ModifiedmhnPolicy CP.PMN.244

Clinical Policy: Tazarotene (Arazlo, Fabior, Tazorac)

Medical necessity and prior authorization criteria for topical tazarotene products (Arazlo lotion, Fabior foam, Tazorac cream/gel) for treatment of plaque psoriasis and acne vulgaris across applicable Centene lines of business.

Policy Summary

Payermhn

PolicyClinical Policy: Tazarotene (Arazlo, Fabior, Tazorac)

Policy CodePolicy CP.PMN.244

Change TypeMaterial revisions and clarifications (step therapy bypass, generic redirection)

Effective DateSep 1, 2020

Next Review Date

Key ActionProvider must submit clinical documentation (office chart notes, lab results, or other clinical information) supporting that the member meets all approval criteria for the requested tazarotene product.

SourceLink

POLICY UPDATE CHANGES

For Illinois HIM requests, step therapy requirements do not apply to tazarotene lotion and foam as of 1/1/2026 per IL HB 5395.

Added requirement that members must use generic formulary topical tazarotene for plaque psoriasis and acne vulgaris unless clinically significant adverse effects or contraindications exist.

Clarified that prior authorization may be required for topical tretinoin and adapalene in step therapy for acne.

2FDA indications

≤20%Max BSA (Tazorac gel)

12 moApproval duration

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IL HB 5395IL statute

Coverage Criteria

Initial Therapy — Plaque Psoriasis

Covered when ALL of the following are met for plaque psoriasis:

Plaque Psoriasis Initial: 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 the agent is contraindicated; 4) Request does not exceed 1 tube per month.

Approval duration: 12 months

Initial Therapy — Acne Vulgaris

Covered when ALL of the following are met for acne vulgaris:

Acne Initial: 1) Diagnosis of acne vulgaris; 2) Request is for Tazorac 0.1% cream or gel, Arazlo lotion, or Fabior foam; 3) Age is appropriate per product: Arazlo ≥ 9 years; Fabior and Tazorac ≥ 12 years; 4) Member must use generic formulary topical tazarotene unless clinically significant adverse effects are experienced or the agent is contraindicated; 5) 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 these agents); 6) Request does not exceed 1 tube (Arazlo, Tazorac) or 1 can (Fabior) per month.

Approval duration: 12 months

Continued Therapy

Continued therapy is covered when ALL of the following are met:

Continued Therapy: 1) Member meets one of the following: a) currently receiving medication via the 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 the agent is contraindicated; 4) If request is for a dose increase, the new request does not exceed 1 tube (Arazlo, Tazorac) or 1 can (Fabior) per month.

Approval duration: 12 months

Other Indications / Off-label

Requests for uses not specifically listed:

Other Indications: 1) If the drug has had a label change within the last 6 months that is not yet reflected in this policy, follow the applicable no-coverage or non-formulary policy for the relevant line of business as specified (see CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16); 2) If the requested use is not listed under section III (Diagnoses/Indications for which coverage is NOT authorized) and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (CP.CPA.09, HIM.PA.154, CP.PMN.53).

See referenced policies for line-of-business specific processes.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (see CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid) or as allowed by the member's evidence of coverage.

Tazarotene products are contraindicated in pregnancy. Additionally, Tazorac is contraindicated in individuals with a known hypersensitivity to any of its components. No boxed warnings are reported for these products.

Coverage and the administration of benefits for tazarotene are subject to the terms, conditions, exclusions, and limitations of the member's coverage documents (for example, evidence of coverage, certificate of coverage, policy or contract) and to applicable state and federal requirements. This policy is a guide to medical necessity and does not guarantee payment; applicable benefit terms and laws govern final coverage decisions.

Requests for use of tazarotene for non‑FDA indications that lack sufficient supporting evidence should be evaluated under the Health Plan's off‑label use policies. Per those policies, uses without adequate documentation of efficacy and safety are considered not authorized.

This segment does not list additional explicit "not medically necessary" conditions beyond the off‑label limits referenced above. Medical necessity determinations and any denial decisions will be guided by the Health Plan's medical necessity guidelines, the member's benefit documents, and applicable policies governing off‑label use.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required and approval is granted only when the coverage criteria in this policy are met. Providers must submit supporting clinical documentation (e.g., office notes, lab results, or other clinical information) demonstrating the member meets all applicable approval criteria. Requests lacking sufficient documentation may be denied.

