WEST CONSHOHOCKEN,
Pennsylvania, August 17, 2016
/PRNewswire/ --
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.
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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."
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
http://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:
http://www.btgplc.com.
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
SOURCE BTG plc
