PBAC Submission For Expanded Listing Of Olaparib

Ovarian Cancer Australia (OCA) is making a submission to the Australian Government Pharmaceutical Benefits Advisory Committee (PBAC) and is calling for consumer input. OCA is advocating for the cost of Olaparib to be subsidised on the Pharmaceutical Benefits Scheme (PBS) for a new group of people who have been shown to benefit from this medication in recent research.  

Specifically, this submission will be discussing the expanded use of Olaparib in combination with another drug Bevacizumab for first line maintenance treatment for: 

• newly diagnosed advanced, platinum-sensitive, high-grade serous ovarian, fallopian tube and peritoneal cancers, 

• following first line chemotherapy,  

• for tumours that have a characteristic called Homologous Recombination Deficiency (also known as HRD.).  

Please see our FAQ section below to learn more about HRD. 

Currently, Olaparib is only subsidised on the PBS for ovarian cancer in people with a BRCA pathogenic variant (also called a mutation). There is still a need to improve maintenance treatment options for all people with ovarian cancer.  

Personalised medicine is a growing area in cancer care and increasingly research is focused on finding treatments which can help specific people. OCA has called for consumer input for submissions to PBAC several times in the last few years. We are thankful to those who have contributed to our previous submissions or who have made their own direct submissions. PBAC considers consumer input an important part of the process, even if the decisions do not always go as we hope. This is a step-by-step process and the voices of people impacted by these decisions need to be heard at every stage. 

This is an area that is changing quickly and can be confusing. We have put together some FAQs to help you.  For any questions about the submission, or for any other information or support, please speak with our ovarian cancer nurses via Helpline on 1300 660 334 (during business hours.)

FREQUENTLY ASKED QUESTIONS

What is Olaparib? 

Olaparib is a type of targeted therapy called a PARP inhibitor. PARP stands for Poly-ADP Ribose Polymerase. It is a protein that helps cells repair themselves if they become damaged. This is important in normal cells, but some cancer cells also rely on PARP to survive. PARP inhibitors stop PARP from repairing cancer cells.  

Olaparib is currently listed on the Australian Government Pharmaceutical Benefits Scheme (PBS) for subsidised use in Australia for people with a BRCA mutation, including a somatic mutation in their tumour, for both newly diagnosed and recurrent ovarian cancer.  However recent data has shown Olaparib with bevacizumab may benefit newly-diagnosed women who have tumours with HRD but don’t have a BRCA mutation. Please see further information on this study.

What is Bevacizumab?

Bevacizumab is a drug that stops the cancer developing new blood cells and growing. It is given as a drip into a vein.    

What is HRD? 

Homologous Recombination Deficiency (HRD) is a characteristic of some cancer cells that makes it harder for them to fix or repair damaged DNA. This mean that these cancer cells can die when treated with Olaparib and Bevacizumab.  

Doctors originally thought that only pathogenic variants (also called mutations) in BRCA genes caused HRD in cancer cells. However, research has now shown that HRD can result from alterations in other genes as well. Up to half of high grade serous ovarian cancers have HRD. 

What is the relevance of HRD for women with ovarian cancer having treatment with PARP inhibitors? 

Like HRD, PARP inhibitors also block DNA being repaired. This means that using PARP inhibitors in tumours with HRD blocks the DNA repair in multiple ways. These tumours are more likely to respond to PARP inhibitor, increasing the chance of the cancer cells dying.

Does HRD affect the upcoming Olaparib application to PBAC? 

PARP inhibitors are being more widely used for some people with ovarian cancer. Olaparib is currently only available to people with ovarian cancer and a BRCA mutation. However recent research has shown that Olaparib with Bevacizumab can be effective in people with newly diagnosed tumours that have HRD, even if they don’t carry a BRCA mutation.  

Olaparib has been approved by the Therapeutic Goods Administration (TGA) for use in Australia as a safe and effective treatment for ovarian tumours with HRD. However, the next step is for the PBAC to decide if the drug can be subsidised on the PBS for this group.  

The application to PBAC will request that access to Olaparib on the PBS expand to include not only those with a BRCA mutation, but also those newly diagnosed with ovarian tumours that have HRD. This listing is for Olaparib to be given in combination with Bevacizumab. 

HRD is not currently a routine test in Australia for ovarian cancer. There will also be an application for HRD testing to be funded through the Australian Government Medicare Benefits Schedule (MBS) to fund HRD testing for anyone with an ovarian tumour.  

How do I find out if I have HRD, and more about what this might mean for me? 

HRD testing and access to Olaparib for people without a BRCA mutation is not yet routine. It is important to discuss genetic testing options and access to treatments and clinical trials with your specialist medical team. You don't need to wait for the outcome of the PBAC submission. Your treatment team is best placed to give you advice about the most appropriate treatment and care for your individual situation.  

What is the Pharmaceutical Benefits Scheme (PBS)? 

The PBS is the main mechanism for the Government to subsidise the cost of medications used by the community. Medicines can only be included on the PBS if they are recommended for listing by the Pharmaceutical Benefits Advisory Committee (PBAC).  

 What is the Pharmaceutical Benefits Advisory Committee (PBAC)? 

PBAC is an independent expert body that includes health professionals, consumers and an industry representative. The group review submissions and then advise the Government which medicines to subsidise.   

How and when will we know if the application is successful? 

The outcomes of each PBAC meeting are available on the PBS website 6 weeks after each meeting (this meeting is scheduled for July 2022).