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CMS Establishes Unique J-Code for BENDEKA

JERUSALEM & WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) and Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) announced today that the Centers for Medicare & Medicaid Services (CMS) has established a unique, product-specific billing code, or J-code (J9034), for BENDEKA® (bendamustine hydrochloride) Injection. The J-code will become effective on January 1, 2017.

“We are pleased that CMS recognized that the unique formulation and delivery mechanism offered by BENDEKA required separate recognition from other bendamustine products currently on the market. We expect the new J-code will provide greater access for patients, facilitate reimbursement and enable greater adoption of BENDEKA in the market”

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The new J-code provides reimbursement coding clarity to outpatient facilities and physicians that administer BENDEKA, facilitating access for patients and Medicare, Medicaid and commercial insurance reimbursement.

“We are pleased that CMS recognized that the unique formulation and delivery mechanism offered by BENDEKA required separate recognition from other bendamustine products currently on the market. We expect the new J-code will provide greater access for patients, facilitate reimbursement and enable greater adoption of BENDEKA in the market,” said Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.

“This is an important milestone for Teva as we continue to advance our bendamustine franchise with BENDEKA,” said Paul Rittman, Senior Vice President and General Manager, Teva Oncology. “We are committed to serving patients in need of this important therapy and are pleased that a unique J-code has been established to assist providers in obtaining reimbursement for BENDEKA.”

BENDEKA, a liquid, low-volume (50 mL) and short-time (10-minute) infusion formulation of bendamustine hydrochloride, was approved by the U.S. Food and Drug Administration (FDA) in December 2015 for the treatment of patients with chronic lymphocytic leukemia (CLL) and 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. Efficacy in CLL relative to first-line therapies other than chlorambucil has not been established. Under a February 2015 exclusive license agreement for BENDEKA, Teva Pharmaceutical Industries, Ltd. is responsible for all U.S. commercial activities for the product including promotion and distribution. BENDEKA was launched by Teva in late January 2016 and now is the most used bendamustine product. Please see Important Safety Information below including contraindication in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine, polyethylene glycol 400, propylene glycol, or monothioglycerol.

Indications

BENDEKA 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.

BENDEKA 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: BENDEKA is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine, polyethylene glycol 400, propylene glycol, or monothioglycerol.

Myelosuppression: Bendamustine hydrochloride caused severe myelosuppression (Grade 3-4) in 98% of patients in the two NHL studies. Three patients (2%) died from myelosuppression-related adverse reactions. Monitor leukocytes, platelets, hemoglobin (Hgb), and neutrophils frequently. Myelosuppression may require dose delays and/or subsequent dose reductions if recovery to the recommended values has not occurred by the first day of the next scheduled cycle.

Infections: Infection, including pneumonia, sepsis, septic shock, hepatitis and death has occurred. Patients with myelosuppression following treatment with BENDEKA are more susceptible to infections. Patients treated with Bendamustine hydrochloride are at risk for reactivation of infections including (but not limited to) hepatitis B, cytomegalovirus, Mycobacterium tuberculosis, and herpes zoster. Patients should undergo appropriate monitoring, prophylaxis, and treatment...


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