Melinta Therapeutics announced expanded reimbursement and access for REZZAYO (rezafungin for injection). REZZAYO, the first new treatment option approved for adult patients with candidemia and invasive candidiasis in over a decade, has been commercially available in the U.S. since July. The Centers for Medicare & Medicaid Services (CMS) issued a permanent product-specific J-Code (J0349, Injection, rezafungin, 1 mg) for REZZAYO injection effective October 1, 2023.

CMS also granted a new technology add-on payment (NTAP) for REZZAYO for eligible participating hospitals when Medicare patients are treated in the inpatient acute care hospital setting. A permanent J-Code plays a pivotal role in establishing reimbursement for medical products and services, offering a standardized way to identify the drug across various payers. The unique J-Code can be used for REZZAYO in all outpatient treatment settings.

The NTAP, in turn, will provide eligible, participating hospitals with an incremental payment for REZZAYO in addition to the standard Medicare Severity Diagnostic Related Group (MS-DRG) reimbursement for inpatient Medicare cases beginning October 1, 2023. Under NTAP, this additional payment is the lesser of 75% of the costs of REZZAYO, or 75% of the amount by which the costs of the qualifying case exceed the MS-DRG payment, up to a maximum payment of $4,387.50 for a patient treated with REZZAYO per qualifying case. REZZAYO was granted Qualified Infectious Disease Product (QIDP) designation and was approved by the U.S. Food and Drug Administration under Priority Review on March 22, 2023.

Last year, Melinta acquired the exclusive rights to commercialize REZZAYO in the U.S. from Cidara Therapeutics. Once-weekly REZZAYO has been available by prescription since July 31, 2023. While echinocandins have been available since the early 2000?s, their use has been primarily limited to the hospital inpatient setting due to their requirement of daily IV infusions.

In contrast, REZZAYO is administered as a once-weekly infusion, which may allow appropriate patients to leave the hospital sooner to continue their treatment at home, potentially reducing the burden on patients and the healthcare system.