Applications

1560 – 17p Deletion Testing by FISH for Access to Ibrutinib in Patients with Previously Untreated Chronic Lymphoid Leukaemia or Small Lymphocytic Lymphoma

Find out about the service or technology in this application and the medical condition it addresses. You can also view the application documents, the deadlines for providing consultation input and the outcome of the application when the MSAC process is complete.

  • Status Complete
  • Type New application
  • Pre-PASC consultation -
  • Pre-MSAC consultation -
  • Outcome Supported

Application details

Reason for application

New MBS item.

Service or technology in this application

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 deletion 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.

The high sensitivity and specificity of FISH and the speed with which the assays can be performed have made FISH a pivotal cytogenetic technique that has provided significant advances in both the research and diagnosis of haematological malignancies, including CLL/SLL.

Type: Investigative

Medical condition this application addresses

Chronic lymphocytic leukaemia (CLL), and small lymphocytic lymphoma (SLL), are life-threatening B-cell malignancies which originate in bone marrow and result in abnormally high numbers of white blood cells. The prognosis of CLL and SLL are similar and the existing approaches to management are consistent with one another. The treatment and outlook of CLL and SLL are identical and, according to the WHO classification, they are considered to be the same entity. Both CLL and SLL are incurable diseases with conventional therapies, with their natural history being one of repeated relapse.The poor prognosis of the subgroup of CLL/SLL patients harbouring a 17p deletion, coupled with their poor response to many of the chemotherapeutic agents frequently used to treat CLL/SLL (Stilgenbauer et al., 2014, Hallek et al., 2010, Zenz et al., 2010) results in a significant unmet clinical need for treatments that have a therapeutic effect in 17p deletion patients.

Meetings to consider this application

  • PASC meeting: 11 April 2019
  • ESC meeting: -
  • MSAC meeting: 28 to 29 November 2019