1607 – 17p deletion testing for access to acalabrutinib in patients with relapsed or refractory chronic lymphocytic leukaemia

Page last updated: 10 March 2020

Application Detail

Description of Medical Service

Fluorescent in situ hybridization (FISH) is a molecular cytogenetic technique used to test the presence or absence of specific chromosome regions and is often used to detect chromosome deletions such as 17p. This involves using a specific DNA probe which recognises the region to be tested. The probe is labelled with a fluorescent dye and is hybridised to the chromosomes on a microscope slide. It will only stick to its matched region. In a normal cell this will give two signals (one from each chromosome) and in a cell with a deletion will give only one signal.

Description of Medical Condition

Chronic lymphocytic leukaemia (CLL) is a life-threatening B-cell malignancy which originates in the bone marrow and results in abnormally high numbers of white blood cells. CLL is an incurable disease with conventional therapies, with its natural history being one of repeated relapse. CLL patients harbouring a 17p deletion have a particularly poor prognosis and generally respond poorly to many of the chemotherapeutic agents used to treat CLL.

Reason for Application

Amendment to existing MBS item

Medical Service Type

Co-dependent technology

Previous Application Number/s

Not Applicable

Associated Documentation

Application Form

Application Form (PDF 1415 KB)
Application Form (Word 303 KB)

Consultation Survey

Consultation Survey (PDF 560 KB)
Consultation Survey (Word 67 KB)

PICO Confirmation

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Assessment Report

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Public Summary Document

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Meetings for this Application

PASC

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ESC

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MSAC

2-3 April 2020