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Oxervate (cenegermin-bkbj ophth soln 0.002%) — Blue Cross Blue Shield of Montana

neurotrophic keratitis (NK)

Initial criteria

  • The patient has a diagnosis of neurotrophic keratitis (NK)
  • The patient has stage 2 (persistent epithelial defect [PED]) or stage 3 (corneal ulcer) NK
  • ONE of the following:
  • A. The patient has NOT been previously treated with the requested agent in the affected eye(s) AND ALL of the following:
  • 1. The patient’s PED and/or corneal ulcer have been present for at least 2 weeks AND
  • 2. ONE of the following:
  • A. BOTH of the following:
  • 1. ONE of the following: The patient has been diagnosed with stage four advanced, metastatic cancer and the requested agent is being used to treat the cancer OR The patient has been diagnosed with stage four advanced, metastatic cancer and the requested agent is being used to treat an associated condition related to stage four advanced metastatic cancer [chart notes required]
  • 2. The use of the requested agent is consistent with best practices for the treatment of stage four advanced, metastatic cancer, or an associated condition; supported by peer-reviewed, evidence-based literature; and approved by the United States Food and Drug Administration OR
  • B. The patient’s NK has been refractory to at least ONE conventional non-surgical treatment (i.e., 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, botulinum A toxin treatment) OR
  • C. The patient has an intolerance or hypersensitivity to at least ONE conventional non-surgical treatment for NK OR
  • D. The patient has an FDA labeled contraindication to ALL conventional non-surgical treatments for NK AND The patient has decreased corneal sensitivity within the area of the PED or ulcer and outside the area of defect in at least one corneal quadrant
  • B. The patient has been previously treated with the requested agent in the affected eye(s) AND BOTH of the following: The patient had complete corneal healing in the previously treated eye(s) (medical records required) AND The patient has a recurrence of neurotrophic keratitis (NK) that requires another treatment course
  • ONE of the following: The patient does NOT have ocular surface disease associated with or in conjunction with NK OR BOTH of the following: The patient has ocular surface disease associated with or in conjunction with NK AND The ocular surface disease has been properly treated
  • The patient will NOT be using the requested agent in combination with a topical ophthalmic NSAID
  • The patient does NOT have any of the following: Active ocular infection or inflammation not related to NK; Severe blepharitis or severe Meibomian gland disease; 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; Corneal perforation, ulceration involving the posterior third of the corneal stroma, or corneal melting
  • 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
  • The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

6 months (BCBSIL and BCBSMT); 16 weeks (other plans)