From June 1, the government will fund treatments to reduce risk of preterm birth among women with a short cervix.
Pregnant women at risk of preterm birth will now pay roughly only a quarter the price for progesterone pessaries following the medicines’ addition to the PBS on June 1.
Vaginal pessaries (Oripro, Orion Laboratories) were indicated for prevention of preterm birth in singleton pregnancies for women who had a history of spontaneous preterm birth or a mid-trimester sonographic cervix measurement of 25mm or less.
The pessaries were available as 100mg or 200mg formulations and were the first progesterone treatments for preterm birth to be reimbursed on the PBS.
They were used once at night, from the second trimester to the end of the 36th gestational week or until delivery.
The medicine previously cost around $170 for 45 of the 200mg pessaries, whereas patients should now expect to pay around $40, according to the PBS listing.
RANZCOG noted in its clinical guidelines that a short cervix detected with transvaginal ultrasound in the mid trimester was a powerful predictor of spontaneous preterm birth.
And a 2016 meta-analysis showed vaginal progesterone reduced the risk of preterm birth prior to 34 weeks from 27.5% to 18.1% among women with a cervix of 25mm or less.
The treatment also reduced the risk of preterm birth complications, including respiratory distress, composite neonatal morbidity and mortality, birth weight <1500g and admission to the neonatal intensive care unit.
“Further research is also needed to determine … the optimal timing, dose and administration of progesterone. Participation in relevant clinical trials should be encouraged,” RANZCOG said.
It noted there was no evidence that giving progesterone supplements to otherwise healthy women in the first trimester of pregnancy reduced the risk of spontaneous miscarriage.
Dr Wendy Burton, a GP and chair of the RACGP Antenatal/Postnatal Care Specific Interests network, told The Medical Republic it was good to have a government-funded option for eligible patients, and “time will tell how many benefit” from the listing.
The S4 medication was also indicated to support embryo implantation and maintain initial pregnancy in women with progesterone deficiency who are undergoing assisted reproductive technology treatment, but the new PBS reimbursement covers only the period from 16 weeks’ gestation to the time of birth.
Contraindications for vaginal progesterone included sensitivity to progesterone or to hard fat, undiagnosed vaginal or urinary tract bleeding, liver disease or dysfunction, known or suspected cancer of the breast or genital organs, ectopic pregnancy, and active or a history of hormone-associated thrombophlebitis or thromboembolic disorder.
