CurrentGeorgia Department of Community HealthPolicy N/A

Keratolytics and Berdazimer (Zelsuvmi) Prior Authorization

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Defines prior authorization (PA) requirements for keratolytic topical products and berdazimer (Zelsuvmi) under Georgia Medicaid Fee-for-Service; applies to prescribers requesting coverage for listed products.

Policy Summary

PayerGeorgia Department of Community Health

PolicyKeratolytics and Berdazimer (Zelsuvmi) Prior Authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with a written letter of medical necessity when requesting non-preferred salicylic or urea products, and ensure Zelsuvmi requests document age, lesion duration, prior treatments, and dermatologist involvement.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearLength of authorization

>=1Minimum age for berdazimer

Preferred / Non-PreferredFormulary status examples

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CurrentGeorgia Department of Community HealthPolicy N/A

Keratolytics and Berdazimer (Zelsuvmi) Prior Authorization

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Policy Summary

PayerGeorgia Department of Community Health

PolicyKeratolytics and Berdazimer (Zelsuvmi) Prior Authorization

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.

1 yearLength of authorization

>=1Minimum age for berdazimer

Preferred / Non-PreferredFormulary status examples

Non-preferred topical keratolytics (salicylic ointment/aerosol; urea 41%)

Covered when ALL of the following are met for listed non-preferred topical formulations:

Non-preferred salicylic/urea approvals: Prescriber submits a written letter of medical necessity stating why the preferred product (salicylic acid gel 6% or urea cream 40%) is not appropriate for the member.

Applies to salicylic acid ointment 3%, salicylic acid aerosol/foam 6%, and urea cream 41%

Zelsuvmi (berdazimer) coverage criteria

Covered when ALL of the following are met:

Zelsuvmi initial coverage: Member is >= 1 year old AND has a diagnosis of molluscum contagiosum with lesions not resolved within 6 months AND has at least one of: lesion in a sensitive area (e.g., face or anogenital), significant discomfort, weakened immune system, OR severe disease (e.g., extensive involvement, bleeding, secondary infection). AND member has experienced inadequate response to cryotherapy, curettage, or cantharidin or is not a candidate for these therapies. AND medication is prescribed by or in consultation with a dermatologist.lesions >6 months

All conditions required for approval

Exceptions to the conditions of coverage described in this policy are not handled outside the standard authorization pathway. Any exception request must be submitted and reviewed via the prior authorization process.

Provider Actions and Documentation Requirements

Prior Authorization

Prior authorization required; 1-year duration

Prior authorization is required for the listed keratolytic products. The length of authorization is 1 year.

Step Therapy

Zelsuvmi prior‑treatment requirement

Before Zelsuvmi will be approved, the member must have experienced an inadequate response to cryotherapy, curettage, or cantharidin, or the member must be a documented non‑candidate for these therapies.

Documentation Required

Written LOMN required for non‑preferred salicylic products

For salicylic acid ointment 3% and salicylic acid aerosol/foam 6%, prescriber must submit a written letter of medical necessity explaining why the preferred product (salicylic acid gel 6%) is not appropriate for the member.

Applies specifically to salicylic acid ointment 3% and salicylic acid aerosol/foam 6%.

Documentation Required

Written LOMN required for non‑preferred urea cream 41%

For urea cream 41%, prescriber must submit a written letter of medical necessity explaining why the preferred product (urea cream 40%) is not appropriate for the member.

Documentation Required

Zelsuvmi: required clinical documentation

For Zelsuvmi, documentation must show the member is ≥1 year old, has molluscum contagiosum with lesions not resolved within 6 months and at least one qualifying condition (sensitive lesion location, significant discomfort, weakened immune system, or severe disease), and that the medication is prescribed by or in consultation with a dermatologist.

Lesions must have not resolved within 6 months.
At least one qualifying condition: sensitive area (e.g., face or anogenital), significant discomfort, weakened immune system, or severe disease (extensive involvement, bleeding, secondary infection).
Prescriber must be a dermatologist or document consultation with a dermatologist.

Denial Risk

Denial risk: missing LOMN for non‑preferred salicylic products

Failure to submit the required written letter of medical necessity for non‑preferred salicylic products (salicylic acid ointment 3% or aerosol/foam 6%) may lead to non‑approval of the request.

Denial Risk

Denial risk: missing LOMN for urea cream 41%

Failure to submit the required written letter of medical necessity explaining why urea cream 40% is not appropriate may lead to non‑approval of urea cream 41%.

Denial Risk

Denial risk: Zelsuvmi coverage prerequisites

Coverage for Zelsuvmi may be denied if the member does not meet age, duration-of-lesions, clinical criteria, prior‑treatment requirements, or if the medication is not prescribed by or in consultation with a dermatologist.

Member must be ≥1 year of age.
Lesions must have persisted >6 months.
Must meet at least one qualifying clinical condition.
Must meet prior‑treatment or non‑candidate requirement.
Medication must be prescribed by or in consultation with a dermatologist.

Background

Keratolytics such as salicylic acid and urea are topical agents commonly used to treat hyperkeratotic skin conditions; specific formulations are designated as preferred or non‑preferred for authorization purposes.

Berdazimer (Zelsuvmi) is a topical antiviral indicated for molluscum contagiosum. Coverage under this policy is limited to patients who meet the documented clinical criteria, including being at least 1 year of age, having molluscum lesions not resolved within 6 months, and one or more qualifying clinical features (for example, lesions in sensitive locations, significant discomfort, immunosuppression, or severe/extensive disease).

For non‑preferred formulations of salicylic acid (e.g., ointment 3% or aerosol/foam 6%) and urea cream 41%, approval requires a written letter of medical necessity explaining why the preferred alternative (salicylic acid gel 6% or urea cream 40%) is not appropriate for the member. For Zelsuvmi, prior treatment with or ineligibility for cryotherapy, curettage, or cantharidin must be documented, and the medication must be prescribed by or in consultation with a dermatologist.

Zelsuvmi (berdazimer)	Listed medication name as non-formulary example
Salicylic acid gel 6%	Preferred product example
Salicylic acid ointment 3%	Non-preferred product example
Salicylic acid aerosol/foam 6%	Non-preferred product example
Urea cream 40%	Preferred product example
Urea cream 41%	Non-preferred product example

Keratolytics and Berdazimer (Zelsuvmi) Prior Authorization

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Keratolytics and Berdazimer (Zelsuvmi) Prior Authorization

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Coverage Criteria

Referenced Products and Coding

Provider Actions and Documentation Requirements

Background

Definitions

Initial Therapy Criteria

Step Therapy / Prior Treatment Requirements

Quantity Limits

Site of Care