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Menopausal Hormone Therapy (MHT) discontinuation and shortages Feb 2024

Australia

Please note that Femoston-Conti 1/5 has been delisted from the PBS and is only available on private script from 1 December 2023. Patients who have been prescribed Femoston-Conti 1/5 before 1 December 2023 will be able to have it dispensed at the PBS listed price until 1 March 2024. We understand that the delisting is a commercial decision made by the sponsor. While private script prices fluctuate between pharmacies, Femoston-Conti 1/5 is currently being sold at a large pharmacy chain for $11.99 on a private script.

Product
Composition
Date of deletion
Climara 25
25mcg oestradiol transdermal patch
Deleted
Climara 50
50mcg oestradiol transdermal patch
15 Mar 2024
Climara 75
75mcg oestradiol transdermal patch
Deleted
Climara 100
100mcg oestradiol transdermal patch
Deleted

There are a number of MHTs that are currently unavailable. Please note that the TGA has approved some unregistered products for supply under Section 19A.

Product
Composition
Expected supply due
Section 19A Approved Equivalent
Estradot 25
25mcg oestradiol
26 Apr 2024
Estramon oestradiol 50mcg
Estradot 37.5
37.5mcg oestradiol
17 May 2024
Estramon oestradiol 37.5mcg
Estradot 50
50mcg oestradiol
26 Apr 2024
Estramon oestradiol 50mcg
Estradot 75
75mcg oestradiol
17 May 2024
Estramon oestradiol 75mcg
Estradot 100
100mcg oestradiol
17 May 2024
Estramon oestradiol 100mcg
Estraderm MX 25
25mcg oestradiol
Available
 
Estraderm MX 75
75mcg oestradiol
15 Mar 2024
 
Estraderm MX 100
100mcg oestradiol
Available
 
Estalis Sequi 50/140
50mcg 17β oestradiol/140mcg norethisterone acetate
Unavailable
 
Estalis Sequi 50/250
50mcg 17β oestradiol/250mcg norethisterone acetate
1 Mar 2024
 
Estalis Conti 50/140
50mcg 17β oestradiol/140mcg norethisterone acetate
Available
 
Estalis Conti 50/250
50mcg 17β oestradiol/250mcg norethisterone acetate
Available
 

The AMS Guide to MHT Doses (Australia only) provides a guideline to approximately equivalent doses of the different MHT/HRT products in Australia.

New Zealand

A list of patch availability is provided below.

Dose
Estradot
Viatris
Mylan
25mcg
Low supply
n/a
Unavailable
50mcg
Low supply
Unavailable
Unavailable
75mcg
Unavailable
Unavailable
Unavailable
100mcg
Unavailable
Available
Unavailable

More information can be found at here

The AMS Guide to MHT Doses (New Zealand only) provides a guideline to approximately equivalent doses of the different MHT/HRT products in New Zealand. 

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Menopausal Hormone Therapy (MHT) Patch discontinuation and shortages

30 May 2023

In Australia, all doses of Climara are being deleted from the market and there will be a reduction in supply until supply is exhausted.

Product
Composition
Date of deletion
Climara 25
25mcg oestradiol transdermal patch
31 Dec 2023
Climara 50
50mcg oestradiol transdermal patch
15 Nov 2023
Climara 75
75mcg oestradiol transdermal patch
15 Mar 2024
Climara 100
100mcg oestradiol transdermal patch
30 Sep 2023

Estalis Sequi 50/140 patches are currently unavailable and supply is expected to return by 26 May 2023. Estradot 100 is also currently unavailable and supply is expected to return by 30 June 2023.The recent shortages of Estraderm MX25, Provera and Tibolone have been resolved. Duavive is still unavailable.

The AMS Guide to MHT Equivalent Doses (Australia only) provides a guideline to approximately equivalent doses of the different MHT/HRT products in Australia.

In New Zealand, there are also supply issues of Estradot 25, 50 and 75mcg and resupply is expected in July 2023. Estraderm and Estradiol TDM Mylan are available on Section 29. Details here

The AMS Guide to MHT Equivalent Doses (New Zealand only) provides a guideline to approximately equivalent doses of the different MHT/HRT products in New Zealand.

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Menopause Survey for Women

AMS Survey page 
 
Would you like to help the #EmbraceTheChange campaign for #perimenopause and #menopause?
You can have a voice about:
+ Impacts of perimenopause and/or menopause on your quality of life
+ Your experiences going to a doctor
+ What you think needs to change
 
This survey is targeted at peri- or post-menopausal Australian women* to inform the Australasian Menopause Society's advocacy campaign.
*Please refer to the AMS Gender Language Policy
 
You may access the survey at Menopause Survey for Women or use the QR COde shown.

QR code for survey

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Micronised progesterone (Utrogestan®) to be unrestricted and fully funded in New Zealand

Pharmac have recently announced that restrictions on the prescription of Utrogestan® will be removed from 1 December 2022. This will mean that women will be able to access fully funded Utrogestan® for a range of uses, including for menopausal hormone therapy.

