Subject: Oxervate 2869-A SGM P2021

Drug

OXERVATE  (cenegermin-bkbj)

Policy:

I.   INDICATIONS

      The indications below including FDA-approved indications and compendial uses are considered
      a covered benefit provided that all the approval criteria are met and the member has no
      exclusions to the prescribed therapy.

      FDA-Approved Indication
      Oxervate is a recombinant human nerve growth factor indicated for the treatment of
      neurotrophic keratitis.

      All other indications are considered experimental/investigational and not medically necessary.

II.  CRITERIA FOR INITIAL APPROVAL

      Neurotrophic keratitis
      Authorization of 8 weeks total per eye may be granted for treatment of Stage 2 and Stage 3
      neurotrophic keratitis when all of the following criteria are met:
      A.  The member must experience persistent epithelial defects (PED) or corneal ulceration of at
           least 2 weeks duration refractory to one or more conventional non-surgical treatments
           (e.g., preservative free artificial tears).
      B.  There is evidence of decreased corneal sensitivity (less than or equal to 4 cm using the
           Cochet-Bonnet aesthesiometer) within the area of the PED or corneal ulcer and outside of
           the area of the defect in at least one corneal quadrant.
      C.  The member has not received a previous 8 week course of Oxervate in the affected eye.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Oxervate [package insert]. Boston, MA: Dompe U.S. Inc.; October 2019.
2. Evaluation of Safety and Efficacy of rhNGF in Patients With Stage 2 and 3 Neurotrophic Keratitis. (REPARO). Available at: https://clinicaltrials.gov/ct2/show/NCT01756456. Accessed October 19, 2021.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

February 14, 2022