XIPERE (triamcinolone acetonide injectable suspension)

XIPERE (triamcinolone acetonide injectable suspension)

Office Administration - suprachoroidal injection

Diagnosis considered for coverage:

For macular edema associated with uveitis:

• Dose does not exceed a single 4 mg (0.1 mL) suprachoroidal injection per affected eye given every 12 weeks; AND
• Prescribed by or in consultation with an ophthalmologist; AND
• Diagnosis of macular edema related to uveitis is confirmed by one of the following tests:
  • Slit lamp exam
  • Funduscopic exam
  • Fluorescein angiography
  • Optical coherence tomography (OCT); AND
• Medical records do not show evidence of current ocular or peri-ocular infections (e.g. ocular herpes simplex, cytomegalovirus, toxoplasmosis, etc.); AND
• Medical records do not show evidence of current, untreated intraocular pressure or uncontrolled glaucoma; AND
• Trial and failure, contraindication or intolerance to at least one other systemic or intraocular corticosteroid (e.g., methylprednisolone, prednisolone, prednisone, triamcinolone, Ozurdex, etc.); AND
• A medically appropriate reason is provided why the patient cannot use generic triamcinolone acetonide intravitreal injections to treat their condition; AND
• Patient has not received any of the following sustained-release intravitreal corticosteroid implants within the following time periods:
  • Dexamethasone intravitreal implant (Ozurdex) within the past 6 months
  • Fluocinolone acetonide intravitreal implant (Retisert) within the past 30 months
  • Fluocinolone acetonide intravitreal implant (Iluvien, Yutiq) within the past 36 months.

Reauthorization Criteria:

For macular edema associated with uveitis:

• Dose does not exceed a single 4 mg (0.1 mL) suprachoroidal injection per affected eye given every 12 weeks; AND
• Documentation of positive clinical response to therapy (e.g., improvement in Best Corrected Visual Acuity, stable vision, etc.)

Coverage Duration:

Initial: 1 year

Reauthorization: 1 year

Authorization is not covering for the following:

• The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• Uveitis can be categorized as anterior, intermediate, posterior, or panuveitis based on the primary anatomical location of inflammation.
• Xipere is the first product to receive Food and Drug Administration (FDA) approval for injection into the suprachoroidal space (SCS) and the first therapy approved for ME associated with uveitis.
• Xipere is a sterile, preservative-free, injectable suspension of triamcinolone acetonide, a synthetic corticosteroid for use with the SCS Microinjector^®, a piston syringe and a needle approximately 1 mm in length (900 µm and 1100 µm needles are included) for conducting the suprachoroidal injection.

Policy Updates:

• 05/17/2022 – New policy approved by P&T.

References:

1. Haghjou, N., Soheilian, M., et al. Sustained Release Intracoular Drug Delivery Devices for Treatment of Uveitis. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3306122/. Accessed December 19, 2021.
2. Henry CR, Shah M, Barakat MR, Dayani P, Wang RC, Khurana RN, Rifkin L, Yeh S, Hall C, Ciulla T. Suprachoroidal CLS-TA for non-infectious uveitis: An open-label, safety trial (AZALEA). British Journal of Ophthalmology. 2021 Feb 5.
3. Khurana RN, Merrill P, Yeh S, Suhler E, Barakat MR, Uchiyama E, Henry CR, Shah M, Wang RC, Kapik B, Ciulla T. Extension study of the safety and efficacy of CLS-TA for treatment of macular oedema associated with non-infectious uveitis (MAGNOLIA). British Journal of Ophthalmology. 2021 Mar 12.
4. Koronis, S., Stavrakas, P., et al. Update in Treatment of Uveitic Macular Edema. Available at https://www.dovepress.com/update-in-treatment-of-uveitic-macular-edema-peer-reviewed-fulltext-article-DDDT. Accessed December 19, 2021.
5. National Organization for Rare Disorders. Posterior Uveitis. Available at https://rarediseases.org/rare-diseases/posterior-uveitis/. Acessed December 19, 2021
6. Xipere Prescribing Information. Clearside Biomedical, Inc. Alpharetta, GA. October 2021.
7. Yeh S, Khurana RN, Shah M, Henry CR, Wang RC, Kissner JM, Ciulla TA, Noronha G, PEACHTREE Study Investigators. Efficacy and safety of suprachoroidal CLS-TA for macular edema secondary to noninfectious uveitis: phase 3 randomized trial. Ophthalmology. 2020 Jul 1;127(7):948-55.
8. Yeh S, Kurup SK, Wang RC, Foster CS, Noronha G, Nguyen QD, Do DV, DOGWOOD Study Team. Suprachoroidal injection of triamcinolone acetonide, CLS-TA, for macular edema due to noninfectious uveitis: a randomized, phase 2 study (DOGWOOD). Retina. 2019 Oct 1;39(10):1880-8.