New pathway could ease HRT shortage crisis for patients

The Therapeutic Goods Administration (TGA) has issued a Serious Scarcity Substitution Instruments (SSSI) to help pharmacists and patients manage the shortage of hormone replacement therapy (HRT) patches.

A global shortage of menopausal hormone therapies (MHT) has persisted throughout 2024, leaving many women ‘unable to function’. 

Around 13% (260,000) of Australian menopausal women take MHT. But with another 80,000 women estimated to have gone through menopause this year, demand is only set to increase.

But it’s not only older women who benefit from using these patches. Younger women undergoing early menopause due to chemotherapy or conditions affecting the ovaries or pituitary gland need oestrogen. So do transgender women and non-binary individuals as part of feminising hormone therapy for gender affirmation.

With shortages of many of these medicines set to persist into 2025, the SSSI allows pharmacists to dispense an alternative brand or strengths to these patients, if appropriate, without a new prescription from the prescriber.  

What HRT substitutions are available for patients?

A representative for Sandoz told Australian Pharmacist that the manufacturer is ‘committed to addressing the global supply challenges for MHT and HRT transdermal patches’.

‘In collaboration with the local authorities and global manufacturing partners, we have taken proactive steps to alleviate supply constraints,’ said the spokesperson.

‘Although Estradot (estradiol) registered products will have constrained supply throughout the first half of 2025, as noted on the TGA medicines shortages website, we are pleased to confirm alternative products have received Section 19A conditional approval for release in Australia.’

Medsurge Healthcare, which sources and supplies essential medicines in times of critical need and uncertainty, has also been able to arrange for the supply of alternative products on a temporary basis until the shortages of Australian registered medicines are resolved, a spokesperson for Medsurge told AP.

‘Medsurge was granted temporary S19A approval under section 19A of the Therapeutic Goods Act 1989 and has worked diligently to fill a critical need for patients,’ said the Medsurge spokesperson.

Under Section 19A, the following brands and strengths of HRT patches can be substituted for out-of-stock Estraderm MX and Estradot patches:

• Estramon estradiol 25 microgram/24 hours transdermal patch (Hexal, Germany) – Sandoz
• Estramon estradiol 50 microgram/24 hours transdermal patch (Hexal, Germany) – Sandoz
• Estramon estradiol 75 microgram/24 hours transdermal patch (Hexal, Germany) – Sandoz
• Estramon estradiol 100 microgram/24 hours transdermal patch (Hexal, Germany) – Sandoz
• Estramon estradiol 75 microgram/24 hours transdermal patch (Germany) – Medsurge
• Estramon estradiol 100 microgram/24 hours transdermal patch (Germany) – Medsurge
• Estramon estradiol 37.5 microgram/24 hours transdermal patch (Germany) – Medsurge
• Estramon estradiol 50 microgram/24 hours transdermal patch (Germany) – Medsurge
• Estradiol Transdermal System 100 mcg/day (0.1 mg/day) (Sandoz, USA) – Sandoz
• Estradiol Transdermal System 37.5 mcg/day (0.0375 mg/day) (Sandoz, USA) – Sandoz.

Are S19A HRT medicines covered under the PBS?

Some of them. 

‘US-labelled Estradot is available on the PBS [Pharmaceutical Benefits Scheme], while Estramon is expected to be subsidised soon,’ said the Sandoz spokesperson.

Meanwhile, Medsurge-sponsored Estramon (estradiol) supplied under S19A is subsidised on the PBS. 

How do pharmacists go about accessing them?

Between the three versions of HRT – Estradot, US-labelled Estradot S19A (Estradiol Transdermal System) and Estramon S19A – the Sandoz spokesperson said there is ‘sufficient supply to meet the demands of Australian patients’.

‘Pharmacists can order through their regular wholesaler,’ said the Sandoz spokesperson.

According to the Medsurge spokesperson, stock availability of S19A HRT patches is primarily influenced by demand from healthcare professionals. 

‘To ensure we meet patient needs effectively, we strongly encourage pharmacies to forecast their requirements at least 8 weeks in advance,’ said the spokesperson. 

‘This lead time allows us to place our order with the licensed distributor overseas, import in Australia and deliver to pharmacies.’

Healthcare Professionals can place their orders for the required products through Medsurge MConnect or their preferred wholesaler.