Dermatologic agents

Dermatologic Agents: Tazorac®, FabiorTM, tretinoin (Avita®, Retin-A®, Retin-A Micro®, Atralin®, Tretin-X®), Ziana®
Medical Benefit
Date of Origin: 3/12
Effective Date: 6/15/2012
Pharmacy Commercial Benefit
Next Review Date: 3/13
Date Published to Web: 5/15/2012
Pharmacy Medicaid/Family Health
Review Dates: 3/12
Plus Benefit
Certain topical medications are used for the treatment of a variety of conditions including acne vulgaris, actinic keratosis and acne rosacea. Tretinoin is a naturally occurring derivate of vitamin A. Tazorac (tazarotene) is a retinoid prodrug of tazarotenic acid. As vitamin A (retinol) derivatives, retinoids are important regulators of cell reproduction, and cell proliferation. Topical tretinoin is indicated for the treatment of mild to moderate acne (grades I-III). Topical tretinoin has also been used in the symptomatic management of keratinization disorders such as ichthyosis and keratosis follicularis. Tazorac is indicated for the treatment of psoriasis, acne vulgaris, and photoaging of the skin. A cream formulation was FDA-approved in October 2000. Avage™ 0.1% cream was approved by the FDA on October 2, 2002 for the adjunctive treatment of fine facial wrinkles, particularly those associated with photoaging. Fabior topical foam is FDA-approved for the treatment of acne vulgaris in patients Coverage is determined through a prior authorization process with supporting clinical documentation for every request for members exceeding an age limit, specified in member’s contract. • Commercial age limits: 25yo, 27yo, or 30yo dependent on contract • Medicaid/Family Health Plus age limits: 30yo Coverage is provided when any of the following criteria are met: • Member has diagnosis of acne vulgaris or acne rosacea • Member has diagnosis of actinic keratosis • Member has diagnosis of basal cell or squamous cell carcinoma • Member has diagnosis of stable plaque psoriasis (Tazorac only) Please refer to package insert for prescribing information for each agent. Page 1 of 3
Dermatologic Agents
Last Review Date: 3/2012
Quantities covered for dosing within FDA approved dosage guidelines. Coverage will be granted for 1 year and can be renewed. Coverage can be renewed based upon the following criteria: • Member is documented as continuing to have a covered diagnosis AND
• Stabilization of disease or in absence of disease progression AND
• Absence of unacceptable toxicity from the drug All indications not described in Section III Policy criteria are not covered and may be considered experimental or investigational. Coverage will not be provided for cosmetic purposes. Examples: • Wrinkles • Hyperpigmentation • Hypopigmentation • Photoaging Please refer to individual prescribing information for full details.
Contraindications: Medications are contraindicated in members with a history of sensitivity reactions to the
Ziana: limit UV exposure (sunlight, sunlamps); patients with sunburn should be advised not to use
Ziana until fully recovered because of the increased susceptibility to sunlight as a result of the use of Page 2 of 3
Dermatologic Agents
Last Review Date: 3/2012
6/12: Fabior (topical tazarotene foam) added to policy. 1. Clinical Pharmacology. Accessed 2/2012. 2. Ziana [clindamycin/tretinoin]. Prescribing information. 3. Tazorac [tazarotene]. Prescribing Information. Allergan. Updated 3/2011. 4. Drugs@FDA – FDA approved products. Accessed online on 5/24/12 at 5. Fabior [tazarotene]. Prescribing information. Stiefel Laboratories, Inc. Research Triangle Park, NC 27709. The Plan fully expects that only appropriate and medically necessary services will be rendered. The Plan reserves the right to conduct pre-payment and post-payment reviews to assess the medical appropriateness of the above-referenced Drug therapy initiated with samples will not be considered as meeting medical necessity for coverage for non-preferred The preceding policy applies only to members for whom the above named pharmacy benefit medications are included on their covered formulary. Members with closed formulary / 2-tier benefits are subject to trying all appropriate formulary alternatives before a coverage exception for a 3rd tier agent will be considered.
The preceding policy is a guideline to allow for coverage of the pertinent medication/product, and is not meant to serve

as a clinical practice guideline. Page 3 of 3


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