PBAC recommends PARP inhibitors be subsidised for an expanded group

Ovarian Cancer Australia has been advocating over the past 2 years for access to funded HRD testing and PARP inhibitor access for this group in Australia.  

Our community have been awaiting the outcomes of two concurrent submissions under consideration by the Pharmaceutical Benefits Advisory Committee (PBAC) and Medical Services Advisory Committee (MSAC) – the committees who decide what medicines and tests should be subsidised (when a medicine or test is funded/subsidised, it means some or all of the cost is covered by the Australian Government to make access more affordable and equitable.)    

The submissions being considered have been put forward by two different companies, who have requested that two PARP inhibitors – Olaparib and Niraparib (which are currently only subsidised for those with a BRCA mutation) - receive expanded listing to allow an additional group of people who have something called Homologous Recombination Deficiency (HRD), to access maintenance PARP inhibitor treatment after finishing first line chemotherapy.   

We recently announced that MSAC had recommended the HRD test be funded. OCA is pleased to note that as well as that recent recommendation to fund the HRD tests, PBAC have now also recommended that the PARP inhibitors be subsidised too. This means both “parts” of the concurrent submissions have been assessed by the committees and all have received recommendations for funding.

Frequently Asked Questions (FAQ)

What are the next steps?

There are a number of processes to occur now, and the recommendations are provided to Government, advising what the outcomes are and the reasons behind the decisions. It will then be for the Health Minister to sign off, before the tests and medicines are formally subsidised. 

In the meantime, OCA is aware of compassionate access programs for HRD testing and PARP inhibitor access for newly and recently diagnosed eligible patients, and we recommend discussing your options further with your treatment team who are best placed to advise you.  . 

Will these PARP inhibitors be available to all people with ovarian cancer? 

These concurrent submissions considered HRD testing and PARP inhibitors for newly diagnosed women with advanced, high grade serous ovarian, fallopian tube and primary peritoneal cancer.   

Whilst we are pleased to see more treatment options becoming available for more people and recognise the significance of these outcomes for the treatment of many ovarian cancers moving forward, we know too there is still so much work to be done for other groups.  

Ovarian Cancer Australia will continue its work to improve access to treatments, advocating for more clinical trials, greater engagement in trials and and ongoing access to personalised medicine research programs to find more treatments for more subtypes of ovarian cancer.  

What has been Ovarian Cancer Australia’s role in this process?

Ovarian Cancer Australia has been advocating for this for many months, and we thank those involved in the assessment processes for listening and responding to the voices of the ovarian cancer community. We are thrilled the committee has acknowledged the great benefit of PARP inhibitors for those with HRD. 

To date, Ovarian Cancer Australia has been the voice of lived experience for these assessments, at each point in the committees’ considerations of these submissions. This means Ovarian Cancer Australia writes on behalf of our community to articulate why the medicines or tests under consideration is of incredible importance to those impacted by ovarian cancer; and what it would mean for someone diagnosed to have access to these tests and treatments.    

Ovarian Cancer Australia has also engaged with representatives of the committees making the decisions, and other stakeholders and groups involved, to ensure we are provided with every opportunity to represent the ovarian cancer community appropriately and adequately; and to identify possible barriers to listing that could be addressed.    

We are so grateful to all the women and their loved ones who have generously shared their experiences and feedback to inform our responses, sharing their lived experience to allow us to highlight the need for greater access to novel therapies in ovarian cancer.   

We will continue to reach out periodically to invite people to share these experiences with us, as the voices of those impacted by ovarian cancer is incredibly important throughout these processes.   

One of our advocacy priorities is to see timely and equitable access to effective and affordable medicines; and we will continue to represent the voices of those with lived experience at all stages of the process. 

When Ovarian Cancer Australia is made aware of opportunities for the community to provide their lived experience to these processes, we will often put them out on social media, as well as include them on our website.   

The importance of advocacy:  

Ovarian Cancer Australia has considered HRD testing and expanded PARP inhibitor access in Australia, an advocacy priority for some time, and we thank those involved in the assessment processes for listening and responding to the voices of the ovarian cancer community.   

We are so grateful to all the women and their loved ones who have generously shared their experiences and feedback to inform our responses.  

We’d also like to extend our thanks to all our donors and fundraisers, your support has meant our advocacy team has been resourced to persevere with these submissions, resulting in more women now being able to access medications that can improve their quality of life and extend their life. 

I have some questions, where can I find out more? 

The process to date for HRD testing and PARP inhibitor access for HRD in Australia has been long, extensive and complex, so we have included some further information below to assist with some questions you may have. We also recommend that any enquiries you might have around access to individual testing and medicines, or clinical trials access, be directed to your treatment team.    

Please do reach out to our ovarian cancer nurses with any further questions, or if there is anything else you wish to discuss, via Helpline on 1300 660 334 (during business hours.)   

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 means that these cancer cells can die when treated with PARP inhibitors.    

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 (the most common form of ovarian cancer) have HRD.    

What was being considered in the submissions? 

PARP inhibitors are being used more widely for some people with ovarian cancer. Olaparib and Niraparib have only been subsidised in Australia for people with ovarian cancer who have a BRCA mutation.    

However, research has shown that PARP inhibitors such as Olaparib and Niraparib can be effective in people with newly diagnosed tumours that have something called “HRD”, even if they don’t carry a BRCA mutation.    

Olaparib and Niraparib have been approved by the Therapeutic Goods Administration (TGA) for use in Australia as safe and effective treatments for ovarian tumours with HRD. The next step was submissions to the two committees (PBAC and MSAC) who make decisions about what tests and medicines will be subsidised.    

The application to PBAC requested that access to the PARP inhibitors, Niraparib and Olaparib, be expanded to include not only those with a BRCA mutation, but also those newly diagnosed with ovarian tumours that have HRD.    

HRD is not currently a routine test in Australia for ovarian cancer so there was also an application made at the same time for HRD testing to be funded through the Australian Government Medicare Benefits Schedule (MBS) to fund HRD testing for anyone with an ovarian tumour.   

The recent PBAC announcement means that now both the tests and medicines have been recommended for funding in Australia.  

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

HRD testing and access to PARP inhibitors for people without a BRCA mutation is not yet subsidised and will take some time to go through the approval processes.   

It is important to discuss genetic testing options, access to treatments and clinical trials, and eligibility for any compassionate access programs 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.     

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.

What is the Medical Services Advisory Committee (MSAC)?

MSAC assesses safety, effectiveness, cost-effectiveness and provides advice on which new medical services should be publicly funded .

MSAC is an independent committee that provides advice to the Government on the safety, effectiveness, cost-effectiveness and which new medical services should be publicly funded.    

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).