CurrentmhnPolicy CP.PMN.110

Crisaborole (Eucrisa)

Policy governing prior authorization and coverage criteria for crisaborole (Eucrisa) topical ointment for treatment of mild to moderate atopic dermatitis in insured members across Commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyCrisaborole (Eucrisa)

Policy CodePolicy CP.PMN.110

Change TypeNo material changes noted

Effective DateJun 1, 2017

Next Review Date

Key ActionSubmit documentation (office notes, labs, or other clinical information) showing the member meets all approval criteria for prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥3 monthsMinimum approved age

60 g/30dDose limit

12 monthsTypical approval duration

Ointment 2%Product availability

Coverage Criteria for Crisaborole (Eucrisa)

inv-01: Initial Therapy (Atopic Dermatitis) — Covered when ALL of the following are met

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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.

Illinois HIM requests: step therapy requirements do not apply as of 1/1/2026 per IL HB 5395 (see policy text).

inv-02: Continuation Therapy — Covered when ALL of the following are met

Covered 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 receiving medication and is enrolled in a state/product with continuity of care 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.

inv-03: Other Indications / Off-label — Alternative pathways if indication not listed

Alternative pathways if indication not listed

Other uses: 1) If the drug has recently (within the last 6 months) undergone a label change not yet reflected in this policy, follow the referenced pathway: for drugs on the formulary/PDL follow the no coverage criteria policy for the line of business (e.g., CP.CPA.190 for commercial, HIM.PA.33 for HIM, CP.PMN.255 for Medicaid) or for drugs NOT on the formulary/PDL follow the non-formulary policy for the line of business (e.g., CP.CPA.190 for commercial, HIM.PA.103 for HIM, CP.PMN.16 for Medicaid); 2) If the requested use (diagnosis, age, dosing) is not listed under section III 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 HIM, CP.PMN.53 for Medicaid).

See referenced policies for process and criteria.

Non‑FDA approved indications that are not explicitly addressed in this policy are not authorized unless the request includes sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policies (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or other applicable evidence of coverage documents.

Product Availability, Dosing, and Coding

Product availability / presentationNDC

NDC not specified

Product availability: Ointment (2%): 60 g, 100 g

inv-08: Dose limit — ≤ 60 grams per 30 days

Dose limitDose does not exceed 60 grams (1 tube) per 30 days.

Rationale in criteriaDose limit applied to both initial and continuation therapy per policy criteria.

Unit and frequency60 grams per 30 days (equivalent to 1 tube per 30 days).

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required. Eucrisa (crisaborole) is medically necessary for atopic dermatitis only when the policy criteria are met and a prior authorization is submitted and approved prior to coverage.

Applicable to commercial, Medicaid, and HIM lines of business unless otherwise noted in step therapy exceptions or state-specific legislation.

Prior Authorization

Prior Authorization Durations

Initial approval durations differ by line of business. For Commercial: initial approval duration is 12 months or duration of request, whichever is less. For Medicaid and HIM: initial approval duration is 12 months. Continued therapy/renewal requests must include documentation supporting ongoing benefit.

Commercial: 12 months or duration of request, whichever is less.
Medicaid/HIM: 12 months initial approval.

Documentation Required

Documentation and Indication

Requests must include documentation and clear indication of diagnosis, patient age, prior trial(s) of required agents (including duration and outcomes), dosing, and quantity requested. Missing documentation (diagnosis, age, prior trials, or dosing/quantity) may result in denial or delay.

Provider must submit office chart notes, lab results, or other clinical information demonstrating the member meets all approval criteria.
Include dates and outcomes of prior trials and reason for failure (lack of efficacy, intolerance, contraindication).
Specify requested dose and confirm quantity does not exceed policy limits (e.g., 60 grams per 30 days for atopic dermatitis).

