13 September 2021: 

Back in May, Sandoz, the supplier of Estradot and Estalis applied to delist these medications from the Pharmaceuticals Benefits Scheme (PBS) as they were not financially viable. The AMS in collaboration with the Royal Australian and New Zealand College of Obstetricians and Gynaeocologists (RANZCOG) and the Endocrine Society of Australia (ESA) wrote to Minister Hunt expressing our concern about access to Estradot and Estalis and the potential health outcomes if these medications were to be delisted from the PBS.

Following further discussions, Sandoz agreed to apply to the Pharmaceutical Benefits Advisory Committee (PBAC) for a price increase instead of delisting Estradot and Estalis from the PBS. Again, in collaboration with RANZCOG and ESA, AMS wrote a joint letter of support to PBAC for a price increase, rather than them being delisted from the PBS.

AMS is now happy to advise that the PBAC has agreed to the price increase for Estradot and Estalis from 1 October. This price increase means that these medications will remain on the PBS and support continuous and sustainable supply to the Australian market. While many women will need to pay more for these medications from 1 October, importantly, women on a healthcare card will only need to pay the concession price. A letter from Sandoz is attached for further information.

HCP Letter Estradot Estalis Sep 2021

12 August 2021: 

Information for Doctors

The Therapeutic Goods Administration (TGA) is advising health professionals and consumers of a current shortage for all strengths of PROGYNOVA estradiol valerate tablets. Due to manufacturing issues the shortage is expected to continue until May 2022.

PROGYNOVA tablets are used for short-term relief of symptoms associated with menopause.

The TGA has made a Serious Scarcity Substitution Instrument (SSSI) to assist patients in accessing their medicine from their pharmacist without delay, ensure treatments are not interrupted and relieve workload pressure on prescribers and pharmacists.

The SSSI is in force from 13 August 2021 until 1 May 2022. The TGA may, however, revoke the SSSI before its end date if the serious scarcity is resolved, or safety concerns are identified.

For more information see Substitution instrument to address shortage of PROGYNOVA estradiol valerate tablets (multiple strengths)

You should be alert to the current shortage of Progynova tablets when prescribing to your patients. Consider prescribing available estradiol-only tablets such as Estrofem and Zumenon tablet.

Zumenon is PBS-listed when prescribed but Estrofem is not.

Information for patients

Talk to your doctor or pharmacist if you have any questions regarding this substitution.

The pack size of estradiol-only tablets varies between brands. However, your pharmacist will supply the correct total dose that your doctor has prescribed.

If you have been prescribed Progynova 1mg or 2mg tablets and you receive a substitute medicine, your pharmacist will explain to you how to take your tablets.

If you are provided 2 mg tablets as a substitute for your usual 1 mg tablets, ask your pharmacist for advice on how to cut the tablets. If someone else is cutting the tablets for you, they may need to consider using personal protective equipment such as gloves and a mask to avoid unintended exposure to estradiol. Low dose of unintended exposure may cause harm or pose a risk of harm.