Oscar Miebo (perfluorohexyloctane) (PG166) Form

Dry Eye Disease (DED)

Dry Eye Disease (DED), commonly referred to as dry eye syndrome, is a common ocular condition that occurs when the tears are not able to provide adequate lubrication for the eyes. This deficiency manifests through symptoms such as blurred vision, discomfort, and if neglected, more severe visual complications. The underlying causes of DED span a multitude of factors, but predominantly arise from reduced tear production or increased tear evaporation. This can be due to a wide range of causes, such as age, environmental conditions, certain medications, or underlying health conditions like Sjogren's disease.

Diagnosis of Dry Eye Disease

Diagnosis of dry eye disease typically involves assessing different aspects of the tear film to provide insights into its stability. One common method is the tear break-up time test, which measures the time it takes for dry spots to appear on the eye after a blink. Other methods may also be used depending on the specific circumstances and symptoms of the patient.

Treatment Options

1. For many patients, symptoms may be improved or relieved by simply making lifestyle changes, such as reducing screen time or using humidifiers to increase moisture in the environment.
2. Over-the-counter eye drops, gels, and ointments that aim to replace or supplement the natural tear film can provide temporary relief for mild to moderate symptoms.
3. Prescription medications may also be used, particularly for more severe cases or when the condition is due to an underlying health issue.
4. In some cases, procedures may be used to help manage dry eye disease. For example, special contact lenses designed to help retain moisture on the eye surface can be used, or surgical procedures may be performed to block the tear ducts and thus reduce tear loss.

Miebo (perfluorohexyloctane)

Miebo (perfluorohexyloctane) is a topical ophthalmic solution used to treat signs and symptoms of dry eye disease. It contains semifluorinated alkanes that help stabilize the tear film and reduce evaporation from the ocular surface. The recommended dosage is one drop instilled in each affected eye four times daily. Miebo works by spreading across the tear film lipid layer to prevent excessive water loss through evaporation. By reducing evaporation, it helps relieve dry eye symptoms like burning, stinging, blurry vision, and discomfort.

Definitions

• Dry Eye Disease (DED)/Dry Eye Syndrome is an ocular condition wherein tears fail to adequately lubricate the eyes, leading to symptoms like blurred vision and discomfort.
• Schirmer's Test is a standardized test to measure tear production.
• Tear Break-Up Time Test is a diagnostic method that measures the time interval before dry patches form on the eye after a blink, providing insights into tear film stability.
• Tear Evaporation is the natural process of tears evaporating from the eye surface. An increased rate can result in DED.
• Tear Film is a thin layer of tears that covers the eye, ensuring lubrication, reducing the risk of infections, and keeping the eye smooth for clear vision.
• Tear Production is the process of producing fluids to keep the eyes moist, which can be diminished in some individuals leading to DED.

Medical Necessity Criteria for Initial Authorization

The Plan considers Miebo (perfluorohexyloctane) medically necessary when ALL of the following criteria are met:

1. The medication is being prescribed by or in consultation with an eye care specialist (ophthalmologist or optometrist); AND
2. The member is 18 years of age or older; AND
3. The member has a diagnosis of chronic dry eye disease; AND
4. The member is unable to use, or has adequately tried and failed TWO different over-the-counter (OTC) eye lubricants/artificial tears (eye drops, gel, or ointment) used daily for at least 30 days each; AND

The prescribing provider has submitted required clinical documentation (e.g., chart notes, names of the OTC products and/or medications that the member has tried and failed, previous treatment outcomes, etc.) for review. If the above prior authorization criteria are met, Miebo (perfluorohexyloctane) will be approved for 12 months.

Medical Necessity Criteria for Reauthorization

Reauthorization for 12 months will be granted if BOTH of the following are met:

1. the member continues to meet the applicable initial criteria; AND
2. chart documentation indicates EITHER of the following:
   • The member has shown a clinical improvement in symptoms since starting the requested medication; or
   • The member has experienced disease stability since starting the requested medication.

Note: Clinical improvement may be characterized by reduction in signs and symptoms such as ocular discomfort, burning, or dryness, and/or an increase in tear production as measured by standardized tests such as Schirmer's test or tear break-up time. Disease stability refers to a halt in disease progression, with signs and symptoms remaining consistent and not worsening over time. These should be supported by the medical documentation.

Experimental or Investigational / Not Medically Necessary

Miebo (perfluorohexyloctane) for any other indication or use is considered not medically necessary by the Plan, as it is deemed to be experimental, investigational, or unproven. Additionally, the safety and efficacy of Miebo (perfluorohexyloctane) has not been established in patients below the age of 18 years.

References

1. Aggarwal S, Galor A. What's new in dry eye disease diagnosis? Current advances and challenges. F1000Res. 2018;7. Epub December 18, 2018. Available at: https://doi.org/10.12688/f1000research.16468.1.
2. American Academy of Ophthalmology: Dry Eye Syndrome PPP - 2018. American Academy of Ophthalmology. Published November 2018. Available at: https://www.aao.org/preferred-practice-pattern/dry-eye-syndrome-ppp-2018.
3. Dogru M, Tsubota K. Pharmacotherapy of dry eye. Expert Opin Pharmacother. 2011;12(3):325-334.
4. Foulks GN, Forstot SL, Donshik PC, et al. Clinical guidelines for management of dry eye associated with sjogren disease. Ocul Surf. 2015;13(2):118-132.
5. Miebo (perfluorohexyloctane) [prescribing information]. Bridgewater, NJ: Bausch & Lomb Americas Inc; May 2023.
6. Pucker AD, Ng SM, Nichols JJ. Over the counter (OTC) artificial tear drops for dry eye syndrome. Cochrane Database of Systematic Reviews 2016, Issue 2. Art. No. : CD009729. DOI: 10.1002/14651858.CD009729.pub2.
7. Goldstein MH et al: Dry eye disease. Ophthalmology. 5th ed. Elsevier; 2019:276-81.e2
8. Milner MS et al: Dysfunctional tear syndrome: dry eye disease and associated tear film disorders - new strategies for diagnosis and treatment. Curr Opin Ophthalmol. 27 Suppl 1:3-47, 2017

Clinical Guideline Revision / History Information

Original Date: 9/21/2023
Reviewed/Revised: