On April 22, 2019 Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (Nasdaq:EGRX) reported that the Centers for Medicare & Medicaid Services (CMS) has established a unique, product-specific billing code, or J-code (J9036), for BELRAPZO (bendamustine 500mL hydrochloride injection) (Press release, Eagle Pharmaceuticals, APR 22, 2019, View Source [SID1234535325]). The J-code will become effective on July 1, 2019. Eagle’s bendamustine 500mL hydrochloride injectable will be sold as BELRAPZO beginning June 3, 2019.
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"We launched our 500mL bendamustine hydrochloride injection, to address the need in the market for our unique formulation at a lower price point. The new J-code provides reimbursement coding clarity to outpatient facilities and physicians that will administer BELRAPZO, facilitating access for patients, and Medicare, Medicaid and commercial insurance reimbursement," said Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.
About BELRAPZO
Indications
BELRAPZO is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL). Efficacy relative to first-line therapies other than chlorambucil has not been established.
BELRAPZO is indicated for the treatment of patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
Important Safety Information
Contraindication: BELRAPZO is contraindicated in patients with a history of a hypersensitivity reaction to bendamustine, polyethylene glycol 400, propylene glycol, or monothioglycerol. Reactions to bendamustine hydrochloride have included anaphylaxis and anaphylactoid reactions.
Myelosuppression: Delay or reduce dose. Restart treatment based on ANC and platelet count recovery. Complications of myelosuppression may lead to death.
Infections: Monitor for fever and other signs of infection or reactivation of infections and treat promptly.
Anaphylaxis and Infusion Reactions: Severe anaphylactic reactions have occurred. Monitor clinically and discontinue bendamustine hydrochloride. Pre-medicate in subsequent cycles for milder reactions.
Tumor Lysis Syndrome: Acute renal failure and death; anticipate and use supportive measures.
Skin Reactions: Discontinue for severe skin reactions. Cases of SJS, DRESS and TEN, some fatal, have been reported.
Hepatotoxicity: Monitor liver chemistry tests prior to and during treatment.
Other Malignancies: Pre-malignant and malignant diseases have been reported.
Extravasation Injury: Assure good venous access and monitor infusion site during and after administration.
Embryo-fetal toxicity: Fetal harm can occur when administered to a pregnant woman. Women should be advised to avoid becoming pregnant when receiving bendamustine hydrochloride.
Most Common Adverse Reactions:
Most common non-hematologic adverse reactions for CLL (frequency ≥15%) are pyrexia, nausea, and vomiting.
Most common non-hematologic adverse reactions for NHL (frequency ≥15%) are nausea, fatigue, vomiting, diarrhea, pyrexia, constipation, anorexia, cough, headache, weight decreased, dyspnea, rash, and stomatitis.
Most common hematologic abnormalities (frequency ≥15%) are lymphopenia, anemia, leukopenia, thrombocytopenia, and neutropenia.