Pharmacy Prior Authorization Criteria

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

P & T Revisions

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

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.
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.

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Revision History

• 2024-09-05: 2024 Annual Review - no changes
• 2024-03-23: update guideline
• 2023-11-21: New UM PA Criteria

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