CurrentmhnPolicy CP.PMN.244

Tazarotene (Arazlo, Fabior, Tazorac)

Defines medical necessity criteria, initial and continued approval, age limits, step therapy and product-specific restrictions for topical tazarotene formulations (Arazlo lotion, Fabior foam, Tazorac cream/gel) across commercial, HIM and Medicaid lines of business.

Policy Summary

Payermhn

PolicyTazarotene (Arazlo, Fabior, Tazorac)

Policy CodePolicy CP.PMN.244

Change TypeAnnual reviews with material revisions (4Q2024, 4Q2025)

Effective DateSep 1, 2020

Next Review Date

Key ActionProvider must submit documentation supporting that member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

4Q 2024 annual review: added generic formulation requirement for plaque psoriasis; clarified acne criteria to specify Tazorac 0.1% cream/gel, Arazlo, or Fabior and added Tazorac age limit per PI; added language on exceptions for generic redirection and prior authorization may be required for tretinoin and adapalene.

4Q 2025 annual review: added step therapy bypass for IL HIM per IL HB 5395.

02.13.24: In initial approval criteria, added clarification stating prior authorization may be required for tretinoin.

2FDA Indications (psoriasis, acne)

≤20%BSA limit for psoriasis

1Max tubes/cans per month

3Products covered (Arazlo, Fabior, Tazorac)

Coverage Summary

Scope: This policy defines medical necessity criteria for topical tazarotene formulations (Arazlo lotion, Fabior foam, and Tazorac cream/gel) and aligns coverage to FDA-approved indications. It covers plaque psoriasis and acne vulgaris per product labeling, includes product-specific age limits and body surface area limits for psoriasis, and sets quantity limits. For plaque psoriasis the policy requires use of Tazorac cream or gel and limits psoriasis involvement to ≤ 20% body surface area. For acne vulgaris the policy specifies requests must be for Tazorac 0.1% cream or gel, Arazlo, or Fabior and applies product age requirements (Arazlo ≥ 9 years; Fabior and Tazorac ≥ 12 years). The policy encourages use of generic formulary topical tazarotene when available and implements step therapy requiring failure of generic topical tretinoin and adapalene for acne unless contraindicated or clinically intolerable.

Initial Therapy Criteria

Initial Approval Criteria - Plaque Psoriasis

Must meet ALL of the following:

ALL of the following

Request is for Tazorac cream or gel
Diagnosis of plaque psoriasis with body surface area involvement of ≤ 20%≤ 20%
Member must use generic formulary topical tazarotene, unless clinically significant adverse effects are experienced or contraindicated
Request does not exceed 1 tube per month1 tube/month

Initial Approval Criteria - Acne Vulgaris

Must meet ALL of the following:

ALL of the following

Diagnosis of acne vulgaris
Request is for Tazorac 0.1% cream or gel, Arazlo, or Fabior
Age requirement (one of)
- For Arazlo: ≥ 9 years>=9 years
- For Fabior and Tazorac: ≥ 12 years>=12 years

Continuation Therapy Criteria

Continued Therapy - All Indications in Section I

Must meet ALL of the following:

ALL of the following

Continuity requirement (one of)
- Currently receiving medication via Centene benefit or member has previously met initial approval criteria
- Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations
  Refer to state specific addendums
Member is responding positively to therapy
Member must use generic formulary topical tazarotene, unless clinically significant adverse effects are experienced or contraindicated

Unapproved / Exclusions

Diagnoses/Indications NOT authorized

Not covered unless exception via off-label policies:

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization is required per this clinical policy for Arazlo, Fabior, and Tazorac. Prior authorization may also be required for tretinoin and adapalene when step therapy is enforced.

Step Therapy

Step therapy for acne vulgaris

Failure of generic formulary topical tretinoin and adapalene is required before approval for acne, unless clinically significant adverse effects are experienced or both are contraindicated. For Illinois HIM requests, the step therapy requirements do not apply to tazarotene lotion and foam as of 1/1/2026 per IL HB 5395.

Applicable Codes

Product Availability (informational NDC-less listing)mixed

Tazorac cream 0.05% and 0.1% (30 g and 60 g tube)	Generic available
Tazorac gel 0.05% and 0.1% (30 g and 100 g tube)	Generic available
Arazlo lotion 0.045% (45 g tube)	Brand
Fabior foam 0.1% (50 g and 100 g can)	Brand

Clinical Evidence

Evidence: Primary references include the FDA prescribing information for Arazlo (2023), Fabior (2023), and Tazorac (2019), as cited in the policy references, and clinical practice guidelines: the J Am Acad Dermatol acne guidelines (Zaenglein et al., 2016) and the Joint AAD–NPF pediatric psoriasis guidelines (Menter et al., 2020).

Background

Background: Tazarotene topical products are retinoids indicated for plaque psoriasis (Tazorac cream/gel) and acne vulgaris (Arazlo lotion, Fabior foam, Tazorac cream/gel) consistent with FDA-approved labeling. The policy aligns coverage to those FDA indications and product-specific age limits: Arazlo for patients ≥ 9 years, and Fabior and Tazorac for patients ≥ 12 years (acne), with Tazorac also indicated for plaque psoriasis. The policy imposes a psoriasis body surface area limit of ≤ 20% for Tazorac gel/cream per the labeling, and sets per-product dispensing limits of 1 tube per month for Arazlo and Tazorac and 1 can per month for Fabior. The policy encourages use of generic formulary topical tazarotene when available and requires failure of generic topical tretinoin and adapalene for acne prior to approval unless there are clinically significant adverse effects or contraindications. Product-specific restrictions and requirements for Arazlo, Fabior, and Tazorac (including dosing, max daily application guidance, and quantity limits) are detailed in the policy and prescribing information.

Revision History

02.13.24clarification

Clarified in the initial approval criteria that prior authorization may be required for tretinoin.

4Q 2024material_change

Annual review (material): added requirement that members use generic formulation for plaque psoriasis; clarified acne criteria to specify requests must be for Tazorac 0.1% cream or gel, Arazlo, or Fabior and added Tazorac age limit per PI; added language that generic formulary topical tazarotene redirection applies unless clinically significant adverse effects or contraindications exist; added clarification that prior authorization may be required for tretinoin and adapalene.

4Q 2025material_changeLatest