CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Anzupgo (delgocitinib) cream — coverage criteria for chronic hand eczema

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Covers criteria for initiation and continuation of topical Anzupgo for adults with moderate to severe chronic hand eczema, including prescribing provider requirements, exclusions for concomitant therapies, and quantity limits.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAnzupgo (delgocitinib) cream — coverage criteria for chronic hand eczema

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization with documentation of age ≥18, dermatologist/allergist prescriber or consult, confirmed chronic hand eczema, disease severity, and prior inadequate response to a medium+ potency topical corticosteroid and tacrolimus.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

>=18minimum patient age

12 moauthorization duration

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CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Anzupgo (delgocitinib) cream — coverage criteria for chronic hand eczema

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Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAnzupgo (delgocitinib) cream — coverage criteria for chronic hand eczema

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

>=18minimum patient age

12 moauthorization duration

Topical steroid + tacrolimusrequired prior therapies

Coverage criteria for Anzupgo (delgocitinib) cream

Initial Therapy

Covered when ALL of the following are met

Initial Authorization for Anzupgo: A. Member is 18 years of age or older; B. Medication is prescribed by, or in consultation with, a dermatologist or allergist/immunologist; C. Documentation that member has a confirmed diagnosis of chronic hand eczema (CHE) that has persisted for more than three months or recurred two or more times within a 12-month time frame after the initial occurrence with complete clearances between relapses; D. Documentation of moderate to severe disease activity with signs and symptoms such as pruritus (itching), burning, stinging, erythema (redness), edema (swelling), xerosis (dry skin), erosions, excoriations (evidence of scratching), oozing and crusting, and/or lichenification (epidermal thickening); E. Documentation that the member experienced an inadequate treatment response to at least one medium or higher potency topical corticosteroid, or documentation that a medium or higher potency topical corticosteroid is not advisable (contraindication, adverse effect, or intolerance); F. Documentation that the member experienced an inadequate treatment response or intolerance to tacrolimus ointment (document contraindication, adverse effect, or intolerance); G. Member is not immunocompromised; H. Anzupgo will not be used concomitantly with any therapeutic biologic drug, any targeted synthetic drug, Opzelura (ruxolitinib) cream, Vtama (tapinoraf) cream, Zoryve (roflumilast) cream, systemic JAK inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine.12 months authorization

Authorization of 12 months may be granted if all criteria met

Continuation Therapy

Continuation therapy covered when ALL of the following are met

Continuation Authorization for Anzupgo: A. Documentation that member has achieved or maintained a positive clinical response evidenced by low disease activity (clear or almost clear skin) or clinical improvement in signs and symptoms of CHE (e.g., improvement in erythema, edema, xerosis, erosions, excoriations, oozing and crusting, lichenification, or pruritus); B. Medication continues to be prescribed by, or in consultation with, a dermatologist or allergist/immunologist; C. Anzupgo will not be used concomitantly with any therapeutic biologic drug, any targeted synthetic drug, Opzelura (ruxolitinib) cream, Vtama (tapinoraf) cream, Zoryve (roflumilast) cream, systemic JAK inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine.12 months authorization

Authorization of 12 months may be granted for continuation if criteria met

Anzupgo (delgocitinib) is approved as a topical Janus kinase (JAK) inhibitor specifically for adults with moderate to severe chronic hand eczema (CHE) who have had an inadequate response to, or for whom topical corticosteroids are not advisable. The policy does not recommend use of Anzupgo in combination with other JAK inhibitors or potent immunosuppressants; such combination therapy is a limitation of use and may lead to denial of coverage. Additionally, use of Anzupgo for any indication other than CHE is considered experimental/investigational and is not covered.

All indications other than treatment of moderate to severe chronic hand eczema are considered experimental or investigational and not medically necessary. The source specifies that Anzupgo is indicated only for topical treatment of CHE in adults meeting the labeled criteria; therefore requests for non‑CHE diagnoses should be denied as not medically necessary.

What providers must do to obtain coverage

Prior Authorization

Prior Authorization Required

Prior authorization required — initiation criteria, prescriber requirements, diagnostic documentation. Authorization of up to 12 months may be granted when ALL initiation criteria are met: patient is ≥18 years old; medication is prescribed by or in consultation with a dermatologist or allergist/immunologist; documentation of confirmed chronic hand eczema (CHE) persisting >3 months or recurring ≥2 times within 12 months with complete clearances between relapses; documentation of moderate to severe disease activity (signs/symptoms such as pruritus, burning, stinging, erythema, edema, xerosis, erosions, excoriations, oozing/crusting, and/or lichenification); documentation of inadequate response to at least one medium- or higher-potency topical corticosteroid OR documentation that a medium- or higher-potency topical corticosteroid is not advisable (with contraindication/adverse effect/intolerance documented); documentation of inadequate response or intolerance to tacrolimus ointment (with contraindication/adverse effect/intolerance documented); member is not immunocompromised; and therapy will not be used concomitantly with therapeutic biologics, targeted synthetic drugs, Opzelura (ruxolitinib) cream, Vtama (tapinarof) cream, Zoryve (roflumilast) cream, systemic JAK inhibitors, or potent immunosuppressants (e.g., azathioprine, cyclosporine).