The Australasian Menopause Society provided a letter of support to Pharmac in June 2022 supporting the funding of Utrogestan® for MHT as the endometrial protection agent when women require oestrogen for the treatment of menopausal symptoms in the perimenopausal time and also as part of hormone replacement therapy for premature ovarian insufficiency. Being a bioidentical progesterone, international opinion says that it is the safest progesterone to use with the lowest side effect profile. it is considered best practice to use this progesterone as it has a more favourable effect on lipid profiles and potentially less likely to impact on breast cancer risk. It has the additional advantage of having a soporific effect.

More information about the announcement can be found here.

Content updated 26 September 2022

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Perimenopause at WinterROC22 August 21

The Australasian Menopause Society is proud to announce that Dr Karen Magraith and Prof Rod Baber have been invited to speak at next weeks WinterROC Online GP Conference on the topic of Perimenopause.

All GPs can attend the WinterROC Online GP Conference, including this session free of charge by registering at www.winterroc.com.au

Winter ROC22 Perimenopause


About WinterROC 22

WinterROC is a free online GP conference covering multiple Women's Health topics including Perimenopause, as well as streams on skin cancer, cardiovascular disease and musculoskeletal conditions.

Registration is free of charge for all General Practitioners.

More information and registration is available at www.winterroc.com.au

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Breaking the silence on Early menopause

Breaking the Silence on Early menopause imageThe theme of International Women’s Day for 2022 is ‘Breaking the bias’. Researchers at Monash Centre for Health Research and Implementation, Monash University, have chosen this day to ‘break the silence’ on early menopause, to launch their new evidenced based App for women Ask Early Menopause. Developed by women for women, and with multidisciplinary early menopause expert input, the App includes women’s stories, evidence-based information, animation and a personalised dashboard to help women manage early menopause and premature ovarian insufficiency. Development of the App was undertaken as part of the CRE in Women’s Health in Reproductive Life (CRE-WHiRL) and builds on previous work from the NHMRC partnership project, Healthtalk Australia Early Menopause Digital Resource where AMS was a project partner.

The App is to be launched by guest speaker, Professor Beverley Vollenhoven AM, former AMS board member, at an online event on March 7 2022, which will include expert speakers and a Q&A session. We hope that you and the women with early menopause you care for can join us.

Clinical A/Prof Amanda Vincent
Head of Early Menopause research, Monash Centre for Health Research and Implementation, Monash University
Endocrinologist, Menopause Clinic, Monash Health
AMS Past President

pdfBreaking the Silence on Early Menopause594.87 KB 

 

 

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Estradot and Estalis to remain on the PBS

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.

pdfHCP Letter Estradot Estalis Sep 2021

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Shortage of PROGYNOVA estradiol valerate addressed with SSSI

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.

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Menopausal Hormone Therapy and Non-Hormonal Options Shortages in Australia – Update 23 June 2021

There has been a recent shortage of a number of menopausal hormone therapy (MHT) preparations and some of these have now been or soon will be resolved:

Oral MHT

Duavive – supply due to be resolved by end January 2022

Progynova 2mg – supply due to be resolved by end of April 2022

Femonston Conti – supply shortage expected between 25 June and 9 July

 

Transdermal MHT

Estradot 100 – supply due to be resolved by 31 August

Estradot 75 – supply due to be resolved by 31 August

Estradot 50 – supply due to be resolved by 1 July

Estradot 37.5 – supply due to be resolved by 31 August

Estradot 25 – supply due to be resolved by 1 July

Estalis Conti 50/140 – supply resolved

Estalis Conti 50/250 – supply resolved

Estalis Sequi 50/140 – supply resolved

Estalis Sequi 50/250 – supply resolved

Estraderm MX 50 – supply resolved

Estraderm MX 100 - supply resolved

Non-Hormonal Options

There is also an expected shortage of supply of non-hormonal treatment options:

Gabapentin-APOTEX 100mg – supply shortage expected between 20 August- 15 October

Gabapentin 300mg- supply shortage expected between 18 June- 16 July

APX-Gabapentin 300mg- supply shortage expected between 16 July- 6 August

Gabapentin-APOTEX 300mg – to be discontinued from 18 July

Combined oral contraceptive pill

There is also an expected shortage of combined oral contraceptive pill:

Qliara – supply due to be resolved by 1 June 2022

Please note that dates for supply have been sourced from either the pharmaceutical supplier or the TGA website and may change at any time.

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Menopausal Hormone Therapy Shortages in Australia – Update 22 February 2021

There has been a recent shortage of a number of menopausal hormone therapy (MHT) preparations and some of these have now been or soon will be resolved:

Oral MHT

Duavive – supply due to be resolved by end January 2022 

Transdermal

Estradot 100 – supply due to be resolved by the end of March

Estradot 75 – supply due to be resolved by the end of April

Estradot 50 – supply due to be resolved by the end of March

Estradot 37.5 – supply due to be resolved by the end of March

Estradot 25 – supply due to be resolved by the end of April

Estalis Conti 50/140 - supply due to be resolved by early April

Estalis Conti 50/250 - supply due to be resolved by early April

Estalis Sequi 50/140 – supply due to be resolved by early May

Estalis Sequi 50/250 – supply due to be resolved by early May

Estraderm MX 50 – supply due to be resolved by end of April

Estraderm MX 100 - supply due to be resolved by end of April

Please note that dates for supply have been sourced from either the pharmaceutical supplier or the TGA website and may change at any time.

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