Government subsidy expands affordable treatment options for Australian women† managing endometriosis pain
- Endometriosis affects 1 in 7* Australian women and girls†3, causing debilitating pain and symptoms that impact work, education, relationships and daily life.3-5
- There is no cure for endometriosis5, and women suffer in silence for too long, facing a preventable on average 6-8 years delay to diagnosis.3
- From 1 May, government subsidy for Ryeqo®‡ (relugolix, estradiol, norethisterone acetate)1 will provide women† living with endometriosis an additional affordable treatment option to manage endometriosis.1,2
Sydney, Australia, 16 March 2025 – Gedeon Richter Australia welcomes today the Australian Government’s announcement that Australian women† living with endometriosis will have access to an additional government-subsidised treatment1,2, offering another option to help manage the complex and often debilitating pain of the condition.3-5 The Federal Government subsidy marks an important step in expanding affordable treatment options for the estimated one in seven women† affected by this chronic disease.3
Ryeqo® 40/1/0.5 (relugolix, estradiol, norethisterone acetate) - a once-daily, oral therapy that combines three active ingredients to treat endometriosis symptoms6 - will be available on the Pharmaceutical Benefits Scheme (PBS) from 1 May 2025, for adult women† of reproductive age who have previously tried medical or surgical treatment for their condition.1,2
Joining Gedeon Richter Australia in welcoming government subsidy of Ryeqo, Professor Jason Abbott, Obstetrician and Gynaecologist, University of NSW, said that while public awareness and diagnosis of endometriosis have improved, access to effective and affordable treatments remains a challenge - and there is no one-size-fits-all approach to care.
“Endometriosis is a lifelong condition that can affect women† for decades, yet too many still face an exhausting cycle of trial and error – moving between hormonal therapies, surgery and pain medications – often with limited success. Research shows that between one-fourth to one-third of women† do not respond to their first treatment7, which is why it is critical to ensure long-term support and access to multiple treatment options. The government subsidy of Ryeqo means that, for many women†, cost will no longer be a barrier to trying this option, and clinicians will have another tool to personalise treatment to each patient’s needs,” said Professor Abbott.
Taking an average six to eight years to diagnose3, endometriosis is a chronic, complex condition caused when tissue similar to the lining of the uterus grows outside of the uterus, often affecting reproductive organs and other areas in the pelvic cavity.4,5 It is marked by distinct and often invisible pain, which for many women† extends beyond period pain to include pain in-between periods, pain during or after sex, and pain when going to the toilet.4,5 These different types of pain can occur unpredictably and severely, impacting every aspect of a woman’s† life.4,5
“For many women† (and those assigned female at birth) living with endometriosis, the pain is relentless – it’s not just during their period, but ongoing pelvic pain, fatigue, nausea, and the anxiety and depression that often come with the disease. These symptoms disrupt every part of life, from work and relationships to simple everyday activities. We hear from women† who have tried multiple treatments but are still in pain and continuing to miss out on work, social events, important milestones, and everyday moments,” said Jessica Taylor, CEO of QENDO and Chair of the Australian Coalition for Endometriosis (ACE).
While endometriosis is often discussed in the context of women’s† health and fertility, its broader impact on women’s† ability to work and fully participate in society is often overlooked. Research shows that one in four people with endometriosis has lost a job because of their condition, and 70% have been forced to take unpaid leave to manage their symptoms.8 Nearly 50% feel unsupported in the workplace9, and one in three has been denied a promotion due to ongoing impact of endometriosis.8
“These figures highlight why affordable access to a range of treatment options is critical – so women† have a better chance of managing their symptoms and living with quality of life; staying engaged in work, family and community life,” Ms Taylor added.
