LONDON, December 21, 2018 /PRNewswire/ --
An estimated 500 patients per year in
France could be
eligible for treatment with
TheraSphere®
BTG plc (LSE: BTG), a global specialist healthcare company,
today announced that the French Ministry of Health and Social
Affairs will reimburse TheraSphere® for patients
with liver cancer who meet certain criteria.
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TheraSphere® will be included on the medical
device reimbursement list (Liste des Produits et Prestations et
Remboursés) for the treatment of patients with hepatocellular
cancer classed as BCLC[i] B or C disease, with
portal vein thrombosis (PVT), with an
ECOG[ii] status of 0-1,
Child-Pugh[iii] A or B and who are intolerant to,
or have progressed on, sorafenib. It is estimated that up to
500 patients per year could be eligible for treatment.
"This reimbursement decision provides access to a new treatment
option for some of the estimated 9,600 people diagnosed with liver
cancer in France each
year[iv]," said Jane
Lapon, VP Global Market Access at BTG.
"TheraSphere® is a powerful, targeted and
well-tolerated therapy and in some cases can lead to patients
becoming eligible for curative therapies. BTG continues to
pursue reimbursement and improved access to
TheraSphere® for liver cancer patients around the
world."
TheraSphere® will be reimbursed for a 5-year
period, during which BTG will collect data on all patients treated
in France. This data will be used to support renewal of the
reimbursement after the 5-year period.
The Ministry of Health's decision follows the positive opinion
reached by the Commission Nationale d'Evaluation des Dispositifs
Medicaux et des Technologies de Santé (CNEDiMTS) in February 2018, recognising that
TheraSphere® showed clinical benefit in this
patient population compared to best supportive care (ASA IV).
About TheraSphere®
TheraSphere® is a targeted therapy that consists
of millions of glass microspheres containing radioactive
yttrium-90. The microspheres are delivered directly to liver
tumours through the hepatic artery via catheter and become
permanently lodged there. Because the procedure delivers the
treatment directly to the liver tumour, the radiation destroys the
tumour cells with minimal impact to the surrounding healthy liver
tissue. The microspheres continue to deliver radiation to the
tumour over the course of several weeks after treatment. Over
20,000 patients worldwide have been treated with
TheraSphere®.
For full instructions for use and important safety information,
please visit http://www.therasphere.com.
About BTG Interventional Oncology
BTG Interventional Oncology is committed to transforming the way
cancer is treated with our portfolio of minimally-invasive, highly
targeted cancer therapies that can be personalised to each
patient's needs. Our products are used to treat or provide
symptomatic relief for people with cancer and benign tumours. To
learn more about BTG Interventional Oncology, please follow @BTGIO
on twitter or visit: http://www.btg-io.com
References:
i. Barcelona Clinic Liver Cancer (BCLC) is a system
for staging liver cancer based on the number and size of
tumours.
ii. Eastern Cooperative Oncology Group (ECOG) is a scale used
assess how a patient's disease is progressing and how the disease
affects the daily living abilities of the patient.
iii. Child-Pugh scores describe the clinical state of patients
with cirrhosis of the liver or chronic liver disease.
iv. INVS. Projection de l'incidence et de la mortalité par
cancer en France métropolitaine en
2015. Rapport technique. Novembre 2015
For further information contact:
Chris Sampson, Corporate
Communications Director
+44(0)20-7575-1595, Mobile: +44(0)7773-251-178
SOURCE BTG plc