CurrentCentenePolicy CP.PMN.283

Tapinarof (Vtama) (PDF)

Defines medical necessity, prior authorization criteria, age limits, dosing limits, approval durations, and therapeutic alternatives for tapinarof (Vtama) cream for plaque psoriasis and atopic dermatitis across Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerCentene

PolicyTapinarof (Vtama) (PDF)

Policy CodePolicy CP.PMN.283

Change TypeAdded atopic dermatitis; IL HIM step therapy bypass

Effective Date12.01.22

Next Review Date

Key ActionProvider must submit documentation supporting that the member has met all approval criteria; prior authorization may be required and requests should not exceed 1 tube per month.

SourceLink

POLICY UPDATE CHANGES

Added newly approved atopic dermatitis indication to criteria.

Added step therapy bypass for IL HIM per IL HB 5395.

4Q 2024 annual review: no significant changes; corrected template changes for continued therapy other diagnosis/indications section; references reviewed and updated.

4Q 2023 annual review: updated Appendix B by removing Enstilar and Duobrii therapeutic alternatives since agents are non-formulary for relevant lines of business; references reviewed and updated.

2FDA Approved Indications

1 tube/moQuantity Limit

12 moApproval Duration

≤20%

Coverage Summary

Tapinarof (Vtama) cream 1% (each gram contains 10 mg tapinarof) is FDA‑approved as a topical treatment for plaque psoriasis in adults and for atopic dermatitis in adults and pediatric patients ≥ 2 years. Coverage stance: covered_with_criteria. Scope summary: Defines medical necessity, prior authorization criteria, age limits, dosing/quantity limits (≤ 1 tube per month), approval duration (12 months), body surface area limit for plaque psoriasis (≤ 20% BSA), and therapeutic alternatives for tapinarof cream across Commercial, HIM, and Medicaid lines of business.

Initial Therapy Criteria

Plaque Psoriasis - Initial Therapy

ALL of the following

Diagnosis of plaque psoriasis
Prescribed by or in consultation with a dermatologist or rheumatologist
Age >= 18 years
Member has <= 20% body surface area involvement
Member meets ONE of the following
- a
  - Failure of both of the following used concurrently, unless clinically significant adverse effects are experienced or all are contraindicated (i and ii):
  - i. Medium to ultra-high potency topical corticosteroid (see Appendix B)
  - ii. Calcipotriene, calcitriol, or tazarotene
- b
  - For face or intertriginous areas (e.g., genitals, armpits, forearms, and groin): Failure of a topical calcineurin inhibitor (see Appendix B), unless contraindicated or clinically significant adverse effects are experienced
For Illinois HIM requests, the step therapy requirements above do not apply as of 1/1/2026 per IL HB 5395
Request does not exceed 1 tube per month
Quantity limit: 1 tube/month
Approval duration: 12 months

Atopic Dermatitis - Initial Therapy

ALL of the following

Diagnosis of atopic dermatitis
Age >= 2 years
Failure of both of the following, each used for >= 2 weeks, unless clinically significant adverse effects are experienced or all are contraindicated:
a
- Two formulary medium-to-very high potency topical corticosteroids (see Appendix B), unless involved areas include the face, neck, or intertriginous areas
b

Diagnoses/Indications Not Authorized

ANY of the following

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.

Continuation Therapy Criteria

Continuation Therapy / Renewal (All Indications)

Must meet ALL of the following:

ALL of the following

Currently receiving medication via Centene benefit or member has previously met initial approval criteria
Member is responding positively to therapy
If request is for a dose increase, new dose does not exceed 1 tube per month
Dose limit on increase: 1 tube/month
Approval duration: 12 months

Other Indications & Diagnoses Not Authorized

Other diagnoses/indications

If not covered elsewhere, meet one of the following:

ANY of the following

If this drug has recently (within the last 6 months) undergone a label change not yet reflected in this policy, follow formulary or non-formulary policies for the relevant line of business (e.g., CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16 as applicable)
If requested use is NOT specifically listed under section III and criterion above does not apply, refer to off-label use policies CP.CPA.09, HIM.PA.154, CP.PMN.53 as applicable

ANY of the following

Non-FDA approved indications not addressed in this policy are not authorized unless sufficient documentation of efficacy and safety exists per off-label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or evidence of coverage documents

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior authorization required. Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria; prior authorization may be required for topical calcineurin inhibitors or topical tacrolimus as noted.

Documentation Required

Documentation of prior therapy failures

Documentation of prior therapy failures. Provider must document failure, contraindication, or intolerance to required prior topical therapies (including specific agents where required), and include durations of therapy and any adverse effects.

Applicable Codes

NDC / ProductNDCCovered

tapinarof cream 1% (per gram contains 10 mg)

Product availability: cream 1%; each gram contains 10 mg tapinarof

Background & Clinical Evidence

Tapinarof (Vtama) is an aryl hydrocarbon receptor agonist formulated as a topical cream. The product is available as a 1% cream (each gram contains 10 mg tapinarof) and is intended for topical application to affected skin areas.

Key trials/publications: Phase 3 trials of tapinarof for plaque psoriasis reported in the New England Journal of Medicine (NEJM 2021), relevant publications in the Journal of the American Academy of Dermatology (J Am Acad Dermatol 2021), and the pivotal ADORING phase 3 trials for atopic dermatitis (J Am Acad Dermatol 2024). Applicable guidelines: American Academy of Dermatology (AAD) / National Psoriasis Foundation (NPF) recommendations are cited in the policy.

Definitions

Revision History

12.26.24RT4 - added indication

RT4 entry added the newly approved atopic dermatitis indication to the policy criteria.

4Q 2025 (effective 01/01/2026)Annual review - step therapy bypass (material)Latest

4Q2025 annual review added an Illinois HIM step therapy bypass per IL HB 5395, effective 1/1/2026.

4Q 2024Annual review - administrative/template corrections (non-material)

4Q2024 annual review made administrative/template corrections to the continued therapy/other diagnosis/indications section; references reviewed and updated.