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ph-0633

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Xipere® (triamcinolone acetonide injectable suspension)

Policy Number: PH-0633

Suprachoroidal

Last Review Date: 09/01/2022

Date of Origin: 12/02/2021

Dates Reviewed: 12/2021, 04/2022, 07/2022, 09/2022

FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.

  1. Length of Authorization

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

  1. Dosing Limits

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

  • Xipere 40 mg/mL single-dose vial: 2 vials every 12 weeks

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

  • 8 billable units (8 mg) every 12 weeks

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

  1. Initial Approval Criteria

Coverage is provided in the following conditions:

  • Patient is at least 18 years of age; AND

Universal Criteria 1

  • 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 intravitreal corticosteroids:
    • Dexamethasone – within the prior 4 months (i.e., Ozurdex®)
    • Fluocinolone acetonide – 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

  1. 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.
  1. Dosage/Administration

Indication

Dose

Macular Edema secondary to non-infectious uveitis

Administer Xipere (triamcinolone acetonide injectable suspension) as a suprachoroidal injection using the SCS Microinjector®.

The recommended dose of Xipere is 4 mg (0.1 mL of the 40 mg/mL injectable suspension) and may be repeated every 12 weeks.
  1. Billing Code/Availability Information

HCPCS code:

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

NDC:

  • Xipere 40 mg/mL injectable suspension single-dose vial: 71565-0040-xx
  1. References
  1. Xipere [package insert]. Alpharetta, GA; Clearside Biomedical, Inc; October 2021. Accessed July 2022.
  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. Efficacy and Safety of Suprachoroidal CLS-TA for Macular Edema Secondary to Noninfectious Uveitis: Phase 3 Randomized Trial. Yeh S, Khurana RN, Shah M, Henry CR, Wang RC, Kissner JM, Ciulla TA, Noronha G, PEACHTREE Study Investigators Ophthalmology, 127(7):948-955, 10 Jan 2020

Appendix 1 – Covered Diagnosis Codes

ICD-10

Diagnosis

H30.001

Unspecified focal chorioretinal inflammation right eye

H30.002

Unspecified focal chorioretinal inflammation left eye

H30.003

Unspecified focal chorioretinal inflammation bilateral

H30.009

Unspecified focal chorioretinal inflammation unspecified eye

H30.011

Focal chorioretinal inflammation, juxtapapillary right eye

H30.012

Focal chorioretinal inflammation, juxtapapillary left eye

H30.013

Focal chorioretinal inflammation, juxtapapillary bilateral

H30.019

Focal chorioretinal inflammation, juxtapapillary unspecified eye

H30.021

Focal chorioretinal inflammation of posterior pole right eye

H30.022

Focal chorioretinal inflammation of posterior pole left eye

H30.023

Focal chorioretinal inflammation of posterior pole bilateral

H30.029

Focal chorioretinal inflammation of posterior pole unspecified eye

H30.031

Focal chorioretinal inflammation, peripheral right eye

H30.032

Focal chorioretinal inflammation, peripheral left eye

H30.033

Focal chorioretinal inflammation, peripheral bilateral

H30.039

Focal chorioretinal inflammation, peripheral unspecified eye

H30.041

Focal chorioretinal inflammation, macular or paramacular right eye

H30.042

Focal chorioretinal inflammation, macular or paramacular left eye

H30.043

Focal chorioretinal inflammation, macular or paramacular bilateral

H30.049

Focal chorioretinal inflammation, macular or paramacular unspecified eye

H30.101

Unspecified disseminated chorioretinal inflammation right eye

H30.102

Unspecified disseminated chorioretinal inflammation left eye

H30.103

Unspecified disseminated chorioretinal inflammation bilateral

H30.109

Unspecified disseminated chorioretinal inflammation unspecified eye

H30.111

Disseminated chorioretinal inflammation of posterior pole right eye

H30.112

Disseminated chorioretinal inflammation of posterior pole left eye

H30.113

Disseminated chorioretinal inflammation of posterior pole bilateral

H30.119

Disseminated chorioretinal inflammation of posterior pole unspecified eye

H30.121

Disseminated chorioretinal inflammation, peripheral right eye

H30.122

Disseminated chorioretinal inflammation, peripheral left eye

H30.123

Disseminated chorioretinal inflammation, peripheral bilateral

H30.129

Disseminated chorioretinal inflammation, peripheral unspecified eye

H30.131

Disseminated chorioretinal inflammation, generalized right eye

H30.132

Disseminated chorioretinal inflammation, generalized left eye

H30.133

Disseminated chorioretinal inflammation, generalized bilateral

H30.139

Disseminated chorioretinal inflammation, generalized unspecified eye

H30.90

Unspecified chorioretinal inflammation unspecified eye

H30.91

Unspecified chorioretinal inflammation right eye

H30.92

Unspecified chorioretinal inflammation left eye

H30.93

Unspecified chorioretinal inflammation bilateral

H35.81

Retinal edema

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

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 Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.

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

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC

 

 

 

XIPERE™ (triamcinolone acetonide injectable suspension)

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