A new drug has been approved in Australia to treat endometriosis.Here's what we know about it

Australia's medicines regulator has approved a new treatment for endometriosis for people living with the moderate to severe pain associated with the disease.

This new addition is aimed at patients with a history of medical or surgical treatment for endometriosis, and is the first addition of its kind in 13 years.

Let's find out what new drugs are, how to get them, and how much they cost.

What is endometriosis?

Endometriosis is a chronic disease that affects one in seven women, or those assigned female at birth.

Tissue that resembles the uterus can grow outside the uterus and join normally separated pelvic organs, forming painful adhesions.

The progressive disease varies in severity depending on the inflammation and scarring caused by the lesions.

What do we know about approved drugs?

It's called Ryeqo and is a product of pharmaceutical company Gedeon Richter Australia.

The Therapeutic Goods Administration (TGA) has 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 fibroids.

The TGA's move to extend the drug's approval as a treatment for endometriosis indicates there is sufficient evidence of the drug's effectiveness in treating related conditions.

Will it be featured on PBS?

At this time, no.

However, Gedeon Richter applied for subsidy for the drug under the scheme, pending a decision by the Pharmaceutical Benefits Advisory Committee to be announced later this month.

Eligible patients must see a specialist for a prescription and can receive up to a two-year supply.

The price for one month is approximately $135.

What are the existing treatments?

There is no cure for this disease, and diagnosis is delayed by an average of 6 to 8 years.

Treatment is aimed at managing endometriosis and associated symptoms such as pain. This includes surgery and medications.

“Many of the drugs used to treat endometriosis are not specifically approved for endometriosis, but are used off-label for this purpose,” a Department of Health and Aged Care spokesperson said. says the person.

“These include hormonal contraceptives and nonsteroidal anti-inflammatory drugs.”

This new addition brings the total number of drugs indicated for the treatment of endometriosis to six available in Australia.

• Norethisterone (PRIMOLUT N)
• Oral medroxyprogesterone acetate (RALOVERA, PROVERA, DEPO PROVERA, DEPO RALOVERA)
• Nafarelin (SYNREL)
• Dieno Guest (VISANNE, DINASANE)
• Goserelin (ZOLADEX 3.6 mg implant)
• Estradiol, norethisterone acetate, relugolix (RYEQO)

How do treatments compare?

Relugolix is ​​a key ingredient in Lyco, which fertility specialist Anush Yazdani says has been shown in high-quality clinical trials to be “effective in managing symptomatic endometriosis by inhibiting hormone production.” states that it was shown.

He added that Ryeqo is offered as a single pill to replace other PBS-listed medications that require more stringent maintenance, such as nafaralin (a daily nasal spray) and goserelin (a monthly implant).

Nasal drops and implants both have a limited shelf life of six months and are often used in conjunction with additional dorsal therapy.

Katrina Moss is a researcher in the epidemiology of endometriosis and a UQ researcher who lives with the chronic disease of endometriosis.

Dr. Moss said the new additions are “exciting” but hopes to see more non-hormone-based medical management options.

“People shy away from hormone treatments because of the side effects…and the longer the symptoms go untreated, the more the disease can progress,” she says.

This often results in endometriosis patients requiring surgery, and it also serves as a diagnostic method.

“Surgery is the only way to remove the lesion, so medical management can reduce the chance that the lesion will come back,” Dr. Moss says.

How do drugs get approved on the PBS?

Pharmaceutical sponsors must first apply for Australian Government funding.

The Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body appointed by the Australian Government, reviews applications.

New drugs can only be listed on the PBS if they receive a positive recommendation from the PBAC.

Both the drug's cost and clinical effectiveness when compared to other treatments for the same condition are considered.

The criteria listed are: PBS site:

• Treat or prevent serious medical conditions that are not covered or only partially covered by currently listed medications.

• more effective and/or less harmful than currently listed drugs

• Efficacy and safety equivalent to existing listed drugs

Affordability 'remains an issue'

Endometriosis Society of Australia spokesperson Anush Yazdani said the organization welcomed the drug's approval as an alternative treatment for people suffering from endometriosis.