PROGESTERONE

The PBAC recommended the listing of progesterone (Utrogestan®) for the treatment of unexplained threatened miscarriage during the first trimester, in patients with vaginal bleeding in the current pregnancy and a history of three or more prior miscarriages. The PBAC welcomed the consumer input received for this item and noted the input strongly supported the submission and highlighted the equity and cost concerns for patients. 

The PBAC noted that the submission requested a listing for use in patients with a history of at least one prior miscarriage. However, this did not align with the indication approved in Australia by the Therapeutic Goods Administration (TGA). Use of progesterone for unexplained threatened miscarriage in patients with one or two prior miscarriages, was not well supported by the evidence presented in the submission by the pharmaceutical company. Therefore, the PBAC recommended a listing within the TGA’s approved uses TGA, which is for use in patients with a history of three or more prior miscarriages, where evidence demonstrated that treatment with progesterone significantly improves live birth rates. The PBAC considered that the economic evaluation based on an incremental cost per live birth was acceptable.