CurrentAgency for Health Care AdministrationPolicy N/A

Adbry (tralokinumab-ldrm) Prior Authorization Criteria for Moderate-to-Severe Atopic Dermatitis

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This policy governs Medicaid fee-for-service prior authorization and continuation criteria for Adbry (tralokinumab-ldrm) in patients with moderate-to-severe atopic dermatitis. It applies to providers requesting initial or continued treatment.

Policy Summary

PayerAgency for Health Care Administration

PolicyAdbry prior authorization for moderate-to-severe atopic dermatitis

Policy CodePolicy N/A

Change TypeNo material clinical or coverage change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit documentation of inadequate response or intolerance after at least 4-week trials of a preferred topical corticosteroid and topical calcineurin inhibitor.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearAuthorization length

≥12 yearsMinimum patient age

4 weeksTopical corticosteroid trial

4 weeksCalcineurin inhibitor trial

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CurrentAgency for Health Care AdministrationPolicy N/A

Adbry (tralokinumab-ldrm) Prior Authorization Criteria for Moderate-to-Severe Atopic Dermatitis

Customize your policy alerts

Sign up for all Agency for Health Care Administration policy alerts

Know when Agency for Health Care Administration releases new policies or updates existing guidance.

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Policy Summary

PayerAgency for Health Care Administration

PolicyAdbry prior authorization for moderate-to-severe atopic dermatitis

Policy CodePolicy N/A

Change TypeNo material clinical or coverage change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit documentation of inadequate response or intolerance after at least 4-week trials of a preferred topical corticosteroid and topical calcineurin inhibitor.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearAuthorization length

≥12 yearsMinimum patient age

4 weeksTopical corticosteroid trial

4 weeksCalcineurin inhibitor trial

150 mg/mL or 300 mg/2 mL

Coverage Criteria

Initial Therapy

Covered when ALL of the following are met:

Initial therapy

Age and diagnosis: Patient is at least 12 years of age and has a diagnosis of moderate-to-severe atopic dermatitis.Age ≥12 years
Topical corticosteroid trial: Patient has had a minimum 4-week trial of at least one preferred medium- to very-high-potency topical corticosteroid and experienced inadequate response or intolerance.Minimum 4-week trial
Clinical documentation required.
Topical calcineurin inhibitor trial: Patient has had a minimum 4-week trial of at least one preferred topical calcineurin inhibitor, including Elidel or Protopic, and experienced inadequate response or intolerance.Minimum 4-week trial
Clinical documentation required.
No concurrent monoclonal antibody biologic: Adbry will not be used in combination with another monoclonal antibody biologic.
Examples include tezepelumab, omalizumab, mepolizumab, reslizumab, benralizumab, and dupilumab.

Continuation Therapy

Covered for continuation when ALL of the following are met:

Continuation therapy

Initial criteria previously met: Patient previously met the initial review criteria.
Improved clinical response: Documentation shows improved clinical response, including clinical reduction in pruritus and flares.Reduction in pruritus and flares
No serious treatment-related adverse events: Patient has not experienced serious treatment-related adverse events.
Examples include serious infection, conjunctivitis, keratitis, and eosinophilia.
Appropriate dosing:

Adbry must not be used in combination with other monoclonal antibody biologics, including tezepelumab, omalizumab, mepolizumab, reslizumab, benralizumab, or dupilumab.

Provider Actions

Prior Authorization

Initial Adbry Authorization

Before Adbry can be authorized, the patient must meet all initial review requirements for treatment of moderate-to-severe atopic dermatitis.

Patient is 12 years of age or older.
Patient has a diagnosis of moderate-to-severe atopic dermatitis.
Patient has completed the required preferred topical corticosteroid and topical calcineurin inhibitor trials, with documentation of inadequate response or intolerance.
Adbry will not be used in combination with another monoclonal antibody biologic.

Prior Authorization

Continuation Authorization

Continued Adbry authorization requires evidence that the patient met initial review criteria and is benefiting from therapy without serious treatment-related toxicity.

Documentation of improved clinical response, including clinical reduction in pruritus and flares.
No serious treatment-related adverse events, such as serious infection, conjunctivitis, keratitis, or eosinophilia.

Definitions

Atopic dermatitis (AD)

DefinitionAtopic dermatitis (AD) is a chronic inflammatory skin condition.

Policy-relevant severityThis policy addresses moderate-to-severe atopic dermatitis.

Adbry relevanceA diagnosis of moderate-to-severe AD is required for Adbry prior authorization.

