CMS grants new prospective reimbursement for Voraxaze®

WEST CONSHOHOCKEN, Pa., Sept. 5, 2012 /PRNewswire/ -- 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

Adverse Reactions:

• In clinical trials, the common related adverse events (occurring in >1% of patients) were paresthesias, flushing, nausea and/or vomiting, hypotension, and headache

Warnings and Precautions

Serious Allergic Reactions:

• Serious allergic reactions, including anaphylactic reactions may occur.

Monitoring Methotrexate Concentration/Interference with Assay

• Methotrexate concentrations within 48 hours following Voraxaze^® administration can only be reliably measured by a chromatographic method due to interference from metabolites. Measurement of methotrexate concentrations within 48 hours of Voraxaze^® administration using immunoassays can overestimate the methotrexate concentration

Continuation and Timing of Leucovorin Rescue

• Leucovorin should not be administered within 2 hours before or after Voraxaze^® dose because leucovorin is a substrate for Voraxaze^®.¹
• For the first 48 hours after Voraxaze^® administer the same leucovorin dose as given prior to Voraxaze^®.
• Beyond 48 hours after Voraxaze^® administer leucovorin based on the measured methotrexate concentration.
• Do not discontinue therapy with leucovorin based on the determination of a single methotrexate concentration below the leucovorin treatment threshold.
• Therapy with leucovorin should be continued until the methotrexate concentration has been maintained below the leucovorin treatment threshold for a minimum of 3 days.
• Continue hydration and alkalinization of the urine as indicated.

Reference

1.     Voraxaze^® (glucarpidase) prescribing information January 2012

About BTG
BTG is an international specialist healthcare company that is developing and commercialising products targeting critical care, cancer and other disorders. The Group is seeking to acquire new products to develop and market to specialist physicians, and is building a sustainable business financed by revenues from sales of its own marketed products and from royalties and milestone payments on partnered products. For further information about BTG please visit our website at www.btgplc.com.

US-VX-2012-0015 September 2012

SOURCE BTG International Inc.