XDEMVY (lotilaner)

XDEMVY (lotilaner)

Self-Administration – ophthalmic solution

Diagnosis considered for coverage:

•  Demodex Blepharitis: Indicated for the treatment of Demodex blepharitis

Coverage Criteria:

For diagnosis of Demodex blepharitis:

• Diagnosis of Demodex blepharitis; AND
• Patient is 18 years of age or older; AND
• Prescribed by or in consultation with an ophthalmologist or optometrist; AND 
• Patient exhibits one of the following signs of Demodex infestation:
  • Collarettes 
  • Eyelid margin erythema 
  • Eyelash anomalies (e.g., eyelash misdirection); AND 
• Patient is experiencing symptoms or architectural changes associated with Demodex infestation (e.g., burning, tearing, itching, foreign body sensation, eyelashes missing, eyelashes growing inward); AND
• Trial and inadequate response to tea tree-oil

Coverage Duration: 

• 2 months 

Dosing:

• Instill one drop of XDEMVY in each eye twice daily (approximately 12 hours apart) for 6 weeks.
• If a dose is missed, continue treatment with the next scheduled dose.
• If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart.

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• Xdemvy is an anti-parasitic and is the first FDA-approved agent for the treatment of Demodex blepharitis.
• Xdemvy kills the "adult" mite. However, the product does not kill the eggs. The life cycle of the mite is about 27 days. The eggs will hatch. If stop prior to this, those 2nd generation mites won’t be killed. Need 2 or 3 generations to eradicate mites and eggs that will hatch. Multiple courses of treatment may be necessary. The physician would re-evaluate patient after 3 months not 6 weeks. Goal of treatment is to get to a threshold below where the patient is not experiencing symptoms. Mites live on clothes, pillowcases, sheets so re-infection possible. For this reason, difficult to eradicate to where there are "zero" mites.
• Collarettes are often referred to in the literature as cylindrical dandruff (CD), sleeves, cuffs, crusting, or lash debris. Collarettes, a pathognomonic sign of Demodex blepharitis, are solidified exudative excretions that form a cylindrical collar around the base of the eyelash follicle.
• If Demodex is not overpopulated and not causing problems, can leave it alone; if burning, tearing, itching, foreign body sensation, etc. or architectural changes in lid, eyelashes missing, eyelashes grow inward (scratching cornea, scarring), consider treating the Demodex blepharitis.
• Tea Tree Oil has been the standard treatment. It suppresses the mite and tricks the mite into coming out of its buried status in the skin. Mites are nocturnal, so they are embedded during the day and come out at night. Tea tree oil is available in shampoos, soaps, and specific ocular products (e.g., Cliradex 10% wipes or foam) and are available OTC. Cliradex 50% is available and is used as an in-office procedure since higher concentrations can be very irritating to the eyes and skin.
• In general, topical formulations containing tea tree oil were reported to be effective in reducing the number of Demodex mites on eyelashes. Other emerging treatment options include anti-parasitic drugs and IPL, but there is currently limited high-quality evidence to ascertain the efficacy of these treatments for ocular Demodex with any certainty.
• More data are needed to evaluate the effect of Xdemvy on relieving symptoms of Demodex blepharitis as well as recurrence rates and the safety and efficacy of repeat treatment courses.

Policy Updates:

• 03/01/2024 – New policy for Xdemvy approved by WHA P&T Committee. (P&T, 02/20/2024)

References:

1.    Xdemvy Prescribing Information. Tarsus Pharmaceuticals, Inc. Irvine, CA. July 2023. 
2.    Rhee, M., Yeu, E., Barnett., M., et al. Demodex Blepharitis: A Comprehensive Review of the Disease, Current Management, and Emerging Therapies. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10351901/. Accessed October 26, 2023. 
3.    Clinical Consult with Ophthalmologist. September 13, 2023. 
4.    Zhang, A., Muntz, A., Wang, M., et al. Ocular Demodex: A systematic review of the clinical literature. Avaialbe at: file:///C:/Users/kdekhtaw/Downloads/Zhang%20et%20al%202020_SR%20(1).pdf. Accessed October 26, 2023. 
5.    ClinicalTrials.gov. Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis (Saturn-1). Available at: https://www.clinicaltrials.gov/study/NCT04784091?cond=demodex%20blepharitis&rank=4. Accessed October 26, 2023. 
6.    ClinicalTrials.gov. Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis (Saturn-2). Available at: https://www.clinicaltrials.gov/study/NCT04784091?cond=demodex%20blepharitis&rank=4. Accessed October 26, 2023.