Ryeqo is a novel, first-in-class combination treatment that includes relugolix, a GnRH (gonadotropin-releasing hormone) receptor antagonist, with hormone add-back therapy (estradiol and norethisterone acetate). It works by reducing the hormones in the body that drive endometriosis symptoms including pain (oestrogen and progesterone), while also helping to maintain hormonal balance.6
Commenting on the reimbursement of Ryeqo, GP and National Clinical Director Evoca Women’s Health, Dr Sneha Wadhwani said, “The listing of an additional therapy for endometriosis on the PBS is an important step forward in patient care. As GPs, we are often the first point of contact for women living with endometriosis and are well placed to support them through their journey from assessment and diagnosis through treatment. Being able to prescribe Ryeqo for up to two years on the PBS means we can offer patients earlier access to treatment. With so many women facing up to seven-year delays to diagnosis and treatment initiation, having more options allows us to better support diagnosed patients to manage their symptoms, improve quality of life, and find the treatment that works for them.”
“We welcome the Government’s decision to subsidise Ryeqo for women† living with endometriosis. The PBS listing recognises the significant - and often overlooked - burden endometriosis places on women’s daily lives, and importantly ensures equitable, affordable access to symptomatic treatment. We are proud to be able to bring this therapy to Australian patients,” said Glen Pearce, General Manager, Gedeon Richter Australia.
“There is still much more to be done to support women† living with endometriosis. At Gedeon Richter Australia, we are committed to making a meaningful difference in women’s health – not only by improving access to treatment, but also by supporting ongoing advocacy and education for healthcare professionals. We also recognise the tireless work of advocacy groups like QENDO, who continue to give a voice to women’s† experiences and drive much-needed change,” he added.
The approval and PBS listing of Ryeqo are supported by two, 24-week, multi-national clinical studies (SPIRIT 1 and SPIRIT 2) in more than 1,200 women with moderate-to-severe pain associated with endometriosis, as well as the 80-week, open-label extension study to assess longer-term use of Ryeqo.10 Together, these data represent up to two years of efficacy and safety information for the symptomatic treatment of endometriosis with Ryeqo.10
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Footnotes
*Based on those diagnosed with the condition by age 44–49.
†Endometriosis can also occur in men, transgender men and non-binary persons who were assigned female at birth/presumed female at birth (AFAB/PFAB).
‡ RYEQO® 40/1/0.5 (relugolix, estradiol, norethisterone) is approved by the Therapeutic Goods Administration (TGA) for adult women of reproductive age for the symptomatic treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis (from January 2024), and for the treatment of moderate to severe symptoms of uterine fibroids (from September 2022).
About Ryeqo
RYEQO® 40/1/0.5 is not yet listed on the PBS.
If you have been prescribed Ryeqo, please refer to the Consumer Medicine Information (CMI) found online here: https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2023-CMI-01327-1&d=20240208172310101.
Ryeqo, like all medicines, may cause side effects. Very common side effects include headache and hot flush, and common side effects decreased libido, hyperhidrosis, night sweats, back pain, arthralgia, uterine bleeding and vulvovaginal dryness.6,10 Please report side effects to your doctor, or via www.tga.gov.au/reporting-problems.
For further information on Ryeqo, please contact the Gedeon Richter Australia Medical Information team by email: medinfo@gedeonrichter.com.au or phone: 1300 433 366.
About endometriosis pain
Endometriosis pain (endo pain) is different from period pain because it occurs due to the inflammation caused when tissue similar to the lining of the uterus (endometrial tissue) grows outside of the uterus.11
While it is unique for everyone, there are some typical features including chronic pelvic pain (CPP), period pain (dysmenorrhea) back pain and lower abdominal pain.12
At worst, endo pain is extreme and can occur at any time of the month and anywhere in the body; importantly, it is not always associated with menstruation or ovulation and can be unpredictable in its severity, timing and duration.5
Endo pain is invisible and is often dismissed or ‘played down’ by healthcare professionals, employers, family members and others. As with any type of pain, ‘endo pain’ is a subjective experience, making it harder for patients to talk about and for healthcare professionals to assess.4,5
Endo pain to a greater or lesser extent affects every facet of a person’s life, including their ability to work, undertake education, maintain friendships, have children, have intimate relationships and participate in leisure activities and exercise.13
About Gedeon Richter Australia
Recognised for its contribution to women’s health, original research and biotechnology, Gedeon Richter is headquartered in Hungary and has over 120 years global experience in healthcare.
