First Formal Listing of PARP Inhibitors for HRD: A Milestone for OCA and Our Community

In July 2023, an exciting development was announced as the Medicines Services Advisory Committee (MSAC) recommended that the government subsidise two Homologous Recombination Deficiency (HRD) tests to enable expanded access to two PARP inhibitor medicines. The Pharmaceutical Benefits Advisory Committee (PBAC) then followed with recommendations that the Government subsidise both PARP inhibitor medicines for this expanded group, allowing affordable and equitable access to treatment for more women. The first of these two listings has just been formalised. With timely access to effective and affordable treatments a key advocacy area for OCA, we are proud to be using our Leading Change platform to play a key role in this process. 

OCA's Advocacy Effort 

OCA has been involved in efforts to bring HRD testing to Australia since early 2022. Funded HRD testing means that more Australian women will be able to access PARP inhibitors in the future. OCA has worked alongside industry and government representatives during the approval processes, providing the voices of lived experience to each submission. Although there were a few attempts along the way, we have now reached the stage where both PARP inhibitors have been recommended for this additional group of women. Today marks a significant milestone: one PARP inhibitor is now formally listed on the PBS for this group, and another is on track for listing in 2024. 

Benefits of PARP Inhibitors 

HRD testing and increased PARP inhibitor access has been available internationally for some time. We know that PARP inhibitors can extend the time between disease recurrences (when the cancer returns), and even improve overall survival for some women. In Australia, eligibility for funded PARP inhibitor drugs has been limited to those with a BRCA mutation. We know evidence shows that an additional group can benefit, so OCA has been wanting to see the eligibility expanded. 

Impact on Patients 

HRD testing allows over 200 additional women access to PARP inhibitor therapy each year after finishing their initial chemotherapy treatment. The significance of these listings is that those in the additional group, for whom the data demonstrates benefit, will no longer have to self-fund testing and drug access, or miss out altogether. By having the treatment subsidised by the Government, we can see more equitable and timely access, leading to improved patient outcomes. 

Collaboration and Stakeholder Involvement 

To bring and list a new test or medicine in Australia requires effective collaboration at all steps of the process. Our team is immensely thankful to industry partners who commit to trialling their products in Australia and subsequently seeking listing here. OCA genuinely appreciates their persistence through multiple resubmissions over this extended period. We are also incredibly grateful to those within the Department of Health who assessed these submissions. They have listened and considered what we and our community have shared about the meaning and significance of these treatments for those affected by ovarian cancer. Most importantly, we extend our gratitude to our community members with lived experiences of ovarian cancer, who bravely and boldly share their personal stories to enhance our submissions and ensure decision-makers grasp the importance of expanded access. 

Challenges in the Advocacy Process 

The process of taking a medicine or test from the time of clinical trial, through to acceptance by TGA, and then subsidy by PBS and MBS in Australia is often lengthy and resource-intensive. This has certainly been our experience as we worked alongside our stakeholders to see two different concurrent MSAC/PBAC submissions through to listing. We have been grateful to meet repeatedly with all groups involved to discuss obstacles and approaches to overcoming them as quickly as possible. OCA has been actively involved with the review here in Australia, examining these processes through the current review into Health Technology Assessment. This Review has provided a platform for experiences such as ours to be shared, with the aim to work towards more timely and affordable access to new treatments in Australia. We look forward to the Review resulting in an improved system for all stakeholders involved. 

Future Advocacy Goals 

Ovarian cancer is an umbrella term for many subtypes of the disease, and we are continually learning more about these different groups. Because each woman’s disease can vary significantly from another’s, we must also personalise treatment for each. OCA will continue to advocate for access to personalised medicine, including genetic and tumour testing for all eligible women, increased availability of clinical trials in Australia, and faster listing of promising treatments for ovarian cancer. 

OCA also works diligently to ensure that advances in treatment are available to all diagnosed, regardless of their location. We know that there is variation in care across the country, so some of our advocacy efforts work to reduce this variation and increase timely access to optimal care. 

The landscape for ovarian cancer can only undergo significant change with substantial investment in research. OCA will continue to lobby the government to see the funding injections needed to shift the dial on survival. 

Frequently Asked Questions (FAQ) 

Listing Information 

Next Steps and access: Formal listing of the medicines on the PBS, and HRD tests on the MBS, means eligible patients can access HRD testing and PARP inhibitors subsidised by the Government moving forward. We encourage you to discuss your individual eligibility and treatment options with your specialist team. They are best placed to guide you. 

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. Ovarian Cancer Australia remains committed to advocating for treatments, clinical trials, and personalised medicine research. 

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. 

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).