CurrentCignaPolicy N/A

Dermatology - Anzupgo Prior Authorization Policy

Defines prior authorization requirements for coverage of Anzupgo cream (delgocitinib 2%) for treatment of chronic hand eczema in adults under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyDermatology - Anzupgo Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateAug 27, 2025

Key ActionObtain prior authorization and document diagnosis, age, duration/recurrence, severity, prior topical corticosteroid trial (≥28 days) and prescriber specialty or consultation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4 monthsinitial approval duration

≥18minimum age

≥28 dayssteroid trial

>3 mo or ≥2/yrrequired chronicity

Dermatologist/allergist/immunologistprescriber requirement

Coverage Criteria for Anzupgo (delgocitinib 2% cream)

Policy Summary

PayerCigna

PolicyDermatology - Anzupgo Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateAug 27, 2025

Key ActionObtain prior authorization and document diagnosis, age, duration/recurrence, severity, prior topical corticosteroid trial (≥28 days) and prescriber specialty or consultation.

SourceLink

On This Page

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Initial coverage criteria

Approve for 4 months if the patient meets ALL of the following (A, B, C, D, and E):

Main criteria

A): Patient is ≥ 18 years of age;
B): Patient has hand eczema that has been present for > 3 months or has returned at least twice in a year after its initial presentation and subsequent clearance;
C): According to the prescriber, patient has moderate to severe chronic hand eczema;
D)
- i.: Patient has tried at least one medium-, medium-high, high-, and/or super-high-potency prescription topical corticosteroid;
- ii.: This topical corticosteroid was applied daily for at least 28 consecutive days;
- iii.: According to the prescriber, inadequate efficacy was demonstrated with this topical corticosteroid therapy;
E): The medication is prescribed by or in consultation with an allergist, immunologist, or dermatologist.

Concurrent use of Anzupgo with other Janus kinase (JAK) inhibitors or with potent immunosuppressants is not recommended. Clinical trials of Anzupgo prohibited use of topical or systemic JAK inhibitors and systemic immunosuppressants prior to and during study participation, and there are no data evaluating safety or efficacy when these agents are combined with Anzupgo. When a prior authorization request is reviewed, combination therapy with other JAK inhibitors or potent immunosuppressants will be regarded as not medically necessary unless clear, documented justification and supporting data are provided by the prescriber.

Use of Anzupgo in combination with other JAK inhibitors or with potent immunosuppressants is considered not medically necessary due to lack of clinical data and potential safety concerns. Examples of other JAK inhibitors are listed in the Appendix (Table 1) and include agents such as ruxolitinib, tofacitinib, upadacitinib, baricitinib, abrocitinib, and others. Because pivotal studies excluded concurrent use of these therapies, concurrent prescribing is not recommended and may lead to denial of coverage for the combination.

Provider Actions, Authorization, and Required Documentation

Prior Authorization

Prior authorization and approval duration

Prior Authorization is recommended for prescription benefit coverage of Anzupgo cream. All approvals are provided for the duration noted in the policy (when measured in months, 1 month = 30 days). Because of the specialized skills required for evaluation and diagnosis of patients treated with Anzupgo cream and the monitoring required for adverse events and long-term efficacy, approval requires Anzupgo cream to be prescribed by or in consultation with a physician who specializes in the condition being treated.

Prior Authorization

Topical corticosteroid trial required

A trial of at least one prescription topical corticosteroid of medium- to super-high potency applied daily for at least 28 consecutive days is required. The prior trial must have demonstrated inadequate efficacy (failure to maintain clear or almost clear skin) per the prescriber. Documentation that the corticosteroid was used for the specified potency, duration, and resulted in inadequate response should be provided; exceptions may include situations where topical corticosteroids are medically inadvisable.

Required: one medium-, medium-high-, high-, or super-high‑potency prescription topical corticosteroid
Applied daily for ≥ 28 consecutive days
Documentation of inadequate efficacy per prescriber or medical contraindication to topical corticosteroids

Documentation Required

Required documentation for prior authorization

Prior authorization requests should document the following: diagnosis (chronic hand eczema), patient age, duration/recurrence of disease (present >3 months or returned ≥2 times in the prior 12 months), disease severity (moderate to severe per prescriber), details of prior therapy including the topical corticosteroid potency, duration of use, and prescriber assessment of inadequate efficacy, and the prescribing or consulting specialist (allergist, immunologist, or dermatologist) when applicable. Also include any rationale for why topical corticosteroids are medically inadvisable if applicable.

Diagnosis and patient age
Duration/recurrence of hand eczema (>3 months or ≥2 recurrences in 12 months)
Severity assessment (moderate to severe)
Details of prior topical corticosteroid trial: potency, daily application for ≥28 days, and prescriber-documented inadequate efficacy
Prescribing or consulting specialist name and specialty
Reason topical corticosteroids are medically inadvisable (if applicable)

Denial Risk

Prohibited combinations

Concurrent use of Anzupgo with other JAK inhibitors or with potent systemic immunosuppressants is not recommended and is considered not medically necessary. The pivotal studies prohibited prior or concurrent use of other topical or systemic JAK inhibitors and systemic immunosuppressants; there are no data evaluating these combinations, and safety and efficacy are unknown.

Concurrent use with other topical or systemic JAK inhibitors — not recommended/not covered
Concurrent use with potent systemic immunosuppressants — not recommended/not covered

Definitions

Inadequate response to topical corticosteroid

DefinitionFailure to maintain clear or almost clear skin despite daily topical corticosteroid application for ≥28 days or for the maximum recommended duration per prescribing information.

Documentation requiredPrescriber must document that the topical corticosteroid was applied daily for at least 28 consecutive days and that inadequate efficacy was demonstrated.

Scope in pivotal trialsDefined the same way in the pivotal studies; patients had hand eczema >3 months or ≥2 recurrences and most (99%) had prior inadequate response to topical corticosteroids.

Alternative when corticosteroids inadvisableIf topical corticosteroids are medically inadvisable, inability to use them was allowed in trials (1% of patients); document medical reason.

Potency considerationsTrials required at least medium- to super-high–potency prescription topical corticosteroids (regional variations noted: Europe required potent to very potent; Canada required medium- to ultra-high potency).

OpenPayer

Dermatology - Anzupgo Prior Authorization Policy

Coverage Criteria for Anzupgo (delgocitinib 2% cream)

Provider Actions, Authorization, and Required Documentation

Definitions

Background