CurrentCentenePolicy CP PMN.186

Cenegermin-bkbj (Oxervate)

Defines medical necessity criteria, initial and continued therapy criteria, dosing limits, covered diagnosis (neurotrophic keratitis stage 2 or 3), approval durations, prescriber requirements, and references for Oxervate for Centene-affiliated lines of business (Commercial, HIM, Medicaid).

Policy Summary

PayerCentene

PolicyCenegermin-bkbj (Oxervate)

Policy CodePolicy CP PMN.186

Change TypeClarified duration; added prescriber; references updated

Effective DateMar 1, 2019

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.

POLICY UPDATE CHANGES

1Q 2023 annual review added criteria clarifying maximum treatment duration: Member has not received ≥ 16 weeks total of Oxervate treatment per affected eye(s) and continued therapy approval limited to lifetime 2 courses per affected eye.

1Q 2024 annual review added optometrist as an additional prescriber option.

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

1Covered Indication (FDA-approved)

≤1Vials per affected eye per day (max)

16 wksMaximum total treatment duration per affected eye

2Lifetime courses per affected eye

Coverage Summary & Indications

Cenegermin (Oxervate) is FDA‑indicated for the treatment of neurotrophic keratitis and the policy covers use for stage 2 or 3 disease. Coverage is subject to Centene medical necessity criteria (prescriber, dosing and duration limits) and applies across Centene lines of business including Commercial, HIM (marketplace), and Medicaid.

Key coverage scope: prescriber requirements, maximum dosing of ≤ 1 vial per affected eye per day, and limits on total treatment courses/duration per affected eye.

Key thresholds

Maximum daily dose≤ 1 vial per affected eye per day

Maximum total treatment duration per affected eyeUp to a total of 16 weeks per affected eye (continued therapy limit)

Lifetime courses per affected eyeMaximum 2 courses of treatment per affected eye (lifetime)

AgeAmbiguous in policy text ('22 years'); policy context notes prescriber expansion to include optometrist — FDA indication generally for adults; clarify age in submitted documentation if needed

Initial Therapy Criteria

Initial Approval Criteria

Oxervate is medically necessary when ALL of the following are met:

Diagnosis of stage 2 or 3 neurotrophic keratitis
See Appendix D for stage definitions
Prescriber requirement: Prescribed by or in consultation with an ophthalmologist or optometrist
Prescriber requirement per policy
Age 22 years
Original policy text lists '22 years' (ambiguous); preserved as stated in source
Dose limit: Dose does not exceed 1 vial per affected eye per day

Continuation Therapy Criteria

Continued Therapy

Member must meet ALL of the following (for continued therapy):

Current therapy/prior criteria: Member is currently receiving medication via Centene benefit or member has previously met initial approval criteria
Includes continuity of care clause per policy
Documented response: Member is responding positively to therapy
Response must be documented in submitted clinical information
Dose increase limit: If request is for a dose increase, new dose does not exceed 1 vial per affected eye per day≤ 1 vial per affected eye per day

Other Diagnoses, Off-Label, and Not Authorized Uses

Other diagnoses/indications

For diagnoses/uses not meeting the above criteria, must meet ONE of the following:

Formulary drugs: For drugs on the formulary/PDL, follow the no coverage criteria policy for the relevant line of business: CP.CPA.190 (commercial), HIM.PA.33 (marketplace), CP PMN.255 (Medicaid)
Recent label changes: If drug has had a label change within the last 6 months not reflected here, refer to the listed formulary/non-formulary policies
Refer to policies listed in source
Non-formulary drugs: For drugs NOT on the formulary/PDL, refer to non-formulary policy: CP.CPA.190 (commercial), HIM.PA.103 (marketplace), CP PMN.16 (Medicaid)

Applicable Codes

Product and formulationNDC

0.002% ophthalmic solution (20 mcg/mL)

Product availability/formulation as listed (no specific NDC provided)

Provider Actions & Billing Rules

Prior Authorization

Prior authorization required with documentation

Provider must submit documentation supporting that the member has met all approval criteria. Include clinical records demonstrating diagnosis, staging, and response as applicable.

office chart notes
lab results
other clinical information

Documentation Required

Prescriber requirement

Prescription must be written by or in consultation with an ophthalmologist or optometrist. Documentation of the diagnosis stage (stage 2 or 3 neurotrophic keratitis) and the member's response to therapy must be provided for approval and continuation.

Clinical Evidence & References

Evidence sources cited in the policy include the Oxervate Prescribing Information (Dompe; October 2023).

Key trials referenced: Phase II and the pivotal randomized vehicle‑controlled trials (Bonini et al. 2018; Pflugfelder et al. 2020).

Background & Definitions

Background: Cenegermin‑bkbj (Oxervate) is recombinant human nerve growth factor (rhNGF) indicated for neurotrophic keratitis. The policy requires treatment be prescribed by or in consultation with an ophthalmologist or optometrist and documents dosing and duration limits: dosing guidance and product formulation list the ophthalmic solution as 0.002% (20 mcg/mL), with administration limited by policy to a maximum of ≤ 1 vial per affected eye per day and initial approval durations and continued therapy limited so that members have not received ≥ 16 weeks total of Oxervate treatment per affected eye (approval up to a total of 16 weeks and lifetime 2 courses of treatment per affected eye).

Term	Definition
rhNGF	recombinant human nerve growth factor
Stage 2 neurotrophic keratitis	Persistent corneal epithelial defect (PED) typically oval or circular with smooth and rolled edges
Stage 3 neurotrophic keratitis	Corneal stroma involvement with corneal ulceration that may progress to perforation or stromal melting if untreated

Revision History

10.12.22clarified

1Q 2023 annual review clarified maximum treatment duration: member has not received ≥ 16 weeks total of Oxervate treatment per affected eye(s); continued therapy approval limited to lifetime 2 courses per affected eye.

10.24.23added

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

10.22.24administrativeLatest

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