Step Therapy

Step Therapy Prior Trials

Step therapy requirement: For atopic dermatitis, the policy requires failure of a 2‑week trial of two generic medium to very high potency topical corticosteroids of different molecular identities, unless contraindicated (e.g., face, neck, intertriginous areas) or clinically significant adverse effects occurred. For patients age ≥2 years, failure of a 2‑week trial of topical tacrolimus is also required unless contraindicated or not tolerated. Prior authorization may be required for topical tacrolimus.

Corticosteroid trials must be of different molecular identities (examples for medium to very high potency provided in appendix).
Topical tacrolimus trial (age ≥2 years) — document trial dates and reason for failure if applicable.
Exceptions apply where corticosteroids are contraindicated (sensitive areas) or where adverse effects occurred.

Step Therapy

Step Therapy Requirements and Exceptions

Step therapy requirements and exceptions: Illinois HIM requests — step therapy requirements for corticosteroids and tacrolimus do not apply for Illinois HIM requests per IL HB 5395 effective 1/1/2026; additionally, for certain HIM plans (e.g., Fidelis), refer to HIM step therapy policy HIM.PA.109. When a requested use is not listed or recent label changes apply, follow the referenced formulary/non-formulary or off-label use policies.

IL HIM: step therapy bypass for the noted requirements effective 1/1/2026 per IL HB 5395.
Fidelis HIM members: refer to HIM.PA.109 for step therapy specifics.
If the drug recently underwent a label change not reflected in this policy, consult the formulary/non-formulary or off-label use policies: CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.CPA.09, HIM.PA.154, CP.PMN.53.

Documentation Required

Required Supporting Documentation

Required supporting documentation: Provider must submit clinical documentation (office notes, medication trial records, pharmacy fill history, lab results, or other relevant clinical information) that verifies the diagnosis, age, prior therapy trials (agents, durations, and outcomes), contraindications or adverse effects if claiming exemptions, and dosing/quantity requested.

Include documentation of two distinct corticosteroid molecular identities and dates/duration of each 2‑week trial.
If claiming contraindication for corticosteroids or tacrolimus, provide clinical rationale and supporting notes.
Include pharmacy fill history or prescribing records when available to corroborate prior therapy trials.

Note

References and Prior‑Review History

References and prior‑review history: Providers should ensure submitted clinical documentation aligns with referenced prescribing information and prior-review history notes. See the policy references for supporting literature and the documented P&T history for changes to step therapy and approval-duration rules.

Key references include Eucrisa Prescribing Information (Pfizer, Apr 2023) and relevant clinical guidelines and trials listed in the policy references.
Policy history includes updates to corticosteroid requirement clarifications, approval-duration revisions, and state-specific step therapy bypasses; ensure documentation reflects applicable dates and rules.

Background and Drug Information

Crisaborole (Eucrisa) is a topical phosphodiesterase‑4 (PDE4) inhibitor FDA‑approved for the treatment of mild to moderate atopic dermatitis in patients aged 3 months and older. The product is supplied as a 2% ointment to be applied to affected areas twice daily; contraindication includes hypersensitivity to crisaborole or any component of the formulation.

Definitions and Product Summary

inv-18: Crisaborole (Eucrisa) — Topical PDE4 inhibitor; indication and dosing summary

Drug class and formulationCrisaborole (Eucrisa) — topical phosphodiesterase-4 (PDE4) inhibitor, ointment 2%.

Indication (FDA)Topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older.

Dosing summaryApply to affected areas twice daily. Maximum dose: see policy dose limit (60 g per 30 days).

Product packaging availableOintment (2%): 60 g, 100 g.

inv-19: Crisaborole — Topical, nonsteroidal PDE4 inhibitor indicated for atopic dermatitis (per prescribing information)

Mechanism and classTopical, nonsteroidal phosphodiesterase-4 (PDE4) inhibitor.

FDA indicationIndicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months and older.

Prescribing information referenceEucrisa Prescribing Information (Pfizer), April 2023; references reviewed/accessed through 2025.

ContraindicationsHypersensitivity to crisaborole or any component of the formulation.