cenegermin-bkbj ophthalmic solution 0.002% — Blue Cross Blue Shield of Oklahoma
neurotrophic keratitis stage 2 (persistent epithelial defect) or stage 3 (corneal ulcer)
Initial criteria
- Diagnosis of neurotrophic keratitis (NK)
- Stage 2 (persistent epithelial defect) or stage 3 (corneal ulcer) NK
- ONE of the following: (A) Patient has NOT been previously treated with requested agent in affected eye(s) AND ALL of: (1) PED/corneal ulcer present ≥ 2 weeks AND ONE of: (a) Stage 4 advanced metastatic cancer use consistent with best practices OR (b) NK refractory to ≥1 conventional non-surgical treatment (e.g., preservative-free lubricant drops/ointment, discontinuation of preserved topical agents, therapeutic soft contact lenses, topical autologous serum, botulinum toxin A) OR (c) intolerance/hypersensitivity to ≥1 conventional non-surgical treatment OR (d) FDA labeled contraindication to ALL conventional non-surgical treatments AND patient has decreased corneal sensitivity in area of PED/ulcer and outside defect in ≥1 corneal quadrant ); OR (B) Previously treated with requested agent and BOTH: (1) Complete corneal healing in previously treated eye(s) AND (2) Recurrence of NK requiring another treatment course
- ONE of the following: (A) No ocular surface disease associated with NK OR (B) ocular surface disease treated
- Patient will NOT be using requested agent with a topical ophthalmic NSAID
- Patient does NOT have: (a) active ocular infection/inflammation not related to NK, (b) severe blepharitis or severe Meibomian gland disease, (c) ocular surgery in affected eye within past 90 days not causing NK, (d) corneal perforation, ulceration involving posterior third of corneal stroma, or corneal melting
- Prescriber is a specialist (optometrist/ophthalmologist) or has consulted with one
- Patient has no FDA labeled contraindications to the requested agent
Reauthorization criteria
- For BCBS MT Fully Insured or HIM members under age <18 years: No FDA labeled contraindications AND indication supported in TWO peer‑reviewed journal articles showing safety/effectiveness in appropriate age bracket (infancy, childhood, adolescence)
- For Ohio Fully Insured or HIM Shop members: No FDA labeled contraindications AND ONE of: (a) FDA labeled indication for agent/route, (b) indication supported in compendia, (c) TWO peer‑reviewed journal articles support proposed use as safe/effective
Approval duration
16 weeks (most plans) or 6 months (BCBSIL/BCBSMT) or 12 months for MT/Ohio exceptions