Pharmacy Prior Authorization Criteria

Oxervate (cenegermin-bkbj) - PA, QL

Indications for Prior Authorization

Oxervate (cenegermin-bkbj)

• For diagnosis of Neurotrophic Keratitis (NK)
  Indicated for the treatment of neurotrophic keratitis (NK).

Criteria

Oxervate

*Initial authorization maximum coverage is limited to one 8-week approval. Oxervate is hard-coded with a quantity limit of 112 mL per lifetime.

Prior Authorization (Initial Authorization)

Length of Approval: 8 weeks*

• Diagnosis of neurotrophic keratitis
AND
• Trial and failure or intolerance to at least one over-the-counter ocular lubricant used at an optimal dose and frequency for at least two weeks (e.g., artificial tears, lubricating gels/ointments, etc.) [3]
AND
• Prescribed by or in consultation with an ophthalmologist

Oxervate

*Reauthorization maximum coverage is limited to one 8-week approval. Oxervate is hard-coded with a quantity limit of 112 mL per lifetime. Subsequent request will be denied for off-label

Prior Authorization (Reauthorization)

Length of Approval: One 8-Week Approval*

• One of the following:
• Both of the following:
• Provider attests patient is being treated for disease recurrence (e.g., new corneal damage following prior corneal healing)
AND
• Provider attests patient has not experienced treatment failure (e.g., patient has not experienced corneal healing after a previous course of Oxervate)
OR
• Provider attests treatment is for an eye that has not previously been treated with Oxervate

Oxervate

*Requests will be denied off-label.

Quantity Limit*

• Requests for additional quantity will not be approved

P & T Revisions

2024-07-11, 2023-05-03, 2022-09-13, 2022-09-07, 2022-04-11, 2021-11-30, 2021-04-22, 2020-04-09

References

1. Oxervate Prescribing Information. Dompe U.S. Inc. Boston, MA. October 2023.
2. FDA Medical Review: Oxervate. Drugs at FDA Web site. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761094Orig1s000MedR.pdf. Accessed April 1, 2021.
3. Per clinical consult with ophthalmologist, December 12, 2018.

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Revision History

• 2024-07-11: Annual review: No criteria changes. Updated references.
• 2023-05-03: Annual review: No criteria changes. Updated operational notes.
• 2022-09-13: Updated criteria
• 2022-09-07: Updated criteria
• 2022-04-11: Annual review: No criteria changes, updated references.
• 2021-11-30: Updated criteria to indicate "Treatment duration of Oxervate has NOT exceeded the Food and Drug Administration (FDA)-approved maximum of 8 weeks (per affected eye).” There is no adequate evidence indicating that additional treatment would be required or effective.
• 2021-04-22: Annual Review
• 2020-04-09: Annual Review

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