Oxervate – NC Standard

Restricted Product(s):

• Oxervate® (cenegermin-bkbj ophth soln 0.002%)

FDA Approved Use:

• For the treatment of neurotrophic keratitis.

Criteria for Approval of Restricted Product(s):

1. The patient has a diagnosis of neurotrophic keratitis (NK); AND
2. The patient has stage 2 (persistent epithelial defect [PED]) or stage 3 (corneal ulcer) NK; AND
3. ONE of the following:
   1. The patient has NOT been previously treated with the requested agent in the affected eye(s); AND
      1. The patient’s PED and/or corneal ulcer have been present for at least 2 weeks; AND
      2. The patient’s NK has been refractory to at least ONE conventional non-surgical treatment (e.g., preservative-free lubricant eye drops or ointment, discontinuation of preserved topical agents that can decrease corneal sensitivity, therapeutic soft contact lenses, topical autologous serum application); OR
         1. The patient has a clinical contraindication/ intolerance ALL conventional non-surgical treatments for NK; AND
      3. The patient has decreased corneal sensitivity (≤4 cm using the Cochet-Bonnet esthesiometer) within the area of the PED or ulcer and outside the area of defect in at least one corneal quadrant; OR
   2. The patient has been previously treated with the requested agent in the affected eye(s); AND
      1. The patient had complete corneal healing in the previously treated eye(s); AND
      2. The patient has a recurrence of neurotrophic keratitis (NK) that requires another treatment course; AND
4. The patient will NOT be using the requested agent in combination with a topical ophthalmic NSAID; AND
5. The patient does NOT have any of the following:
   1. Active ocular infection or active ocular inflammation not related to NK in the affected eye; OR
   2. Schirmer test without anesthesia ≤3 mm/5 min in the affected eye; OR
   3. Severe blepharitis and/or severe Meibomian gland disease in the affected eye; OR
   4. History of any ocular surgery in the affected eye within the past 90 days that has not been determined to be the cause of NK; OR
   5. Corneal perforation, ulceration involving the posterior third of the corneal stroma, or corneal melting; AND
6. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., optometrist, ophthalmologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis; AND
7. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 56 days (8 weeks)

Quantity Limitations:

Quantity limitations apply to brand and associated generic products.

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. The patient has bilateral NK; AND
   1. The requested quantity does NOT exceed TWICE the program quantity limit; OR
5. 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: 56 days (8 weeks)

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 2023: Criteria update: Formatting review.

July 2023: Criteria change: Criteria review and formatting changes. Decreased the duration of approval to 8 weeks. Added duration of approval to quantity limit exception criteria.

April 2021: Original utilization management criteria issued.