Verkazia - NC Standard

Restricted Product(s)

• Verkazia® (cyclosporine ophthalmic emulsion) 0.1%

FDA Approved Use

• For the treatment of vernal keratoconjunctivitis in children and adults

Criteria for Approval of Restricted Product(s)

Initial Coverage

1. The patient has a diagnosis of vernal keratoconjunctivitis (VKC); AND 
2. The patient has tried and had an inadequate response to a combination of a topical ophthalmic mast cell stabilizer AND an antihistamine used in the treatment of VKC; OR 
   1. The patient has an FDA labeled contraindication or intolerance to ALL topical ophthalmic mast cell stabilizers AND antihistamines; AND 
3. The patient has tried and had an inadequate response to a topical ophthalmic corticosteroid used in the treatment of VKC; OR 
   1. The patient has an FDA labeled contraindication or intolerance to ALL topical ophthalmic corticosteroids; AND 
4. The patient will NOT be using the requested agent in combination with another ophthalmic immunomodulator agent (e.g., Restasis, Cequa, Xiidra); AND 
5. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies. 

Duration of Approval: 4 months (120 days)

Continuation Coverage

1. The patient has a prior approval for this medication from Blue Cross NC or would have met criteria at initiation of therapy; AND 
2. The patient has had clinical benefit with the requested agent; AND
3. The patient will NOT be using the requested agent in combination with another ophthalmic immunomodulator agent (e.g., Restasis, Cequa, Xiidra). 

Duration of Approval: 365 days (1 year)

Quantity Limit Exception Criteria

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)

References

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

Policy Implementation/Update Information

April 2022: Original utilization management criteria issued.