CurrentCignaPolicy IP0174

Topical tazarotene products (Arazlo, Fabior, Tazorac, generic tazarotene) — Coverage Criteria

Defines medical necessity and authorization rules for topical tazarotene products for Cigna-administered health benefit plans, including indications, required prior failures/contraindications, reauthorization, and exclusions; applies to providers submitting formulary exceptions and prior authorizations.

Policy Summary

PayerCigna

PolicyTopical tazarotene products (Arazlo, Fabior, Tazorac, generic tazarotene) — Coverage Criteria

Policy CodePolicy IP0174

Change TypeNo material change

Effective DateFeb 15, 2024

Next Review DateFeb 15, 2025

Key ActionObtain prior authorization with documentation of failure, contraindication, or intolerance to all listed comparator topical therapies.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

up to 12 monthsApproval duration

Arazlo, Fabior, Tazorac, genericProducts covered

Acne, plaque psoriasis, otherPrimary indications

Cosmetic usesNot covered

Coverage Criteria

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Product-specific initial medical necessity criteria

Products are considered medically necessary when the individual meets ONE of the following indication-specific criteria for the requested product:

Fabior (tazarotene 0.1% foam) - Covered Indications: 1) Acne vulgaris: Documentation of failure, contraindication, or intolerance to ALL of: A) tazarotene 0.1% cream or 0.1% gel; B) adapalene cream, 0.3% gel, lotion, or solution; C) tretinoin cream, gel, or microgel. 2) Plaque psoriasis: Documentation of failure, contraindication, or intolerance to ALL of: A) tazarotene 0.05% gel, 0.1% gel, or 0.1% cream; B) calcipotriene cream, foam, ointment, or solution; C) prescription topical corticosteroid. 3) Other non-cosmetic conditions: Documentation of failure, contraindication, or intolerance to ALL of: A) tazarotene 0.05% gel, 0.1% gel, or 0.1% cream; B) adapalene cream, 0.3% gel, lotion, or solution.N/A

All alternatives must be failed/unacceptable

Tazarotene 0.1% foam (generic) - Covered Indications: 1) Acne vulgaris: Documentation of failure, contraindication, or intolerance to ALL of: A) tazarotene 0.1% cream or 0.1% gel; B) adapalene cream, 0.3% gel, lotion, or solution; C) tretinoin cream, gel, or microgel. 2) Plaque psoriasis: Documentation of failure, contraindication, or intolerance to ALL of: A) tazarotene 0.05% gel, 0.1% gel, or 0.1% cream; B) calcipotriene cream, foam, ointment, or solution; C) prescription topical corticosteroid. 3) Other non-cosmetic conditions: Documentation of failure, contraindication, or intolerance to ALL of: A) tazarotene 0.05% gel, 0.1% gel, or 0.1% cream; B) adapalene cream, 0.3% gel, lotion, or solution.N/A

All alternatives must be failed/unacceptable

Tazorac 0.05% cream and 0.05%/0.1% gel - Covered Indications: 1) Acne vulgaris: Documentation of failure, contraindication, or intolerance to ALL of: A) trial of the bioequivalent tazarotene product (generic) AND inability to take brand due to inactive ingredient formulation differences causing significant allergy or serious adverse reaction; B) adapalene cream, 0.3% gel, lotion, or solution; C) tretinoin cream, gel, or microgel. 2) Plaque psoriasis: Documentation of trial of bioequivalent tazarotene gel AND inability to use brand due to inactive ingredient differences, plus failure, contraindication, or intolerance to calcipotriene and prescription topical corticosteroid. 3) Other non-cosmetic conditions: Documentation of trial of bioequivalent tazarotene gel AND inability to use brand due to inactive ingredient differences, plus failure/contraindication to listed comparators.N/A

Brand-specific requirement: trial of bioequivalent generic and documented inability to use brand due to inactive ingredient formulation differences

Tazorac 0.1% cream - Covered Indications: 1) Acne vulgaris: Trial of bioequivalent tazarotene 0.1% cream (generic) AND documented inability to take brand due to formulation difference in inactive ingredient(s) resulting in significant allergy or serious adverse reaction; plus failure, contraindication, or intolerance to adapalene and tretinoin as listed. 2) Plaque psoriasis and 3) Other non-cosmetic conditions: same trial-of-generic AND inability-to-use-brand requirement plus failures of listed comparators.N/A

Brand coverage requires documented generic trial and intolerance to brand inactive ingredients

Initial Therapy

Initial authorization criteria per product and indication

Initial therapy - see product-specific nodes: Initial authorization requires documentation of failure, contraindication, or intolerance to ALL listed comparator topical therapies for the requested indication (see product-specific criteria). For certain brand products, a trial of the bioequivalent generic with documented inability to use the brand due to inactive ingredient formulation differences is required. Receipt of sample product does not satisfy criteria.N/A

