Expanded Listing Announcement: Niraparib Now Accessible on PBS for Patients with HRD

The expanded listing of Niraparib on the Pharmaceutical Benefits Scheme (PBS) to now include those newly diagnosed with Homologous Recombination Deficiency (HRD) is a welcomed development for the ovarian cancer community.   

Since early 2022, Ovarian Cancer Australia has been advocating for HRD testing, prioritising patient involvement, and pushing for increased access to PARP inhibitor therapies. This collaborative effort has resulted in an expanded PBS listing of Niraparib, announced by Health and Aged Minister, Mark Butler, alongside the recent expansion of Olaparib earlier this year for the same indication, increasing treatment options for ovarian cancer patients. Niraparib has been available to those with a BRCA mutation through the PBS for some time, and can now also be accessed for advanced ovarian cancer patients with HRD, as first line maintenance treatment. 

Key Milestones

April 2022: PBAC recommendation of Niraparib for advanced ovarian cancer treatment on the PBS, restricted to those with BRCA mutations.  

May 2022: OCA seeks consumer input to submit to PBAC, advocating for Olaparib subsidy on the PBS for a new eligible group with something called Homologous Recombination Deficiency (HRD) based on research findings.  

September 2022: Niraparib is listed on the PBS for advanced ovarian cancer treatment in BRCA mutation carriers.  

July 2023: PBAC recommends Niraparib for advanced ovarian cancer treatment for those with HRD. 

July 2023: MSAC recommends subsidising two HRD tests for expanded PARP inhibitor access, following OCA’s community advocacy efforts.  

August 2023: PBAC recommends expanding listing of PARP inhibitors Olaparib and Niraparib for those with HRD.  

January 2024: Formal listing of Olaparib as the first PARP Inhibitor for HRD in Australia.  

April 2024: Expanded listing of Niraparib (for first-line maintenance treatment) as the second PARP Inhibitor for HRD in Australia.  

Niraparib's expanded PBS listing represents further exciting developments in ovarian cancer treatment with its proven ability to extend time between recurrences. Government subsidies enhance accessibility, leading to better outcomes for hundreds of women a year who now have access after finishing their initial chemotherapy treatment.  

Ovarian Cancer Australia extends gratitude to all involved, especially the women and loved ones who shared their experiences to help shape these permissions. We also express our thanks to the healthcare sector, industry partners, government, and our donors and fundraisers who have supported resourcing our advocacy team, enabling us to persevere with these submissions aimed at extending and improving the quality of life for our community.   

Looking ahead, Ovarian Cancer Australia remains dedicated to our four key advocacy priorities: reducing variation in care, timely and affordable access to novel treatments, increasing large scale research investment, and ensuring more equitable access to patient and family centred care and support. Our ultimate vision is to save lives and ensure no one affected by ovarian cancer walks alone.  

Frequently Asked Questions (FAQ)

Listing Information   

Inclusion of Niraparib: We welcome the addition of this therapy as it expands treatment options for advanced ovarian cancer patients who have HRD, providing patients with more choices. It's important to acknowledge that having similar treatments listed for the same indication can be confusing for our community. This indication specifically applies to first-line maintenance treatment for advanced ovarian cancer. Ovarian Cancer Australia advises patients to engage in discussions with their treatment team to make informed choices about their eligibility and what might be most suitable for them.  

Next steps and access: Expanded listings of novel medicines and tests on the PBS and MBS ensures more equitable access for Australians. The Government will now subsidise HRD testing and PARP inhibitor access for eligible patients, significantly reducing costs.   

New treatment availability: These submissions focused on HRD testing and PARP inhibitors for newly diagnosed women with advanced, high-grade serous ovarian, fallopian tube, and primary peritoneal cancer. While we celebrate expanded treatment options, we acknowledge that there's more work to be done for other groups in our community. Ovarian Cancer Australia remains committed to advocating for more novel therapies to be brought to Australia.  

OCA’s Involvement   

OCA's role in advocacy: Ovarian Cancer Australia has played a vital role in advocating for HRD testing and expanded PARP inhibitor access. We've represented the voices of the ovarian cancer community throughout the assessment processes, engaging with decision-making committees and stakeholders to ensure our community's concerns are addressed. We cannot see these changes without efforts across our sector, and we are grateful to all stakeholders involved in this process alongside our community including clinicians, assessment committees, Government, and Industry; who have listened and enabled these exciting steps forward in ovarian cancer care.  

Advocacy's importance: Advocacy has been a long-standing priority for Ovarian Cancer Australia. We appreciate those who've shared their experiences, strengthening our advocacy efforts. Donors and fundraisers have supported our work, enabling more women to access life-improving medications.   

Submissions overview: The submissions considered expanding the use of the PARP inhibitors Olaparib and Niraparib, initially reserved for BRCA-mutated ovarian cancer, to newly diagnosed tumours with HRD, even without a BRCA mutation. Additionally, HRD testing, which until recently wasn’t routine in Australia, was proposed for funding, making both tests and medicines more accessible.   

Further Information   

Understanding HRD: Homologous Recombination Deficiency (HRD) is a trait in certain cancer cells that impairs their ability to repair damaged DNA, making them vulnerable to PARP inhibitors. Research has shown that HRD can result from gene alterations other than BRCA mutations, with up to half of high-grade serous ovarian cancers exhibiting HRD.   

Understanding PBS, PBAC, and MSAC: The Pharmaceutical Benefits Scheme (PBS) subsidises medication costs, following recommendations by the Pharmaceutical Benefits Advisory Committee (PBAC), an independent body comprising health professionals, consumers, and an industry representative. The Medical Services Advisory Committee (MSAC) assesses the safety, effectiveness, and cost-effectiveness of new medical services and tests, advising on public funding of items for listing on the Medical Benefits Scheme (MBS).   

For any queries about your treatment options and eligibility, discussions with your treating medical team are encouraged as they are best placed to advise you. If you require any additional support or information, please contact our Ovarian Cancer Nurses via our Helpline on 1300 660 334 (9 am – 5 pm AEDT).