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Miebo (perfluorohexyloctane) Prior Authorization with Quantity Limit Program Summary
Policy Number: PH-1210
This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
1/1/2024 |
1/1/2024 |
FDA APPROVED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
MIEBO™ |
Treatment of the signs and symptoms of dry eye disease |
|
1 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
Dry Eye Disease |
Dry eye disease (also known as dry eye syndrome) is a multifactorial disease of the ocular surface with loss of homeostasis of the tear film. It is accompanied by ocular symptoms where tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles.(4) The tear film secreting glands and ocular surface function as an integrated system. Disease or dysfunction of this system results in unstable and poorly maintained tear film that causes symptoms of ocular irritation and possible damage to the ocular surface. Dry eye disease may be exacerbated by systemic medications (e.g., diuretics, antihistamines, anticholinergics, systemic retinoids, antidepressants) and rosacea.(2) Dry eye disease is often associated with Sjogren syndrome, an autoimmune multisystem disorder that most often affects the tear and salivary glands. Tear deficiency may occur in other systemic diseases, such as lymphoma, sarcoidosis, hemochromatosis, and amyloidosis. Dry eye disease may also develop due to systemic viral infections, such as retroviruses, Epstein-Barr virus, and HIV.(2) The American Academy of Ophthalmology and the Tear Film and Ocular Surface Society (TFOS) categorized dry eye into three severity levels based on both symptoms and signs. Because of the nature of the disease, this classification is imprecise because characteristics overlap at each level of severity.(2,4,5)
The American Academy of Ophthalmology recommend treating mild dry eye with the following:(2,6)
For treatment of moderate dry eye, the following are recommended in addition to mild dry eye treatment options:(2,6)
For treatment of severe dry eye, the following are recommended in addition to mild and moderate dry eye treatment options:(2,6)
Because of the inconsistent correlation between reported symptoms and clinical signs as well as the relatively poor specificity and/or sensitivity of clinical tests, patients with suggestive symptoms without signs should be placed on trial treatments with artificial tears when other potential causes of ocular irritation have been eliminated. As the severity of the dry eyes increases, aqueous enhancement of the eye using topical agents is appropriate. Emulsions, gels, and ointments can be used. The use of artificial tears may be increased, but the practicality of frequent tear instillation depends on the lifestyle or manual dexterity of the patient. Non-preserved tear substitutes are generally preferable; however, tears with preservatives may be sufficient for patients with mild dry eye and an otherwise healthy ocular surface. When tear substitutes are used frequently and chronically (e.g., more than 4 times a day), non-preserved tears are generally recommended. It is imperative to treat any causative factors that are amenable to treatment.(2) Anti-inflammatory therapies may be considered in addition to aqueous enhancement therapies. However, since dry eye symptoms tend to wax and wane over long periods of time, the lack of long-term data on the effectiveness of cyclosporine and the costs of longer-term (e.g., annual, lifetime) treatment should be weighed.(2) Pre-treatment with topical ophthalmic corticosteroids either before or during initiation with a non-glucocorticoid anti-inflammatory agent may provide more rapid improvement in symptoms of dry eye disease and decrease the incidence of severe stinging associated with a topical immunomodulator agent compared to a topical immunomodulator alone.(6) The AAO also notes that topical corticosteroid use for dry eye disease is controversial, but note that they can be used for induction therapy prior to initiating non-glucocorticoid anti-inflammatory agents for maintenance therapy. Once the patient is in a successful maintenance phase, steroids are used for acute flare-ups triggered by travel, allergies, respiratory infections, or exposures to environmental irritants with maintenance therapy.(7) The Sjogren’s Syndrome Foundation’s Clinical Practice Guidelines on Ocular Management in Sjögren’s Patients states the following:(3)
|
Safety |
Perfluorohexyloctane ophthalmic solution has no FDA labeled contraindications for use.(1) |
REFERENCES
Number |
Reference |
1 |
Miebo prescribing information. Bausch & Lomb Inc. May 2023. |
2 |
Dry eye syndrome Preferred Practice Pattern. American Academy of Ophthalmology. October 2018. https://doi.org/10.1016/j.ophtha.2018.10.023 |
3 |
Ocular Management in Sjögren’s Patients. Sjögren’s Syndrome Foundation’s Clinical Practice Guidelines. https://sjogrens.org/sites/default/files/inline-files/SF_CPG-Ocular_2022_0.pdf |
4 |
Craig, J. P., Nichols, K. K., Akpek, E. K., Caffery, B., Dua, H. S., Joo, C.-K., Liu, Z., Nelson, J. D., Nichols, J. J., Tsubota, K., & Stapleton, F. (2017). TFOS DEWS II definition and classification report. The Ocular Surface, 15(3), 276–283. https://doi.org/10.1016/j.jtos.2017.05.008 |
5 |
Wolffsohn, J. S., Arita, R., Chalmers, R., Djalilian, A., Dogru, M., Dumbleton, K., Gupta, P. K., Karpecki, P., Lazreg, S., Pult, H., Sullivan, B. D., Tomlinson, A., Tong, L., Villani, E., Yoon, K. C., Jones, L., & Craig, J. P. (2017). TFOS DEWS II Diagnostic Methodology Report. The Ocular Surface, 15(3), 539–574. https://doi.org/10.1016/j.jtos.2017.05.001 |
6 |
Jones, L., Downie, L. E., Korb, D., Benitez-del-Castillo, J. M., Dana, R., Deng, S. X., Dong, P. N., Geerling, G., Hida, R. Y., Liu, Y., Seo, K. Y., Tauber, J., Wakamatsu, T. H., Xu, J., Wolffsohn, J. S., & Craig, J. P. (2017). TFOS DEWS II management and therapy report. The Ocular Surface, 15(3), 575–628. https://doi.org/10.1016/j.jtos.2017.05.006 |
7 |
Savvy steroid use. American Academy of Ophthalmology. (2016, May 5). https://www.aao.org/eyenet/article/savvy-steroid-use |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Targeted MSC |
Available MSC |
Final Age Limit |
Preferred Status |
|
||||||
Miebo |
perfluorohexyloctane ophth soln |
1.338 GM/ML |
M ; N ; O ; Y |
N |
|
|
POLICY AGENT SUMMARY QUANTITY LIMIT
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
QL Amount |
Dose Form |
Day Supply |
Duration |
Addtl QL Info |
Allowed Exceptions |
Targeted NDCs When Exclusions Exist |
|
|||||||||
Miebo |
perfluorohexyloctane ophth soln |
1.338 GM/ML |
4 |
Bottles |
30 |
DAYS |
|
|
|
CLIENT SUMMARY – PRIOR AUTHORIZATION
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Miebo |
perfluorohexyloctane ophth soln |
1.338 GM/ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
CLIENT SUMMARY – QUANTITY LIMITS
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Miebo |
perfluorohexyloctane ophth soln |
1.338 GM/ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
PA |
Initial Evaluation Target Agent(s) will be approved when ALL of the following are met:
Length of Approval: 2 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. *Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required.
Renewal Evaluation Target Agent(s) will be approved when ALL of the following are met:
Length of Approval: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. |
QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
QL with PA |
Quantity limit for the Target Agent(s) will be approved when ONE of the following is met:
Length of Approval: Initial - 2 months, Renewal - 12 months |
This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment. The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients. Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment
BCBSAL _ Commercial _ CSReg _ Miebo (perfluorohexyloctane) _PAQL _ProgSum_ 1/1/2024