CurrentMass General Brigham Health PlanPolicy N/A

Zoryve (roflumilast)

Prior authorization policy for Zoryve topical formulations (0.15% cream, 0.3% cream, 0.3% foam) under the pharmacy benefit for Commercial/Exchange members, including initial and continuation criteria, age limits, diagnoses, and quantity limits.

Policy Summary

PayerMass General Brigham Health Plan

PolicyZoryve (roflumilast)

Policy CodePolicy N/A

Change TypeAdded foam; added 0.15% cream criteria; age lowered

Effective DateNov 1, 2024

Next Review Date

Key ActionPrior authorization is required; provide documentation showing the member meets the formulation-specific criteria or is new-to-plan and currently receiving therapy.

SourceLink

POLICY UPDATE CHANGES

Added Zoryve 0.3% foam to criteria and reduced minimum age for Zoryve cream to 6 years effective 10/01/2024.

Added criteria for Zoryve 0.15% cream and appendix with relative potency of select topical corticosteroids effective 11/01/2024.

3Formulations covered

6 monthsApproval duration (initial/reauth)

60 g/30 daysQuantity limit

Coverage Summary

Coverage stance: covered_with_criteria for Zoryve (roflumilast) topical formulations under the pharmacy benefit for Commercial/Exchange members. Scope summary: Prior authorization is required for Zoryve 0.15% cream, 0.3% cream, and 0.3% foam with formulation-specific age limits and diagnoses. Age thresholds are ≥ 6 years for Zoryve 0.15% cream and 0.3% cream, and ≥ 9 years for Zoryve 0.3% foam. Initial approval requires documentation of diagnosis and prior treatment history or documented contraindication as specified for each formulation; quantity limits are enforced at 60 grams per 30 days per formulation. Prior authorization also allows members new to the plan within the last 90 days who are currently receiving the medication (excluding samples or manufacturer patient assistance) to qualify.

Initial Therapy Criteria (by formulation)

Zoryve 0.15% Cream - Initial Authorization

Covered when ALL of the following are met:

ALL of the following

Member is 6 years of age or older.
Member has a diagnosis of mild to moderate atopic dermatitis.
ONE of
- ALL of the following
  - Medium or higher potency topical corticosteroids
  - Calcineurin inhibitors: Pimecrolimus cream OR tacrolimus ointment
  - Eucrisa (crisaborole) ointment
- Member has a contraindication to topical corticosteroids, calcineurin inhibitors, and Eucrisa.

Zoryve 0.3% Cream - Initial Authorization

Covered when ALL of the following are met:

ALL of the following

Member is 6 years of age or older.
Member has a diagnosis of plaque psoriasis.
ONE of
- Member has had inadequate treatment response, intolerance or has contraindication to a topical steroid.
- Medication will be used on sensitive skin area (e.g., face, genitals, or skin folds).

Zoryve 0.3% Foam - Initial Authorization

Covered when ALL of the following are met:

ALL of the following

Member is 9 years of age or older.
Member has a diagnosis of seborrheic dermatitis.
ONE of
- ALL of the following
  - Corticosteroids (e.g., betamethasone, clobetasol)
  - Antifungals (e.g., ciclopirox, ketoconazole)

General Coverage Guidance

Authorization may be granted for members new to the plan within the last 90 days who are currently receiving treatment with the requested medication (excluding samples or manufacturer patient assistance) OR when all of the following are met with documentation:

ANY of the following

Member is new to the plan within the last 90 days and currently receiving treatment with the requested medication (excluding samples or manufacturer's patient assistance programs).
Documentation provided to support criteria for the specific formulation requested (see formulation-specific trees).

Unproven Uses and Exclusions

Limitations and exclusions: Use is limited to the indicated diagnoses and ages listed for each formulation and requires meeting the formulation-specific criteria (e.g., prior inadequate response or intolerance to specified topical therapies, or documented contraindication). Non-indicated uses, or use in patients who do not meet the age, diagnosis, prior-treatment, or documentation requirements, are not covered. Reauthorization requires continued meeting of initial criteria and physician documentation of clinical improvement; failure to provide required documentation may result in denial.

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for Zoryve formulations under the pharmacy benefit for Commercial/Exchange; documentation must demonstrate the criteria listed for the requested formulation or proof the member is new to the plan and currently receiving therapy.

Documentation Required

Document prior treatment or contraindication

For initial approvals, prescriber must document inadequate response or intolerance to the specified prior topical therapies (or provide a contraindication or clinical rationale where allowed) according to the formulation-specific criteria (see formulation sections for required prior therapies and allowed exceptions).

Billing Rule

Quantity limit enforcement

Enforce quantity limits of 60 grams per 30 days for each Zoryve formulation:

Zoryve 0.15% cream — 60 grams per 30 days; Zoryve 0.3% cream — 60 grams per 30 days; Zoryve 0.3% foam — 60 grams per 30 days

Denial Risk

Reauthorization requirement

Reauthorization may be denied if physician documentation does not show improvement and continued meeting of the initial criteria for the requested formulation.

Background

Background: Zoryve (roflumilast) is a topical phosphodiesterase 4 inhibitor available as 0.15% cream for mild to moderate atopic dermatitis (approved in patients 6 years and older), 0.3% cream for plaque psoriasis (approved in patients 6 years and older), and 0.3% foam for seborrheic dermatitis (approved in patients 9 years and older). Policy aligns coverage to these age limits and requires prior treatment failure, intolerance, or contraindication to established topical therapies (or clinical rationale) as specified in the formulation-specific criteria; prior authorization and quantity limits apply.

Definition

TermNew to the plan

DefinitionMembers who joined the plan within the previous 90 days; may qualify if currently receiving the requested medication (excluding samples or manufacturer assistance).

Policy Summary

PayerMass General Brigham Health Plan

PolicyZoryve (roflumilast)

Policy CodePolicy N/A

Change TypeAdded foam; added 0.15% cream criteria; age lowered

Effective DateNov 1, 2024

Next Review Date

Key ActionPrior authorization is required; provide documentation showing the member meets the formulation-specific criteria or is new-to-plan and currently receiving therapy.

SourceLink

On This Page

OpenPayer

Zoryve (roflumilast)

Coverage Summary

Initial Therapy Criteria (by formulation)

Continuation Therapy Criteria

Unproven Uses and Exclusions

Applicable Codes & Quantity Limits

Provider Actions & Requirements

Clinical Evidence & References

Background

Revision History

Zoryve 0.15% cream	Quantity Limit = 60 grams per 30 days
Zoryve 0.3% cream	Quantity Limit = 60 grams per 30 days
Zoryve 0.3% foam	Quantity Limit = 60 grams per 30 days