Initial approval up to 12 months

Reauthorization Criteria

Reauthorization (continuation) criteria:

Reauthorization: Continuation is medically necessary when the original medical necessity criteria are still met AND there is documentation of beneficial response to therapy.N/A

Documentation of benefit required

Continuation therapy

Reauthorization and duration

Continuation (reauthorization) and duration: Reauthorization is available when medical necessity criteria continue to be met and there is documented beneficial response. Reauthorization approval duration: up to 12 months.up to 12 months

Reauthorization duration mirrors initial approval

Excluded uses: Coverage does not include cosmetic uses of topical tazarotene products or any other uses considered experimental, investigational, or unproven. Requests for these indications are not recommended for coverage under a typical pharmacy benefit and may be denied.

Examples of cosmetic conditions that are not considered medically necessary include: wrinkles, stretch marks, age spots (solar lentigines/liver spots), melasma/chloasma, photo-aged or photo-damaged skin, mottled hyperpigmentation or hypopigmentation, milia, seborrheic keratosis, sebaceous hyperplasia, skin laxity or roughness, solar elastosis, actinic purpura, pokiloderma (of Civatte), premature aging, scarring, and similar non–medical aesthetic concerns.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prior authorization is required when plan coverage is sought for tazarotene products (including Arazlo, Fabior, Tazorac, and bioequivalent tazarotene formulations). Approval is contingent on meeting the product-specific medical necessity criteria described in the Medical Necessity Criteria section.

Affected products include branded and bioequivalent tazarotene topical formulations
Prior authorization decisions depend on documented evidence that medical necessity criteria are met

Step Therapy

Step Therapy Requirement

Step therapy — documentation must show failure, contraindication, or intolerance to all listed alternative topical agents (AND logic). All specified alternatives in the applicable indication's criteria must be tried and documented as failed, contraindicated, or not tolerated prior to approval.

Acne Vulgaris: failure/contraindication/intolerance to tazarotene 0.1% cream/gel; adapalene formulations; tretinoin formulations
Plaque Psoriasis: failure/contraindication/intolerance to tazarotene gels/creams; calcipotriene topical; prescription topical corticosteroid
Other non-cosmetic conditions: failure/contraindication/intolerance to listed topical agents per indication

Documentation Required

Required Documentation of Prior Failure or Contraindication

Documentation Requirement — Providers must document prior failure, contraindication, or intolerance to ALL specified alternative topical agents for the requested indication. When reliance on a bioequivalent or generic tazarotene product is claimed (trial of tazarotene gel/cream), document why the bioequivalent cannot be used due to a formulation difference in inactive ingredients that would cause a significant allergy or serious adverse reaction.

Explicit clinical documentation of prior trials, duration, and reason for discontinuation (failure, intolerance, or contraindication)
If claiming exemption due to inactive-ingredient sensitivity, include clinical rationale and evidence of the allergy or adverse reaction

Denial Risk

Non‑Covered Uses

Non‑covered Uses: Requests for cosmetic or other experimental/unproven uses may be denied. Cosmetic indications are excluded from coverage (examples include age spots, melasma, photo-damage, scarring, wrinkles, and other solely cosmetic conditions).

Cosmetic conditions are not covered under the typical pharmacy benefit
Denials may be issued for indications considered experimental, investigational, or unproven

