CurrentCentenePolicy CP.PMN.186

Cenegermin-bkbj (Oxervate) for neurotrophic keratitis

Defines medical necessity criteria, dosing limits, and authorization rules for Oxervate (cenegermin) for treatment of neurotrophic keratitis for Centene lines of business including Commercial, HIM, and Medicaid.

Policy Summary

PayerCentene

PolicyCenegermin-bkbj (Oxervate) for neurotrophic keratitis

Policy CodePolicy CP.PMN.186

Change TypeMaterial clinical updates (diagnostic criteria, step therapy, lifetime limits)

Effective DateMar 1, 2019

Next Review Date

Key ActionObtain prior authorization and submit documentation showing stage 2 or 3 neurotrophic keratitis, age ≥2, decreased corneal sensitivity, prior non-surgical treatment attempts, and prior Oxervate exposure per eye.

SourceLink

POLICY UPDATE CHANGES

Added diagnostic requirement for documented evidence of decreased corneal sensitivity.

Added requirement that disease is refractory to at least one conventional non-surgical treatment.

Clarified continued therapy: for a second 8-week treatment course, member must not have achieved complete corneal healing or must have recurrence requiring retreatment.

Added requirement that prior total Oxervate exposure per affected eye must be less than 16 weeks for initial or continued approval.

Added optometrist as an authorized prescriber (in addition to ophthalmologist).

8 weeksInitial approval duration

16 weeksMaximum per eye (lifetime)

≥2

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1 vial/dayMax daily dose/eye

6 dropsMax drops/day/eye

Coverage Criteria

Coverage for indications not specifically addressed in this policy (i.e., non‑FDA approved indications) is not authorized unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policies (see referenced off‑label policies).

For requests to treat non‑FDA indications, providers must follow the off‑label use requirements referenced in this policy (CP.CPA.09, HIM.PA.154, CP.PMN.53). If sufficient documentation per those off‑label policies is not provided, use for non‑FDA approved indications is considered not authorized.

Coding and Dosing

Product detailsmixed

0.002% (20 mcg/mL)

Ophthalmic solution concentration

Dosing regimen (informational)mixed

1 drop every 2 hours, six times a day for 8 weeks	Typical dosing regimen for neurotrophic keratitis
Maximum: 6 drops per affected eye per day	Maximum daily dose per affected eye

Daily dosing per affected eye — maximum 1 vial/day/eye (6 drops/day/eye)

Maximum daily vials per affected eye1 vial per affected eye per day

Equivalent maximum drops per affected eye per day6 drops per affected eye per day

Dosing frequency1 drop in affected eye every 2 hours, six times per day

Maximum total treatment duration per affected eye — ≤ 16 weeks lifetime (typically up to two 8-week courses)

Lifetime maximum treatment per affected eye≤ 16 weeks total per affected eye (lifetime)

Typical course structureTypically up to two 8-week courses per affected eye

Approval duration for initial course8 weeks per course

Provider Actions and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required — documentation must demonstrate member meets criteria for initial or continued therapy. Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.

Prescriber specialty: ophthalmologist or optometrist (or in consultation with one).
Age requirement: ≥ 2 years.
Diagnosis: stage 2 or 3 neurotrophic keratitis.
Dose limit: ≤ 1 vial per affected eye per day.
Approval durations: Initial — 8 weeks; Continued — up to total 16 weeks (lifetime 2 courses per affected eye).

Step Therapy

Step Therapy Requirement

Step therapy requirement — disease must be refractory to at least one conventional non-surgical treatment prior to approval.

Background

Neurotrophic keratitis is a degenerative corneal disorder caused by decreased corneal innervation that impairs epithelial healing. Clinical severity is described in stages ranging from superficial punctate keratopathy (stage 1) through a persistent epithelial defect (stage 2) to stromal involvement and corneal ulceration (stage 3). Cenegermin (Oxervate) is indicated to promote corneal healing in affected eyes; this policy defines the coverage criteria, required documentation, and treatment limits for its use.

Definitions and Stages of Neurotrophic Keratitis

Stage 1 neurotrophic keratitis — punctate keratopathy / epithelial irregularity

Stage 1 definitionPunctate keratopathy and/or corneal epithelial hyperplasia and irregularity.

Clinical featuresSuperficial punctate epithelial defects and epithelial irregularity without persistent defect.

Implication for therapyStage 1 is not the primary indication for Oxervate per initial approval criteria which require stage 2 or 3.

Stage 2 neurotrophic keratitis — persistent epithelial defect (PED)

Stage 2 definitionPersistent corneal epithelial defect (PED), typically oval or circular in shape, with smooth and rolled edges.

Diagnostic requirement linkInitial approval requires diagnosis of stage 2 or 3 neurotrophic keratitis.

Policy Summary

PayerCentene

PolicyCenegermin-bkbj (Oxervate) for neurotrophic keratitis

Policy CodePolicy CP.PMN.186

Change TypeMaterial clinical updates (diagnostic criteria, step therapy, lifetime limits)

Effective DateMar 1, 2019

Next Review Date

SourceLink

On This Page

Examples of required prior therapies: preservative-free artificial tears, gels or ointments; discontinuation of preserved topical drops/medications that decrease corneal sensitivity; therapeutic contact lenses; botulinum induced ptosis; tarsorrhaphy; for stromal melting: N-acetylcysteine, oral tetracycline, medroxyprogesterone, autologous serum tears, punctal occlusion.

Documentation Required

Required Documentation

Required documentation — provider must submit clinical documentation such as office chart notes, test results, or other clinical information to demonstrate all criteria are met.

Documented decreased corneal sensitivity within the area of the PED or corneal ulcer and outside the area of the defect in at least one corneal quadrant (e.g., ≤ 4 cm using Cochet-Bonnet aesthesiometer, cotton swab method, CRCERT-Belmonte non-contact aesthesiometer).
Documentation of diagnosis stage (2 or 3) and prior treatment history.
If prior Oxervate use, documentation of total weeks received per affected eye (must be < 16 weeks to qualify for additional treatment).

Denial Risk

Documentation Triggers and Denial Risk

Documentation triggers — lack of required documentation may trigger denial or requests for additional information.

Missing stage documentation (stage 2 or 3 NK) may result in denial.
Absence of documented decreased corneal sensitivity testing results will prompt request for more information or denial.
Failure to document prior treatment attempts or total prior Oxervate exposure (≥16 weeks per eye) may result in denial.
Requests for continued therapy must show positive response and meet criteria for retreatment or recurrence as specified.

Clinical significanceStage 2 lesions (PED) are the primary target for cenegermin treatment per policy criteria.

Stage 3 neurotrophic keratitis — corneal stromal involvement/ulceration

Stage 3 definitionCorneal stroma involvement and a corneal ulcer is observed; may progress to perforation and/or stromal melting if not treated.

SeverityRepresents full-thickness stromal involvement and highest risk of complications without prompt treatment.

Policy relevanceDiagnosis of stage 3 meets initial approval criteria for Oxervate when other requirements are satisfied.