Subject: Jublia PA with Limit 1160-C P10-2025

Drug

JUBLIA  (efinaconazole)

Policy:

Indications

FDA-approved Indications

Jublia (efinaconazole) topical solution, 10% is an azole antifungal indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.

Coverage Criteria

Onychomycosis of the Toenail(s)

Authorization may be granted when the requested drug is being prescribed for onychomycosis of the toenail(s) due to Trichophyton rubrum or Trichophyton mentagrophytes when ALL of the following criteria are met:

• The patient’s diagnosis has been confirmed with a fungal diagnostic test (e.g., potassium hydroxide [KOH] preparation, fungal culture, or nail biopsy).
• The patient meets ONE of the following:
  • The patient has experienced an inadequate treatment response to an oral antifungal therapy (e.g., terbinafine, itraconazole).
  • The patient has experienced an intolerance to an oral antifungal therapy (e.g., terbinafine, itraconazole).
  • The patient has a contraindication that would prohibit a trial of an oral antifungal therapy (e.g., terbinafine, itraconazole).
• The requested drug is NOT being used in a footbath.
• If additional quantities are required, multiple toenails are being treated.

Quantity Limits Apply

Treatment of a single toenail: 4 mL per 21 days or 12 mL per 63 days

Treatment of multiple toenails: 16 mL per 21 days or 48 mL per 63 days

The duration of 21 days is used for a 28-day fill period and 63 days is used for an 84-day fill period to allow time for refill processing.

Duration Of Approval (DOA)

• 1160-C: DOA: 12 months

Place of Service:

Outpatient

The above policy is based on the following references:

1. Jublia [package insert]. Bridgewater, NJ: Bausch Health US LLC; July 2025.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2025. https://online.lexi.com. Accessed August 26, 2025.
3. Micromedex (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 08/26/2025).
4. Frazier WT, Santiago-Delgado ZM, Stupka KC. Onychomycosis: Rapid Evidence Review. American Academy of Family Physicians. 2021;104:359-367.
5. Centers for Disease Control (CDC) and Prevention. Treatment of Ringworm and Fungal Nail infections. Available at: https://www.cdc.gov/ringworm/treatment/index.html. Accessed September 10, 2025.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

February 14, 2026