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CMS Grants Vistogard® New Technology Add-on Payment Status Effective 1 October 2016


West Conshohocken, PA, BTG plc (LSE: BTG), the specialist healthcare company, today announces that Centers for Medicare and Medicaid Services (CMS) has approved a New Technology Add-on Payment (NTAP) for Vistogard®, effective 1 October 2016. The CMS decision means that Medicare will pay up to 50% reimbursement of the cost of Vistogard® within the hospital setting, and it is expected to stay in place for two years until the cost of Vistogard® is included in the recalibration of diagnosis-related group (DRG) payments.

CMS also agreed that Vistogard® will have a unique ICD-10 procedure code XW0DX82 (introduction of Uridine Triacetate into Mouth and Pharynx). This specific procedure code needs to be included by hospital billing within the first 25 ICD-10 procedure codes reported in Field 74 of the CMS-1450 (UB-04) claim form for reimbursement under the NTAP for treatment using Vistogard®.

NTAP payments compensate hospitals for about half the estimated extra cost of using a product that is new and able to demonstrate a substantial clinical advantage compared to existing treatments. Regarding Vistogard®, CMS has established the maximum allowable add-on payment for Vistogard® as $37,500 for a 5 day course of the treatment.

The final rule for Hospital Inpatient Prospective Payment System (IPPS) for Fiscal Year 2017 is scheduled for publication in the Federal Register on August 22, 2016. In this final rule, CMS states that: “After consideration of the information provided by the applicant, we agree that Vistogard® meets all of the criteria for approval of new technology add-on payments for FY2017.” The final rule can be found here: https://www.federalregister.gov/articles/2016/08/22/2016-18476/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-etc]

As the first and only antidote for overdose and early-onset, severe, or life-threatening toxicities from the administration of fluorouracil or capecitabine – both commonly used chemotherapy treatments – Vistogard® was approved by the U.S. Food and Drug Administration (FDA) in December 2015 for use in adults and children. Vistogard® was developed by Wellstat Therapeutics and BTG holds the rights to market, sell and distribute Vistogard® for this indication in the U.S.

“CMS's decision to make Vistogard® eligible for NTAP recognizes the significant therapeutic advance of this first-of-its-kind life-saving treatment. Up until now, there was no alternative for adults or pediatric patients other than managing the symptoms for treating this rare and often deadly complication from fluorouracil or capecitabine administration,” said Christine Coyne, Vice President and US Commercial Lead for Specialty Pharmaceuticals.

"We’re proud to have worked with CMS to secure this NTAP status for Vistogard® which will ultimately help improve access to this life-saving treatment in the IPPS hospital setting for Medicare beneficiaries."

For further information contact:

BTG

Andy Burrows, VP Corporate & Investor Relations
+44 (0)20 7575 1741; Mobile: +44 (0)7990 530 605

Stuart Hunt, Investor Relations Manager
+44 (0)20 7575 1582; Mobile: +44 (0)7815 778 536

Chris Sampson, Corporate Communications Director
+44 20 7575 1595; Mobile: +44 7773 251 178


Selected Important Safety Information for Vistogard® (Uridine Triacetate) oral granules

INDICATION
Vistogard® is indicated for the emergency treatment of adult and pediatric patients: following a fluorouracil or capecitabine overdose regardless of the presence of symptoms, or who exhibit early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system, and/or early-onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration.
Limitations of use:
Vistogard® is not recommended for the non-emergent treatment of adverse reactions associated with fluorouracil or capecitabine because it may diminish the efficacy of these drugs.

The safety and efficacy of Vistogard® initiated more than 96 hours following the end of fluorouracil or capecitabine administration have not been established.
IMPORTANT SAFETY INFORMATION
In clinical studies, adverse reactions occurring in > 2% patients receiving Vistogard® were vomiting (10%), nausea (5%) and diarrhea (3%).

One patient receiving uridine triacetate experienced grade 3 nausea and vomiting.

Vistogard® was discontinued for adverse reactions in 2 (1.4%) patients.
Please see full Prescribing Information

About Vistogard® (uridine triacetate) oral granules

Vistogard® (uridine triacetate) is an orally administered drug approved by the FDA to treat patients following an overdose of 5-fluorouracil (5-FU) or capecitabine or in patients exhibiting early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system, and/or early-onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of 5-FU or capecitabine administration. Vistogard® received orphan drug designation from the FDA as an antidote in the treatment of 5-FU poisoning and from the European Medicines Agency (EMA) as a treatment for 5-FU overdose. In Europe, under a named patient program, Vistogard® is currently provided to patients at risk of excess 5-FU toxicity due to overdose and patients exhibiting severe toxicities to 5-FU within 96 hours of 5-FU administration.

For more information please visit www.vistogard.com.

About 5-Fluorouracil (5-FU)

5-FU is on the World Health Organization’s List of Essential Medicines, a compilation of the most important medications needed in a basic health system. Because 5-FU is administered in different doses and schedules as a frequent component of standard chemotherapy regimens for a variety of cancers, patients can experience dramatically different patterns of toxicity.

Used in combination with other chemotherapy agents and/or radiation, 5-FU has been for decades a mainstay of various treatment regimens for solid tumors, including those of the colon, pancreas, stomach, esophagus, breast, and head and neck. The drug is most commonly administered by infusion pump at or near what is considered the maximum tolerated dose. Expected side effects of 5-FU include myelosuppression (a reduction in white-blood-cell counts and thus increased risk of infection), diarrhea, nausea, vomiting, and mucositis (a painful inflammation and ulceration of the mucous membranes lining the digestive tract). Overexposure to 5-FU can lead to severe myelosuppression, gastrointestinal hemorrhage, septic shock, multiple organ failure, cardiac and neurological complications, and death.

About Capecitabine

Capecitabine is an orally administered chemotherapy prodrug 5-FU that is enzymatically activated within the body and transformed into 5-FU. When capecitabine comes into contact with a naturally occurring protein called thymidine phosphorylase, capecitabine is transformed into 5-FU. Because many cancers have higher levels of thymidine phosphorylase than do normal tissues, more 5-FU is delivered to the tumor than to other tissue.

About Wellstat Therapeutics

Wellstat Therapeutics Corporation is a privately-held biopharmaceutical company located in Gaithersburg, Maryland. Wellstat Therapeutics is committed to discovering, developing and commercializing products that will provide new and improved treatments for patients in the fields of oncology and metabolic, neurometabolic and neurodegenerative diseases. For more information, please visit the website at http://www.wellstattherapeutics.com. Wellstat Therapeutics is part of the Wellstat group of companies (http://www.wellstat.com).

About BTG

BTG is a growing international specialist healthcare company bringing to market innovative products in specialist areas of medicine to better serve doctors and their patients. We have a portfolio of Interventional Medicine products to advance the treatment of cancer tumors, advanced emphysema, severe blood clots and varicose veins, and Specialty Pharmaceuticals that help patients overexposed to certain medications or toxins. Inspired by patient and physician needs, BTG is investing to expand its portfolio to address some of today’s most complex healthcare challenges. To learn more about BTG, please visit: www.btgplc.com.