MIEBO (perfluorohexyloctane)

MIEBO (perfluorohexyloctane)

Self-Administration – ophthalmic solution

Diagnosis considered for coverage:

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

Coverage Criteria:

For diagnosis of dry eye disease:

• Diagnosis of dry eye disease confirmed by ONE of the following diagnostic tests: 
  • Schirmer test 
  • Ocular surface dye staining (e.g., rose bengal, fluorescein, lissamine green) 
  • Tear function index/fluorescein clearance test 
  • Tear break up time 
  • Tear film osmolarity 
  • Slit lamp lid evaluation 
  • Lacrimal gland function; AND
• Patient is 18 years of age or older; AND
• Prescribed by or in consultation with an ophthalmologist or optometrist; AND
• Trial and failure, contraindication, or intolerance to at least one OTC ocular lubricant (e.g., artificial tears, lubricating gels/ointments); AND
• Trial and failure, contraindication, or intolerance to both of the following: 
  • Restasis (cyclosporine 0.05%) 
  • Xiidra (lifitegrast)

Reauthorization Criteria:

For diagnosis of dry eye disease:

• Documentation of positive clinical response to therapy (e.g., increased tear production or improvement in dry eye symptoms)

Coverage Duration: 

• Initial: 3 months
• Reauthorization: 12 months

Dosing:

• MIEBO is administered as one drop four times daily into the affected eye(s).
• Contact lenses should be removed prior to and for at least 30 minutes after administration of MIEBO

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: 

• The safety and effectiveness of MIEBO in pediatric patients below the age of 18 years have not been established.
• 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.
• 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.

Policy Updates:

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

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.