Delgocitinib (Anzupgo) topical for chronic hand eczema
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Defines medical necessity, prior authorization, and continuation criteria for topical delgocitinib (Anzupgo) for chronic hand eczema in eligible members covered by the payer.
No material clinical or coverage changes in this revision.
Coverage Criteria
inv-01: Initial Therapy — Covered when ALL of the following are met:
Covered when ALL of the following are met:
Prior authorization documentation required
inv-02: Prior Therapy Requirements / Step Therapy — 1 top-level node
State-specific variation: Illinois HIM vs other requests
inv-03: Continuation Therapy — Covered for continuation when ALL of the following are met:
Covered for continuation when ALL of the following are met:
Approval duration: 12 months
Non-FDA approved indications for delgocitinib (Anzupgo) topical are not authorized by this policy unless there is sufficient documentation of efficacy and safety consistent with the plan’s off-label use requirements. Providers should follow the referenced off-label use policies (CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or submit evidence of coverage documentation to support approval for an off-label indication.
For Medicaid members, if a state Medicaid coverage provision conflicts with the coverage provisions in this clinical policy, the state Medicaid coverage provisions take precedence. Refer to the applicable state Medicaid manual for specific coverage requirements.
Use of delgocitinib for diagnoses or indications not listed in this policy is not authorized without supporting evidence per the plan’s off-label use procedures. Requests for off-label use lacking documentation of efficacy and safety consistent with the referenced off-label policies may be considered not medically necessary and are not eligible for coverage.
Coding and Product Availability
| NDC | Delgocitinib (Anzupgo) cream 2% in 30 g and 60 g tubes |
Provider Actions and Prior Authorization
Obtain prior authorization and document all approval criteria
Prior authorization is required and must demonstrate the member meets all policy criteria for chronic hand eczema, including diagnosis, disease duration/severity, prescriber specialty, age ≥ 18 years, prior topical therapy failure per the policy, and adherence to dosing limits (one 30‑g tube per 2 weeks; 60 g/month). Product availability (Anzupgo cream 2% in 30 g and 60 g tubes) is noted in the policy.
- Show diagnosis of chronic hand eczema and duration (>3 months or ≥2 recurrences in 12 months).
- Provide prescriber attestation of moderate to severe disease and that prescriber is a dermatologist or allergist (or in consultation).
- Document prior topical therapy failures per policy (see step therapy node).
- Confirm requested dose does not exceed one 30 g tube per 2 weeks and 60 g/month.
Follow payer prior authorization processes
This clinical policy is intended as medical necessity guidance to assist coverage determinations; providers must follow the Health Plan's prior authorization processes and administrative procedures when submitting requests.
- Follow the Health Plan's specific prior authorization forms, submission portals, and timelines.
- Policy guidance does not guarantee payment; adhere to plan coverage documents.
Meet step therapy prior topical treatment requirements
Step therapy requires documented failure of specified topical corticosteroid regimens and/or a topical calcineurin inhibitor as detailed by state: Illinois HIM requests require failure of one formulary topical corticosteroid used ≥2 weeks; all other requests require failure of one formulary topical corticosteroid used ≥2 weeks plus either a second formulary topical corticosteroid used ≥2 weeks or one topical calcineurin inhibitor used ≥4 weeks, unless contraindicated or adverse effects occur.
- Illinois HIM: failure of one formulary topical corticosteroid (≥2 weeks) unless contraindicated.
- Other requests: failure of one formulary topical corticosteroid (≥2 weeks) AND either a second formulary topical corticosteroid (≥2 weeks) OR a topical calcineurin inhibitor (≥4 weeks).
- Prior authorization may be required for topical calcineurin inhibitors.
When step therapy is not specified, follow plan/state guidance
The policy also notes that no explicit step therapy requirements are provided in some policy chunks; where step logic is not specified, follow the plan-specific prior authorization instructions and the state-specific criteria described elsewhere in the policy.
- If step therapy details are unclear for a specific line of business, use the Health Plan's administrative guidance and applicable state addenda.
Provide required clinical documentation with the request
Submit supporting clinical documentation with the prior authorization request — e.g., office chart notes, test results, and other clinical information — that demonstrates the member meets each approval criterion.
- Include documentation of diagnosis, symptom duration/recurrence, prescriber attestation of severity, prior topical therapy details (agents, durations, responses), and current dosing.
- Attach consultation notes when prescribed in consultation with a specialist.
Policy is guidance — apply professional judgment and follow plan rules
Providers are expected to exercise professional medical judgment; this policy is guidance for medical necessity determinations and does not guarantee coverage or payment — documentation and decisions must align with plan coverage documents and legal/regulatory requirements.
- Policy does not replace provider clinical judgment or plan contract terms.
- Ensure documentation aligns with applicable laws, regulations, and the Health Plan's coverage documents.
Denial risk if criteria, prior therapy, specialty, age, or dosing limits not met
Requests that fail to meet the documented criteria — including missing/incorrect diagnosis, lack of required prior topical therapy failure, prescriber not a dermatologist/allergist or lacking consultation, age <18, or exceeding dosing limits — may be denied.
- Denial risks include non-FDA indications without off-label documentation and failure to meet continuity/continuation requirements for renewals.
- Exceeding dose limits (more than one 30 g tube per 2 weeks or >60 g/month) can result in denial.
Coverage is conditional on plan documents, state/federal law
Coverage and benefit administration are subject to the Health Plan's coverage documents, applicable state and federal requirements, and legal regulations; where conflicts exist, law/regulation and plan documents govern.
- For Medicaid members, state Medicaid provisions take precedence where they conflict with this clinical policy.
- This policy does not constitute a contract or guarantee of payment.
Background
Delgocitinib (Anzupgo) is a topical Janus kinase (JAK) inhibitor formulated as a 2% cream and is FDA-approved for adults with moderate to severe chronic hand eczema who have had an inadequate response to, or for whom topical corticosteroids are not advisable. The product is available in 30 g and 60 g tubes, and dosing in the approval criteria aligns with the trial and prescribing information recommendations.
Definitions
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