CurrentmhnPolicy CP.PHAR.744

Clinical Policy: Delgocitinib (Anzupgo)

Covers medical necessity and prior authorization criteria for topical delgocitinib (Anzupgo) for treatment of moderate to severe chronic hand eczema in eligible members across specified lines of business.

Policy Summary

Payermhn

PolicyClinical Policy: Delgocitinib (Anzupgo)

Policy CodePolicy CP.PHAR.744

Change TypeNo material changes

Effective DateDec 1, 2025

Next Review Date

Key ActionObtain prior authorization with documentation that the member meets all initial or continued therapy criteria, including diagnosis, prior topical therapy failures, provider specialty, age, and dose limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

60 g/momaximum dosing limits

≥18minimum age

12 moapproval duration

moderate–severe CHEFDA indication

Coverage Criteria

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Initial CHE criteria

Prior therapy requirement branching: 6. One of the following (a or b): a) For Illinois HIM requests only: failure of one formulary topical corticosteroid unless clinically significant adverse effects or contraindications; b) For all other requests: failure of BOTH (i and ii) unless clinically significant adverse effects or contraindications: i) one formulary topical corticosteroid used ≥ 2 weeks; ii) one of the following: (1) a second formulary topical corticosteroid used ≥ 2 weeks; OR (2) one topical calcineurin inhibitor used ≥ 4 weeks. *Prior authorization may be required for topical calcineurin inhibitors.

Continuation Therapy (Chronic Hand Eczema)

Covered for continuation when ALL of the following are met:

Continued therapy CHE: 1. Member meets one of the following (a or b): a) currently receiving medication via Centene benefit or previously met initial approval criteria; OR b) member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy as evidenced by reduction in itching and scratching and absence of signs (erythema, scaling, hyperkeratosis/lichenification, vesiculation, edema, or fissures); 3. Anzupgo is not prescribed concurrently with biologic medications, biologic disease-modifying antirheumatic drugs, JAK inhibitors, or potent immunosuppressants; 4. If request is for a dose increase, the new dose does not exceed both: a) one 30-gram tube per 2 weeks; and b) 60 grams per month.

Approval duration: 12 months.

Coverage is NOT authorized for non‑FDA‑approved indications that are not specifically addressed in this policy unless the provider submits sufficient documentation of efficacy and safety in accordance with applicable off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid), or unless the member’s evidence of coverage document allows the use.

Use of Anzupgo (delgocitinib) concurrently with biologic medications, other JAK inhibitors, or potent immunosuppressants is not authorized under these criteria. Examples include biologics (e.g., Dupixent, Adbry), biologic DMARDs (e.g., Humira, Enbrel, Taltz, Stelara), JAK inhibitors (e.g., Cibinqo, Opzelura, Xeljanz, Rinvoq, Olumiant), and potent immunosuppressants (e.g., azathioprine, cyclosporine). Requests that propose concurrent use with these agents do not meet the coverage criteria.

Product Availability and Coding

Product availability / NDCNDC

NDC not listed

Delgocitinib (Anzupgo) cream 2% available in 30 g and 60 g tubes (product availability); specific NDCs not provided in this document.

inv-07: Maximum topical quantity

Maximum topical quantityOne 30-gram tube per 2 weeks; 60 grams per month.

Dosing frequencyApply a thin layer twice daily to affected areas of hands and wrists.

Maximum per indication statementDose limits for CHE: 30 g per 2 weeks or 60 g per month (per Dosage and Administration).

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required — Prior authorization is required. Provider must submit documentation that all initial or continued therapy criteria are met, including diagnosis, duration of disease, prior treatment trials and failures, provider specialty, dosing, and any other information necessary to support medical necessity.

Applies to initial and renewal requests for Anzupgo (delgocitinib).
Include office chart notes, lab results, medication history, and consultation notes as applicable.

Note

Prior Authorization Requirement and Administrative Governance

Prior authorization requirements and coverage decisions are governed by this clinical policy in conjunction with Health Plan-level administrative policies and the member's coverage documents. Coverage is subject to the terms, conditions, exclusions, and limitations of the member's benefit plan.

Refer to the member's Evidence of Coverage / Certificate of Coverage for benefit-specific limitations.
State-specific continuity of care regulations may apply for members transitioning care.

Step Therapy

Step Therapy Requirements

Step therapy — Failure of specified topical therapies is required before approval of Anzupgo for chronic hand eczema. Document prior use, duration, and reasons for discontinuation or intolerance.

