Harrow announced earlier this week that the Centers for Medicare & Medicaid Services (CMS) has approved TRIESENCE (triamcinolone acetonide injectable suspension) 40 mg/mL for transitional pass-through reimbursement.
Refresh me on TRIESENCE.
TRIESENCE is a preservative-free (PF) synthetic corticosteroid indicated for visualization during vitrectomy and to treat ocular inflammatory conditions that are unresponsive to topical corticosteroids, including:
- Sympathetic ophthalmia
- Temporal arteritis
- Uveitis
The recommended dosage for those indications: 4 mg (100 microliters of 40 mg/mL suspension) with subsequent dosage as needed over the course of treatment.
The recommended dosage for just its visualization indication: 1 to 4 mg (25 to 100 microliters of 40 mg/mL suspension), administered intravitreally.
Talk about its regulatory background.
The corticosteroid was originally FDA-approved in 2007 (under Alcon ownership) before being acquired by Novartis in 2010 and, more recently, Harrow in 2023.
Its commercial availability: TRIESENCE was re-launched across the United States by Harrow in October 2024 after years of supply issues—including its placement on the FDA Drug Shortage List and 2 years of inventory depletion. See the “why” behind this here.
Now to this new status. Explain, please.
Granted by CMS for newly-approved drugs, biologics, and devices, a transitional pass-through reimbursement status provides additional payments for such products that demonstrate substantial clinical improvements over existing technologies.
- This recognizes that cost considerations may otherwise limit patient access and, essentially, ensures Medicare beneficiaries have access to such treatments.
- The duration: Ranges from at least 2 years and not beyond 3 years while CMS gathers additional data on the cost of the new treatment.
Got it. And in the case of TRIESENCE?
TRIESENCE will be eligible for separate reimbursement aside from the surgical bundled payment available in the Ambulatory Surgical Center (ASC) and Hospital Outpatient Department (HOPD) settings of care, according to Harrow.
Specifically: Moving forward, CMS will separately reimburse TRIESENCE at the average sales price (ASP; the average price it will be sold for over a specific period of time) plus 6% in both aforementioned settings.
- The time period for this: Starting on April 1, 2025—and extending for 3 years.
So what does this mean?
In terms of reimbursement, TRIESENCE will now be “the only (PF) synthetic corticosteroid with separate reimbursement” in all traditional clinical care settings:
- In-office
- ASC
- HOPD
Keep in mind: The therapeutic was previously granted a permanent, product-specific J-code to allow its reimbursement in eyecare professionals’ (ECPs’) offices.
- That code: J330
And where can it be ordered?
As we previously reported, TRIESENCE is available for direct purchase through major pharmaceutical specialty distributors (see here).
As Harrow noted: TRIESENCE is currently listed under both NDC 00078-0897-78 and NDC 82667-0800-01.
See here for more details on ordering.