Permanent J-Code for REZZAYO™ (rezafungin for injection): Effective October 1, 2023 – 9/19/23

Effective for claims on or after October 1, 2023:

J0349

Injection, rezafungin, 1 mg

REZZAYOTM (rezafungin for injection) is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data.

Product Specifications:

HCPCS Code

J0349

HCPCS Code Descriptor

Injection, rezafungin, 1 mg

11-Digit NDC

70842-0240-01

Package Description

200 mg as a solid (cake or powder) in a single-dose vial for reconstitution

WAC Pricing

$9.75 per HCPCS Unit

Potential Diagnosis Codes:

ICD-10-CM

Description

B37.1

Pulmonary candidiasis

B37.7

Candidal sepsis

B37.81

Candidal esophagitis

B37.82

Candidal enteritis

B37.89

Other sites of candidiasis

The content of this email is general in nature, strictly for informational purposes only, and does not cover all situations or all payers’ policies and guidance. The information in this email was obtained from third-party sources and is subject to change without notice as a result of changes in reimbursement laws, regulations, rules, policies, and payment amounts. This email is not intended to provide clinical practice guidelines. Melinta Therapeutics (Melinta) cannot guarantee, and is not responsible for, the payment of any claim. The coding, coverage, and payment of REZZAYO™ may vary by payer, plan, patient, and setting of care. Coding determinations and analysis should always be independently researched and assessed. For more information, please check with individual payers for specific coding, coverage, and payment requirements. It is the sole responsibility of the healthcare provider to code properly and to ensure the accuracy of all claims submitted for reimbursement. Additionally, as a prerequisite for submitting a claim, the provider is responsible for ensuring that all services are medically necessary and properly supported in the patient’s medical records. Melinta specifically disclaims liability or responsibility for the results or consequences of any actions taken in reliance on the information in this email.

Visit the REZZAYO™ HCP website

INDICATION AND USAGE

REZZAYO™ (rezafungin for injection) is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data.

Limitations of Use

REZZAYO™ has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida.

IMPORTANT SAFETY INFORMATION

Contraindications

REZZAYO™ is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins.

Warnings and Precautions

    • Infusion-related Reactions: REZZAYO™ may cause infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, or chest tightness. If these reactions occur, slow or pause the infusion.

    • Photosensitivity: REZZAYO™ may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation.

    • Hepatic Adverse Reactions: Abnormalities in liver tests have been seen in clinical trial patients treated with REZZAYO™. Monitor patients who develop abnormal liver tests and evaluate patients for their risk/benefit of continuing REZZAYO™ therapy.

Adverse Reactions

Most common adverse reactions (incidence ≥ 5%) are hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia.

Please see full Prescribing Information for REZZAYO™ (rezafungin for injection).

©2023 Melinta Therapeutics, LLC. All Rights Reserved. 08/2023 PP-REZ-US-0181