WHA

Xdemvy (lotilaner) PA, NF

Indications for Prior Authorization

Xdemvy (lotilaner ophthalmic solution)
  • For diagnosis of Demodex Blepharitis
    Indicated for the treatment of Demodex blepharitis.

Criteria

Xdemvy

Prior Authorization

Length of Approval: 2 months [A, 3]

  • Diagnosis of Demodex blepharitis
    • AND
  • Patient exhibits one of the following signs of Demodex infestation [2]
    • Collarettes [B, 2]
    • 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) [C, 3]
    • AND
  • Trial and inadequate response to tea tree-oil [D-E, 3-4]
    • AND
  • Prescribed by or in consultation with one of the following:
    • Ophthalmologist
    • Optometrist
Xdemvy

Non Formulary

Length of Approval: 2 months [A, 3]

  • Diagnosis of Demodex blepharitis
    • AND
  • Submission of medical records (e.g., chart notes) confirming that patient exhibits one of the following signs of Demodex infestation confirmed by slit lamp examination [F-H, 2, 7-9]
    • Collarettes [B, 2]
    • Eyelid margin erythema
    • Eyelash anomalies (e.g., eyelash misdirection)
    AND
  • Submission of medical records (e.g., chart notes) confirming that patient is experiencing symptoms or architectural changes associated with Demodex infestation (e.g., burning, tearing, itching, foreign body sensation, eyelashes missing, eyelashes growing inward) [C, 3]
    • AND
  • Submission of medical records (e.g., chart notes) confirming trial and inadequate response (minimum 6 weeks) to tea tree-oil [D-E, I, 3-4, 10-11]
    • AND
  • Symptoms persist despite practicing good eye-lid hygiene (e.g.,treatment with warm compress, eyelid cleansing, artificial tears, non-prescription tree-tea oil)
    • AND
  • Prescribed by or in consultation with one of the following:
    • Ophthalmologist
    • Optometrist

  • Guideline ID
    GL-154190

  • Formulary
    premium

  • Effective date
    Nov 1, 2024

  • P&T approval date
    Nov 16, 2023

P & T Revisions

2024-09-05, 2024-03-23, 2023-11-21

  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.
  7. Odell, L., and Garlich, J. A Primer on Demadex Blepharitis. Available at: https://modernod.com/articles/2020-nov-dec/a-primer-on-idemodexi-blepharitis?c4src=article:infinite-scroll. Accessed February 23, 2024.
  8. Matossian, C. Eye Care Products in the Pipeline for Demadex Blepharitis. Available at: https://www.ajmc.com/view/eye-care-products-pipeline-demodex-blepharitis-interview-cynthia-matossian. Accessed February 23, 2024.
  9. Ayres, B., Donnenfeld, E., Farid, M.. et al. Clinical diagnosis and management of Demodex blepharitis: the Demodex Expert Panel on Treatment and Eyelid Health (DEPTH). Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10564779/. Accessed February 23, 2024.
  10. Savla, K., Le, J., Pucker, A., et al. Tea Tree Oil for Demadex blepharitis. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7388771/. Accessed February 23, 2024.
  11. Cheng AM, Sheha H, Tseng SC. Recent advances on ocular Demodex infestation. Current Opinion in Ophthalmology 2015;26(4):295-300.
  1. 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.[3]
  2. Collarettes are often referred to in the literature as cylindrical dandruff (CD), sleeves, cuffs, crusting, or lash debris [2]
  3. If Demodex is not overpopulated and not causing problem 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 [3]
  4. 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 [3]
  5. 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. [4]
  6. Because patients with Demodex blepharitis can often be asymptomatic, it is important to begin every clinical evaluation at the slit lamp with the patient’s eyes closed for a better view of the superior lid and lash margin, looking for the presence of collarettes. [7]
  7. Slit-lamp examination is all an eye care provider needs to do to make the diagnosis [8]
  8. Several conditions such as rosacea, MGD, and DED often occur with DB [52–55]. Since clinically these conditions are often very similar, the panel concurred that DB is frequently underdiagnosed or misdiagnosed. The consensus, therefore, was that all patients presenting for an eye exam should be evaluated for collarettes, especially those with lid abnormalities or those not responding to treatment for DED or MGD. DEPTH panellists shared that slit lamp examination with the patient looking down is simple and easy to incorporate into routine exams. [9]
  9. It has been recommended to use tea tree oil treatments for at least two Demodex mite life cycles (i.e. approximately six weeks) in order to ensure adequate killing of the parasite [10]
  • 2024-09-05: 2024 Annual Review - no changes
  • 2024-03-23: update guideline
  • 2023-11-21: New UM PA Criteria