate.com. Accessed September 14, 2022.

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End Notes

1. The use of topical retinoids for the following conditions was clarified as either medical or cosmetic (plan exclusions). [10] Please refer to Background section for table with details.

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Revision History

• 2024-10-09: 2024 Annual Review. Added generic tazarotene cream 0.05% as a target drug for Plaque Psoriasis indication. Background updates.
• 2023-10-24: 2023 Annual Review - No changes to criteria; updated background table section from cosmetic to medical for alopecia areata indication.
• 2023-08-28: Updated GPIs in criteria sections, no changes to criteria
• 2023-06-29: Removed generic adapalene cream, gel, and pump as targets from guideline.
• 2023-05-26: Formulary strategy update to revise trial requirement for Aklief to require 1 agent.
• 2023-01-31: Removed generic tretinoin and generic tretinoin microsphere products as targets from guideline. Updated background.
• 2022-10-04: Annual review - updated background table and references. Added generic tazarotene 0.05% and 0.1% gel to guideline.
• 2021-12-17: Annual review - Updated background and references. Removed obsolete adapalene lotion as target and as ST option.
• 2021-09-28: Updated GPIs for Fabior criteria section.
• 2021-06-04: Updated GPIs for Fabior criteria section.
• 2021-05-17: Added new authorized brand alternative for Fabior with criteria to mirror Fabior. Added EHB formulary.
• 2021-02-04: Added Arazlo to guideline mirroring Fabior. Added T/F requirement through topical corticosteroids for brand Tazorac and generic tazarotene for plaque psoriasis. Updated background and references.
• 2020-10-21: Annual review - no changes (previous criteria changes will be effective 1/1/2021)
• 2020-09-18: Added criteria for Differin, Tazorac and Fabior. Embedded ST will apply to all ages. Diagnosis criterion will only apply to patients older than 25 years of age for acne vulgaris. Updated background and references.
• 2020-04-01: Brand Retin-A Micro 0.08% and 0.06% moved to section with only diagnosis requirement
• 2019-10-30: Added new product Aklief. Added an embedded step through generic adapalene for brand Differin. Removed obsolete products Plixda and Tretin-X. Updated background and references.
• 2019-07-26: June P&T autoupdate to add brand Retin-A micro as a ST target. No changes to clinical criteria. XC 7/26/19.

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