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Flexion Therapeutics Announces Product-Specific J Code (J3304) for ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) Effective January 1, 2019
BURLINGTON, Mass., Nov. 05, 2018 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that the Centers for Medicare and Medicaid Services (CMS) has issued a product-specific J code for ZILRETTA (triamcinolone acetonide extended-release injectable suspension). Under the Healthcare Common Procedure Coding System (HCPCS), the permanent code for ZILRETTA (J3304) will become effective on January 1, 2019, and it will supersede the current Q code (Q9993), which has been in place since July 1, 2018.
“We are very pleased that ZILRETTA will have its own product-specific J code beginning on January 1, 2019,” said Michael Clayman, M.D., President and Chief Executive Officer of Flexion. “Our prescriber base has great familiarity with J codes, and we believe that J3304 will further enhance their confidence regarding reimbursement for ZILRETTA, which can translate into improved access for the millions of people in the U.S. who are seeking effective pain relief from osteoarthritis of the knee.”
J codes are routine reimbursement codes assigned to physician administered “buy and bill” products under Medicare Part B. They are granted by CMS and are utilized by Medicare, commercial insurers and other government payers. Additionally, CMS publishes defined payment rates for each J code, which are determined by the average sales price (ASP) of the product.
Indication and Select Important Safety Information for ZILRETTA
Indication: ZILRETTA is indicated as an intra-articular injection for the management of osteoarthritis pain of the knee. It is not intended for repeat administration.
Contraindication: ZILRETTA is contraindicated in patients who are hypersensitive to triamcinolone acetonide, corticosteroids, or any components of the product.
Warnings and Precautions:
- Intra-articular Use Only: ZILRETTA has not been evaluated and should not be administered by epidural, intrathecal, intravenous, intraocular, intramuscular, intradermal, or subcutaneous routes. ZILRETTA should not be considered safe for epidural or intrathecal administration.
- Serious Neurologic Adverse Reactions with Epidural and Intrathecal Administration: Serious neurologic events have been reported following epidural or intrathecal corticosteroid administration. Corticosteroids are not approved for this use.
- Hypersensitivity reactions: Serious reactions have been reported with triamcinolone acetonide injection. Institute appropriate care if an anaphylactic reaction occurs.
- Joint infection and damage: A marked increase in joint pain, joint swelling, restricted motion, fever and malaise may suggest septic arthritis. If this occurs, conduct appropriate evaluation and if confirmed, institute appropriate antimicrobial treatment.
Adverse Reactions: The most commonly reported adverse reactions (incidence ≥1%) in clinical studies included sinusitis, cough, and contusions.
Please see ZilrettaLabel.com for full Prescribing Information.
On October 6, 2017, ZILRETTA was approved by the U.S. FDA as the first and only extended-release intra-articular therapy for patients confronting osteoarthritis-related knee pain. ZILRETTA employs proprietary microsphere technology combining triamcinolone acetonide — a commonly administered, short-acting corticosteroid — with a poly lactic-co-glycolic acid (PLGA) matrix to provide extended pain relief over 12 weeks.
About Osteoarthritis (OA) of the Knee
OA, also known as degenerative joint disease, affects more than 30 million Americans and accounts for more than $185 billion in annual expenditures. In 2016, more than 15 million Americans were diagnosed with OA of the knee and the average age of physician-diagnosed knee OA has fallen by 16 years, from 72 in the 1990s to 56 in the 2010s. The prevalence of OA is expected to continue to increase as a result of aging, obesity and sports injuries. Each year, more than 15 million Americans are treated for OA-related knee pain, and approximately five million OA patients receive either an immediate-release corticosteroid or hyaluronic acid intra-articular injection to manage their knee pain.
About Flexion Therapeutics
Flexion Therapeutics (Nasdaq:FLXN) is a biopharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with osteoarthritis, a type of degenerative arthritis. The company's core values are focus, ingenuity, tenacity, transparency and fun. For the past two years, Flexion has been named one of the Best Places to Work by the Boston Business Journal, and Flexion was also recognized as a Top Place to Work in Massachusetts by The Boston Globe in 2017.
This release contains forward-looking statements that are based on the current expectations and beliefs of Flexion. Statements in this release regarding matters that are not historical facts, including, but not limited to, statements relating to the future of Flexion; ZILRETTA’s market potential; expected increases in the prevalence of OA of the knee; the potential therapeutic and other benefits of ZILRETTA; and the impact of the J code for ZILRETTA on the processing timelines and reimbursement rates for Medicare, commercial insurers and other governmental payers, are forward-looking statements. These forward-looking statements are based on management's expectations and assumptions as of the date of this release and are subject to numerous risks and uncertainties which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, the risk that a dedicated J code for ZILRETTA may not result in faster adjudication of claims; risks associated with commercializing new pharmaceutical products; risks regarding our ability to obtain adequate reimbursement from payers for ZILRETTA; risks related to the manufacture and distribution of ZILRETTA, including our reliance on sole sources of supply and distribution; risks related to key employees, markets, economic conditions, health care reform, prices and reimbursement rates; the risk that we may use our capital resources in ways that we do not currently expect; and other risks and uncertainties described in our filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2018 filed with the SEC on August 7, 2018 and subsequent filings with the SEC. The forward-looking statements in this release speak only as the date of this release, and we undertake no obligation to update or revise any of the statements. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.
Vice President, Corporate Communications & Investor Relations
Flexion Therapeutics, Inc.
Manager, Corporate Communications
Flexion Therapeutics, Inc.