Oxervate (cenegermin) for Neurotrophic Keratitis — Coverage Criteria
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This policy governs coverage and authorization criteria for Oxervate (cenegermin) for treatment of neurotrophic keratitis for Wellmark Blue Cross and Blue Shield members; it applies to providers prescribing and billing for this medication under the member's benefit plan.
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity Criteria
Initial authorization criteria
Covered when ALL of the following are met
Treatment with Oxervate is not covered when plan exclusions or contract limitations apply. The indications in this policy are considered covered benefits only when all approval criteria are met and the member has no exclusions to the prescribed therapy. This policy may not apply to members covered under the Federal Employee Program (FEP); verify applicability of this policy to the member’s benefit plan prior to authorization.
This policy covers Oxervate use only for Stage 2 or Stage 3 neurotrophic keratitis meeting the specified criteria. Use of Oxervate for disease stages other than Stage 2 or Stage 3, or in the absence of a documented persistent epithelial defect (PED) or corneal ulceration of at least 2 weeks duration refractory to one or more conventional non-surgical treatments, or without documented decreased corneal sensitivity, does not meet the approval criteria and is not authorized. Prior treatment with an 8-week course of Oxervate in the affected eye disqualifies repeat authorization for that eye.
Procedures, Codes, Quantity and Duration Limits
| No codes listed |
Prior Authorization, Documentation, and Denial Triggers
Prior authorization required; authorization up to 16 weeks
Prior authorization is required for Oxervate for Stage 2 or Stage 3 neurotrophic keratitis; approvals may be granted for up to 16 weeks total (8 weeks therapy per affected eye). The medication must be prescribed by or in consultation with an ophthalmologist or optometrist.
Conservative therapy failure required prior to Oxervate
Member must have a persistent epithelial defect (PED) or corneal ulceration of at least 2 weeks' duration that is refractory to one or more conventional non-surgical treatments (for example, preservative-free artificial tears) before Oxervate will be authorized.
Required clinical documentation to support authorization
Provide clinical documentation showing PED/corneal ulcer duration, prior non-surgical treatments tried, corneal sensitivity testing results, and prescriber specialty.
- Duration of the PED or corneal ulcer (≥ 2 weeks).
- Details of conventional non-surgical treatments tried (e.g., preservative-free artificial tears).
- Corneal sensitivity testing results (e.g., cotton swab, Cochet-Bonnet aesthesiometer, CRCERT-Belmonte non-contact aesthesiometer) demonstrating decreased sensitivity within the defect and outside the defect in at least one corneal quadrant.
- Prescriber specialty or documentation of consultation with an ophthalmologist or optometrist.
Document quantity requested and affected eye (lifetime limit applies)
Document the specific quantity requested and identify the affected eye to ensure the lifetime limit of 8 kits per affected eye is not exceeded.
- State number of kits requested (1 kit = 7 x 1 mL multiple-dose vials).
- Specify which eye is affected (right or left) for lifetime-per-eye tracking.
Triggers for denial — missing corneal sensitivity or therapy failure evidence
Common reasons for denial include missing documentation of decreased corneal sensitivity in the area of the defect and outside the defect in at least one corneal quadrant, or lack of documentation that the PED/corneal ulcer is refractory to ≥2 weeks of conventional non-surgical treatments.
- No corneal sensitivity test results showing decreased sensitivity within the PED/ulcer and outside the defect in ≥1 corneal quadrant.
- No documentation that the lesion has been present ≥2 weeks and refractory to conventional non-surgical therapy.
Background and Context
Oxervate (cenegermin) is recombinant human nerve growth factor that is FDA‑approved for the treatment of neurotrophic keratitis. This policy authorizes Oxervate for FDA‑approved use in Stage 2 and Stage 3 neurotrophic keratitis when the documented clinical criteria are met, including decreased corneal sensitivity and a refractory persistent epithelial defect or corneal ulceration of at least 2 weeks duration. Authorization may be granted for up to 16 weeks (8 weeks total therapy per eye) when all criteria are satisfied.
Key Definitions
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