CurrentCignaPolicy N/A

Oxervate (cenegermin) prior authorization for neurotrophic keratitis

Defines Cigna's prior authorization requirements, coverage criteria, and treatment duration limits for Oxervate (cenegermin-bkbj) for the treatment of neurotrophic keratitis for covered members and prescribers.

Policy Summary

PayerCigna

PolicyOxervate (cenegermin) prior authorization for neurotrophic keratitis

Policy CodePolicy N/A

Change TypeDuration limits clarified (material)

Effective DateJul 23, 2025

Next Review DateJul 23, 2025

Key ActionObtain prior authorization for Oxervate; approvals are for up to 8 weeks per affected eye for initial therapy and up to an additional 8 weeks for recurrence (maximum 16 weeks per affected eye).

SourceLink

POLICY UPDATE CHANGES

Policy Statement added that 8 weeks of treatment is approved for initial neurotrophic keratitis and 8 weeks of treatment is approved for recurrent neurotrophic keratitis (total 16 weeks).

For initial and recurrent therapy, the wording referencing 'previously' received weeks was removed and duration thresholds were adjusted (e.g., '< 16 weeks').

8Approved initial treatment duration per affected eye

8Approved retreatment course for recurrence (per affected eye)

16Maximum total treatment duration per affected eye

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Recommended dosing frequency

2 yrsPediatric use supported ≥

Coverage Criteria for Oxervate (cenegermin)

FDA-Approved Indication — Neurotrophic Keratitis

Oxervate is covered as medically necessary for neurotrophic keratitis when the specified conditions for an initial course or for recurrence are met.

Top-level indication: Patient has neurotrophic keratitisFDA indication

Reference: Oxervate indication

A) Initial Course

Initial criteria details: i. Patient has received < 8 weeks of treatment in the affected eye(s); AND ii. The medication is prescribed by an ophthalmologist or optometrist.prescriber specialty required
Allows partial additional weeks to reach an 8-week total

B) Recurrence

Recurrence criteria details: i. Patient has received < 16 weeks of treatment per affected eye(s); AND ii. The medication is prescribed by an ophthalmologist or optometrist.prescriber specialty required
Permits a second 8-week course if prior 8 weeks completed

Oxervate (cenegermin-bkbj ophthalmic solution) is not medically necessary for indications other than neurotrophic keratitis. The policy explicitly states that any use outside the FDA‑approved indication for neurotrophic keratitis is considered not medically necessary.

Treatment durations exceeding 16 weeks per affected eye per episode are considered not medically necessary. The available data support an initial 8‑week course for neurotrophic keratitis and up to an additional 8‑week course for recurrence (maximum 16 weeks total per affected eye).

Coding and Dosing Information

Product reference (no billing codes provided)NDC | mixed

NDC not listed

Oxervate (cenegermin-bkbj ophthalmic solution) — policy references product but does not list NDC/CPT/HCPCS codes in the document

inv-05: Maximum treatment duration per affected eye

Maximum treatment duration per affected eye16 weeks total per affected eye (8 weeks initial course + up to 8 weeks for recurrence)

Initial course limit8 weeks of treatment in the affected eye per initial episode

Recurrence course limitUp to an additional 8 weeks for recurrent neurotrophic keratitis per affected eye

Denial thresholdRequests for treatment > 16 weeks per affected eye per episode will be denied as not medically necessary

inv-06: Dosing frequency

Recommended dosing frequencyOne drop to the affected eye(s) six times daily (at ~2-hour intervals) for an 8-week course

Provider Actions, Documentation, and Billing Rules

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prior authorization (PA) is required for Oxervate. All approvals are provided for the durations specified below; approval requires the medication to be prescribed by an ophthalmologist or optometrist (a physician who specializes in the condition being treated).

Oxervate approvals are managed per affected eye.
PA approvals are time-limited (see duration limits).

Documentation Required

Duration Limits

Duration Limits: Initial therapy is approved for up to 8 weeks per affected eye. For recurrence, an additional up to 8 weeks per affected eye may be approved, allowing a maximum cumulative duration of 16 weeks per affected eye per episode.

Initial course = up to 8 weeks per affected eye.
Recurrence = up to an additional 8 weeks per affected eye (total up to 16 weeks per affected eye).

Background

Neurotrophic keratitis is a rare, degenerative corneal disease caused by impaired corneal sensory innervation leading to loss of protective sensation. This impaired innervation results in corneal epithelial breakdown and impaired healing, which increases the risk of progressive epithelial defects, ulceration, melting, and perforation. Oxervate (recombinant human nerve growth factor) is indicated to promote corneal healing in this condition.

Definitions and Disease Staging

inv-14: Definition of neurotrophic keratitis

DefinitionNeurotrophic keratitis is a degenerative disease of the cornea characterized by epithelial breakdown, impaired corneal healing, and risk of ulceration, melting, and perforation due to impaired corneal sensory innervation.

PathophysiologyImpaired corneal sensory innervation reduces protective reflexes and trophic neuromodulators essential for ocular surface vitality and wound healing.

Clinical consequenceIf untreated, the condition can progress to anatomical loss of the eye and commonly results in vision loss even with treatment.

inv-15: Disease staging

Stage 1Mild corneal epithelial changes (mild epithelial alterations)

Stage 2Corneal epithelial defect (moderate disease)

Policy Summary

PayerCigna

PolicyOxervate (cenegermin) prior authorization for neurotrophic keratitis

Policy CodePolicy N/A

Change TypeDuration limits clarified (material)

Effective DateJul 23, 2025

Next Review DateJul 23, 2025

SourceLink

On This Page

Course length per prescription8 weeks per course (each course follows the 6x/day dosing regimen)

Vial supply noteOxervate is supplied in cartons of seven multi-dose vials; each vial contains enough medication to treat one eye per day

Denial Risk

Exceeding Maximum Duration

Exceeding Maximum Duration — Denial Risk: Requests for treatment duration exceeding 16 weeks per affected eye per episode will be denied as not medically necessary.

Any request > 16 weeks per affected eye per episode = not medically necessary denial.

Documentation Required

Bilateral Treatment Documentation

Bilateral Treatment Documentation: When both eyes are being treated, clinical documentation must clearly indicate bilateral involvement and justification for two-eye treatment. Note that each vial treats one eye per day; bilateral treatment typically requires two vials per day (one vial per eye).

Document prior weeks of Oxervate received for each affected eye separately.
If requesting simultaneous bilateral treatment, note that two vials per day are required and justify medical necessity for treating both eyes.

Note

Adjunctive Treatments Noted

Adjunctive Treatments Noted: Optimal care includes identifying and treating underlying causes and using supportive/adjuvant measures. Documentation of adjunctive therapies and supportive measures (when used) should be included in the record.

Examples of adjunctive/supportive measures: preservative-free tear substitutes/lubricants, discontinuation of preservative-containing ophthalmic meds when possible, prophylactic preservative-free topical antibiotics, oral tetracyclines (e.g., doxycycline), corneal therapeutic contact lenses, fresh‑frozen self‑retained amniotic membrane, synthetic tissue adhesive, tarsorrhaphy, amniotic membrane transplant, and corneal neurotization.
Include corrective treatment of underlying conditions (e.g., antiviral therapy for herpetic disease, eyelid abnormality correction, glycemic control in diabetes) where applicable.

Stage 3Corneal ulcer, perforation, or melting (severe disease)