OXERVATE, Cenegermin-bkbj Form

Cenegermin-bkbj (Oxervate™) is recombinant human nerve growth factor (rhNGF). FDA Approved Indication(s) Oxervate is indicated for the treatment of neurotrophic keratitis. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Oxervate is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Neurotrophic Keratitis (must meet all):

1. Diagnosis of stage 2 or 3 neurotrophic keratitis (see Appendix D);
   2. Prescribed by or in consultation with an ophthalmologist or optometrist;
   3. Age ≥ 2 years;
   4. Dose does not exceed 1 vial per affected eye per day. Approval duration: 8 weeks B. Other diagnoses/indications (must meet 1 or 2):
2. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

3. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line Page 1 of 5

   CLINICAL POLICY Cenegermin-bkbj of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Neurotrophic Keratitis (must meet all):

4. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
   2. Member is responding positively to therapy;
   3. Member has not received ≥ 16 weeks total of Oxervate treatment per affected eye(s);
   4. If request is for a dose increase, new dose does not exceed 1 vial per affected eye per day.
      Approval duration: Up to a total of 16 weeks (lifetime 2 courses of treatment per affected eye) B. Other diagnoses/indications (must meet 1 or 2):
5. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

6. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents.
   IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration rhNGF: recombinant human nerve growth factor Page 2 of 5

   CLINICAL POLICY Cenegermin-bkbj Appendix B: Therapeutic Alternatives Not applicable
   Appendix C: Contraindications/Boxed Warnings None reported Appendix D: General Information • Definitions of neurotrophic keratitis stages 1-3:
   o Stage 1: Punctate keratopathy and/or corneal epithelial hyperplasia and irregularity. o Stage 2: Persistent corneal epithelial defect (PED), typically oval or circular in shape, with smooth and rolled edges. o Stage 3: Corneal stroma and a corneal ulcer is observed. Corneal ulceration tends to progress to perforation and/or stromal melting if not promptly and properly treated. V. Dosage and Administration
   Indication Neurotrophic keratitis Dosing Regimen 1 drop in the affected eye every 2 hours six times a day for 8 weeks Maximum Dose 6 drops per affected eye per day VI. Product Availability
   Ophthalmic solution: 0.002% (20 mcg/mL) VII.