1726 – Testing of tumour tissue to determine a positive homologous recombination deficiency status in women newly diagnosed with advanced (FIGO stage III-IV) high grade epithelial ovarian, fallopian tube or primary peritoneal cancer, for access to PBS niraparib

New MBS item

The medical service is for the testing of tumour tissue to determine HRD status.

The HRD test involves the next generation sequencing (NGS) of DNA from a biopsy or preserved specimens (archived FFPE block) of tumour tissue. An assay detects how your body repairs double strand breaks in DNA, which is constantly being damaged and repaired. When DNA is repaired, the process is called homologous recombination.

HRD positive means your body is unable to effectively repair these double strand breaks in the DNA. HRD can include a number of genes, including BRCA1 and BRCA1 genes.

Type: Investigative – PBAC codependent application

Ovarian cancer is a diverse disease comprising different subtypes. The majority of ovarian cancers are of epithelial origin, with most classified as high-grade tumours. Early symptoms are often nonspecific, such as pelvic or abdominal discomfort, bloating, difficulty eating or feeling full and urinary urgency or frequency. Most patients are therefore diagnosed at an advanced stage (Stage 3 and 4) when prominent symptoms such as ascites (fluid build-up in spaces within the abdomen) and abdominal masses are evident.

• PASC consultation: Expedited – bypassing PASC
• MSAC consultation: MSAC consultation input closed Friday, 10 February 2023.

• PASC meeting: Bypassing PASC
• ESC meeting: 9–10 February 2023
• MSAC meeting: 30–31 March 2023