Pharma Focus Europe

Melinta Therapeutics Announces Enhanced Reimbursement and Accessibility Options for REZZAYO™ (Rezafungin Injection)

Tuesday, October 03, 2023

Melinta Therapeutics (Melinta), a company specializing in innovative therapies for acute and life-threatening diseases, has announced expanded reimbursement and access for their product, REZZAYO™ (rezafungin for injection). REZZAYO is the first new treatment option approved for adult patients with candidemia and invasive candidiasis in over a decade and has been available in the U.S. since July.

The Centers for Medicare & Medicaid Services (CMS) has issued a permanent product-specific J-Code (J0349, Injection, rezafungin, 1 mg) for REZZAYO injection, effective from October 1, 2023. Additionally, CMS has granted a new technology add-on payment (NTAP) for REZZAYO in eligible participating hospitals when treating Medicare patients in the inpatient acute care hospital setting.

Christine Ann Miller, Melinta's President and CEO, expressed excitement about these developments, emphasizing their significance in facilitating access to this innovative treatment option both in inpatient and outpatient settings. She stated that these milestones are crucial steps toward ensuring that all patients who require Melinta's therapies can receive them.

The issuance of a permanent J-Code is essential in establishing reimbursement for medical products and services, providing a standardized identifier for the drug across different payers. This unique J-Code can be used for REZZAYO in all outpatient treatment settings. The NTAP, on the other hand, will offer eligible participating hospitals an additional payment for REZZAYO, in addition to the standard Medicare Severity Diagnostic Related Group (MS-DRG) reimbursement for inpatient Medicare cases starting October 1, 2023. Under NTAP, this additional payment is capped at the lesser of 75% of REZZAYO's costs or 75% of the amount by which the costs of the qualifying case exceed the MS-DRG payment, up to a maximum of $4,387.50 for a patient treated with REZZAYO per qualifying case.

REZZAYO was granted Qualified Infectious Disease Product (QIDP) designation and received approval from the U.S. Food and Drug Administration under Priority Review on March 22, 2023. Melinta acquired exclusive rights to commercialize REZZAYO in the U.S. from Cidara Therapeutics last year, and the once-weekly REZZAYO has been available by prescription since July 31, 2023.

While echinocandins have been available since the early 2000s, their use has mainly been limited to the hospital inpatient setting due to their requirement for daily IV infusions. In contrast, REZZAYO is administered as a once-weekly infusion, which may enable suitable patients to leave the hospital sooner for continued treatment at home, potentially reducing the burden on patients and the healthcare system.

John Harlow, Melinta's Chief Commercial Officer, noted that REZZAYO provides a much-needed option for physicians and patients who may be able to transition out of the hospital earlier. He highlighted that the J-Code and NTAP would support broader access to this innovative treatment for patients suffering from invasive Candida infections, aligning with Melinta's mission to provide innovative therapies for acute and life-threatening illnesses.

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