Blood cancers

FISH testing to be funded for first line ibrutinib in CLL patients


Medicare funding for FISH testing for del(17p) has been recommended for all people with chronic lymphoid leukaemia (CLL) or small lymphocytic lymphoma (SLL), regardless of treatment line, so they can access first-line ibrutinib on the PBS.

The genetic testing is already funded to allow second line treatment in people with relapsed or refractory CLL, and now the Medicare Services Advisory Committee (MSAC) has backed an application from Janssen-Cilag for the test to be funded to help determine eligibility for first-line ibrutinib.

The decision follows a November 2019 recommendation by the Pharmaceutical Benefits Advisory Committee (PBAC) to fund ibrutinib on the PBS as first-line treatment for CLL.

In its decision statement MSAC notes that if the fluorescence in situ hybridisation (FISH) test shows a person has the del(17p)  deletion, this means they are more likely to respond well to agents such as ibrutinib and venetoclax rather than chemotherapy. People with relapsed/refractory CLL or SLL who have del(17p) can already get ibrutinib, venetoclax and idelalisib through the PBS as second line treatment.

MSAC said it reviewed the evidence and found that FISH testing at the time that a patient’s CLL or SLL is diagnosed is sufficiently accurate to help determine eligibility for all patients with CLL or SLL requiring treatment, agnostic of line of therapy.

“The modification of existing MBS item 73343 to allow FISH testing for the detection of del(17p) for all patients with CLL or SLL requiring treatment, regardless of treatment line, would enable the identification of patients with a high clinical need who would benefit from first-line treatment with ibrutinib instead of chemoimmunotherapy, whilst also identifying patients with a normal karyotype who may otherwise be managed with chemoimmunotherapy,” its review states.

MSAC advised the Minister for Health that it would recommend expanding the MBS eligible population for the test to include previously untreated patients and to limit the testing to no more frequently than one test per year.

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