BENLYSTA J CODE NOW ASSIGNED

Posted Tuesday, November 1, 2011

The Centers for Medicare & Medicaid Services (CMS) has assigned a J code
to BENLYSTA, which will apply to dates of service on or after January 1, 2012.
The code is: J0490, INJECTION, BELIMUMAB, 10 MG.
For more information, visit the CMS website at:
https://www.cms.gov/MedHCPCSGenInfo.
Please update your systems to allow for accurate and timely processing of claims for dates of service on or after January 1, 2012.
NOTE: For Medicare Part D Formulary submission purposes, the RxNorm Concept Unique Identifier (RXCUI) for BENLYSTA is 109244.

NDC NO. CARTON CONTENTS J CODE WHOLESALE ACQUISITION COST (WAC)*
49401-0101-01 120 mg belimumab in a 5-mL
single-use vial for injection,
for intravenous use only
J0490, injection,
belimumab, 10 mg
$443.18
49401-0102-01 400 mg belimumab in a 20-mL
single-use vial for injection,
for intravenous use only
J0490, injection,
belimumab, 10 mg
$1,477.26

*Wholesale Acquisition Cost is the listed price to wholesalers and warehousing chains, not including prompt pay, stocking or distribution allowances, or other discounts, rebates, or chargebacks. Listed price may not represent prices charged to other customers, including specialty distributors.

For questions regarding BENLYSTA, please contact your Account Manager for BENLYSTA or call BENLYSTA® Gateway
at 1-877-4-BENLYSTA (1-877-423-6597), Monday through Friday, 8 AM to 8 PM ET.
Indication
BENLYSTA is indicated for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE)
who are receiving standard therapy.

Limitations of Use: The efficacy of BENLYSTA has not been evaluated in patients with severe active lupus nephritis or severe active
central nervous system lupus. BENLYSTA has not been studied in combination with other biologics or intravenous cyclophosphamide.
Use of BENLYSTA is not recommended in these situations.

Important Safety Information
CONTRAINDICATION
BENLYSTA is contraindicated in patients who have had anaphylaxis with belimumab.

MORTALITY
There were more deaths reported with BENLYSTA than with placebo during the controlled period of the clinical trials. Out of
2133 patients in 3 clinical trials, a total of 14 deaths occurred in the following groups: 3/675 in placebo, 5/673 in BENLYSTA
1 mg/kg, 0/111 in BENLYSTA 4 mg/kg, and 6/674 in BENLYSTA 10 mg/kg. No single cause of death predominated. Etiologies
included infection, cardiovascular disease, and suicide.

Important Safety Information continued on reverse.

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