Tazarotene (Arazlo, Fabior, Tazorac) Form

Tazarotene lotion (Arazlo®), foam (Fabior®), cream and gel (Tazorac®) are topical retinoids.
FDA Approved Indication(s) Tazarotene is indicated for the topical treatment of: • Plaque psoriasis (Tazorac cream and gel 0.05% and 0.1%) • Acne vulgaris: o That is facial and of mild to moderate severity (Tazorac cream and gel 0.1%)
o In patients 9 years of age and older (Arazlo lotion) o In patients 12 years of age or older (Fabior foam) Limitation(s) of use: The safety of Tazorac gel use on more than 20% body surface area has not been established. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Arazlo, Fabior, and Tazorac are medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Plaque Psoriasis (must meet all):

1. Request is for tazarotene cream or gel;

   2. Diagnosis of plaque psoriasis with body surface area involvement of ≤ 20%;
   3. Request does not exceed 1 tube per month. Approval duration: 12 months B. Acne Vulgaris (must meet all):
   4. Diagnosis of acne vulgaris;
   5. For Arazlo and Fabior requests only, member meets all of the following (a, b, and c): a. Member meets one of the following (i or ii): i. For Arazlo: age ≥ 9 years; ii. For Fabior: age ≥ 12 years; b. Member must use generic formulary topical tazarotene; Page 1 of 6

   CLINICAL POLICY
   Tazarotene c. Failure of generic formulary topical tretinoin and adapalene, unless clinically significant adverse effects are experienced or both are contraindicated; Prior authorization may be required for tretinoin

2. Request does not exceed 1 tube (Arazlo, Tazorac) or 1 can (Fabior) per month. Approval duration: 12 months C. Other diagnoses/indications (must meet 1 or 2):
3. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
4. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. All Indications in Section I (must meet all):
5. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
   2. Member is responding positively to therapy;
   3. If request is for a dose increase, new request does not exceed 1 tube (Arazlo, Tazorac) or 1 can (Fabior) per month. Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2):

6. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or Page 2 of 6

   CLINICAL POLICY
   Tazarotene b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

7. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents.
   IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization. Drug Name Dosing Regimen tretinoin
   (Retin-A®) adapalene (Differin®) Acne Vulgaris 0.025% gel, 0.05% cream, 0.1% cream: Apply once daily Acne Vulgaris Lotion, Cream: 0.1%; Gel: 0.1%, 0.3% Apply topically QD Dose Limit/ Maximum Dose Not applicable Not applicable Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Appendix C: Contraindications/Boxed Warnings • Contraindication(s): o Pregnancy o Tazorac: Individuals who have known hypersensitivity to any of its components • Boxed warning(s): none reported V. Dosage and Administration
   Drug Name Indication Dosing Regimen Tazarotene (Tazorac) cream and Apply gel or cream, 0.05% with strength increased to 0.1% if tolerated and medically indicated, qPM to psoriatic Plaque psoriasis Maximum Dose 2 mg/cm2/day Page 3 of 6

   CLINICAL POLICY
   Tazarotene Drug Name Indication Dosing Regimen gel 0.05% and 0.1% lesions, using enough (2 mg/cm2) to cover only the lesion with a thin film. Maximum Dose Acne Acne Acne Tazarotene (Tazorac) cream and gel 0.1% Tazarotene (Arazlo) lotion 0.045% Tazarotene (Fabior) foam 0.1% *Do not cover more than 20% of body surface area with the gel formulation. Apply a thin film (2 mg/cm2) of gel or cream 0.1% qPM, to the skin where acne lesions appear. 2 mg/cm2/day Apply a thin layer to the affected areas once daily. Avoid the eyes, mouth, paranasal creases and mucous membranes. Not for oral, ophthalmic or intravaginal use.
   Apply a thin layer to the entire affected areas of the face and/or upper trunk once daily in the evening. Avoid the eyes, lips, and mucous membranes. Once daily application Once daily application VI. Product Availability
   Drug Name Tazarotene (Tazorac)
   Tazarotene (Arazlo) Tazarotene (Fabior) Availability Cream (30 g and 60 g tube): 0.05%, 0.1% (generic available) Gel (30 g and 100 g tube): 0.05%, 0.1% Lotion (45 g tube): 0.045% Foam (50 g and 100 g can): 0.1% VII.