Ovarian Cancer Australia notes the release of the July 2022 Pharmaceutical Benefits Advisory Committee (PBAC) meeting outcomes and wishes to advise the community that the expanded use of Olaparib for those with Homologous Recombination Deficiency (HRD) has not yet been recommended for listing on the PBS. Whilst it is not unusual for a medicine to require multiple submissions to PBAC, we know this will be disappointing for many people impacted by ovarian cancer.
OCA looks forward to supporting a resubmission in an effort to ensure that a greater number of people can access maintenance PARP inhibitor treatments for ovarian cancer. Further details will be released about the decision in about 6 weeks’ time, and we will continue to update you on both the progress of the HRD test approval and expanded Olaparib submissions, as well as further opportunities to contribute to these submissions.
We know this process can be confusing so please see some frequently asked questions below. Please note our ovarian cancer nurses are available to provide further information and support, via the OCA Helpline on 1300 660 334 (9am – 5pm AEST.)
Frequently Asked Questions (FAQ)
What are PARP inhibitors?
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 are a type of targeted therapy that stop PARP from repairing cancer cells.
What is Olaparib?
Olaparib is a type of PARP inhibitor. Olaparib is currently listed on the Australian Government Pharmaceutical Benefits Scheme (PBS) for subsidised use in Australia for people with a pathogenic variant (also called a mutation). This applies whether it is an inherited germline mutation, or a somatic mutation that has happened just in their tumour, for both newly diagnosed and recurrent advanced ovarian cancer. Your treatment team is best placed to advise you on your individual eligibility.
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 was different about this submission for Olaparib and Bevacizumab?
Although people with BRCA mutations can already access Olaparib, recent data has shown that Olaparib with bevacizumab may also benefit some people who don’t have a BRCA mutation. Please see further information on this study.
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. Specifically, this submission discussed the expanded use of Olaparib in combination with another drug Bevacizumab for first line maintenance treatment for advanced, platinum-sensitive, high-grade serous ovarian, fallopian tube and peritoneal cancers,
- that are newly diagnosed
- following first line chemotherapy,
- that have a characteristic called Homologous Recombination Deficiency (also known as HRD, please see further info below).
What is Homologous Recombination Deficiency (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 be caused by changes in other genes as well. Up to half of high grade serous ovarian cancers have HRD, while only about 20% caused by a BRCA mutation.
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.
What does HRD have to do with the submission for expanded use of Olaparib?
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 of people.
The application to PBAC requested 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. The listing is for Olaparib to be given in combination with Bevacizumab.
Testing for HRD is not currently routine in Australia for ovarian cancer. There was also 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. This application was assessed by the Medical Services Advisory Committee (MSAC) alongside the PBAC submission.
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. Your treatment team is best placed to give you advice about the most appropriate treatment and care for your individual situation.
Why are PARP inhibitors only approved for some groups with ovarian cancer and not all?
Personalised medicine is a growing area of cancer care and increasingly research is focused on finding treatments which can help specific people by targeting specific types of tumours. This will mean a growing number of people with an ovarian cancer diagnosis will be receiving different treatments to others, moving away from a one size fits all approach. Whilst this progress is exciting, it can be difficult if your cancer is not a type that can access these newer therapies yet.
What is the Pharmaceutical Benefits Scheme (PBS)?
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.
What is the Medical Services Advisory Committee (MSAC)?
MSAC is an independent committee that provides advice to the Government on whether a new medical service should be publicly funded. The group review submissions that assess safety, effectiveness, and cost.
Where can I get further details about this outcome?
Detailed reasoning on the outcomes from each PBAC meeting are published on their website approximately 6 weeks post the initial announcement.
Initial information on the outcome can be found here.
I want to share my story and lend my voice to these processes; how can I go about that?
At each occasion where a medicine is considered by PBAC for ovarian cancer, we will invite our community to either make their own personal submissions, or to share their story and experience to be included in Ovarian Cancer Australia’s submission. We will advise our community when this is next put forward to PBAC and MSAC to provide the opportunity for contributions. 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.
Want to know more?
We understand this information can be confusing and encourage all women to discuss their eligibility with their treating medical team. We also know that discussion of treatment options might cause distress and whilst we are unable to advise on individual eligibility, we can provide additional support and information. Please call our Ovarian Cancer Nurses on our Helpline on 1300 660 334 (9am – 5pm AEST).