CurrentCentenePolicy CP.PMN.24

Ciclopirox (Penlac) (PDF)

Policy governing medical necessity, prior authorization criteria, and coverage for ciclopirox topical solution 8% (nail lacquer) for treatment of onychomycosis across Commercial, HIM, and Medicaid lines of business managed by Centene.

Policy Summary

PayerCentene

PolicyCiclopirox (Penlac) (PDF)

Policy CodePolicy CP.PMN.24

Change TypeAnnual review / clarifications / template updates

Effective Date09.01.07

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

1Q 2022: modified medical justification for brand Penlac, clarified continued therapy criteria, and set approval duration to allow up to 48 weeks.

1Q 2023: removed requirement to redirect brand Penlac to generic (branded product obsolete).

1Q 2024–2026: annual reviews with no significant changes; references updated.

1Approved Indications (FDA)

48 wksMax treatment duration

6.6 mLMax dose per claim

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≥12 yrsMinimum age

Coverage Summary

This policy governs medical necessity, prior authorization criteria, and coverage for ciclopirox topical solution 8% (nail lacquer) across Commercial, HIM, and Medicaid lines of business managed by Centene. Coverage stance: covered_with_criteria. The drug is FDA-approved as a topical treatment for mild to moderate onychomycosis of fingernails and toenails without lunula involvement in immunocompetent patients due to Trichophyton rubrum; coverage per this policy is contingent on meeting the listed prior authorization and medical necessity criteria (including age and prior terbinafine trial requirements where applicable).

Threshold summary

Maximum dose per claim≤ 6.6 mL (1 bottle) per claim

Total duration of therapy≤ 48 weeks (approval duration)

Age for initiation≥ 12 years

Terbinafine trial requirement (adults)Failure of oral terbinafine within past 12 months: 12-week trial for toenails or 6-week trial for fingernails unless contraindicated

Initial Therapy Criteria

Initial Approval Criteria

Ciclopirox topical solution 8% is medically necessary when the following criteria are met:

Onychomycosis (must meet all)
- Diagnosis of onychomycosis
- Age ≥ 12 years≥ 12 years
- Terbinafine trial (adults): If age ≥ 18 years, failure of a trial of oral terbinafine within the past 12 months: 12-week trial for toenails or 6-week trial for fingernails, at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced12 weeks (toenails) or 6 weeks (fingernails) within past 12 months

Continuation Therapy Criteria

Continued Therapy

Coverage for continued therapy when all criteria below are met:

Member status
- Status option A: Currently receiving medication via Centene benefit or member has previously met initial approval criteria
- Status option B: Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums CC.PHARM.03A and CC.PHARM.03B)
Response: Member is responding positively to therapy
Provider must document positive response

Unapproved Indications / Exclusions

Diagnoses/Indications Not Authorized

Coverage exclusions

Diagnoses/Indications Not Authorized: Non-FDA approved indications which are not addressed in this policy are not authorized unless sufficient documentation of efficacy and safety is provided per off-label use policies or evidence of coverage documents

Refer to off-label use policies: CP.CPA.09, HIM.PA.154, CP.PMN.53

Applicable Codes

Product availability (HCPCS/NDC not specified)mixed

Topical solution 6.6 mL, 8%

Product formulation and bottle size listed; no specific HCPCS/NDC provided in policy

Provider Actions

Prior Authorization

Prior authorization required

Requests require prior authorization and are subject to medical necessity review. For adults (age ≥ 18 years), documentation must show a prior trial of oral terbinafine within the past 12 months or a contraindication/clinically significant adverse effect that precludes terbinafine. Required terbinafine trial durations: 12 weeks for toenail onychomycosis and 6 weeks for fingernail onychomycosis.

Terbinafine trial (toenails): 12 weeks (within past 12 months)
Terbinafine trial (fingernails): 6 weeks (within past 12 months)

Documentation Required

Submit supporting documentation

Provider must submit supporting documentation such as office chart notes, lab results, or other clinical information that demonstrates the member has met all approval criteria.

