A new drug has been approved for endometriosis treatment in Australia. Here’s what we know about it
Australia’s drug regulator has approved a new medication to treat endometriosis, aimed at people living with moderate to severe pain associated with the condition.
The new addition is the first of its kind in 13 years, directed at patients with a history of medical or surgical treatment for endometriosis.
Let’s unpack what the new drug is, how to access it and how much it costs.
What is endometriosis?
Endometriosis is a chronic disease that affects one in seven women or those assigned female at birth.
Tissue similar to the womb grows outside the womb and can form painful adhesions, joining pelvic organs that are normally separate.
The progressive disease varies in severity due to inflammation and scarring caused by lesions.
What do we know about the approved drug?
It’s called Ryeqo, a product of pharmaceutical company Gedeon Richter Australia.
The Therapeutic Goods Administration (TGA) specifically approved Ryeqo for the treatment of moderate to severe pain associated with endometriosis, which sets it apart from many existing treatments.
Ryeqo is already available to treat symptoms of uterine fibroids, commonly known as myomas.
The TGA’s move to extend the drug’s approval for endometriosis treatment shows there is enough evidence on its efficacy for treating related symptoms.
Will it be covered by PBS?
At the present moment, no.
However, Gedeon Richter has applied for the drug to be subsidised under the scheme, pending a decision by the Pharmaceutical Benefits Advisory Committee – to be announced later this month.
Eligible patients will be required to consult their specialist for a prescription – and receive a supply for up to two years.
One month’s supply will cost approximately $135.
What are the existing treatments?
The disease has no cure with delayed diagnosis of an average of six to eight years.
Treatments are aimed at managing endometriosis and related symptoms such as pain. This includes surgery and medicines.
“Many of the medicines used to treat endometriosis were not approved specifically for endometriosis but are used as off-label for this purpose,” a spokesperson for the Department of Health and Aged Care says.
“These include hormonal contraceptives and non-steroidal anti-inflammatory drugs.”
With the new addition, there are altogether six types of medications indicated for the treatment of endometriosis available in Australia.
- Norethisterone (PRIMOLUT N)
- Oral medroxyprogesterone acetate (RALOVERA, PROVERA, DEPO PROVERA, DEPO RALOVERA)
- Nafarelin (SYNREL)
- Dienogest (VISANNE, DINASANE)
- Goserelin (ZOLADEX 3.6 mg implant)
- Estradiol, norethisterone acetate, relugolix (RYEQO)
How do the treatments compare?
Relugolix is a key component in Ryeqo which fertility specialist Anusch Yazdani says high-quality clinical trials have shown to be “effective in managing symptomatic endometriosis by suppressing hormone production”.
He adds Ryeqo presents as a single-pill alternative to other PBS-listed medications that require heavier up-keeping such as Nafaraline (a daily nasal spray) or Goserelin (a monthly implant).
Both the nasal spray and the implant are limited to six months use and often combined with additional back therapy.
Katrina Moss is a UQ researcher in epidemiology of endometriosis who also suffers from the chronic condition.
While the new addition is “exciting”, Dr Moss hopes to see more medical management options that are not hormone-based.
“People shy away from hormonal treatments because of associated side effects … and the longer they go without treating symptoms, the more advanced their disease can become,” she says.
This often leads endometriosis sufferers down the path of needing surgery, which also doubles up as a diagnosis method.
“The only way to get rid of lesions is by surgery and then medical management can reduce the chance of those coming back,” Dr Moss says.
How do medicines get approved on the PBS?
It requires the sponsor of the medicine to first apply for the Australian government subsidy.
The Pharmaceutical Benefits Advisory Committee (PBAC), which is an independent expert body appointed by the Australian government, will review the application.
A new medicine can only be listed on the PBS if it receives a positive recommendation from the PBAC.
Both the cost and clinical effectiveness of the medicine when compared to other treatments for the same condition are taken into account.
Here’s what the criteria looks like as listed on the PBS site:
It treats or prevents significant medical conditions that are not covered, or only partially covered, by currently listed drug(s)
It is more effective and/or less harmful than a currently listed drug
It is as effective and safe as an existing listed drug
Affordability ‘remains an issue”
Anusch Yazdani, who is also a spokesperson for Endometriosis Australia, says the organisation welcomes the approval of the drug as another therapeutic option for those struggling with endometriosis.
However, Dr Yazdani notes the cost could further exacerbate the inequity of access to health care.
“Endometriosis is more likely to be diagnosed and treated in urban, higher socio-economic, non-Indigenous Australians aged 30 to 39,” Dr Yazdani says.
“The lack of PBS-subsidised endometriosis treatment compromises patient care. It is likely, therefore, that Ryeqo will be primarily used by the sub-population listed.”
As a result, he says, this will create a “high economic burden”, for patients who cannot tolerate or achieve symptom relief from the current PBS-subsidised options.
While Ryeqo is pending PBS approval, Dr Yazdani says the process is flawed given how TGA approval is gained through sponsor-supported application.
“PBS subsidisation should be driven by need, demand and evidence rather than third party commercial incentives,” he says.
“This failure preferentially disadvantages vulnerable sub-populations, delays treatment and imposes unrealistic financial burden.”
