Recently a number of menopause hormone therapy (MHT) products have been unavailable or in short supply. Brand names including Climara, Angeliq and Duavive have been affected, and the TGA has advised that there are anticipated shortages of various doses of Estradot and Estalis Sequi until July 2021 (apps.tga.gov.au/prod/msi/Search/Details/estradiol). The shortages are due to a change in manufacturing processes that require a new approval by the TGA which can take up to six months. New Zealand has already approved the new manufacturing process for Estradot. In an effort to maintain the availability of Estradot, the TGA have agreed to allow an ‘unregistered product’ to be supplied in Australia. This unregistered product is the one that is supplied in New Zealand – same name (Estradot) and same dosage as Australia but it has different packaging and Australian Registered Number. The TGA anticipate that supply should be sufficient now that there is authority to distribute the New Zealand approved product.
However, as Estalis Sequi is not registered in New Zealand, the same mechanism for supply in Australia cannot be used. Sandoz are expecting that there will be critical supply issues between August and September 2020. Sandoz/TGA will be writing to all relevant health professionals about the supply issue and advise of alternative prescriptions. Sandoz have also advised that the TGA will expedite the approval process and they anticipate that approval should be reached by around September 2020.
Prescribers should check the AMS Guide to Equivalent MHT/HRT Doses to guide them on prescription alternatives. Options to replace Estalis Sequi include:
- Estradot combined with a progestogen
- Estrogel Pro
- Oral MHT if appropriate
Patients who are having issues with filling their prescription are encouraged to see their doctors to discuss alternative options.