Dry Eye Disease (Keratoconjunctivitis) – Enhanced & Essential

• Cequa™ (cyclosporine ophthalmic solution 0.09%) 
• Cyclosporine ophthalmic emulsion 0.05% (generic Restasis®)
• Eysuvis™ (loteprednol ophthalmic suspension 0.25%)
• Miebo™ (perfluorohexyloctane ophthalmic solution) 
• Restasis® (cyclosporine ophthalmic emulsion 0.05%) 
• Tyrvaya™ (varenicline solution) nasal spray 
• Vevye™ (cyclosporine ophthalmic solution 0.1%) 
• Xiidra™ (lifitegrast ophthalmic solution 5%)

• 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. 
• Restasis: 
  • Indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. 
• Miebo, Tyrvaya, Vevye & Xiidra: 
  • Indicated for the treatment of the signs and symptoms of dry eye disease

1. ONE of the following:
   1. The patient has a diagnosis of dry eye disease (i.e., dry eye syndrome, keratoconjunctivitis sicca [e.g., Sjőgren’s Syndrome]); AND
      1. The patient has previously tried or is currently using aqueous enhancements (e.g., artificial tears, gels, ointments); OR
      2. The patient has an intolerance or hypersensitivity to aqueous enhancements; OR
      3. The patient has an FDA labeled contraindication to ALL aqueous enhancements (e.g., artificial tears, gels, ointments); OR
   2. The patient is being treated for corneal inflammatory conditions for which the patient has required extemporaneously compounded cyclosporine ophthalmic preparations; AND 
2. If the requested medication is generic cyclosporine emulsion 0.05%:
   1. The patient had a documented life-threatening side effect that required medical intervention to Brand Restasis that is not anticipated with the generic; AND
      1. The prescriber completed and submitted an FDA MedWatch Adverse Event Reporting Form (The prescriber must provide a copy of the completed MedWatch form. Authorization will not be considered unless the form is completed and submitted to the FDA); AND
3. If the requested medication is Eysuvis:
   1. The requested medication will only be used for short-term treatment (up to two-weeks) increments; AND
   2. Eysuvis will not be used in combination with Restasis or ocular lubricating solutions or ointments (i.e. artificial tears); AND
4. If the requested medication is Miebo or Vevye: 
   1. The patient has tried and failed, is intolerant to, or has a contraindication to Restasis (cyclosporine ophthalmic emulsion), Tyrvaya (varenicline nasal spray solution), and Xiidra (lifitegrast ophthalmic solution); AND 
5. If the requested medication is Tyrvaya:
   1. The patient has tried and failed, is intolerant to, or has a contraindication to Restasis (cyclosporine ophthalmic emulsion); AND
6. If the requested medication is Brand Restasis or cyclosporine emulsion 0.05% (generic Restasis): 
   1. The patient will utilize the single use vials only; AND
7. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 365 days (1 year)

Quantity limitations apply to brand and associated generic products.

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND
3. 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
4. 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

All information referenced is from FDA package insert unless otherwise noted below. 

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 and Restasis multidose vial): Updated quantity limits for Vevye and Restasis multidose vial to 1 bottle per 28 days. 

July 2024: Criteria change: Added additional step requirement for Miebo and Vevye. Decreased step requirement for Tyrvaya from two-step to one-step.

December 2023: Criteria update: Added new to market Vevye to policy.

July 2023: Criteria update: Added new to market Miebo to policy.

July 2022: Criteria change: Added quantity limits to Cequa, Restasis and Xiidra. Prefer Restasis single use vials over multidose bottle.

March 2022: Criteria change: Removed requirement for specialist. Removed restriction of use for Restasis in combination with topical steroids.

February 2022: Criteria update: Added new generic Restasis to the policy and required Brand trial before generic approval.

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. Changed name of the policy to Dry Eye Disease (keratoconjunctivitis) – Enhanced & Essential

December 2019: Criteria change: Removed QL on Xiidra.

December 2018: Added new to market Cequa 0.09% solution to policy.

January 2017: Reviewed for Essential formulary; non-formulary verbiage added.

July 2016: Added new to market Xiidra to policy

May 2015: Historical update

October 2010: Original utilization management criteria issued.