Last Review Date: 06/04/2024

Date of Origin: 12/02/2021

Dates Reviewed: 12/2021, 04/2022, 07/2022, 09/2022, 08/2023, 06/2024

1. Length of Authorization

Coverage will be provided for 12 weeks and may be renewed.

2. Dosing Limits

A. Quantity Limit (max daily dose) [NDC Unit]:

• Xipere 36 mg/0.9 mL (40 mg/mL concentration) single-dose vial: 2 vials every 12 weeks

B. Max Units (per dose and over time) [HCPCS Unit]:

• 72 billable units (72 mg; 2 vials) every 12 weeks

(Quantity Limits/Max Units are based on administration to BOTH eyes)

3. Initial Approval Criteria

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND

Universal Criteria ^1,3

• Patient is free of ocular and periocular infections, including but not limited to, active epithelial herpes simplex keratitis; AND
• Patient has not received any of the following sustained-release corticosteroids in the same eye:
  • Dexamethasone intravitreal implant – within the prior 4 months (i.e., Ozurdex®)
  • Dexamethasone intracanalicular insert – within the prior 30 days (i.e., Dextenza®)
  • Fluocinolone acetonide intravitreal implant – within the prior 30 months (i.e., Retisert®) or 36 months (i.e., Iluvien®/Yutiq™); AND
• Patient’s best corrected visual acuity (BCVA) is measured at baseline and periodically during treatment; AND
• Patient does not have untreated intraocular pressure or uncontrolled glaucoma; AND

Macular Edema † ^1-3

• Patient has macular edema related to a diagnosis of non-infectious uveitis (pan, anterior, intermediate, and/or posterior)

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ¹

Coverage can be renewed based upon the following criteria:

• Patient continues to meet the universal and indication-specific relevant criteria as identified in section III; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: cataracts, increase in intraocular pressure, glaucoma, alterations in endocrine function (e.g., hypothalamic-pituitary-adrenal [HPA] axis suppression, Cushing’s syndrome, hyperglycemia), etc.; AND
• Disease response as indicated by stabilization of visual acuity or improvement in best-corrected visual acuity (BCVA) score when compared to baseline.

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS code:

• J3299 – Injection, triamcinolone acetonide (xipere), 1 mg; 1 billable unit = 1 mg

NDC:

• Xipere 36 mg/0.9 mL (40 mg/mL concentration) injectable suspension single-dose vial: 24208-0040-xx

7. References

1. Xipere [package insert]. Bridgewater, NJ; Bausch & Lomb Americas Inc.; September 2022. Accessed May 2024.
2. Yeh S, Kurup SK, Wang RC, et al for the DOGWOOD Study Team. Suprachoroidal injection of triamcinolone acetonide, CLS-TA, for macular edema due to noninfectious uveitis - A Randomized, Phase 2 Study (DOGWOOD). Retina: Oct2019;39,10;1880-1888. doi: 10.1097/IAE.0000000000002279.
3. Yeh S, Khurana RN, Shah M, et al; PEACHTREE Study Investigators. Efficacy and Safety of Suprachoroidal CLS-TA for Macular Edema Secondary to Noninfectious Uveitis: Phase 3 Randomized Trial. Ophthalmology. 2020 Jul;127(7):948-955. doi: 10.1016/j.ophtha.2020.01.006.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A