PBS listing of Bayer’s endometriosis therapy ends a 30-year wait, marking a milestone in women’s health

Australians living with endometriosis, a chronic and debilitating condition causing severe pain and infertility, now have subsidised access to Bayer’s Visanne (dienogest), marking the first new treatment for the disease in more than three decades.

Endometriosis, which results in over 40,000 hospital admissions annually, has seen a 40% rise in hospitalisations over the past decade. The Pharmaceutical Benefits Scheme (PBS) listing of Visanne addresses a pressing need for improved management options in a condition affecting 14% of women of reproductive age.

Professor Jason Abbott, a former President of the Australasian Gynaecological Endoscopy & Surgery Society (AGES) and an obstetrician-gynaecologist at the University of New South Wales, emphasised the critical nature of this development.

“Subsidised access to this medicine will be very welcome news for a large number of women living with this invisible disease,” he said. “There is no cure for endometriosis, and it can last for decades. Affordable access to treatment options to help control symptoms is extremely important for a patient’s quality of life.”

He highlighted that even post-surgery, patients often require ongoing medication to manage symptoms, which can severely impact participation in work, education, and social activities.

Visanne, is a fourth-generation progestin daily tablet that works by preventing ovulation and menstruation to shrink and suppress abnormal tissue growth. Despite its prevalence – affecting one in seven women and teens – endometriosis often goes undiagnosed for years, with an average diagnostic delay exceeding six years.

Although Gedeon Richter’s Ryeqo (relugolix, estradiol, norethisterone acetate), a once-daily oral GnRH receptor antagonist, received the first PBAC nod in April, Bayer has taken the lead by securing the first reimbursed endometriosis therapy with Visanne.

Lesley Freedman, co-founder of advocacy group EndoActive, pointed to the lack of awareness as a major barrier. Her daughter, Syl Freedman, was diagnosed at 21 after enduring chronic pelvic pain for a decade.

“Misconceptions about endometriosis being only period pain or related to a person’s pain threshold greatly undermine the experiences of people with this condition,” Freedman said. “Endometriosis can be an incredibly painful condition. Many patients also deal with heavy periods, fatigue, fertility challenges, and a range of other symptoms.”

Twenty-two (22) pelvic pain and endometriosis clinics have been established nationwide, offering free or low-cost services through multidisciplinary teams. This initiative, stemming from a 2022 bipartisan election promise by the Coalition and Labor, has seen most clinics integrated into existing GP practices. Each clinic receives approximately $700,000 in government funding over four years.

Manoj Saxena, CEO of Bayer ANZ and Country Division Head for the Pharmaceutical Division, said “Efforts by organisations like EndoActive have been pivotal in raising awareness of endometriosis and putting the disease at the top of the government’s agenda.”

Approximately 30% of women undergoing in vitro fertilisation (IVF) are affected by endometriosis, and half of all endometriosis patients face infertility. An interim analysis from a randomised clinical trial suggests that Visanne may influence reproductive outcomes for IVF or intracytoplasmic sperm injection (ICSI). The study, presented at the recent American Society for Reproductive Medicine (ASRM) congress, found that women with endometriosis who were treated with Visanne had lower birth rates per single embryo transfer compared to those who received no prior treatment (17.4% vs. 38.2%, P=0.042).

Syl Freedman, co-founder of EndoActive, celebrated the PBS listing as a vital step in supporting those living with endometriosis.

“Endo is a debilitating condition that can impact every facet of life – employment, family, intimate relationships, physical and mental health. Affordable and equal access to treatment options is incredibly important,” she said. “Endo remains taboo and continues to be shrouded in mystery. Although awareness has been improving, there are still significant gaps. We need ongoing education and support to ensure women are not continuing to suffer in silence.”

Saxena echoed this sentiment, saying “The PBS listing of Visanne is an important step towards addressing inequalities in women’s health access, and Bayer is proud to have played a role. We remain committed to partnering with patient groups and government to meet reproductive health needs.”

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