CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Vtama

Defines coverage criteria, prior authorization requirements, continuation criteria, quantity limits, and exclusions for Vtama (tapinarof) cream for plaque psoriasis in adults and atopic dermatitis in patients >=2 years. Also states other indications are experimental/investigational and lists concomitant-therapy exclusions.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVtama

Policy CodePolicy N/A

Change TypeClarified

Effective DateDec 1, 2022

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of age, diagnosis, BSA affected, specialist prescriber or consult, required prior therapy trials (with durations, dates, and intolerances/contraindications), and ensure quantity limits and concomitant-therapy exclusions are addressed.

SourceLink

POLICY UPDATE CHANGES

Policy lists FDA-approved indications for plaque psoriasis and atopic dermatitis and specifies coverage criteria including prior treatment trials and specialist prescriber requirements.

2Covered Indications

60 g/30 daysQuantity Limit

12 moAuth Length

Coverage Summary

Defines coverage criteria, prior authorization requirements, continuation criteria, quantity limits, and exclusions for Vtama (tapinarof) cream for plaque psoriasis in adults and atopic dermatitis in patients ≥2 years. Vtama is FDA-approved for these indications and other uses are considered experimental/investigational and not medically necessary.

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Medical-Necessity Criteria

FDA-Approved Indications (Covered when all criteria met)

The following FDA-approved indications are covered provided all approval criteria are met and member has no exclusions:

Indication

Plaque psoriasis in adults
Atopic dermatitis in adults and pediatric patients 2 years of age and older

Plaque Psoriasis - Initial Authorization (12 months)

Covered when ALL of the following are met:

ALL of the following

Member is 18 years of age or older, diagnosed with plaque psoriasis
Documentation of affected area(s) and that the affected body surface area (BSA) is between 3-20%. Documentation of BSA affected is provided.3-20%
Vtama is prescribed by, or in consultation with, a specialist in dermatology, allergy/immunology or rheumatology.
Documentation that the member experienced an inadequate treatment response to at least a 2-4 consecutive week trial within the last 12 months of a high or super-high potency topical corticosteroid (e.g., augmented betamethasone, clobetasol). Contraindications, adverse effects and/or intolerance must be documented.2-4 consecutive weeks within last 12 months
Failure/intolerance to two of the following therapies (in combination with a topical corticosteroid) within last 12 months
- Topical calcineurin inhibitors (e.g., tacrolimus ointment, pimecrolimus cream)
- Topical vitamin D analogs (e.g., calcipotriene 0.005% ointment, cream, solution)
- Topical retinoid (e.g., tazarotene cream 0.1%)
- Phototherapy
- Oral systemic non-biologic drugs (e.g., methotrexate, cyclosporine, or acitretin)
Documentation that the member experienced an inadequate treatment response or intolerance from Zoryve (roflumilast) cream 0.3% within the last 12 months. Contraindications, adverse effects and/or intolerance must be documented.last 12 months
If switching from a biologic for psoriasis treatment, trial of Zoryve is not required before Vtama.
If the member is switching from a biologic for psoriasis treatment, they are not required to trial Zoryve before Vtama.
Concomitant therapy exclusions: Vtama will not be used concomitantly with Zoryve (roflumilast) cream, any therapeutic biologic drug (e.g., adalimumab, infliximab), or any targeted synthetic drug (e.g., apremilast).

Atopic Dermatitis - Initial Authorization (12 months)

Covered when ALL of the following are met:

ALL of the following

Member is 2 years of age or older.
Vtama is prescribed by, or in consultation with, a specialist in dermatology or allergy/immunology.
Member has a diagnosis of AD. Documentation of BSA affected is provided.
Documentation that member experienced an inadequate treatment response or intolerance to at least one medium to super-high potency topical corticosteroid for at least 2 consecutive weeks. Contraindications, adverse effects and/or intolerance must be documented.>= 2 consecutive weeks
Failure/intolerance to one formulary topical drug

Continuation of Therapy (12 months)

Authorization may be granted when ALL of the following are met:

ALL of the following

Documentation that member achieves or maintains a positive clinical response as evidenced by improvement in signs and symptoms of the condition when any of the following is met:
Evidence of positive clinical response (any)
- Reduction in body surface area (BSA) affected from baseline
- Improvement in signs and symptoms from baseline (e.g., itching, redness, flaking, scaling, burning, cracking, pain, clear or almost clear skin)
Concomitant therapy exclusions: Vtama will not be used concomitantly with Zoryve (roflumilast) cream, Eucrisa (crisaborole) ointment, Opzelura (ruxolitinib) cream, Anzupgo (delgocitinib) cream, any therapeutic biologic drug (e.g., adalimumab, infliximab) or any targeted synthetic drug (e.g., apremilast, upadacitinib).

