Triamcinolone Acetonide Injectable Suspension (Xipere)

Number: 1000

Table Of Contents

Policy
Applicable CPT / HCPCS / ICD-10 Codes
Background
References


Policy

Scope of Policy

This Clinical Policy Bulletin addresses triamcinolone acetonide injectable suspension (Xipere) for commercial medical plans. For Medicare criteria, see Medicare Part B Criteria.

 

  1. Criteria for Initial Approval

    Macular edema associated with uveitis

    Aetna considers triamcinolone acetonide injectable suspension (Xipere) medically necessary for the treatment of macular edema associated with uveitis when all of the following criteria are met:

    1. The member has a diagnosis of macular edema associated with uveitis; and
    2. The member does not have infectious uveitis; and
    3. The member will not exceed a dose of 4 mg (0.1 mL) administered as a suprachoroidal injection per eye into the affected eye(s).

    Aetna considers all other indications as experimental, investigational, or unproven.

  2. Continuation of Therapy

    Aetna considers continuation of triamcinolone acetonide injectable suspension (Xipere) therapy medically necessary for an indication listed in Section I when the member meets all initial medical necessity selection criteria and has demonstrated a positive clinical response to therapy (e.g., improvement or maintenance in best corrected visual acuity [BCVA] or visual field, reduction or maintenance in central subfield thickness (CST), a reduction in the rate of vision decline or the risk of more severe vision loss, reduction in inflammation).

Dosage and Administration

Triamcinolone acetonide injectable suspension is available as Xipere 40 mg/mL in a single-dose vial.

Macular Edema Associated with Uveitis

The recommended dosage is 4 mg (0.1 mL) administered as a suprachoroidal injection.

Source: Bausch & Lomb Americas, 2022


Table:

CPT Codes / HCPCS Codes / ICD-10 Codes

Code Code Description

Information in the [brackets] below has been added for clarification purposes.   Codes requiring a 7th character are represented by "+" :

Other CPT codes related to the CPB:

0465T Suprachoroidal injection of a pharmacologic agent (does not include supply of medication)

HCPCS codes covered if selection criteria are met:

J3299 Injection, triamcinolone acetonide (xipere), 1 mg

ICD-10 codes covered if selection criteria are met:

H35.81 Retinal edema

ICD-10 codes not covered if selection criteria are met:

H20.031 – H20.039 Secondary infectious iridocyclitis

Background

U.S. Food and Drug Administration (FDA)-Approved Indications 

Xipere is a corticosteroid indicated for the treatment of macular edema associated with uveitis.

Triamcinolone acetonide injectable suspension is available as Xipere (Cleaside Biomedical, Inc.) which is a sterile, preservative-free, injectable suspension for use with the SCS Microinjector. Triamcinolone acetonide functions primarily as a corticosteroid hormone receptor agonist with immunosuppressive and anti-inflammatory activity (Clearside Biomedical, 2021).

According to the prescribing information, triamcinolone acetonide injectable suspension (Xipere) carries the following contraindications:

  • Ocular or periocular infections
  • Hypersensitivity to triamcinolone or any component of this product.

Per the prescribing information, warnings and precautions include the following:

  • Potential corticosteroid-related effects: Use of corticosteroids may produce cataracts, increased intraocular pressure, and glaucoma.
  • Alteratiions in endocrine function: Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and hyperglycemia can occur following administration of a corticosteroid. 

Per the prescribing information, the most common adverse reactions (≥10%), in controlled studies and at a rate greater than control, included elevated intraocular pressure and eye pain.

On October 25, 2021, the United States Food and Drug Administration (FDA) approved Xipere (triamcinolone acetonide injectable suspension) for suprachoroidal use for the treatment of macular edema associated with uveitis. The FDA approval of Xipere was based on supporting data from the PEACHTREE pivotal study. 