Authorization duration: up to 12 months
Prescriber: dermatologist or allergist/immunologist (or in consultation)
Diagnosis documentation: CHE >3 months or ≥2 recurrences in 12 months with complete clearances between relapses
Disease severity: documentation of moderate to severe signs/symptoms

Key definitions used in this policy

Chronic hand eczema (CHE) — definition criteria

Duration thresholdDisease persisting for more than 3 months or recurring two or more times within a 12‑month timeframe with complete clearances between relapses.

Minimum age>= 18 years at initiation of therapy.

Prescriber requirementPrescribed by, or in consultation with, a dermatologist or allergist/immunologist.

Moderate to severe disease activity — signs and symptoms

Core signs and symptomsPruritus (itching), burning, stinging, erythema (redness), and edema (swelling).

Skin changes and damageXerosis (dry skin), erosions, excoriations (evidence of scratching), oozing and crusting, and/or lichenification (epidermal thickening).

Background and clinical context

Chronic hand eczema (CHE) is an inflammatory skin condition for which Anzupgo is indicated when disease is moderate to severe and topical corticosteroids have been ineffective or are not advisable. As a topical JAK inhibitor, Anzupgo targets inflammatory pathways in affected skin of the hands. The product labeling limits use to adults and explicitly cautions against combining Anzupgo with other JAK inhibitors or potent immunosuppressants; prescribing should follow the clinical criteria for CHE and account for safety considerations before initiation.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAnzupgo (delgocitinib) cream — coverage criteria for chronic hand eczema

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

Step therapy required: inadequate response to ≥1 medium- or higher-potency topical corticosteroid OR corticosteroid not advisable (documented)

Step therapy required: inadequate response or intolerance to tacrolimus ointment (documented)

Exclusions: immunocompromised members; concomitant use with listed biologics, targeted synthetics, other topical prescription agents for CHE, systemic JAK inhibitors, or potent immunosuppressants

Step Therapy

Step Therapy Requirements

Step therapy requirements — prior inadequate response or intolerance to specified topical therapies. Members must have documented inadequate response or intolerance to both: 1) at least one medium- or higher-potency topical corticosteroid (or documentation that such corticosteroid is not advisable with justification), AND 2) tacrolimus ointment. Contraindications, adverse effects, or intolerance must be clearly documented in the medical record for either agent when claimed.

Required prior therapies: ≥1 medium- or higher-potency topical corticosteroid
Required prior therapy: tacrolimus ointment
Allowable alternative: documented reason why a medium- or higher-potency topical corticosteroid is not advisable (e.g., contraindication, adverse reaction, intolerance)

Documentation Required

Required Documentation

Required documentation — medical record requirements for diagnosis, duration/frequency, and clinical response. Providers must submit clinical notes supporting the CHE diagnosis, duration or recurrence pattern, baseline disease severity signs/symptoms, prior treatment histories with dates, specific reasons for inadequate response or intolerance to prior agents, and documentation that the member is not immunocompromised. For continuation requests, provide documentation of positive clinical response (clear or almost clear skin, or other documented improvement in signs/symptoms) since initiation.

Diagnosis: confirmation of chronic hand eczema with duration >3 months or ≥2 recurrences in 12 months with complete clearances between relapses
Severity: baseline documentation of moderate to severe disease signs/symptoms
Prior therapy details: dates, agents, doses, duration, and clinical response or documented intolerance/adverse events
Immunocompetence: documentation that member is not immunocompromised
Continuation requests: documentation of clinical improvement or maintenance of low disease activity

Denial Risk

Denial Triggers

Denial triggers — uses outside indications, missing criteria, concomitant disallowed therapies. Requests will be denied if the member is under 18 years, lacks required prescriber or consult, does not have adequate diagnostic/duration documentation, has not met step therapy requirements, is immunocompromised, or if the medication is to be used concomitantly with prohibited agents (therapeutic biologics, targeted synthetic drugs, Opzelura, Vtama, Zoryve, systemic JAK inhibitors, or potent immunosuppressants). All other indications are considered experimental/investigational and not medically necessary.

Age <18 years — not eligible
Missing prescriber specialty or consult (dermatology/allergy-immunology)
Incomplete documentation of CHE diagnosis, duration/recurrence, or disease severity
Failure to document prior adequate trials or documented intolerance of required topical therapies
Concomitant use with disallowed therapies (listed biologics, targeted synthetics, other specified topical prescription agents, systemic JAK inhibitors, azathioprine, cyclosporine)
Requests for non-CHE indications — considered experimental/investigational

Severity context for coverageDocumentation of moderate to severe disease activity with the above signs/symptoms is required for authorization of Anzupgo.