Prior authorization required for branded products (Arazlo, Fabior, Tazorac) per criteria
Provider must submit office chart notes, labs, or other clinical info supporting criteria

Prior Authorization

PA May Be Required for Step Therapy Alternatives

Prior authorization may be required for topical tretinoin and adapalene when used as part of step therapy requirements for acne vulgaris. Providers should verify PA requirements for these agents prior to submission.

PA may be required for tretinoin and adapalene when used to satisfy step therapy for acne

Definitions and Background

Tazarotene product formulations

TazoracCream and gel, 0.05% and 0.1% (indicated for plaque psoriasis and acne depending on strength)

ArazloLotion 0.045% (indicated for acne in patients ≥9 years)

FabiorFoam 0.1% (indicated for acne in patients ≥12 years)

Maximum body surface area (BSA) for Tazorac gel

Maximum BSA for Tazorac gelUse on more than 20% body surface area has not been established; do not cover more than 20% BSA with the gel formulation.

Dose guidanceApply a thin film (2 mg/cm2) qPM to lesions; maximum dose 2 mg/cm2/day.

Policy Summary

Payermhn

PolicyClinical Policy: Tazarotene (Arazlo, Fabior, Tazorac)

Policy CodePolicy CP.PMN.244

Change TypeMaterial revisions and clarifications (step therapy bypass, generic redirection)

Effective DateSep 1, 2020

Next Review Date

SourceLink

On This Page

Step Therapy

Step Therapy and Statutory Bypass

Member must use the generic formulary topical tazarotene prior to approval of branded products unless clinically significant adverse effects occur or the generic is contraindicated. For acne vulgaris, members must also fail generic formulary topical tretinoin and adapalene unless clinically significant adverse effects or contraindications exist. Illinois HIM requests have a statutory bypass for tazarotene lotion and foam per IL HB 5395 effective 1/1/2026.

Step therapy: use generic formulary topical tazarotene before branded product
For acne: fail generic tretinoin and adapalene prior to branded approval unless contraindicated
IL statutory bypass: tazarotene lotion and foam exempt for Illinois HIM per IL HB 5395 (effective 1/1/2026)

Note

PA Governed by Medical Necessity and Benefit Documents

Coverage decisions, prior authorization determinations, and benefit administration are governed by the member's coverage documents (e.g., evidence of coverage, certificate of coverage, policy, contract) and are subject to state and federal laws and Health Plan administrative policies. Claims may be denied if not covered under the member's benefit terms.

Coverage decisions subject to all terms, conditions, exclusions, and limitations of the member's coverage documents
Decisions also subject to applicable state and federal requirements and Health Plan administrative policies
Claims may be denied per contract terms and coverage documents

Documentation Required

Provider Obligations

Providers must follow applicable Health Plan coverage documents and state/federal rules when submitting requests. This clinical policy is a guide to medical necessity and does not replace professional medical judgment. Providers are responsible for the medical care of members and for ensuring submissions comply with plan and regulatory requirements.

Providers are responsible for appropriate clinical decision-making and documentation
Follow state and federal regulations and Health Plan-level administrative policies

Denial Risk

Insufficient Documentation or Unsupported Off‑Label Use

Requests for indications not addressed in this policy (non–FDA approved/off‑label) require sufficient documentation of efficacy and safety per applicable off‑label use policies (e.g., CP.CPA.09 for commercial, HIM.PA.154 for HIM, CP.PMN.53 for Medicaid) or evidence of coverage documents. Requests lacking such documentation or for unsupported off‑label use may be denied.

Non‑FDA indications require documentation per off‑label use policies
Insufficient documentation or unsupported off‑label use may result in denial

Indication-specific note

Tazorac gel 0.1% is indicated for facial mild-to-moderate acne and Tazorac 0.05%–0.1% for plaque psoriasis with BSA limitation for gel formulation.

Health Plan definition

AuthorityThe Health Plan may change, amend, or withdraw this clinical policy and is governed by applicable law and regulatory requirements.

Tazarotene is a topical retinoid approved for treatment of plaque psoriasis and acne vulgaris. Marketed formulations include Tazorac cream and gel (0.05% and 0.1%), Arazlo lotion (0.045%), and Fabior foam (0.1%). For some products, age indications apply (for example, Arazlo for age ≥9 years; Fabior and Tazorac formulations for age ≥12 years). Note that safety of Tazorac gel when applied to > 20% body surface area has not been established. Dosing is typically once daily and is product- and indication‑specific.