Subject: Oxervate 2869-A SGM P2023a

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 16 weeks (8 weeks total therapy 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 (e.g., cotton swab method, Cochet-
               Bonnet contact aesthesiometer, CRCERT-Belmonte non-contact 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 2023.
2. Bonini S, Lambiase A, Rama P, et al. Phase II randomized, double-masked, vehicle-controlled trial of recombinant human nerve growth factor for neurotrophic keratitis. Opthalmol. 2018;125(9):1332-433.
3. Bunya VY, Woodward MA, Rabiolo A, et al. Neurotrophic Keratitis. Neurotrophic Keratitis. American Academy of Ophthalmology. Published December 30, 2021. Available at: https://eyewiki.aao.org/Neurotrophic_Keratitis. Accessed October 12, 2023.

 

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.

September 29, 2024