CurrentMass General Brigham Health PlanPolicy N/A

Oxervate (cenegermin-bkbj) — Prior Authorization, Quantity Limits, and Specialty Pharmacy Requirements

This policy governs prior authorization, quantity limits, and specialty pharmacy requirements for Oxervate (cenegermin-bkbj) for treatment of neurotrophic keratitis for Mass General Brigham Health Plan members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyOxervate (cenegermin-bkbj) — Prior Authorization, Quantity Limits, and Specialty Pharmacy Requirements

Policy CodePolicy N/A

Change TypeRevised

Effective DateMar 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document age, diagnosis of neurotrophic keratitis, and failure of one conventional non-surgical therapy.

SourceLink

POLICY UPDATE CHANGES

Updated language for members who are new to the plan regarding authorization for ongoing treatment.

8 weeksmaximum treatment duration authorized

4 boxesquantity limit per eye per 28 days

≥2 yrsminimum member age

90 daysnew-member lookback

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Initial Authorization

Covered when ALL of the following are met:

Oxervate authorization criteria: Member is ≥ 2 years of age

Oxervate authorization criteria: Documented diagnosis of neurotrophic keratitis

Oxervate authorization criteria: Medication is prescribed by a specialist

Oxervate authorization criteria: Member has had treatment failure with one conventional non-surgical treatment for neurotrophic keratitis (e.g., preservative-free artificial tears or ointments/gels)

Treatment courses limited to 8 weeks per eye; quantity limits apply (4 boxes per eye per 28 days).

Authorization exclusions: products obtained only as samples or via the manufacturer's patient assistance programs are excluded from consideration for continued authorization under the new-member provision. This means members new to the plan within the past 90 days who are receiving therapy will not have those supplies considered for coverage if the medication was provided solely as samples or through the manufacturer assistance program.

Use beyond an 8-week course per eye is not supported by this policy. In addition, the policy applies a quantity limit of 4 boxes per eye per 28 days; requests that exceed these limits are not authorized.

Coding and Quantity Limits

Codes (not specified)mixed

No explicit CPT/HCPCS/ICD codes listed in document

inv-05: Quantity limit — 4 boxes per eye per 28 days

Quantity limit4 boxes per eye per 28 days

Measurement periodPer 28 days

ScopeLimit applies per eye (not per patient)

inv-06: Treatment duration — Limit to 8 weeks per eye

Maximum treatment duration8 weeks per eye

Authorization unitPer eye course

Policy noteUse beyond an 8-week course per eye is not supported by this policy

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Members who are new to the plan within the past 90 days and are currently receiving Oxervate may be authorized to continue therapy (does not apply to samples or medications obtained via manufacturer patient assistance programs).

Applies to Commercial/Exchange and MassHealth UPPL as specified by the plan
Contact specialty pharmacy for prior authorization: Phone 877-519-1908; Fax 855-540-3693

Step Therapy

Step Therapy Requirement

Provider must document failure of one conventional non-surgical treatment for neurotrophic keratitis prior to authorization.

Examples of conventional non-surgical treatments: preservative-free artificial tears, ocular ointments or gels
Step therapy requirement applies before initial authorization

Documentation Required

Required Documentation

Documentation must include the member's age, a documented diagnosis of neurotrophic keratitis, and evidence of treatment failure with one conventional therapy.

Include member age (must be ≥ 2 years)
Include clinical notes or history demonstrating failure of one conventional non-surgical treatment
Specify prior treatments tried (e.g., preservative-free artificial tears, ointments/gels)

Denial Risk

Denial Triggers

Authorization may be denied if the member is under 2 years of age, does not have a documented diagnosis of neurotrophic keratitis, or does not meet the step therapy or other plan exclusion criteria.

Denial triggers: age < 2 years, no documented neurotrophic keratitis, lack of documented failure of one conventional therapy
Medications obtained only as samples or via manufacturer assistance do not qualify for continuity-of-care authorization

Revision History

2019-11-20review

Policy reviewed by Pharmacy & Therapeutics (P&T)

2019-11-25review_approval

Reviewed and approved by DCC

2020-01-22approval

Approved at P&T meeting

2022-09-21review

Reviewed at September P&T; administrative separation of Commercial/Exchange vs Medicare/Health policies with no clinical updates documented

2024-12-11revisionLatest

Reviewed at December P&T and updated language clarifying authorization for members new to the plan who are currently receiving treatment; effective date set for 2025-03-01