Topical Tretinoin Products – NC Standard

Restricted Products:

Restriction applies to brand and generic products

• Atralin® (tretinoin)
• Altreno™ (tretinoin)
• Avita® (tretinoin)
• Retin-A® (tretinoin)
• Retin - A Micro/ pump (tretinoin microsphere)
• Twyneo® (benzoyl peroxide-tretinoin)
• Veltin® (clindamycin phosphate- tretinoin)
• Ziana® (clindamycin phosphate- tretinoin)

FDA Approved Use:

• For the topical treatment of acne vulgaris

Criteria for Approval of Restricted Product(s):

1. The patient is using for the treatment of acne vulgaris, actinic keratosis, or ichthyoses; AND
2. For members requesting brand name tretinoin containing products, a trial and failure of, or clinical intolerance/contraindication to generic tretinoins is required; AND
3. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 365 days (1 year)

References:

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information:

March 2022: Criteria update: Added new to market Twyneo cream to policy.

March 2022: Criteria update: Annual criteria review. Updated duration of approval to one year. Removed Tretin-X (obsolete product).

January 2020: Criteria update: Removed unrestricted/suggested alternatives. Added Avita to policy.

December 2018: Updated unrestricted drugs – added generic tretinoin gel

October 2018: Added new to market drug, Altreno™, to the policy.

June 2017: Criteria Reformatting; Clarified duration of approval

May 2017: Reformatting and consolidating of criteria into one document for all formularies.

January 2017: Formulary specific criteria written for Net Results formulary

July 2014: Historical revision.

January 2011: Original utilization management criteria issued