Yeh and Shah (2020) evaluated the efficacy and safety of Xipere in the PEACHTREE sudy, a 6-month pivotal phase 3 randomized, multicenter, double-masked, sham-controlled trial, consisting of 160 participants with macular edema (ME) secondary to noninfectious uveitis (i.e., anterior-, intermediate-, posterior-, or pan-uveitis). Additionally, participants were required to have a best-corrected visual acuity (BCVA) of 5 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters  (Snellen equivalent, 20/800) and 70 or fewer ETDRS letters read (Snellen equivalent, 20/40 ) in the sudy eye. The participants were randomized 3:2 to suprachoroidally injected triamcinolone acetonide formulation (CLS-TA) 4 mg, which was supsension of triamcinolone acetonide, or sham treatment, with administrations at day 0 and week 12. The primary efficacy outcome was improvement from baseline in BCVA by ≥ 15 letters after 24 weeks of follow up. The secondary efficacy outcome was reduction from baseline in central subfield thickness (CST) after 24 weeks. The results were as follow: 47% of participants gained 15 or more ETDRS letters in BCVA in the CLS-TA arm and 16% in the control arm (p<0.001), meeting the primary endpoint, and mean reductions in CST from baseline were 153 μm versus 18μm (p<0.001), respectively. There was an absence of serious adverse events (AEs) related to treatment. Corticosteroid-associated AEs of elevated intraocular pressure were noted in 11.5% and 15.6% of the CLS-TA and control arms, and cataract AE occurrence was comparable as 7.3% and 6.3%, respectively. The study investigators concluded that participants in the CLS-TA study arm demonstrated clinically significant improvement in vision relative to the sham procedure, thereby, supporting the efficacy of suprachoroidal injection of CLS-TA for the treatment of ME in a vision-threatening disorder.

Thomas et al (2022) stated that macular edema due to non-infectious uveitis is a sight-threatening complication that is routinely treated with corticosteroids.  Triamcinolone acetonide injectable suspension for supra-choroidal use (Xipere) is an alternative therapeutic option for patients with non-infectious uveitis associated macular edema.  These investigators described the recently FDA-approved triamcinolone acetonide injectable suspension that can be injected into the supra-choroidal space, which allows for therapeutic targeting of the retina and choroid.  The authors concluded that supra-choroidal administration of triamcinolone acetonide has shown improvement in vision and inflammation in studies with non-infectious uveitis associated macular edema.  This unique delivery method suggested the potential to decrease side effects of anterior segment exposure such as glaucoma and cataract, but head-to-head studies are needed for further investigation of safety and effectiveness.  Furthermore, there are promising prospective studies underway for use of the supra-choroidal space for other diseases including macular degeneration, diabetic macular edema (DME), and ocular tumors.


References

The above policy is based on the following references:

  1. Bausch & Lomb Americas Inc. Xipere (triamcinolone acetonide injectable suspension), for suprachoroidal use. Prescribing Information. Bridgewater, NJ: Bausch & Lomb Americas; revised February 2022.
  2. Clearside Biomedical. Bausch + Lomb and Clearside Biomedical announce FDA approval of Xipere (triamcinolone acetonide injectable suspension) for suprachoroidal use for the treatment of macular edema associated with uveitis. News Release. Alpharetta, GA: Clearside Biomedical; October 25, 2021.
  3. Price KW, Albini TA, Yeh S. Suprachoroidal injection of triamcinolone - review of a novel treatment for macular edema caused by noninfectious uveitis. US Ophthalmic Rev. 2020;13(2):76-79.
  4. Thomas J, Kim L, Albini T, Yeh S. Triamcinolone acetonide injectable suspension for suprachoroidal use in the treatment of macular edema associated with uveitis. Expert Rev Ophthalmol. 2022;17(3):165-173.
  5. Yeh S, Ciulla T. Suprachoroidal triamcinolone acetonide injectable suspension for macular edema associated with noninfectious uveitis: An in-depth look at efficacy and safety. Am J Manag Care. 2023;29(2 Suppl):S19-S28.
  6. Yeh S, Henry CR, Kapik B, Ciulla TA. Triamcinolone acetonide suprachoroidal injectable suspension for uveitic macular edema: Integrated analysis of two phase 3 studies. Ophthalmol Ther. 2023;12(1):577-591.
  7. Yeh S, Khurana RN, Shah M, et al. Efficacy and safety of suprachoroidal CLS-TA for macular edema secondary to noninfectious uveitis: Phase 3 randomized trial. Ophthalmology. 2020;127(7):948-955.