Step Therapy Requirements

Requested Product	Required prior failure/contraindication/intolerance (all listed must be failed/unacceptable)
Arazlo (tazarotene 0.045% lotion)
1) Acne vulgaris: A) tazarotene 0.1% cream or 0.1% gel; B) adapalene (cream, 0.3% gel, lotion, or solution); C) tretinoin (cream, gel, or microgel). 2) Plaque psoriasis: A) tazarotene 0.05% gel, 0.1% gel, or 0.1% cream; B) calcipotriene (cream, foam, ointment, or solution); C) prescription topical corticosteroid. 3) Other non-cosmetic dermatologic conditions (e.g., ichthyosis, pseudofolliculitis barbae, molluscum contagiosum, Darier's disease): A) tazarotene 0.05% gel, 0.1% gel, or 0.1% cream; B) adapalene (cream, 0.3% gel, lotion, or solution).
Fabior (tazarotene 0.1% foam)
1) Acne vulgaris: A) tazarotene 0.1% cream or 0.1% gel; B) adapalene (cream, 0.3% gel, lotion, or solution); C) tretinoin (cream, gel, or microgel). 2) Plaque psoriasis: A) tazarotene 0.05% gel, 0.1% gel, or 0.1% cream; B) calcipotriene (cream, foam, ointment, or solution); C) prescription topical corticosteroid. 3) Other non-cosmetic dermatologic conditions: same comparator requirements as above (tazarotene topical formulations and adapalene where indicated).
Tazarotene 0.1% foam (generic)
1) Acne vulgaris: A) tazarotene 0.1% cream or 0.1% gel; B) adapalene (cream, 0.3% gel, lotion, or solution); C) tretinoin (cream, gel, or microgel). 2) Plaque psoriasis and 3) Other non-cosmetic conditions: same comparator requirements as specified for other products (tazarotene topical formulations, calcipotriene for psoriasis, and topical corticosteroid where indicated).
Tazorac 0.05% cream and 0.05% or 0.1% gel
For all indications: 1) Acne vulgaris: A) trial of a bioequivalent generic tazarotene product AND documented inability to use brand due to an inactive-ingredient formulation difference causing significant allergy or serious adverse reaction; B) adapalene (cream, 0.3% gel, lotion, or solution); C) tretinoin (cream, gel, or microgel). 2) Plaque psoriasis: A) trial of a bioequivalent generic tazarotene gel AND documented inability to use brand due to inactive-ingredient differences; B) calcipotriene (cream, foam, ointment, or solution); C) prescription topical corticosteroid. 3) Other non-cosmetic conditions: same generic-trial plus comparator failure requirements (adapalene and/or tretinoin as applicable).
Tazorac 0.1% cream
1) Acne vulgaris: Trial of tazarotene 0.1% cream (bioequivalent generic) AND documented inability to use brand due to formulation differences in inactive ingredient(s) causing significant allergy or serious adverse reaction; plus failure/contraindication to adapalene and tretinoin as listed. 2) Plaque psoriasis and 3) Other non-cosmetic conditions: same trial-of-generic AND inability-to-use-brand requirement plus failures of listed comparators (calcipotriene and topical corticosteroid for psoriasis; adapalene/tretinoin as applicable for other conditions).

Initial Therapy Criteria

Initial Therapy

Initial authorization criteria per product and indication (see product-specific requirements below):

Arazlo (tazarotene 0.045% lotion) - Initial authorization: Acne vulgaris: Documentation of failure, contraindication, or intolerance to ALL of: A) tazarotene 0.1% cream or 0.1% gel; B) adapalene cream, 0.3% gel, lotion, or solution; C) tretinoin cream, gel, or microgel. Plaque psoriasis: Documentation of failure, contraindication, or intolerance to ALL of: A) tazarotene 0.05% gel, 0.1% gel, or 0.1% cream; B) calcipotriene cream, foam, ointment, or solution; C) prescription topical corticosteroid. Other non-cosmetic conditions: Documentation of failure, contraindication, or intolerance to ALL of: A) tazarotene 0.05% gel, 0.1% gel, or 0.1% cream; B) adapalene cream, 0.3% gel, lotion, or solution.N/A

Receipt of sample does not satisfy criteria

Fabior (tazarotene 0.1% foam) - Initial authorization: Acne vulgaris: Documentation of failure, contraindication, or intolerance to ALL of: A) tazarotene 0.1% cream or 0.1% gel; B) adapalene cream, 0.3% gel, lotion, or solution; C) tretinoin cream, gel, or microgel. Plaque psoriasis and other non-cosmetic conditions: same comparator requirements as above.N/A

All alternatives must be failed/unacceptable

Tazarotene 0.1% foam (generic) - Initial authorization: Acne vulgaris, plaque psoriasis, and other non-cosmetic conditions: Documentation of failure, contraindication, or intolerance to ALL listed comparators for the indication as above (tazarotene 0.1% cream/gel, adapalene, tretinoin; and for psoriasis calcipotriene and topical corticosteroid where applicable).N/A

All alternatives must be failed/unacceptable

Tazorac products (brand) - Initial authorization: For Tazorac 0.05% cream/gel and 0.1% cream/gel: Initial authorization requires trial of the bioequivalent generic tazarotene product and documented inability to use the brand due to inactive ingredient formulation differences causing significant allergy or serious adverse reaction, AND failure, contraindication, or intolerance to the listed comparator therapies for the relevant indication.N/A

Brand-specific generic trial and documented intolerance to brand inactive ingredients required

OpenPayer

Topical tazarotene products (Arazlo, Fabior, Tazorac, generic tazarotene) — Coverage Criteria

Coverage Criteria

Provider Actions and Requirements

Step Therapy Requirements

Initial Therapy Criteria

Continuation / Reauthorization Criteria

Definitions

Background

Site of Care and Dosing Considerations