CurrentCentenePolicy CP.PMN.110

Crisaborole (Eucrisa) topical ointment

Policy governing medical necessity and prior authorization criteria for crisaborole (Eucrisa) topical ointment for treatment of mild-to-moderate atopic dermatitis for Centene-affiliated health plans (Commercial, HIM, Medicaid).

Policy Summary

PayerCentene

PolicyCrisaborole (Eucrisa) topical ointment

Policy CodePolicy CP.PMN.110

Change TypeNo material changes

Effective DateJun 1, 2017

Next Review Date

Key ActionProvider must submit clinical documentation (office chart notes, lab results, or other information) supporting that the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥3 moMinimum age (FDA)

≤60 gMax dose/30 days

12 moApproval duration

2%Concentration

2017Policy effective

Coverage Criteria

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Initial Therapy

Covered when ALL of the following are met:

Atopic Dermatitis Initial Approval: 1) Diagnosis of atopic dermatitis; 2) Age >= 3 months; 3) Failure of a 2-week trial of two generic medium to very high potency topical corticosteroids of different molecular identities, unless contraindicated (e.g., areas involving the face, neck, or intertriginous areas) or clinically significant adverse effects are experienced; 4) For age >= 2 years: failure of a 2-week trial of topical tacrolimus, unless contraindicated or clinically significant adverse effects are experienced; 5) Dose does not exceed 60 grams (1 tube) per 30 days.<= 60 grams per 30 days

For Illinois HIM requests, step therapy requirements for corticosteroids and tacrolimus do not apply as of 1/1/2026 per IL HB 5395 (see policy).

Continuation Therapy

Covered for continuation when ALL of the following are met:

Continuation: 1) Member currently receiving medication via Centene benefit or member has previously met initial approval criteria OR member is in a continuity of care situation as defined by state-specific regulations; 2) Member is responding positively to therapy; 3) If request is for a dose increase, new dose does not exceed 60 grams (1 tube) per 30 days.<= 60 grams per 30 days

Documentation of prior response or continuity of care should be provided.

Other Diagnoses/Indications

Other/unlisted indications:

Label changes or off-label use guidance: 1) If the drug has had a label change within the last 6 months that is not yet reflected in this policy, follow the applicable no-coverage or non-formulary policy for the member's line of business (see policy references for CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16); 2) If the requested use (diagnosis, age, dosing) is not listed in the exclusions and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, CP.PMN.53 for Medicaid).

References to specific policy numbers are provided in the source document.

Non‑FDA approved (off‑label) indications that are not explicitly addressed in this policy are not authorized unless the provider supplies sufficient clinical documentation demonstrating efficacy and safety consistent with the applicable off‑label use policy or the member’s evidence of coverage. Refer to the specific off‑label use policy that applies by line of business: CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace (HIM), and CP.PMN.53 for Medicaid when seeking authorization for off‑label uses.

When there is a conflict between this clinical policy and state Medicaid coverage provisions for a Medicaid member, the state Medicaid provisions take precedence. Providers should consult the applicable state Medicaid manual for specific coverage rules and instructions related to this policy.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for requests for Eucrisa. Providers must submit supporting clinical documentation (e.g., office chart notes, prior treatment records, lab results) demonstrating the member meets the approval criteria. Approval durations vary by line of business as noted below.

Approval duration — Medicaid/HIM: 12 months
Approval duration — Commercial: 12 months or duration of request, whichever is less
For HIM/Fidelis members, refer to HIM.PA.109 for step therapy policies where applicable

Denial Risk

Documentation and Denial Triggers

Prior authorization requests should include documentation that addresses the step therapy requirements and any exceptions (e.g., contraindication or prior adverse effect). Missing or incomplete documentation is a common reason for denial.

Examples of required documentation: office chart notes documenting diagnosis and symptom history; records of prior topical corticosteroid and topical tacrolimus trials including dates, agents, potency, durations, and outcomes; documentation of contraindications or adverse effects; dosing and quantity rationale if requesting >60 g/30 days.
Denial triggers include missing clinical documentation, member age below policy minimum, lack of documented trials of required therapies, requests exceeding dose/quantity limits ( >60 g per 30 days), or requests for non‑covered/experimental indications.

Step Therapy

Step Therapy Requirements

Step therapy requires documented trials of topical corticosteroids and, for age ≥ 2 years, topical tacrolimus unless contraindicated. For Illinois HIM requests, step therapy bypass applies per IL HB 5395 beginning 1/1/2026 for the specified requirements — confirm state and line-of-business applicability.

Required trials: two different generic medium to very high potency topical corticosteroids of different molecular identities, each for a 2-week trial, unless contraindicated or adverse effects occur.
For age ≥ 2 years: failure of a 2-week trial of topical tacrolimus, unless contraindicated or adverse effects occur. Note: prior authorization may be required for topical tacrolimus.
Dose limit: do not exceed 60 grams (1 tube) per 30 days.

Documentation Required

Clinical Judgment and Recordkeeping

This policy is a guide to medical necessity and does not replace clinical judgment. Providers remain responsible for exercising professional medical judgment and for maintaining complete clinical records to support the requested therapy.

Policy guides but does not dictate individual patient care; document rationale when deviating from step therapy due to clinical judgment.
Retain and submit clinical notes that justify exceptions (e.g., contraindication to topical corticosteroids or tacrolimus, prior significant adverse events).

Note

Medicaid Coverage Conflict

For Medicaid members, state Medicaid coverage provisions supersede this clinical policy when conflicts exist. Refer to the applicable state Medicaid manual for coverage specifics.

If a state Medicaid rule conflicts with this policy, follow the state Medicaid provision.
Check state-specific Medicaid guidance and manuals prior to submitting or appealing PA requests for Medicaid members.

Definitions

Crisaborole (Eucrisa) — definition and indications

Drug classTopical phosphodiesterase-4 (PDE4) inhibitor (Crisaborole / Eucrisa)

FDA indicationTopical treatment of mild to moderate atopic dermatitis in adults and pediatric patients 3 months of age and older.

Dosing regimenApply to affected areas twice daily for mild-to-moderate atopic dermatitis.

FormulationTopical ointment formulation (2% concentration).

Age limitsApproved for patients aged ≥ 3 months.

Crisaborole — product strength and packaging

Product strengthOintment 2% concentration (crisaborole 2% ointment).

Package sizes referencedAvailable in 60 g and 100 g sizes per prescribing information and references.

ReferenceSee Eucrisa Prescribing Information (Pfizer Labs), April 2023; dosing: apply twice daily.

OpenPayer

Crisaborole (Eucrisa) topical ointment

Coverage Criteria

Coding and Quantity Limits

Provider Actions and Requirements

Background

Definitions