CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Oxervate (cenegermin) for neurotrophic keratitis — coverage criteria

Covers authorization, quantity limits, and duration criteria for Oxervate prescribed by ophthalmologists or optometrists for patients with persistent epithelial defects or corneal ulceration due to neurotrophic keratitis under the payer's Medicaid scope.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOxervate (cenegermin) for neurotrophic keratitis — coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date05/01/2019

Next Review Date

Key ActionObtain prior authorization for an 8-week course when all clinical criteria are documented.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

8 weeksauthorization duration

28quantity limit (one eye)

56quantity limit (both eyes)

>=2minimum patient age

Coverage Criteria for Oxervate (cenegermin)

Initial authorization

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOxervate (cenegermin) for neurotrophic keratitis — coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date05/01/2019

Next Review Date

Key ActionObtain prior authorization for an 8-week course when all clinical criteria are documented.

SourceLink

On This Page

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Oxervate approval criteria

A. Patient is 2 years of age or older.
B. Medication prescribed by an ophthalmologist or optometrist.
C. Documentation of persistent epithelial defect (PED) or corneal ulceration of at least 2 weeks duration refractory to one or more conventional non-surgical treatments (e.g., preservative-free artificial tears).
D. Documentation of decreased corneal sensitivity (<= 4 cm by Cochet-Bonnet aesthesiometer) within the area of the PED/ulcer and outside the defect in at least one corneal quadrant.
E. Documentation that Schirmer test without anesthesia resulted in greater than 3 mm of moisture in 5 minutes.
F. No prior course of Oxervate in the affected eye.
G. Patient counseled on proper administration technique.
H. Ophthalmologist confirms member or caregiver has sufficient dexterity to perform administration.

Product and Test Coding / Key Clinical Measures

Covered product (by name/strength)NDCCovered

Oxervate 0.002%

Product/strength as listed in quantity limit

inv-04: Cochet-Bonnet aesthesiometer — <=4 cm

Threshold value≤4 cm measured with the Cochet-Bonnet aesthesiometer

Measurement locationWithin the area of the PED or corneal ulcer and outside the area of the defect

Quadrant requirementDecreased sensitivity must be present in at least one corneal quadrant outside the defect

inv-05: Schirmer test without anesthesia — >3 mm in 5 minutes

Threshold value>3 mm moisture in 5 minutes on Schirmer test without anesthesia

Test typeSchirmer test performed without anesthesia

Documentation requirementResult must be recorded in clinical documentation for authorization

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization may be granted for an 8‑week course when all clinical criteria are met.

Authorization length: 8 weeks

Note

Refractory to Conventional Therapy

Patient must have disease refractory to one or more conventional non‑surgical treatments (e.g., preservative‑free artificial tears). The defect or ulcer must be at least 2 weeks duration and not improved with prior conservative therapy.

Refractory to >=1 conventional non‑surgical treatments
Duration: ≥2 weeks

Documentation Required

Required Clinical Documentation

Required documentation includes: patient age (≥2 years); prescriber specialty (ophthalmologist or optometrist); documentation of persistent epithelial defect (PED) or corneal ulceration ≥2 weeks duration; documentation of decreased corneal sensitivity (≤4 cm on Cochet‑Bonnet aesthesiometer) within the defect area and outside the defect in at least one corneal quadrant; Schirmer test without anesthesia >3 mm in 5 minutes; confirmation patient has not received a prior course of Oxervate in the affected eye; counseling on proper administration technique; and ophthalmologist confirmation that the member/caregiver has sufficient dexterity to perform administration.

Age ≥2 years
Prescriber: ophthalmologist or optometrist
PED or corneal ulceration ≥2 weeks
Corneal sensitivity ≤4 cm (Cochet‑Bonnet) in affected area and outside defect in ≥1 quadrant
Schirmer without anesthesia >3 mm / 5 minutes
No prior Oxervate course in affected eye
Counseled on technique
Ophthalmologist confirms adequate dexterity

Denial Risk

Documentation Omissions That May Trigger Denial

Denial may occur for failure to document age ≥2 years, prescriber specialty, presence and duration of PED or corneal ulceration, refractoriness to conventional therapy, corneal sensitivity results, Schirmer test results, prior Oxervate exposure, counseling on technique, or ophthalmologist confirmation of dexterity.

Missing age or prescriber specialty
No documentation of PED/corneal ulceration or duration
No evidence of failure of conventional therapy
Missing Cochet‑Bonnet or Schirmer test results
Prior Oxervate in affected eye not addressed
No counseling or dexterity confirmation

Background

Neurotrophic keratitis can lead to persistent epithelial defects (PED) and corneal ulceration associated with reduced corneal sensitivity. Oxervate (cenegermin) is indicated for these cases when objective criteria are met, including documented PED or corneal ulceration of at least 2 weeks’ duration that is refractory to one or more conventional non-surgical treatments, measurement of decreased corneal sensitivity (≤4 cm by Cochet-Bonnet aesthesiometer) within and around the defect in at least one corneal quadrant, and Schirmer test without anesthesia showing >3 mm of moisture in 5 minutes. Prior authorization for an 8‑week course may be granted when all clinical requirements are satisfied.

Definitions

inv-11: Persistent epithelial defect (PED) / corneal ulceration — PED or corneal ulceration of at least 2 weeks duration refractory to one or more conventional non-surgical...

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

Refractory requirementMust be refractory to one or more conventional non-surgical treatments (e.g., preservative-free artificial tears)

Documentation necessityClinical documentation of PED or corneal ulceration and prior conservative treatments required for authorization

inv-12: Decreased corneal sensitivity — Decreased corneal sensitivity defined as <=4 cm using the Cochet-Bonnet aesthesiometer within the area of the defect and outside the area ...

DefinitionDecreased corneal sensitivity defined as ≤4 cm using the Cochet-Bonnet aesthesiometer

Measurement locationsMeasured within the area of the PED/ulcer and outside the area of the defect

Quadrant requirementDecreased sensitivity must be present outside the defect in at least one corneal quadrant