Application Detail

Status

On hold

Description of Medical Service

SIR-Spheres (Selective Internal Radiation Spheres) are yttrium-90 resin microspheres that are implanted into malignant liver tumours for the purpose of selectively delivering high doses of ionising radiation to the tumour. They are injected into the hepatic artery by means of a trans-femoral catheter or a permanently implanted hepatic artery port with a catheter. Following injection, the SIR-Spheres Y-90 resin microspheres become concentrated in the microvasculature of the liver tumours, where they have a local radiotherapeutic effect. As tumours within the liver derive their blood supply almost exclusively from the hepatic artery, the SIR-Spheres Y-90 resin microspheres are preferentially delivered in greater amounts to the tumour rather than to the normal liver parenchyma, which is supplied by both the hepatic artery and the portal vein. Following decay of the yttrium-90, the inert resin microspheres remain implanted in the tissue.

Description of Medical Condition

Part 1

This application is requesting full listing for interim-listed MBS items 35404, 35406 and 35408. These items cover selective internal radiation therapy (SIRT) using SIR-Spheres for the treatment of hepatic metastases which are secondary to colorectal cancer and are not suitable for resection or ablation, used in combination with systemic chemotherapy using 5-fluorouracil (5FU) and leucovorin.

Part 2

This application is also requesting new MBS listings for SIRT for the treatment of the following indications:

* non-resectable, non-ablatable hepatocellular carcinoma (advanced HCC)

* unresectable intrahepatic cholangiocarcinoma (ICC)

* liver dominant tumours (incl. breast cancer)

* neuroendocrine tumours (NETs)

Reason for Application

Amendment to existing MBS items/New MBS items

Medical Service Type

Therapeutic

Previous Application Number

Application 1082

Associated Documentation

Application Form

Application Form (PDF 891 KB)
Application Form (Word 211 KB)

Other Indications (PDF 312 KB)
Other Indications (Word 556 KB)

Primary Liver (PDF 302 KB)
Primary Liver (Word 558 KB)

Consultation Survey

Consultation Survey (PDF 97 KB)
Consultation Survey (Word 508 KB)

PICO Confirmation

PICO Confirmation (Word 331 KB)

PICO Confirmation (PDF 955 KB)

Assessment Report

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Public Summary Document

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Meetings for this Application

PASC

12 April 2017

ESC

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MSAC

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