Clinical Evidence & Safety

Evidence cited includes the FDA prescribing information: Ciclodan (ciclopirox topical solution) Prescribing Information, Acella Pharmaceuticals; January 2024. Safety limitations noted in the product background include that the safety and efficacy of daily use for greater than 48 weeks have not been established, and clinical trials excluded several special populations (pregnant or nursing patients, those who planned to become pregnant, patients with a history of immunosuppression, HIV seropositive patients, organ transplant recipients, insulin-dependent diabetics, and patients with diabetic neuropathy).

Background & Definitions

Ciclopirox topical solution 8% is an FDA-approved nail lacquer indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement due to Trichophyton rubrum. The product is supplied as a topical solution in a 6.6 mL bottle and is applied once daily with the provided applicator brush; daily applications are made over the previous coat and removed with alcohol every seven days.

Onychomycosis: Fungal infection of the nail (fingernails or toenails).

Revision History

09.27.21material_change

1Q 2022 annual review modified medical justification language for brand Penlac requests, clarified continued therapy criteria to ensure member has not received more than 48 weeks of treatment, and modified approval duration to allow up to 48 weeks of total treatment per prescribing information.

10.13.22policy_update

1Q 2023 annual review removed requirement for brand Penlac redirection to generic as the branded product is obsolete; references reviewed and updated.

02.24annual_review

Policy Summary

PayerCentene

PolicyCiclopirox (Penlac) (PDF)

Policy CodePolicy CP.PMN.24

Change TypeAnnual review / clarifications / template updates

Effective Date09.01.07

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that member has met all approval criteria.

SourceLink

On This Page

Dose limit: Dose does not exceed 6.6 mL (1 bottle) per claim≤ 6.6 mL per claim

Do not exceed 6.6 mL (1 bottle) per claim; approval duration 48 weeks

Initial Approval — Other diagnoses/indications

Requests for uses not covered under the primary criteria

Must meet one

Recent label change (formulary/no-coverage): If the drug has undergone a label change within the last 6 months not yet reflected in this policy, refer to relevant formulary/no-coverage or non-formulary policies for the line of business
Policies: CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16
Off-label use: If requested use is not listed under section III and criterion 1 above does not apply, refer to off-label use policy for the relevant line of business
Policies: CP.CPA.09, HIM.PA.154, CP.PMN.53

Total duration: Member has not received more than 48 weeks of treatment with ciclopirox 8% topical solution≤ 48 weeks cumulative

Dose increase limit: If request is for a dose increase, new dose does not exceed 6.6 mL (1 bottle) per claim≤ 6.6 mL per claim

Do not exceed 6.6 mL (1 bottle) per claim

Continued Therapy — Other diagnoses/indications

If initial continued therapy criteria do not apply

Must meet one

Recent label change (formulary/no-coverage): If the drug has undergone a label change within the last 6 months not yet reflected in this policy, refer to relevant formulary/no-coverage or non-formulary policies for the line of business
Policies: CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16
Off-label use: If requested use is not listed under section III and criterion 1 above does not apply, refer to off-label use policy for the relevant line of business
Policies: CP.CPA.09, HIM.PA.154, CP.PMN.53

Billing Rule

Dose per claim limit

Do not exceed 6.6 mL (one 6.6 mL bottle) per claim.

Any requested dose increase must not exceed 6.6 mL (1 bottle) per claim.

Documentation Required

Continued therapy documentation

For continued therapy, the provider must document that the member is responding positively to treatment and that cumulative exposure to ciclopirox 8% topical solution has not exceeded 48 weeks.

1Q 2024 annual review: no significant changes; removed references to Penlac as branded product is discontinued; references reviewed and updated.

02.25annual_review

1Q 2025 annual review: no significant changes; references reviewed and updated.

02.26annual_reviewLatest

1Q 2026 annual review: no significant changes; references reviewed and updated. Policy last review date 02.26; approval duration remains up to 48 weeks and maximum dose per claim 6.6 mL (1 bottle).