CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Oxervate (cenegermin) — coverage criteria for neurotrophic keratitis

Defines authorization, quantity, and duration criteria for Oxervate (cenegermin-bkbj) treatment for members with neurotrophic keratitis or persistent epithelial defects, applicable to prescribers (ophthalmologists/optometrists) and pharmacy/professional review staff.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOxervate (cenegermin) — coverage criteria for neurotrophic keratitis

Policy CodePolicy N/A

Change TypeAdministrative review — no material change

Effective Date05/01/2019

Next Review DateN/A

Key ActionObtain prior authorization for an 8-week course when all specified clinical criteria and documentation requirements are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

8 weeksauth duration

28 vialsqty (one eye)

56 vialsqty (both eyes)

>=2 yrsmin age

Coverage Criteria — Oxervate (cenegermin)

Initial Therapy Criteria

Authorization of 8 weeks may be granted when ALL of the following are met:

Oxervate initial approval criteria

Age: Patient is 2 years of age or older.>=2 years
Diagnosis duration and refractoriness: Persistent epithelial defect (PED) or corneal ulceration of at least 2 weeks' duration that is refractory to one or more conventional non-surgical treatments (e.g., preservative-free artificial tears).>=2 weeks and prior conservative therapy failed
Prescriber:

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOxervate (cenegermin) — coverage criteria for neurotrophic keratitis

Policy CodePolicy N/A

Change TypeAdministrative review — no material change

Effective Date05/01/2019

Next Review DateN/A

Key ActionObtain prior authorization for an 8-week course when all specified clinical criteria and documentation requirements are met.

SourceLink

On This Page

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Key Clinical Thresholds and Coding-related Criteria

Age

Minimum agePatient is 2 years of age or older

Policy effective date05/01/2019 (last review 2024-05)

Typical authorization duration8 weeks when all criteria are met

Duration of PED or corneal ulcer

Minimum durationPersistent epithelial defect (PED) or corneal ulceration of at least 2 weeks duration

Refractoriness requirementDefect or ulcer must be refractory to one or more conventional non-surgical treatments (e.g., preservative-free artificial tears)

Related actionDocumentation must demonstrate duration and refractoriness for prior authorization

Schirmer test

Schirmer test thresholdSchirmer test without anesthesia resulting in greater than 3 mm of moisture in 5 minutes

Test conditionMust be performed without topical anesthesia

Use for eligibilityResult required as part of prior authorization evidence for treatment

Provider Requirements, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization required: An authorization for an 8-week course may be granted only when all listed clinical criteria are met. Submit documentation showing each criterion has been satisfied.

Authorization length: 8 weeks
Affected product: Oxervate (per policy)

Step Therapy

Conservative Therapy Requirement

Conservative therapy requirement — prior to approval, the patient must have tried and failed at least one conventional non-surgical treatment for the persistent epithelial defect (PED) or corneal ulceration. Examples include preservative-free artificial tears and other standard topical supportive measures.

Documented trial and inadequate response to ≥1 conventional non-surgical treatment (e.g., preservative-free artificial tears)
Duration of conservative therapy: at least 2 weeks with persistent disease

Documentation Required

Required documentation to support prior authorization must include: patient age, diagnosis, duration of the PED or corneal ulcer, documentation of refractoriness to conservative therapy, prescribing clinician specialty, corneal sensitivity testing results, Schirmer test result, prior exposure to Oxervate, and confirmation of caregiver/member ability and counseling.

Patient age (must be ≥ 2 years)
Diagnosis and duration of PED or corneal ulcer (≥ 2 weeks)
Documentation of failure of ≥1 conventional non‑surgical treatments
Prescriber specialty: ophthalmologist or optometrist
Corneal sensitivity: decreased sensitivity documented (Cochet‑Bonnet aesthesiometer)
Schirmer test without anesthesia: > 3 mm moisture in 5 minutes
No prior course of Oxervate in the affected eye
Confirmation that member/caregiver has sufficient dexterity to administer and that proper technique counseling was provided

Denial Risk

Denial Triggers

Denial triggers — requests will be denied if required criteria or documentation are missing or not met.

Patient < 2 years of age
PED or corneal ulcer duration < 2 weeks or not refractory to conservative therapy
No documented trial/failure of conventional non‑surgical therapy
Prescriber is not an ophthalmologist or optometrist
Missing or non‑confirmatory corneal sensitivity testing
Schirmer test ≤ 3 mm in 5 minutes or not provided
Previous course of Oxervate in the affected eye
No documentation of caregiver/member dexterity or counseling on administration technique

Background — Drug Indication and Context

Oxervate (cenegermin) is indicated for patients with neurotrophic keratitis presenting as persistent epithelial defects (PED) or corneal ulceration. The policy permits an 8‑week authorization when criteria are met, including patient age of ≥ 2 years, a PED or corneal ulcer that is refractory to conventional non‑surgical treatments for at least 2 weeks, objective evidence of decreased corneal sensitivity by Cochet‑Bonnet aesthesiometer, and a Schirmer test without anesthesia showing > 3 mm moisture in 5 minutes. Additional requirements include prescription by an ophthalmologist or optometrist, confirmation that the member or caregiver has adequate dexterity for administration, and counseling on proper technique.

Definitions and Test Criteria

Persistent epithelial defect (PED)

DefinitionA corneal epithelial defect or ulceration that is present for at least 2 weeks and is refractory to one or more conventional non-surgical treatments

Examples of conservative therapyPreservative-free artificial tears and other non-surgical measures

Role in approvalPresence of a PED meeting this definition is required for authorization of Oxervate

Decreased corneal sensitivity

Measurement methodMeasured using the Cochet-Bonnet aesthesiometer

ThresholdDecreased corneal sensitivity defined as less than 0 to 4 cm on the Cochet-Bonnet aesthesiometer

Anatomic requirementMeasured within the area of the PED or corneal ulcer and outside the defect in at least one corneal quadrant

Schirmer test criterion

TestSchirmer test without anesthesia

Threshold resultGreater than 3 mm of moisture in 5 minutes required

PurposeObjective measurement of tear production required for prior authorization