For Illinois HIM requests only: failure of one formulary topical corticosteroid (used ≥ 2 weeks) unless contraindicated.
For all other requests: failure of both of the following unless contraindicated: (i) one formulary topical corticosteroid used ≥ 2 weeks, and (ii) either a second formulary topical corticosteroid used ≥ 2 weeks OR one topical calcineurin inhibitor used ≥ 4 weeks.
Prior authorization may be required for topical calcineurin inhibitors.

Documentation Required

Required Documentation

Required documentation — Provider must submit documentation (office chart notes, lab results, prior medication trials, specialty consultation notes, and any other relevant clinical information) supporting that the member meets all approval criteria (diagnosis, disease duration or recurrence, provider attestation of severity, prior treatment failures or contraindications, current dosing, and concurrent medication exclusions).

Documentation should include evidence of moderate to severe chronic hand eczema, duration (>3 months or ≥2 recurrences in 12 months), and response to prior therapies.
If request is for continuation, include documentation of positive response to therapy (reduction in symptoms/signs such as itching, erythema, scaling, hyperkeratosis/lichenification, vesiculation, edema, or fissures).

Documentation Required

Documentation and Administrative Requirements

Documentation and Administrative Requirements — Providers must follow applicable Health Plan-level administrative policies and the member's coverage documents when requesting coverage. Requests lacking required documentation (diagnosis, duration, prior treatment failures, provider specialty, dosing) may be denied. The clinical policy is a medical necessity guide and does not guarantee payment.

Ensure requests indicate whether member previously met initial approval criteria or is subject to continuity of care provisions.
Coverage decisions are subject to plan terms, exclusions, and state/federal requirements.

Denial Risk

Documentation and Indication-Related Denials

Documentation-related denials — Requests that lack sufficient documentation to demonstrate that all approval criteria are met may be denied. Examples include missing evidence of prior topical therapy trials, no provider attestation of severity, absence of specialty involvement when required, or exceeding dosing limits.

Dose limits: not to exceed one 30-gram tube per 2 weeks and 60 grams per month.
Anzupgo must not be prescribed concurrently with specified biologics, JAK inhibitors, or potent immunosuppressants.

Note

Coverage and Benefit Limitations

Coverage/Benefit Limitations — Coverage decisions and the administration of benefits are subject to all terms, conditions, exclusions, and limitations of the member's coverage documents and applicable laws and regulations.

This clinical policy does not constitute a contract or guarantee of payment.
State-specific addendums and off-label use policies apply for non-FDA indications.

Background

Delgocitinib (topical, Anzupgo) is a Janus kinase (JAK) inhibitor indicated for adults with moderate to severe chronic hand eczema (CHE) who have an inadequate response to topical corticosteroids or when topical corticosteroids are not advisable. Clinical trials (DELTA 1 and DELTA 2) used Investigator’s Global Assessment for Chronic Hand Eczema (IGA‑CHE) and Physician Global Assessment (PGA) scales to define moderate‑to‑severe disease. For dosing, apply a thin layer to affected areas twice daily, with a maximum quantity limit of one 30‑gram tube per 2 weeks (≤ 60 g/month).

Definitions

inv-17: IGA-CHE / PGA definitions

IGA-CHE definitionUsed in DELTA 1 and DELTA 2 trials to enroll participants with moderate to severe CHE (score 3 or 4); requires at least one clearly perceptible or marked erythema, scaling, or hyperkeratosis/lichenification and at least one clustered/high-density vesicle, definite/marked edema, or definite/deep fissures.

PGA definition - moderatePresence of two or more mild to moderate skin changes (erythema, scaling, hyperkeratosis, lichenification, vesiculation, edema, fissures, pruritus, pain) involving 10%–30% of hand surface.

PGA definition - severePresence of two or more moderate to severe skin changes involving >30% of hand surface.

inv-18: Anzupgo (delgocitinib)

ProductAnzupgo (delgocitinib) — topical cream formulation referenced in prescribing information (LEO Pharma, July 2025).

Strength and presentationsDelgocitinib cream 2% available in 30 g and 60 g tubes.

Primary sourcesPrescribing information: Anzupgo Prescribing Information, LEO Pharma Inc., July 2025; clinical trials DELTA 1 and DELTA 2 published in 2024–2025.