Ophthalmic Riboflavin (Photrexa, Photrexa Viscous) Form

Photrexa® and Photrexa® Viscous are topical ophthalmic photoenhancers. FDA Approved Indication(s) Photrexa and Photrexa Viscous are indicated for use in corneal collagen cross-linking in combination with the KXL™ System for the treatment of: • Progressive keratoconus
• Corneal ectasia following refractive surgery
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 Photrexa and Photrexa Viscous are medically necessary when the following criteria are met:
I. Initial Approval CriteriaApproval of the drug does not translate to an approval of the corneal cross linking procedure
A. Progressive Keratoconus and Corneal Ectasia (must meet all):

1. Diagnosis of one of the following (a or b): a. Progressive keratoconus;
   b. Corneal ectasia following refractive surgery;
2. Prescribed by or in consultation with an ophthalmologist;
   3. Age ≥ 14 years;
   4. Dose does not exceed one kit per eye. Approval duration: 6 months (up to one kit per eye) B. Other diagnoses/indications (must meet 1 or 2):

3. 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: Page 1 of 5

   CLINICAL POLICY Ophthalmic Riboflavin CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

4. 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.
   II. Continued TherapyApproval of the drug does not translate to an approval of the corneal cross linking procedure
   A. Progressive Keratoconus and Corneal Ectasia (must meet all):
5. 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);
6. At least 6 months have passed since member’s last collagen cross linking procedure;
   3. Member is responding positively to therapy as evidenced by a reduction in diopters in the treated eye(s);
7. If request is for a dose increase, new dose does not exceed one kit per eye. Approval duration: 6 months (up to one kit per eye) B. Other diagnoses/indications (must meet 1 or 2):
8. 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

9. 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.
   Page 2 of 5

   CLINICAL POLICY Ophthalmic Riboflavin IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives
   Not applicable Appendix C: Contraindications/Boxed Warnings None reported V. Dosage and Administration
   Drug Name Dosing Regimen Riboflavin 5’- phosphate in 20% dextran ophthalmic solution) 0.146% for topical ophthalmic use (Photrexa Viscous) Riboflavin 5’- phosphate ophthalmic solution) 0.146% for topical ophthalmic use (Photrexa) Dosage and Administration, Section 2: Prescribing Information: • Debride the epithelium using standard aseptic technique using topical anesthesia.
   • Then instill 1 drop of Photrexa Viscous topically on the eye every 2 minutes for 30 minutes.
   • After 30 minutes, examine the eye under slit lamp for presence of a yellow flare in the anterior chamber. If flare is not detected, instill 1 drop of Photrexa Viscous every 2 minutes for an additional 2 to 3 drops and recheck for yellow flare. Repeat as necessary.
   • Once flare is observed, perform ultrasound pachymetry. If corneal thickness is less than 400 microns, instill 2 drops of Photrexa every 5 to 10 seconds until the corneal thickness increases to at least 400 microns.
   Irradiation should not be performed unless this 400 micron threshold is met and the yellow flare is seen. • Maximum Dose See dosing regimen VI. Product Availability
   Cross-linking kit: containing the following components for use with the KXL® System: • Riboflavin 5’-phosphate ophthalmic solution 0.146% for topical ophthalmic use (Photrexa) • Riboflavin 5’-phosphate in 20% dextran ophthalmic solution 0.146% for topical ophthalmic use (Photrexa Viscous) Page 3 of 5

   CLINICAL POLICY Ophthalmic Riboflavin VII.