CurrentmhnPolicy CP.PMN.293

Berdazimer (Zelsuvmi) for molluscum contagiosum

Policy governing medical necessity and prior authorization criteria for topical berdazimer (Zelsuvmi) for treatment of molluscum contagiosum in covered populations across specified lines of business.

Policy Summary

Payermhn

PolicyBerdazimer (Zelsuvmi) for molluscum contagiosum

Policy CodePolicy CP.PMN.293

Change TypeMaterial and non-material updates

Effective DateJun 1, 2024

Next Review Date

Key ActionSubmit prior authorization documentation showing diagnosis, age ≥1 year, lesion characteristics or risk factors, lesion duration ≥6 months, symptoms, dosing limits, and requested duration ≤12 weeks.

SourceLink

POLICY UPDATE CHANGES

Incorporated requirement that the requested duration of treatment does not exceed 12 weeks into approval criteria.

Added ICHRA (health insurance marketplace/ICHRA) as a line of business.

≥1 yrminimum age for coverage

12 wksmaximum requested treatment duration allowed

1 kit/14dmaximum dosing frequency

3 moinitial authorization length

No re-auth

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Coverage Criteria

Initial Therapy (Molluscum Contagiosum)

Covered when ALL of the following are met for Molluscum Contagiosum:

Molluscum Contagiosum Initial Criteria: 1. Diagnosis of molluscum contagiosum (MC).

Age: 2. Member is aged ≥ 1 year.

Risk features (one of)

(a): Lesion is located in a sensitive area (e.g., face or anogenital areas).
(b): Member has atopic dermatitis.
(c): Member has a weakened immune system (e.g., HIV/AIDS, receiving immunosuppressive therapy, or children with underdeveloped immunocompetency).

Disease duration: 4. Lesion(s) did not resolve within six months since diagnosis.

Symptoms: 5. Member experiences lesion-related bleeding or discomfort (such as itchiness or pain).

Concomitant therapy: 6. Zelsuvmi (berdazimer) is not prescribed concurrently with any other pharmacologic treatments for molluscum contagiosum.

See dosing and Appendix D for other therapies referenced in policy.

Dose frequency limit: 7. Dose does not exceed one kit per 14 days.No more than one kit per 14 days

Requested duration: 8. Requested duration of treatment does not exceed 12 weeks.Requested duration must not exceed 12 weeks

Approval duration: 3 months (initial).

Re-authorization / Continuation

Continuation/Re-authorization:

Re-authorization is not permitted; members must meet the initial approval criteria for any future requests.

Approval duration: Not applicable.

Other Indications / Off-label routing

Requests for other diagnoses/indications:

Other Indications: 1) If the drug has recently (within the last 6 months) undergone a label change not yet reflected in this policy, refer to the appropriate formulary/no-coverage or non-formulary policy for the member's line of business (see policy references). OR 2) If the requested use (diagnosis, age, dosing) is not listed under section III and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business.

See related policies (e.g., CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16, CP.CPA.09, HIM.PA.154, CP.PMN.53) for routing and coverage determinations.

Non-FDA approved indications that are not specifically addressed by this policy are not authorized for coverage unless the provider submits sufficient documentation of efficacy and safety in accordance with applicable off-label use policies. Refer to the off-label use policies for the member's line of business: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace/ICHRA), and CP.PMN.53 (Medicaid), or other applicable evidence of coverage documents when evaluating requests for non‑label uses.

Requests for continuation or re-authorization of therapy under this policy are not permitted. Any future request for berdazimer (Zelsuvmi) must satisfy the full initial approval criteria; re-authorization or extension of an existing authorization will not be granted under this policy.

Coding and Product Information

Product availability / NDCNDC

NDC	Topical gel: 10.3% berdazimer supplied as two tubes (Tube A contains berdazimer gel; Tube B contains hydrogel) — specific NDC not provided in document

Maximum treatment duration

Maximum treatment durationRequested duration of treatment must not exceed 12 weeks

Approval duration (initial)Approval duration: 3 months (initial)

Re-authorization policyRe-authorization is not permitted; members must meet initial approval criteria for any future requests

Dose frequency limit

Dose frequency limitDose does not exceed one kit per 14 days

Concurrent pharmacologic treatmentsZelsuvmi must not be prescribed concurrently with any other pharmacologic treatments for MC

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required. Provider must obtain prior authorization before initiating Zelsuvmi for molluscum contagiosum and submit documentation to meet initial approval criteria.

Diagnosis: Molluscum contagiosum (MC).
Age: Patient is ≥ 1 year.
Lesion characteristics: One of the following—lesion in a sensitive area (facial or anogenital), coexisting atopic dermatitis, or patient has a weakened immune system (for example HIV/AIDS, immunosuppressive therapy, post-transplant).
Duration and symptoms: Lesion did not resolve within 6 months of diagnosis and member experiences bleeding or discomfort (itchiness, pain).
Concomitant therapy: Zelsuvmi is not prescribed concurrently with any other pharmacologic treatments for MC (see Appendix D for alternatives).
Dose limits: No more than one kit per 14 days; requested duration of treatment must not exceed 12 weeks.
Approval duration: Initial approval = 3 months; re-authorization is not permitted (must meet initial criteria for treatment).

Definitions

Zelsuvmi (berdazimer)

ProductZelsuvmi (berdazimer) — topical nitric oxide–releasing gel indicated for treatment of molluscum contagiosum

Supply configurationSupplied as two tubes: Tube A contains berdazimer gel and Tube B contains hydrogel; mix 0.5 mL from each tube prior to application

Dosing regimenApply mixed gel topically once daily (QD) to affected area for up to 12 weeks

Molluscum contagiosum (MC)

DefinitionMolluscum contagiosum (MC) is a self-limited viral skin infection producing small, raised papules (commonly 2–5 mm) often with central umbilication

Typical clinical courseLesions usually resolve spontaneously within 6 to 12 months but may persist for years

Background

Molluscum contagiosum is a typically self-limited viral skin infection that commonly produces small papules which often resolve spontaneously within 6 to 12 months, although lesions can persist longer. The condition can cause symptoms such as itching, soreness, or pain and may involve cosmetically or functionally sensitive areas; these clinical features inform treatment considerations and the policy's approval criteria.

Revision History

2026-03-30material_updateLatest

Incorporated existing approval duration into criteria by adding a requirement that requested treatment duration does not exceed 12 weeks and added ICHRA as a line of business.

2024-03-12creation

Policy created (initial document creation).