ModifiedCentenePolicy CP.PMN.244

Clinical Policy: Tazarotene (Arazlo, Fabior, Tazorac)

Clinical coverage and medical necessity criteria for topical tazarotene products (Arazlo lotion, Fabior foam, Tazorac cream/gel) for plaque psoriasis and acne vulgaris across Centene lines of business.

Policy Summary

PayerCentene

PolicyClinical Policy: Tazarotene (Arazlo, Fabior, Tazorac)

Policy CodePolicy CP.PMN.244

Change TypeMaterial revisions: formulary-first requirement, product-specific age clarifications, IL HIM step therapy bypass added

Effective DateSep 1, 2020

Next Review Date

Key ActionObtain prior authorization and submit clinical documentation demonstrating the member meets all approval criteria, including trial of generic formulary topical tazarotene when required.

SourceLink

POLICY UPDATE CHANGES

For plaque psoriasis and acne vulgaris the policy now redirects to use of generic formulary topical tazarotene unless clinically significant adverse effects are experienced or contraindicated.

For acne vulgaris, requests are clarified to be for specific products (Tazorac 0.1% cream/gel, Arazlo, or Fabior) and age limits per product are specified.

A step therapy bypass for Illinois HIM (per IL HB 5395) was added for tazarotene lotion and foam.

2FDA-approved indications

20%Max BSA for Tazorac gel

12 moApproval duration

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Coverage and Medical Necessity Criteria

Initial Therapy

Arazlo, Fabior, and Tazorac are medically necessary when the following criteria are met:

I.A Plaque Psoriasis - Initial Approval: 1. Request is for Tazorac cream or gel; 2. Diagnosis of plaque psoriasis with body surface area involvement of ≤ 20%; 3. Member must use generic formulary topical tazarotene, unless clinically significant adverse effects are experienced or contraindicated; 4. Request does not exceed 1 tube per month.

I.B Acne Vulgaris - Initial Approval: 1. Diagnosis of acne vulgaris; 2. Request is for Tazorac 0.1% cream or gel, Arazlo, or Fabior; 3. Age requirement: (a) For Arazlo: ≥ 9 years; (b) For Fabior and Tazorac: ≥ 12 years; 4. Member must use generic formulary topical tazarotene, unless clinically significant adverse effects are experienced or contraindicated (note: Illinois HIM requests are exempt from step therapy for lotion and foam per IL HB 5395 effective 1/1/2026); 5. Failure of generic formulary topical tretinoin and adapalene unless clinically significant adverse effects or both are contraindicated (prior authorization may be required for tretinoin and adapalene); 6. Request does not exceed 1 tube (Arazlo, Tazorac) or 1 can (Fabior) per month.

I.C Other diagnoses/indications: 1. If this drug has had a label change within the last 6 months that is not yet reflected in this policy, refer to the applicable formulary/no-coverage or non-formulary policy for the relevant line of business (see policy references); OR 2. If the requested use is not listed in Section III and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business.

Continuation Therapy

Continued therapy for all indications in Section I (must meet all):

II.A Continued Therapy: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; OR (b) currently receiving medication and enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy; 3. Member must use generic formulary topical tazarotene, unless clinically significant adverse effects are experienced or contraindicated (note: Illinois HIM requests are exempt from step therapy for lotion and foam per IL HB 5395 effective 1/1/2026); 4. If request is for a dose increase, new request does not exceed 1 tube (Arazlo, Tazorac) or 1 can (Fabior) per month.

Non‑FDA approved indications that are not specifically addressed in this clinical policy are not authorized for coverage unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, CP.PMN.53 for Medicaid) or the member's evidence of coverage documents.

Coverage for tazarotene topical products is subject to all terms, conditions, exclusions, and limitations of the member’s coverage documents (for example, evidence of coverage, certificate of coverage, policy, or contract of insurance). This clinical policy is a guide to medical necessity and does not guarantee payment or results; providers must follow applicable state and federal requirements and Health Plan administrative procedures when seeking coverage.

The safety of Tazorac gel when applied to greater than 20% body surface area has not been established. Use of Tazorac gel on more than 20% body surface area is therefore not authorized by this policy.

Policy Identifiers and Coding Notes

Policy identifiersmixed

CP.PMN.244

Policy reference number

inv-07: Maximum body surface area for Tazorac gel

Maximum body surface areaTazorac gel use limited to ≤ 20% body surface area (safety of use on >20% not established).

Dosage noteApply thin film (2 mg/cm2) to lesions; maximum dose 2 mg/cm2/day; do not cover more than 20% BSA with gel formulation.

Indication contextLimit specified in dosing for plaque psoriasis when using Tazorac cream/gel 0.05%–0.1%.

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approval is limited to specified products, diagnoses, age ranges, formulary sequencing, and quantity limits as outlined in the policy (see Initial Approval Criteria and Continued Therapy).

Prior authorization required for branded products (Arazlo, Fabior, Tazorac) and may be limited to specified formulations, ages, and diagnoses.
Quantity limits: generally limited to 1 tube (Arazlo, Tazorac) or 1 can (Fabior) per month; see policy criteria for indication-specific limits.

Note

Policy Governs Coverage

Coverage for tazarotene topical products is governed by this clinical policy. Coverage decisions are subject to the member's evidence of coverage, certificate of coverage, policy, contract of insurance, and applicable state and federal requirements.

This policy is a guide to medical necessity and does not guarantee payment.
The Health Plan may change, amend, or withdraw this policy and apply state-specific addendums (e.g., continuity of care or statutory step-therapy exceptions).

Clinical Background

Tazarotene is a topical retinoid approved for the treatment of plaque psoriasis (Tazorac cream and gel 0.05% and 0.1%) and certain forms of acne vulgaris (Tazorac cream and gel 0.1% for facial mild‑to‑moderate acne; Arazlo lotion 0.045% for patients ≥9 years; Fabior foam 0.1% for patients ≥12 years). Dosage and administration are formulation‑specific, typically involving once‑daily topical application of a thin film to affected areas; for Tazorac gel the product labeling specifies not to cover more than 20% body surface area.

Formulations and Health Plan Definition

inv-17: Tazarotene formulations

Included productsTazarotene formulations covered: Tazorac (cream and gel 0.05% and 0.1%), Arazlo lotion 0.045%, Fabior foam 0.1%.

Product-specific age indicationsArazlo lotion: ≥9 years for acne; Fabior foam and Tazorac products: ≥12 years for Fabior and ≥12 years for Tazorac acne use per product labeling (Tazorac acne indication applies to 0.1% formulations).

Dosing summary by formulationTazorac cream/gel: apply thin film (2 mg/cm2) once daily qPM; Arazlo lotion: apply thin layer once daily; Fabior foam: apply thin layer once daily to affected areas.

Quantity/administration notesApply only to affected lesions; gel formulation should not cover >20% BSA; maximum dose 2 mg/cm2/day.

inv-18: Health Plan

Definition of Health Plan