Pharmaceutical company Sandoz Australia is in a standoff with the federal government over the pricing of hormone patches relied on by thousands of women. There is a risk that if an agreement is not reached the drug will only be available under private prescription, which would significantly increase the price.
Estradot, Estalis Sequi and Estalis Continuous patches are subsidised by the government under the Pharmaceutical Benefits Scheme (PBS), and are used by women for the relief of symptoms of menopause.
Women with medical conditions such as cancer and endometriosis who have undergone hysterectomy are among those who rely on the patches. The PBS listing means the government covers most of the cost of the patches, while the patient contributes a small co-payment.
The patches are also used as feminising hormones for gender-diverse people.
Sandoz Australia, the supplier of the drug, recently asked the PBS to increase the price of the patches because the listed cost was no longer sustainable due to manufacturing costs increasing during the Covid-19 pandemic. When the request was refused, Sandoz announced it had requested the products be delisted from the PBS from June, a move that would make the patches available via private prescription only meaning patients would have to pay full price.
It prompted the Australasian Menopause Society, the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, and the Endocrine Society of Australia to write a joint letter to the health minister Greg Hunt to urgently reconsider and to work with Sandoz to strike an agreement.
“This decision has the potential to exacerbate the recognised negative gendered impact of the Covid pandemic currently experienced by Australian women in regard to adverse effects on mental health, financial burden, work, and quality of life,” the letter said. It said there were no equivalent patch alternatives for women, with pills and gels the only alternatives. But many women preferred patches because of their ease of use, health benefits and range of dosing options, the letter said.
The patch products are already in short supply due to the Covid-19 pandemic, and medical experts fear a delisting would exacerbate the situation.
“We understand that these medications will be available on a private script at a higher price – the list price will be up to $24.87 more expensive per script,” the letter said.
“In particular, it will mean that those women eligible for a concession card will need to pay full price for these medications from 1 June. There are potential adverse health and economic outcomes associated with this decision which will not only impact postmenopausal women aged over 45 years but also women with early (menopause before age 45 years) or premature menopause (menopause before age 40 years).”
Early and premature menopause affects up to 12% of women and current clinical guidelines recommends estrogen therapy until the age of natural menopause to prevent osteoporosis and cardiovascular disease.
“This means that a woman who has premature menopause at age 20 may require menopausal hormone therapy (MHT) for up to 30 years representing a significant financial impost,” the letter said.
However Sandoz Australia general manager Guy Strong said after concerns were raised, the company had withdrawn the request to delist the products from the PBS. Sandoz Australia was now working with the department of health, the PBS and relevant stakeholder bodies, to determine the future listing of the Estradot and Estalis range on the PBS, he said.
But he said to provide continuous, sustainable supply of Estradot, Estalis Sequi and Estalis Continuous to Australian patients, there must be changes to the pricing. If negotiations proved unsuccessful, Sandoz Australia would need to again move to delist the products from the PBS, he said.
“Due to the existing PBS list price to pharmacies and the increasing cost to manufacture this medicine, Sandoz has been selling Estradot/Estalis at below the cost to manufacture for a number of years,” Strong said.
“Stick-on skin patches that deliver medications are far more complex to manufacture than a pill, and with all medicines it is important that we can adequately cover costs so that we can sustainably supply quality, affordable medicines to our Australian patients.
“Therefore, we are applying to the PBS to be listed at a more sustainable price. Should this be unsuccessful, we would need to revisit the decision to delist and these products would only be available by private prescription.”
In the meantime, a spokesperson for the Therapeutic Goods Administration, which regulates medicines in Australia, said the Estradot range of products is being replaced by new, equivalent products, but these are not yet in supply.
“The TGA has given temporary approval for supply of an overseas Estradot product,” the spokesperson said.
“There are also two alternative patches on the Australian Register of Therapeutic Goods, Climara and Estraderm MX. To assist patients in obtaining one of these products, the TGA has published ‘serious shortage substitution notices’ for Estradot 25 and Estradot 75. These allow a pharmacist to dispense a nominated substitute product without the patient needing a new prescription.”
