Subject: Xdemvy PA with Limit 6968-C P11-2025

Drug

XDEMVY  (lotilaner ophthalmic solution )

Policy:

Indications

FDA-approved Indications

Xdemvy is indicated for the treatment of Demodex blepharitis.

Coverage Criteria

Demodex Blepharitis

Authorization may be granted when the requested drug is being prescribed for the treatment of Demodex blepharitis when ALL of the following criteria are met:

• The patient displays cylindrical dandruff at the base of the lash (collarettes).
• The patient has mild eyelid margin erythema.
• The requested drug is being prescribed by, or in consultation with an optometrist or ophthalmologist.

Quantity Limits Apply

1 bottle (10 mL) / 6 weeks.

These drugs are for short-term acute use.

Duration of Approval (DOA)

• 6968-C: DOA: 6 weeks.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Xdemvy [package insert]. Irvine, CA: Tarsus Pharmaceuticals, Inc.; July 2023.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2025. https://online.lexi.com.https://www.micromedexsolutions.com/ Accessed September 05, 2025.
3. Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 09/05/2025).
4. Rhee MK, Yeu E, Barnett M, et al. Demodex Blepharitis: A Comprehensive Review of the Disease, Current Management, and Emerging Therapies. Eye Contact Lens. 2023 Aug 1;49(8):311-318.

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