The commonly used abortion medication has had its approval expanded in two critical ways.
The Therapeutic Goods Administration has approved two major changes for the use of mifepristone and misoprostol in the medical termination of pregnancy and the medical management of miscarriage.
Mifepristone and misoprostol (MS-2 Step, MS Health) can now be used for medical abortion in pregnancies up to 10 weeks’ gestation – a one-week increase from the previous approval – and, for the first time, can be used for the medical management of missed miscarriage up to 10 weeks.
A missed miscarriage refers to when the embryo or fetus has died, but pregnancy tissues remain in the uterus and has not yet been passed from the body. In this circumstance, gestational date is determined by ultrasound rather than the date of the last menstrual period.
The changes came into effect on 21 October.
The TGA felt there was “strong evidence” for the effectiveness of MS-2 Step in the medical termination of pregnancies between 64 and 70 days’ gestation, citing two large studies where successful medical termination occurred in more than 92% of women that particular stage of pregnancy – equivalent to the effectiveness of the treatment in pregnancies between 57 and 63 days’ gestation.
“The safety information did not reveal any new concerns in women with pregnancies between 64-70 days gestation who were given mifepristone followed by misoprostol for the purposes of medical termination of pregnancy. The reported side effects were consistent with the known effects of MS-2,” the TGA noted.
The TGA also felt there was enough evidence to support the use of MS-2 Step in the management of missed miscarriages, pointing to studies that showed mifepristone improved the effectiveness of misoprostol for this purpose, and that using the mifepristone-misoprostol combination was more effective than waiting for the miscarriage to complete naturally.
There were no safety concerns associated with the use of MS-2 Step for the medical management of miscarriage up to 70 days of gestation, and the reported side effects were again consistent with the known effects of MS-2.
Professor Danielle Mazza AM, head of the Monash Department of General Practice and lead researcher at the NHMRC Centre of Research Excellence in Sexual and Reproductive Health for Women in Primary Care (SPHERE), described the announcement as a “highly significant” change for Australian women and healthcare practitioners.
“Being able to use the medication for a medical abortion up to 10 weeks gestation gives women more time to find an abortion provider and access care,” she said in a statement.
“This is especially important for women in rural and remote communities who often face delays navigating to care. It will also reduce the need for having to have a surgical abortion simply because you have passed the nine-week mark.”
These changes mean the approved uses of MS-2 Step are now consistent with national clinical guidelines, according to Professor Mazza.
“Approving MS-2 Step for the management of missed miscarriage is equally significant. It gives women another treatment option for early pregnancy loss enabling GPs to provide more comprehensive care.
“These new indications will also help GPs become more familiar and confident with prescribing the medication, further destigmatising abortion and hopefully encouraging provision of both abortion and miscarriage care by a larger number of practitioners in the community.”
Dr Nisha Khot, president of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, welcomed the TGA’s decision.
“This decision aligns the approved use with RANZCOG’s Clinical Guideline for Abortion Care, and with practice in comparable countries including the United Kingdom, the United States, and Aotearoa New Zealand,” the Victorian-based obstetrician said in a statement.
“Women experiencing miscarriage should be offered a choice of expectant, medical, or surgical management.
“A registered medical option, with approved prescribing information, gives clinicians clear guidance and gives women greater choice in their care.”
The Pharmaceutical Benefits Advisory Committee recommended extending the existing PBS restrictions for MS-2 Step for medical termination of an intrauterine pregnancy from 63 days to 70 days’ gestation in July.
“The PBAC considered that medical termination of pregnancy (MTOP) using MS-2 Step at a gestation age of 64 to 70 days is an effective option, noting that a small number of patients would require a follow-up procedure following MTOP to complete the medical termination of the intra-uterine pregnancy,” the committee said in its meeting outcomes report earlier this year.
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The 70-day miscarriage-specific listing of MS-2 Step will be considered by the PBAC in its November meeting.
“PBS listing is what makes this care affordable,” said MS Health CEO Adurty Rao.
“Without it, women can pay several hundred dollars rather than the standard co-payment. We look forward to the PBAC’s process continuing, so that every woman can access this care.”
The TGA said more detailed information regarding its decision to extend the approved uses of MS-2 Step would be published in the Australian Public Assessment Report (AusPAR) within the next three months.
