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West Conshohocken, PA, 05 September 2012
New Technology Add-on Payment provides up to 50% of the cost of Voraxaze®prescribed in the inpatient setting
BTG International Inc., the specialist healthcare company, today announces that the Centers for Medicare & Medicaid Services (CMS) has granted a temporary New Technology Add-on Payment (NTAP) for Voraxaze® (glucarpidase), effective 1 October 2012. This new add-on payment means that the US government will pay up to 50% of the cost of Voraxaze® to hospitals in addition to the standard diagnosis-related group (DRG) reimbursement payment. The new add-on payment for Voraxaze® will last 2-3 years until the standard DRGs are recalibrated to include this new technology.
Along with the add-on payment, CMS has also granted Voraxaze® a new ICD-9 procedure code 00.95 (injection or infusion of glucarpidase). Hospitals need to document this new procedure code 00.95 in the first 25 procedure code spaces on the claim form to allow for payment under the NTAP.
NTAP is only available for new technologies which provide a substantial clinical benefit and meet appropriate cost criterion. As it relates to costs, CMS will provide a maximum add-on payment for Voraxaze® of $45,000 per case.
As published in the Federal Register for Medicare inpatient prospective payment system (IPPS) fiscal year 2013, CMS stated, “After reviewing the totality of the evidence and the public comments we received, we agree that Voraxaze®represents a substantial clinical improvement for Medicare beneficiaries.” The IPPS final rule can be found at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/FY-2013-IPPS-Final-Rule-Home-Page.html.
Voraxaze® received US regulatory approval in January 2012 for the treatment of toxic plasma methotrexate concentrations (>1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function and is sold in the US by BTG’s dedicated acute care field force. It works by breaking down methotrexate into its inactive metabolites which are then eliminated from the body by routes other than the kidney (primarily the liver).
High dose methotrexate chemotherapy is used to treat or prevent the recurrence of certain types of cancer, such as osteosarcoma, leukemia, and lymphoma. Some patients treated with methotrexate develop impaired kidney function, which leads to the accumulation of toxic levels of methotrexate in the blood and puts patients at risk of additional toxicity.
Matt Gantz, Executive Vice President, US at BTG commented: “Receiving this new inpatient prospective payment highlights the fact that Voraxaze®meets a significant unmet medical need and should help ensure that appropriate patients gain access to it when they need it most. The NTAP will help hospitals cover costs associated with the use of Voraxaze®.”
Indications and Use
Voraxaze® (glucarpidase) is indicated for the treatment of toxic plasma methotrexate concentrations (>1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function. Voraxaze® is not indicated for use in patients who exhibit the expected clearance of methotrexate or those with normal or mildly impaired renal function because of the potential risk of subtherapeutic exposure to methotrexate.
Important Safety Information
Warnings and Precautions
Serious Allergic Reactions:
Monitoring Methotrexate Concentration/Interference with Assay
Continuation and Timing of Leucovorin Rescue
1. Voraxaze® (glucarpidase) prescribing information January 2012
For further information contact:
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