CurrentmhnPolicy CP.PMN.186

Cenegermin-bkbj (Oxervate) for neurotrophic keratitis

Medical necessity policy governing coverage of Oxervate (cenegermin-bkbj) for treatment of neurotrophic keratitis for Centene-affiliated health plans, specifying initial and continued therapy criteria, dosing limits, prescriber requirements, and exclusions.

Policy Summary

Payermhn

PolicyCenegermin-bkbj (Oxervate) for neurotrophic keratitis

Policy CodePolicy CP.PMN.186

Change TypeNo material change

Effective Date03.01.19

Next Review DateN/A

Key ActionObtain prior authorization and submit documentation showing member meets all approval criteria (stage 2 or 3 neurotrophic keratitis, prescriber requirement, age ≥2 years, dose ≤1 vial/eye/day).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Age ≥ 2minimum age for coverage

8 weeksinitial approval duration

Up to 16 wksmax total treatment/eye

2 lifetimetreatment courses limit

1 vial/daydose limit

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Neurotrophic keratitis

FDA approved indication

Coverage Criteria

Other Diagnoses/Indications

Coverage for other indications/uses

Other Indications Pathways: 1. If the drug has undergone a label change within the last 6 months that is not reflected in this policy, refer to the applicable formulary/no-coverage or non-formulary policy for the relevant line of business (see policy references). OR 2. If the requested use (diagnosis, age, dosing) is not listed under section III and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business.

See referenced policies (CP.CPA.190, HIM.PA.33, CP.PMN.255; CP.CPA.190, HIM.PA.103, CP.PMN.16; CP.CPA.09, HIM.PA.154, CP.PMN.53) for adjudication

Non-FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless the provider supplies sufficient documentation supporting efficacy and safety in accordance with the applicable off‑label use policies (see CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid) or other evidence of coverage documents.

Use of cenegermin (Oxervate) for non‑FDA approved indications not listed in this policy, without adequate supporting documentation per the referenced off‑label use policies or evidence of coverage, is considered not authorized/not covered.

Coding

Coding implications (referenced)mixed

No codes listed

inv-07: Maximum drops/day

Maximum drops/day6 drops per affected eye per day (maximum)

Typical dosing interval1 drop in the affected eye every 2 hours (per dosing regimen section)

ContextListed under Dosage and Administration for neurotrophic indication

inv-08: Dose limit and related dosing limits

Dose limit (per eye)Maximum 1 vial per affected eye per day

Continued-therapy dose constraintIf request is for dose increase, new dose must not exceed 1 vial per affected eye per day

Approval context

Provider Actions

Prior Authorization

Prior Authorization Required

Prior authorization required. Initial approval is for 8 weeks when all initial criteria are met.

Initial approval duration: 8 weeks

Step Therapy

Step Therapy / Dosing Guidance

Dose/regimen guidance provided in the dosing section; there is no explicit prerequisite medication or step-therapy requirement in this policy.

Follow dosing limits: ≤ 1 vial per affected eye per day (initial)

Documentation Required

Background

Cenegermin (Oxervate) is a recombinant human nerve growth factor indicated by the FDA for treatment of neurotrophic keratitis. This policy delineates coverage pathways and exclusions for that indication; requests for uses outside the FDA‑approved indication should be evaluated only when adequate evidence is provided per the off‑label use policies referenced above.

Definitions — Stages of Neurotrophic Keratitis

inv-13: Stage 1 neurotrophic keratitis

DefinitionStage 1: Punctate keratopathy and/or corneal epithelial hyperplasia and irregularity.

Clinical featuresSuperficial punctate epithelial disease and epithelial irregularity without persistent epithelial defect

Policy relevanceStage 1 described in Appendix D as part of staging reference used by coverage criteria

inv-14: Stage 2 neurotrophic keratitis

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

Clinical featuresPresence of a persistent epithelial defect (PED) distinguishing it from stage 1

Revision History

03.01.19effective_date

Policy effective date established.

10.26.20annual_review

1Q 2021 annual review: no significant changes; references revised and coding implications added.

10.04.21annual_review

1Q 2022 annual review: no significant changes; references reviewed and updated.

Policy Summary

Payermhn

PolicyCenegermin-bkbj (Oxervate) for neurotrophic keratitis

Policy CodePolicy CP.PMN.186

Change TypeNo material change

Effective Date03.01.19

Next Review DateN/A

SourceLink

On This Page

Dose limit enforced for both initial approval and continued therapy criteria

Required Documentation

Provider must submit documentation (office chart notes, lab results, prior treatment history, and other clinical information) supporting that the member meets all approval criteria.

Include documentation of diagnosis, prescribing clinician (ophthalmologist or optometrist), age, dosing, and treatment response as applicable.

Denial Risk

Denial Triggers

Requests for non‑FDA‑approved indications not addressed in this policy may be denied unless sufficient documentation of efficacy and safety is provided per applicable off‑label use policies. Denials may also occur if documentation does not demonstrate that the member meets the written approval criteria (including dosing limits and prior treatment/continuity provisions).

Non‑FDA indications require supporting evidence per CP.CPA.09, HIM.PA.154, or CP.PMN.53 as applicable.
Denial triggers include missing or insufficient clinical documentation, requests exceeding dosing limits, or requests for treatment beyond allowed durations.

Policy relevanceStage 2 is one of the approved diagnoses for initial coverage under this policy

inv-15: Stage 3 neurotrophic keratitis

DefinitionStage 3: Corneal stroma involvement and corneal ulcer observed; corneal ulceration tends to progress to perforation and/or stromal melting if not promptly treated.

Clinical featuresStromal involvement and corneal ulceration with risk of perforation or stromal melting without treatment

Policy relevanceStage 3 is an approved diagnosis for initial coverage and indicates more severe disease requiring therapy

10.05.22template_update

Template changes applied to other diagnoses/indications and continued therapy section.

10.12.22annual_review

1Q 2023 annual review: clarified continued therapy maximum treatment duration to a maximum of 16 weeks total and lifetime limit of 2 courses per affected eye; references reviewed and updated.

10.24.23annual_review

1Q 2024 annual review: added optometrist as an additional prescriber option; references reviewed and updated.

10.22.24annual_reviewLatest

1Q 2025 annual review: no significant changes; references reviewed and updated.