Pharmacy Prior Authorization Criteria

Miebo (perfluorohexyloctane ophthalmic solution)

Indications for Prior Authorization

Miebo (perfluorohexyloctane ophthalmic solution)

• For diagnosis of Dry Eye Disease
  Indicated for the treatment of the signs and symptoms of dry eye disease.

Criteria

Miebo

For initial authorization request, approve through 12/31/2039 For reauthorization request, bypass criteria review and approve through 12/31/2039

Prior Authorization

Length of Approval: When approved; no reauthorization required

• Diagnosis of dry eye disease

P & T Revisions

2025-05-29, 2024-07-12, 2023-11-17, 2023-07-12, 2022-06-01, 2021-11-17

References

1. Miebo Prescribing Information. Bausch & Lomb Americas Inc. Bridgewater, NJ. May 2023.
2. American Academy of Ophthalmology. Dry Eye Syndrome Preferred Practice Pattern. October 2018. Available at file:///C:/Users/kdekhtaw/OneDrive%20-%20UHG/Homedir/2020%20CLIENT%20LISTS/UTILIZATION%20MANAGEMENT/M/MIEBO/Dry%20Eye%20Syndrome%20Preferred%20Practice%20Pattern%202018.pdf. Accessed July 11, 2023.
3. Wood, S., Mian, S. Diagnostic Tools for Dry Eye Disease. Available at https://www.touchophthalmology.com/wp-content/uploads/sites/16/2017/01/Diagnostic-Tools-for-Dry-Eye-Disease_1.pdf. Accessed Nov 9. 2021.
4. Zeev, M., Miller, D, et al. Diagnosis of dry eye disease and emerging technologies. Clin Ophthalmol 2014;8:581-590. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3964175/#b16-opth-8-581. Accessed November 9, 2021.
5. Tauber, J., Berdy, G., et al. NOV03 for Dry Eye Disease Associated with Meibomian Gland Dysfunction: Results of the Randomized Phase 3 GOBI Study. American Academy of Ophthalmology. Dec 2022: 516-524. Available at:https://www.aaojournal.org/article/S0161-6420(22)01016-8/pdf#:~:text=NOV03%2C%20a%20novel%2C%20nonaqueous%2C%20single-entity%2C%20preservative-%20free%2C%20ophthalmic,glands%20through%2024%20hours%2C%20with%20minimal%20systemic%20exposure.26. Accessed July 11, 2023.
6. Sheppard,J., Kurata, F., et al. NOV03 for Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction: The Randomized Phase 3 MOJAVE Study. American Journal of Ophthalmology. Mar 2023: 265-274. Available at: https://www.ajo.com/action/showPdf?pii=S0002-9394%2823%2900098-3. Accessed July 11, 2023.

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End Notes

1. Traditional diagnostic tests include the Schirmer test, ocular surface dye staining, tear function index/fluorescein clearance test, tear break up time, tear film osmolarity, slit lamp evaluation of lid [2-4]
2. As disease severity increases, aqueous enhancement of the eye using topical agents is appropriate (e.g., emulsions, gels, ointments). Anti-inflammatory therapies (e.g., topical cyclosporine, corticosteroids), systemic omega-3 fatty acid supplements, punctal plugs, and eyeglass side shields/moisture chambers may also be considered in addition to aqueous enhancement therapies in patients who need additional symptom management [2-4]

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Revision History

• 2025-05-29: Removing reauthorization requirement as part of extended reauthorization program.
• 2024-07-12: 2024 Annual Review
• 2023-11-17: update guideline
• 2023-07-12: New PA UM Criteria for Miebo
• 2022-06-01: Removed requirement for paid claims/submission of medical records.
• 2021-11-17: 2022 New PA UM Criteria

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