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Innovative Cancer Treatment Supported by NICE


News provided by

Sirtex Medical Limited

24 Jul, 2013, 16:36 GMT

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LONDON, July 24, 2013 /PRNewswire/ --

NEW UK GUIDANCE SHOULD IMPROVE PATIENT ACCESS TO SIR-SPHERES® MICROSPHERES FOR PRIMARY LIVER CANCER

The UK National Institute for Health and Clinical Excellence (NICE) has published guidance to support the routine use of SIRT (Selective Internal Radiation Therapy) for the treatment of patients with primary liver cancer.[1] This decision is good news for patients with the most-common form of primary liver cancer, called hepatocellular carcinoma or HCC, for whom few effective treatment options are available currently.

SIRT is used for the treatment of inoperable liver tumours and involves injecting millions of tiny radioactive microspheres into the liver via the hepatic artery (blood supply). Each microsphere is coated with a beta-emitting radioactive isotope called yttrium-90. The radiation delivers localised treatment to tumour cells whilst conserving normal liver cells. SIR-Spheres microspheres, a form of SIRT, were approved in Europe in 2002 and more than 35,000 treatments have been supplied worldwide. Over 500 patients have received this treatment in Britain. The NICE guidance, released on 24th July 2013, confirmed that the scientific evidence of the safety and efficacy of SIRT for patients with HCC is now considered adequate, which means that eligible National Health Service (NHS) patients are now likely to have improved access to this treatment.

About Hepatocellular Carcinoma

HCC occurs most commonly in people whose livers have become severely damaged or cirrhotic, usually due to underlying liver conditions such as previous viral hepatitis infection or alcohol related liver damage. It is one of the ten most-common cancers in the world, with nearly 750,000 cases diagnosed annually, and is the third-leading cause of cancer deaths.[2] HCC occurs with greatest frequency in regions where hepatitis is most often diagnosed, such as in the Asia Pacific region and Southern Europe.

HCC can be cured only by surgery, either by resecting or ablating the diseased parts of the liver, or by transplantation with a liver from a donor. These interventions, however, are unsuitable for the great majority of patients, whose survival may range from a few months to two or more years depending largely on the state of their liver at the time of their diagnosis and the extent of tumour in the liver.

Patient Access to SIRT in England

NHS England is currently agreeing on guidelines for funding SIRT for patients with liver metastases due to colorectal cancer that are no longer responding to chemotherapy.[3]  It is anticipated that with the publication of this NICE guidance, eligible HCC patients in England may now also be given access to SIRT treatment through a similar mechanism.  Before 1st April 2013, SIRT was available to patients with chemotherapy refractory colorectal cancer in most areas of England through the Cancer Drugs Fund (CDF).  When NHS England took responsibility for the CDF on 1st April 2013, SIRT was removed from a national list of drugs to be funded through the CDF.  Since then SIRT has been subject to assessment by NHS England together with physicians representing the associated Clinical Reference Groups.  The details of conditions upon which patients can have access to SIRT in England are currently being agreed.

Dr Harpreet Wasan, Consultant Oncologist at Hammersmith Hospital, Imperial College, said:

"SIRT is an innovative treatment for patients with inoperable primary liver tumours where few other effective treatment options are available.  It is excellent news that NICE has now published guidance supporting the latest evidence on SIRT in HCC and this should ensure suitable patients can access SIRT on the NHS.  I hope that, as a result, 'postcode prescribing' and treatment delays due to a lengthy funding application and approval process will no longer be a problem for treating eligible NHS patients with SIRT."

For Further Information:

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 FDA PMA-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.

References:

  1. National Institute for Health and Clinical Excellence. Selective internal radiation therapy for primary hepatocellular carcinoma (Interventional Procedure Guidance 460). London: NICE, July 2013.
  2. GLOBOCAN. Liver Cancer Incidence and Mortality Worldwide in 2008.
  3. NHS England. Interim Clinical Commissioning Policy Statement: Selective Internal Radiotherapy (SIRT). June 2013. Reference: B01/PS/a

732-EUA-0713

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