Ciclopirox (Penlac) Form

Ciclopirox is a synthetic antifungal agent. FDA Approved Indication(s) Ciclopirox topical solution 8% is a 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. Limitation(s) of use:
• No studies have been conducted to determine whether ciclopirox might reduce the effectiveness of systemic antifungal agents for onychomycosis. Therefore, the concomitant use of 8% ciclopirox topical solution and systemic antifungal agents for onychomycosis is not recommended.
• Ciclopirox topical solution 8% should be used only under medical supervision.
• The effectiveness and safety of Ciclopirox topical solution 8% in the following populations has not been studied. The clinical trials with use of Ciclopirox topical solution 8% excluded patients who: were pregnant or nursing, planned to become pregnant, had a history of immunosuppression (e.g., extensive, persistent, or unusual distribution of dermatomycoses, extensive seborrheic dermatitis, recent or recurring herpes zoster, or persistent herpes simplex), were HIV seropositive, received organ transplant, required medication to control epilepsy, were insulin dependent diabetics, or had diabetic neuropathy. Patients with severe plantar (moccasin) tinea pedis were also excluded.
• The safety and efficacy of using Ciclopirox topical solution 8% daily for greater than 48 weeks have not been established. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information ) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Ciclopirox topical solution 8% is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Onychomycosis (must meet all):

1. Diagnosis of onychomycosis;

2. Age ≥ 12 years; Page 1 of 6

   CLINICAL POLICY Ciclopirox Topical Solution 8%

   3. If age ≥ 18 years, failure of a 12-week trial of oral terbinafine (for toenails) or a 6- week trial of oral terbinafine (for fingernails), at up to maximally indicated doses within the past 12 months, unless contraindicated or clinically significant adverse effects are experienced;
   4. Dose does not exceed 6.6 mL (1 bottle) per claim. Approval duration: 48 weeks
      B. Other diagnoses/indications (must meet 1 or 2):
   5. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
   6. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
      II. Continued Therapy A. Onychomycosis (must meet all):
   7. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
3. Member is responding positively to therapy;

4. Member has not received more than 48 weeks of treatment with ciclopirox 8% topical solution;

   4. If request is for a dose increase, new dose does not exceed 6.6 mL (1 bottle) per claim. Approval duration: up to 48 weeks of total treatment B. Other diagnoses/indications (must meet 1 or 2):
   5. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: Page 2 of 6

   CLINICAL POLICY Ciclopirox Topical Solution 8% CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

   2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
      III. Diagnoses/Indications for which coverage is NOT authorized:
      A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents.
      IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives
      This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent and may require prior authorization.
      Drug Name Dosing Regimen Dose Limit/ Maximum Dose 250 mg/day terbinafine (Lamisil®) Fingernail onychomycosis: 250 mg PO QD for 6 weeks Toenail onychomycosis: 250 mg PO QD for 12 weeks Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Appendix C: Contraindications/Boxed Warnings • Contraindication(s): hypersensitivity to any of its components • Boxed warning(s): none reported V. Dosage and Administration
      Indication Onychomycosis Apply once daily (preferably at bedtime or eight Dosing Regimen hours before washing) to all affected nails with the applicator brush provided.
      Daily applications should be made over the previous coat and removed with alcohol every seven days. Maximum Dose See dosing regimen Page 3 of 6

   CLINICAL POLICY Ciclopirox Topical Solution 8% Indication Dosing Regimen This cycle should be repeated throughout the duration of therapy. The safety and efficacy of using ciclopirox daily for > 48 weeks have not been established. Maximum Dose VI. Product Availability
   Topical solution (6.6 mL bottle): 8%
   VII.