Dry Eye Disease (Keratoconjunctivitis) – Net Results
Restricted Product(s):
- Cequa™ (cyclosporine ophthalmic solution 0.09%)
- Eysuvis™ (loteprednol ophthalmic suspension 0.25%)
- Miebo™ (perfluorohexyloctane ophthalmic solution)
- Vevye™ (cyclosporine ophthalmic solution 0.1%)
- Xiidra™ (lifitegrast ophthalmic solution 5%)
FDA Approved Use:
- Cequa:
- Indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye).
- Eysuvis:
- Indicated for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease.
- Miebo, Vevye, & Xiidra:
- Indicated for the treatment of the signs and symptoms of dry eye disease.
Criteria for Approval of Restricted Product(s):
- ONE of the following:
- The patient is being treated for moderate to severe dry eye syndrome (i.e., keratoconjunctivitis sicca, dry eye disease); AND
- The patient has required frequent use of ocular lubricating solution or ointment (e.g., ≥ 3 times per day use of artificial tears) or other treatments such as punctal plugs or goggles for chronic dry eyes; OR
- The patient is being treated for corneal inflammatory conditions for which the patient has required extemporaneously compounded cyclosporine ophthalmic preparations; AND
- The patient is being treated for moderate to severe dry eye syndrome (i.e., keratoconjunctivitis sicca, dry eye disease); AND
- If the requested medication is Eysuvis:
- The requested medication will only be used for short-term treatment (up to two-weeks) increments; AND
- Eysuvis will not be used in combination with Restasis or ocular lubricating solutions or ointments (i.e. artificial tears); AND
- If the requested medication is Miebo, Vevye, or Xiidra:
- The patient has tried and failed, is intolerant to, or has a contraindication to Restasis (cyclosporine ophthalmic emulsion) and Tyrvaya (varenicline solution nasal spray); AND
- For products that require Value PA, refer to the Value PA UM Criteria.
Duration of Approval: 365 days (1 year)
Quantity Limitations:
Quantity limitations apply to brand and associated generic products.
Medication | Quantity per Day (unless specified) |
---|---|
Cequa (cyclosporine) 0.09% ophthalmic solution | 2 vials |
Eysuvis (loteprednol) 0.25% ophthalmic suspension | 1 bottle (8.3mL) per 28 days |
Miebo (perfluorohexyloctane) 1.338 gm/mL ophthalmic solution | 4 bottles (12mL) per 30 days |
Vevye (cyclosporine) 0.1% ophthalmic solution | 1 bottle (2mL) per 28 days |
Xiidra (lifitegrast) 5% ophthalmic solution | 2 containers |
Quantity Limit Exception Criteria:
- The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND
- The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND
- The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR
- If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).
Duration of Approval: 365 days (1 year)
These agents are NOT covered for the following: Treatment of dry eye or other symptoms that have occurred as a result of the effects of refractive surgeries, which are not BCBSNC covered services. Please refer to:http://www.bcbsnc.com/assets/services/public/pdfs/medicalpolicy/refractive_surgery.pdf
References:
All information referenced is from FDA package insert unless otherwise noted below.
Policy Implementation/Update Information:
Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q4 annually.
December 2024: Criteria change (Vevye): Updated quantity limit for Vevye to 1 bottle per 28 days.
July 2024: Criteria change: Removed Tyrvaya from the policy and added Xiidra to the policy. Removed requirement for specialist. Added requirement that Eysuvis is not used in combination with Restasis or ocular lubricating solutions or ointments.
December 2023: Criteria update: Added new to market Vevye to policy.
November 2023: Criteria update: Updated terminology from Medical Necessity PA to Value PA.
July 2023: Criteria update: Added new to market Miebo to policy.
October 2022: Criteria change: Removed criteria point regarding using Eysuvis in combination with Restasis or ocular lubricating solutions/ointments.
July 2022: Criteria change: Added quantity limits to Cequa.
November 2021: Criteria change: Added new to market Tyrvaya to the policy. Changed approval from 1095 days 365 days.
December 2020: Criteria change: Added new to market Eysuvis suspension to the policy. Created separate Net Results policy Dry Eye Disease (keratoconjunctivitis) – Net Results
December 2018: Original utilization management criteria issued.
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