Gedeon Richter Australia was established in 2017 and offers solutions with a focus on providing real health support for women and those assigned female at birth.
Gedeon Richter offer a comprehensive portfolio of treatments for fertility and gynaecological conditions, including endometriosis. Research efforts are focused on developing non-invasive medical treatments for common gynaecological conditions which are currently under-treated and can have a severe impact on the patient's quality of life.
Media contacts
Kelly Smith: 0402 994 120
Rita Corrente: 0414 552 426
Disclosures
In relation to this Gedeon Richter Australia media announcement, no honoraria were provided to Professor Jason Abbott, Dr Sneha Wadhwani or Jessica Taylor.
References
1. Department of Health and Aged Care. Pharmaceutical Benefits Advisory Committee. PBAC Meeting Outcomes. Available at: https://www.pbs.gov.au/industry/listing/elements/pbac-meetings/pbac-outcomes/2024-11/pbac-web-outcomes-11-2024.pdf
2. Department of Health and Aged Care. Minister Butler’s Media. Available at: https://www.health.gov.au/ministers/the-hon-mark-butler-mp/media Accessed March 2025.
3. Australian Institute of Health and Welfare. 2023. Available at: www.aihw.gov.au/reports/chronic-disease/endometriosis-in-australia/contents/about Accessed March 2025.
4. Jean Hailes. Endometriosis Fact Sheet. Available at https://www.jeanhailes.org.au/resources/endometriosis-fact-sheet. Accessed March 2025.
5. World Health Organisation. Endometriosis Factsheet. 2023. Available at: https://www.who.int/news-room/fact-sheets/detail/endometriosis Accessed March 2025.
6. Ryeqo® 40/1/0.5 (relugolix, estradiol, norethisterone acetate). Approved Consumer Medicine Information. January 2024. Available at: https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2023-CMI-01327-1. Accessed March 2025. 7. Cetera GE, Merli CEM, Facchin F, Viganò P, Pesce E, Caprara F, Vercellini P. Non-response to first-line hormonal treatment for symptomatic endometriosis: overcoming tunnel vision. A narrative review. BMC Womens Health. 2023 Jun 30;23(1):347. doi: 10.1186/s12905-023-02490-1. PMID: 37391793; PMCID: PMC10311799. Available at https://pmc.ncbi.nlm.nih.gov/articles/PMC10311799/. Accessed March 2025.
8. Armour, M., Ciccia, D., Stoikos, C. and Wardle, J. (2022), Endometriosis and the workplace: Lessons from Australia’s response to COVID-19. Aust N Z J Obstet Gynaecol, 62: 164-167. https://doi.org/10.1111/ajo.13458
9. Share the Dignity, Bloody Big Survey, 2024. Available at: https://d1fzx274w8ulm9.cloudfront.net/3e3fc9333e8d563b28fc41810e5d0e9b.pdf Accessed March 2025.
10. Ryeqo® 40/1/0.5 (relugolix, estradiol, norethisterone acetate). Approved Product Information. January 2024. Available at: https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2022-PI-01955-1&d=20250315172310101. Accessed March 2025.
11. Sachedin A, Todd N. Dysmenorrhea, Endometriosis and Chronic Pelvic Pain in Adolescents. Journal of Clinical Research in Pediatric Endocrinology. 2020;12(1):7–17. Available at https://pubmed.ncbi.nlm.nih.gov/32041388/. Accessed March 2025.
12. Maddern J,et al. Pain in Endometriosis. Front Cell Neurosci. 2020;14:590823. Available at https://pubmed.ncbi.nlm.nih.gov/33132854/. Accessed March 2025.
13. Armour, M, Ng, C. 2023. Tackling the burden of endometriosis: patients must be put first. Australian Medical Association, Australian Medical Publishing Company. Available at: https://insightplus.mja.com.au/2023/33/tackling-the-burden-of-endometriosis-patients-must-be-put-first/ Accessed March 2025.
Gedeon Richter Australia Pty Ltd ABN 98 602 550 274. Suite 902/15 Blue St, North Sydney NSW 2060. Date of preparation: March 2025. COMS-0267-Mar-2025