1456 – 17p Deletion Testing for Access to Venetoclax in Patients with Relapsed/Refractory Chronic Lymphoid Leukaemia

Page last updated: 15 February 2019

Application Detail



Description of Medical Service

Venetoclax is a BCL-2 inhibitor listed on the Australian Register of Therapeutic Goods (ARTG). The TGA-approved indications are as a treatment for:
• Patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) with 17p-del, or
• Patients with relapsed or refractory CLL for whom there are no other suitable treatment options.

Description of Medical Condition

Chronic lymphoid leukaemia (CLL), which is also known as B-cell Chronic lymphoid leukaemia (B-CLL), is a specific type of leukaemia, a group of cancers usually originated in bone marrow and resulting in abnormally high numbers of white blood cells. The presence of a 17p deletion is associated with a significantly poorer prognosis, and patients harbouring a 17p deletion show marked resistance to genotoxic chemotherapies recommended as first-line treatment for CLL.

Reason for Application

Amendment to MBS item

Medical Service Type

Co-dependent technology

Previous Application Number

Not Applicable

Associated Documentation

Application Form


PICO Confirmation


Assessment Report


Public Summary Document

Public Summary Document - updated (PDF 867 KB)
Public Summary Document - updated (Word 79 KB)

Meetings for this Application




8 June 2017


6 - 7 April 2017
27 July 2017
22-23 November 2018