NHS revision of Clinical Policy Commissioning Statement on SIRT will
allow patients in England with metastatic colorectal cancer (mCRC) and
intrahepatic cholangiocarcinoma (ICC) who may benefit from SIR-Spheres®
microspheres to get treatment in specialist NHS centres
LONDON, Oct. 1, 2013 /CNW/ - NHS England has issued an interim Clinical
Commissioning Policy Statement that updates its policy on Selective
Internal Radiation Therapy (SIRT) for use in treating eligible patients
with metastatic colorectal cancer (mCRC) and intrahepatic
cholangiocarcinoma (ICC). As a result of the NHS announcement, which
can be found at http://www.england.nhs.uk/2013/09/26/com-through-eval/, SIR-Spheres microspheres are now one of the first medical technologies
that will be made available in specialist NHS centres through a new NHS
England initiative called Commissioning through Evaluation (CtE). The
CtE initiative allows specialist NHS centres to use services like SIRT,
whose initial safety and efficacy has been shown and supported by
guidance from the National Institute for Clinical Excellence (NICE),
but still require further evidence of relative clinical and cost
effectiveness to support routine commissioning.
The CtE statement on SIRT was developed by NHS England in collaboration
with the Clinical Reference Groups for Radiotherapy, Hepatobiliary and
Pancreas, and Interventional Radiology. The outcomes of the use of
SIRT under CtE will be evaluated in 2014.
"This announcement brings a moment of very good news to the large
number of patients with liver metastases from colorectal cancer who
have previously received chemotherapy and biological treatments, many
of whom have been waiting for several difficult months in anticipation
of this announcement," said Dr Ricky Sharma, Consultant Oncologist at
the Oxford University Hospitals NHS Trust. "It is also excellent news
for patients with cholangiocarcinoma, a rare and aggressive form of
liver cancer for which there are very few treatments available.
Enabling suitable patients across the whole of England to have access
to SIRT in this important evaluation process represents a significant
advance for the NHS."
"The NHS deliberations that led to today's announcement demonstrate that
NHS England, medical experts and healthcare companies can collaborate
together to provide appropriate access to innovative therapies for
patients who stand to benefit measurably from them," said Nigel Lange,
Chief Executive Officer of Sirtex Medical Europe, which developed and
continues to study new uses of SIR-Spheres microspheres in the
treatment of liver tumours.
What is SIRT?
Selective Internal Radiation Therapy (SIRT) is a non-surgical procedure,
in which an interventional radiologist uses a catheter directed through
an incision in the patient's femoral artery to deliver a treatment
comprising millions of radioactive microspheres (more than 30 million
resin microspheres coated in radioactive Yttrium-90 in the case of
SIR-Spheres microspheres) directly into branches of the hepatic (liver)
artery. The microspheres are carried by the blood flow through the
arteries into the small vessels that nourish tumours in the liver,
where they ultimately become trapped due to their size and deliver high
doses of beta-radiation directly to the tumours. Because internal
radiation is delivered directly to the tumours, patients may receive
radiation doses many times greater than possible with external beam
NHS Policy for SIRT in mCRC
Colorectal cancer (CRC) is the third-most prevalent cancer in the world.
It is also a cancer that too often spreads (or metastasizes) to other
organs in the body, most commonly the liver. Despite increased emphasis
on colorectal cancer screening, patients will often present with mCRC
at initial diagnosis.
The NHS commissioning statement recognises that SIRT should not
routinely be used in the initial treatment of mCRC, for which
chemotherapy and biological therapy are the current standards of care.
However, the NHS commissioning statement also recommends that eligible
mCRC patients be offered enrolment in a UK clinical trial called
FOXFIRE, where SIR-Spheres microspheres are administered concomitantly
with first-line chemotherapy and biologic agents to determine if an
additive treatment benefit exists from first-line use of SIRT.
In addition, the new NHS statement language notes that mCRC patients who
are chemo-refractory (no longer responsive to chemotherapy or
biological therapy) may be offered SIRT at NHS specialist centres under
the CtE process, or encouraged to enrol in other SIRT clinical trials
NHS Policy for SIRT in ICC
Intrahepatic cholangiocarcinoma (ICC) is a cancer that arises in the
epithelium or wall of the liver's bile ducts. It is a relatively rare
cancer that is becoming somewhat more common, suggesting that
occurrence may be linked to changes in diet or lifestyle.
The NHS recognises that few proven treatments exist for ICC and
recommends that SIRT may now be offered to chemo-refractory patients at
NHS specialist centres under the new CtE process.
NHS Policy on Patient Selection Criteria for SIRT
In addition to the use of SIRT in treating patients with liver tumours
due to mCRC and ICC, NHS England is looking into whether they should
employ a similar scheme of CtE for patients with hepatocellular
carcinoma following recent NICE guidance supporting SIRT in HCC. To be
eligible for SIRT for treating any of these forms of liver tumours, NHS
states that patients must have or be:
Not amenable to surgical resection of the liver
Not suitable for treatment with radio-frequency ablation (RFA)
WHO performance status 0-1
Disease that is predominantly located in the liver, with no
life-threatening disease outside of the liver
Adequate liver function
Less than 60% of the liver involved by tumour
No ascites or other signs of liver failure
A life expectancy of greater than 3 months
About SIR-Spheres microspheres:
Manufactured by Sirtex Medical Limited, SIR-Spheres microspheres are
approved for use in Australia, the European Union (CE Mark), New
Zealand, Switzerland, Turkey and several other countries for the
treatment of unresectable liver tumours.
SIR-Spheres microspheres are also fully PMA FDA-approved and are
indicated in the U.S. for the treatment of non-resectable metastatic
liver tumours from primary colorectal cancer in combination with
intra-hepatic artery chemotherapy using floxuridine.
SIR-Spheres® is a Registered Trademark of Sirtex SIR-Spheres Pty Ltd.
SOURCE: Sirtex Medical Europe
For further information:
Iga Rawicka, firstname.lastname@example.org, +48-600-600-166 ; Gill Dunn, email@example.com, +44(0)7713-112-600. Downloadable images, background information, a mode-of-action video and further supporting materials are available online at http://www.SIRTnewsroom.com. http://www.sirtex.com