FLASCO / Assignment of Product-Specific HCPCS Code for Portrazza® (necitumumab) for Injection

Amanda Bridges
December 8, 2016
News

We are sending this communication on behalf of Eli Lilly and Company to announce the assignment of a product‐specific Healthcare Common Procedure Coding System (HCPCS) code for Portrazza® (necitumumab) for injection.

The new code, J9295, is defined as “injection, necitumumab, 1 mg.” This code is effective January 1, 2017.¹

Trade Name	HCPCS Code	Strength	NDC*	Effective Date
Portrazza	J9295 injection, necitumumab, 1 mg	800 mg/50 mL (16 mg/mL)	00002-7716-01	January 1, 2017

*Note that the product’s NDC code has been “zero‐filled” to ensure creation of an 11‐digit code that meets CMS standards.

The zero‐fill location is indicated in bold.
NDC=National Drug Code.

Portrazza was approved by the US Food and Drug Administration on November 24, 2015. Portrazza is an epidermal growth factor receptor (EGFR) antagonist indicated, in combination with gemcitabine and cisplatin, for first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC). Portrazza is not indicated for the treatment of nonsquamous NSCLC.

WARNING: CARDIOPULMONARY ARREST and HYPOMAGNESEMIA

Cardiopulmonary arrest and/or sudden death occurred in 3% of patients treated with Portrazza in combination with gemcitabine and cisplatin. Closely monitor serum electrolytes, including serum magnesium, potassium, and calcium, with aggressive replacement when warranted during and after Portrazza administration.
Hypomagnesemia occurred in 83% of patients receiving Portrazza in combination with gemcitabine and cisplatin, and was severe in 20% of patients. Monitor patients for hypomagnesemia, hypocalcemia, and hypokalemia prior to each dose of Portrazza during treatment and for at least 8 weeks following completion of Portrazza. Withhold Portrazza for grade 3 or 4 electrolyte abnormalities. Replete electrolytes as medically appropriate.

Please see here for full Prescribing Information.

For additional information, please visit www.Portrazza.com/hcp.