Initial Therapy Criteria

Adbry Initial Authorization

Initial therapy requires ALL of the following:

Adbry initial therapy

Age and diagnosis: Patient is at least 12 years of age and has a diagnosis of moderate-to-severe atopic dermatitis.Age ≥12 years
Preferred topical corticosteroid trial: Patient has had a minimum 4-week trial of at least one preferred medium- to very-high-potency topical corticosteroid and experienced inadequate response or intolerance.Minimum 4-week trial
Clinical documentation required.
Preferred topical calcineurin inhibitor trial:

Continuation Criteria

Adbry Continuation

Continuation requires ALL of the following:

Adbry continuation

Initial criteria previously met: Patient previously met the initial review criteria.
Improved clinical response: Documentation shows improved clinical response, including clinical reduction in pruritus and flares.Reduction in pruritus and flares
No serious treatment-related adverse events: Patient has not experienced serious treatment-related adverse events.
Examples include serious infection, conjunctivitis, keratitis, and eosinophilia.

Step Therapy Requirements

Step	Required prior therapy	Minimum duration	Requirement
1
Preferred medium- to very-high-potency topical corticosteroid
4 weeks
Inadequate response or intolerance; clinical documentation required

Step	Required prior therapy	Minimum duration	Requirement
2
Preferred topical calcineurin inhibitor, including Elidel or Protopic
4 weeks
Inadequate response or intolerance; clinical documentation required

Policy Summary

PayerAgency for Health Care Administration

PolicyAdbry prior authorization for moderate-to-severe atopic dermatitis

Policy CodePolicy N/A

Change TypeNo material clinical or coverage change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit documentation of inadequate response or intolerance after at least 4-week trials of a preferred topical corticosteroid and topical calcineurin inhibitor.

SourceLink

On This Page

Dosing is appropriate according to product labeling or is supported by compendia.

Dosing is appropriate according to product labeling or supported by compendia.

Step Therapy

Preferred Topical Corticosteroid Trial

Document a minimum 4-week trial of at least one preferred topical corticosteroid before initial Adbry authorization. The trial must involve a preferred agent with medium to very-high potency and must result in inadequate response or intolerance.

Minimum trial duration: 4 weeks.
Required potency: preferred medium, high, or very-high potency topical corticosteroid.
Document inadequate response or intolerance.

Unsupported block type: step_therapy},{

Documentation Required

Required Prior-Treatment Documentation

Clinical documentation is required to establish that each required topical therapy trial was unsuccessful or not tolerated.

Document the agent used, treatment duration, and response for the preferred topical corticosteroid trial.
Document the agent used, treatment duration, and response for the preferred topical calcineurin inhibitor trial.
Specify whether the patient had an inadequate response or intolerance.

Documentation Required

Continuation Documentation

For continuation, document both therapeutic benefit and treatment safety, along with dosing support.

Document improved clinical response, including reduced pruritus and flares.
Document that the patient has not experienced serious treatment-related adverse events, including serious infection, conjunctivitis, keratitis, or eosinophilia.
Confirm dosing is consistent with labeling or supported by compendia.

Denial Risk

Initial Criteria Not Met

Initial Adbry authorization should be denied when any required initial criterion is not met or cannot be clinically documented.

Patient is younger than 12 years.
No diagnosis of moderate-to-severe atopic dermatitis.
Required 4-week preferred topical corticosteroid trial is absent, inadequate, or not documented.
Required 4-week preferred topical calcineurin inhibitor trial is absent, inadequate, or not documented.
Inadequate response or intolerance to required prior treatments is not documented.
Adbry would be used with another monoclonal antibody biologic.

Denial Risk

Concurrent Biologic Therapy Prohibited

Adbry must not be combined with another monoclonal antibody biologic. Confirm that the patient is not receiving concurrent therapy with any affected biologic.

Examples include tezepelumab, omalizumab, mepolizumab, reslizumab, benralizumab, and dupilumab.

Denial Risk

Continuation Criteria Not Met

Continuation authorization should be denied when the patient does not satisfy the continuation requirements or when required response, safety, or dosing documentation is absent.

Initial review criteria were not met or cannot be confirmed.
No documented improvement in pruritus or flares.
Patient experienced a serious treatment-related adverse event, such as serious infection, conjunctivitis, keratitis, or eosinophilia.
Dosing is not consistent with labeling and is not supported by compendia.

Patient has had a minimum 4-week trial of at least one preferred topical calcineurin inhibitor, including Elidel or Protopic, and experienced inadequate response or intolerance.

Minimum 4-week trial

Clinical documentation required.

No concurrent monoclonal antibody biologic: Adbry will not be used in combination with another monoclonal antibody biologic.

Examples include tezepelumab, omalizumab, mepolizumab, reslizumab, benralizumab, and dupilumab.

Appropriate dosing: Dosing is appropriate according to product labeling or is supported by compendia.