Provider Actions

Prior Authorization

Prior authorization required with documentation

Prior authorization is required. Initial approvals are for 12 months. Providers must submit documentation including: patient age and diagnosis; documentation of affected body surface area (BSA); that Vtama was prescribed by or in consultation with a specialist (dermatology, allergy/immunology, or rheumatology as applicable); prior treatment trials with dates, durations, and documentation of inadequate response, adverse effects, intolerance, or contraindications (e.g., required trial of a high or super‑high potency topical corticosteroid for 2–4 consecutive weeks within the last 12 months for plaque psoriasis; required topical corticosteroid trial of ≥2 consecutive weeks for atopic dermatitis); documentation of failures/intolerances to specified comparator therapies (see documentation callout) including duration and dates; and documentation that excluded concomitant therapies cannot be used. Initial approvals are 12 months.

Age and diagnosis
Affected BSA and documentation
Specialist prescriber or consult (dermatology, allergy/immunology, or rheumatology)
Prior therapy trials with dates and durations and reason for failure/intolerance/contraindication
Documentation that excluded concomitant therapies cannot be used

Documentation Required

Document prior therapy trials and intolerance

Document inadequate response, adverse effects, contraindications, or intolerance to required prior therapies with dates and durations. Trials must be within the specified timeframes (e.g., within the last 12 months where noted). Examples of required comparator therapies and durations: for plaque psoriasis, a 2–4 consecutive week trial within the last 12 months of a high or super‑high potency topical corticosteroid plus inadequate response or intolerance to two of the following within the last 12 months — topical calcineurin inhibitors (e.g., tacrolimus ointment, pimecrolimus cream), topical vitamin D analogs (e.g., calcipotriene 0.005%), topical retinoid (e.g., tazarotene 0.1%), phototherapy, or oral systemic non‑biologic drugs (e.g., methotrexate, cyclosporine, acitretin). For atopic dermatitis, document at least one medium to super‑high potency topical corticosteroid for ≥2 consecutive weeks and failure/intolerance to one formulary topical drug: tacrolimus ointment for 6 consecutive weeks, pimecrolimus cream for 6 consecutive weeks, or Eucrisa (crisaborole) ointment for 4 consecutive weeks. Where required, Zoryve trial(s) (specified concentrations) must be documented within the last 12 months unless switching from a biologic.

Plaque psoriasis: high/super‑high potency topical corticosteroid 2–4 consecutive weeks (within last 12 months)
Plaque psoriasis: failure/intolerance to two of — tacrolimus, pimecrolimus, calcipotriene, tazarotene, phototherapy, or oral systemic non‑biologic agents (within last 12 months)
Atopic dermatitis: topical corticosteroid ≥2 consecutive weeks; plus one of — tacrolimus 6 weeks, pimecrolimus 6 weeks, or Eucrisa 4 weeks
Zoryve trial(s) where indicated within last 12 months unless switching from a biologic

Billing Rule

Quantity limit enforcement

Quantity limits are enforced. Vtama cream 1% has a limit of 60 grams per 30 days. Claims exceeding 60 grams per 30 days may be denied or require additional justification/documentation.

Quantity limit: 60 grams per 30 days
Claims >60 g/30 days may be denied or need justification

Denial Risk

Concomitant therapy exclusions

Vtama must not be used concomitantly with specified topical drugs, therapeutic biologics, or targeted synthetic drugs. Claims may be denied if Vtama is used at the same time as these excluded therapies.

Excluded topicals: Zoryve (roflumilast) cream, Eucrisa (crisaborole) ointment, Opzelura (ruxolitinib) cream, Anzupgo (delgocitinib) cream
Excluded therapeutic biologics (e.g., adalimumab, infliximab)
Excluded targeted synthetic drugs (e.g., apremilast, upadacitinib)
Concomitant use may result in claim denial

Background & Evidence

Vtama (tapinarof) cream is FDA-approved for plaque psoriasis in adults and atopic dermatitis in adults and pediatric patients ≥2 years. Coverage is limited to these FDA-approved indications and requires prior authorization with documentation of age, diagnosis, and affected body surface area (BSA). The policy requires that Vtama be prescribed by, or in consultation with, a specialist in dermatology, allergy/immunology, or rheumatology (as applicable), and documents prior trials of topical/systemic therapies and/or intolerance as specified in the criteria. All other uses are considered investigational and not covered.

FDA label reference: Vtama (tapinarof) cream, US FDA approved product information; Dermavant Sciences; December 2024.

Term	Definition
BSA	Body surface area affected by disease.

OpenPayer

Vtama

Coverage Summary

Medical-Necessity Criteria

Not Covered / Investigational Uses

Provider Actions

Coding

Background & Evidence

Revision History