CurrentCignaPolicy N/A

Topical Products - Zoryve Foam Step Therapy Policy

Defines step therapy requirements for coverage of Zoryve 0.3% topical foam (roflumilast) for seborrheic dermatitis and plaque psoriasis for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyTopical Products - Zoryve Foam Step Therapy Policy

Policy CodePolicy N/A

Change TypeStep 1 product list and prior therapy exceptions revised

Effective Date

Next Review DateFeb 14, 2024

Key ActionSubmit prior authorization with documentation of required Step 1 therapy trials to obtain 1-year approval for Zoryve 0.3% foam.

SourceLink

POLICY UPDATE CHANGES

Step 1 products changed to brand and generic medium, medium-high, high, and super-high potency topical corticosteroids instead of topical generic steroids and topical generic antifungals.

For seborrheic dermatitis, exceptions were added allowing trial of one prescription topical corticosteroid or one topical antifungal, or combination products containing those agents, to satisfy Step 1.

For plaque psoriasis, exceptions were added allowing trial of a topical vitamin D analog, a combination vitamin D analog + topical corticosteroid product, or when plaque psoriasis affects sensitive areas (face, eyelids, skin folds, genitalia).

0.3%Zoryve foam concentration covered

2indications listed

1 yrauthorization duration

Step 1→2step therapy steps

Coverage Criteria for Zoryve 0.3% Foam

Step Therapy Approval Criteria (Initial/Step 2)

Approve Zoryve 0.3% foam (Step 2) if patient meets ONE of the following:

Main

A: Patient has tried one Step 1 Product (one prescription topical corticosteroid of medium-, medium-high-, high-, or super-high potency; brand or generic).
B
- B.i: Patient has tried one prescription topical corticosteroid (brand or generic).
- B.ii: Patient has tried a combination product containing a topical corticosteroid.

Policy Summary

PayerCigna

PolicyTopical Products - Zoryve Foam Step Therapy Policy

Policy CodePolicy N/A

Change TypeStep 1 product list and prior therapy exceptions revised

Effective Date

Next Review DateFeb 14, 2024

Key ActionSubmit prior authorization with documentation of required Step 1 therapy trials to obtain 1-year approval for Zoryve 0.3% foam.

SourceLink

On This Page

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Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Step 2 product (Zoryve 0.3% foam). Approvals are granted for 1 year when criteria are met.

Step Therapy

Two-step Therapy Requirement

The program requires use of one Step 1 Product (a prescription topical corticosteroid of medium- to super-high potency, brand or generic) prior to a Step 2 Product. The Step 1 → Step 2 flow must be followed; if the Step Therapy rule is not met at point of service, coverage will be determined by the Step Therapy criteria.

Documentation Required

Required Documentation for Prior Therapy

Providers must submit documentation of prior therapy trials to support that Step 1 requirements were met. Documentation should include medication name, formulation, brand or generic, dates of therapy, and reason for discontinuation if applicable.

Include medication name and formulation (e.g., topical corticosteroid, vitamin D analog, antifungal).
Provide brand or generic name.
Provide start and stop dates for each trial.
State reason for discontinuation when relevant (e.g., inefficacy, intolerance, adverse reaction).

Denial Risk

Step Therapy Noncompliance May Lead to Denial

Failure to complete required Step Therapy may result in denial at point of service or a request for additional documentation to establish medical necessity per the Step Therapy criteria.

Coverage requires completion of Step Therapy prior to Step 2 (Zoryve) unless alternative criteria in the policy are met.
If Step Therapy rule not met, adjudication will follow the Step Therapy criteria and may delay or deny coverage.

Key Definitions

Zoryve 0.3% foam — product definition and age limits

ProductZoryve (topical roflumilast) 0.3% foam

IndicationsTreatment of seborrheic dermatitis (patients ≥9 years) and plaque psoriasis of the scalp and body (patients ≥12 years)

Formulation/Concentration0.3% foam (topical)

Prior authorization/Step therapy roleDesignated Step 2 product — prior authorization required; approval granted for 1 year when step therapy criteria are met

Related formulations noted in policyOther roflumilast topical formulations described in overview (0.05%, 0.15%, 0.3% creams) but the covered product is 0.3% foam

Topical vitamin D analogs — definition and examples

DefinitionTopical vitamin D analogs are topical agents used for plaque psoriasis, including calcipotriene and calcitriol preparations and Sorilux.

ExamplesCalcipotriene 0.005% (cream, ointment, solution, foam); calcitriol 3 mcg/g ointment; Sorilux (calcipotriene foam)

Role in therapyIncluded as an acceptable Step 1 therapy alternative for plaque psoriasis per step therapy criteria (single trial of a topical vitamin D analog satisfies criteria)

Common use/duration guidanceVitamin D analogs can be used long-term (up to 52 weeks) for psoriasis per guideline recommendations cited in the policy.

OpenPayer

Topical Products - Zoryve Foam Step Therapy Policy

Coverage Criteria for Zoryve 0.3% Foam

Provider Actions and Requirements

Key Definitions

Background