Conditional award of Principal Supply Status for oestradiol patches

We are pleased that this decision will support the long-term supply of, and access to, oestradiol patches.

The Estradiol TDP Mylan brand of oestradiol patches are currently funded. They are provisionally approved by Medsafe and are undergoing Medsafe evaluation for full approval. The award of Principal Supply Status is conditional on Viatris gaining full Medsafe approval for Estradiol TDP Mylan.

This decision comes as a result of Pharmac’s 2023/24 Annual Invitation to Tender (ITT) and means that:

• Estradiol TDP Mylan, supplied by Viatris, will be awarded Principal Supply Status for its brand of oestradiol patches from 1 December 2025 until 30 June 2027, if Medsafe approval occurs within the timeframes Viatris and Pharmac are aiming for (by 1 July 2025).
• awarding Principal Supply Status to a brand of a medicine means it will be the main funded brand available, and will be supplied to at least 95% of the New Zealand market.
• the Estradot, Estraderm MX, Lyllana, Estradiol Viatris, and Estradiol Sandoz brands will be delisted from 1 December 2025.

What this decision means for people

Oestradiol patches are used to increase oestradiol levels in the body. They are commonly used to manage menopause symptoms and other conditions associated with low levels or a lack of oestradiol. Oestrogen patches are applied to the skin and slowly release the hormone oestradiol, which is then absorbed into the body. It is common to use oestradiol patches for anywhere between 2 to 5 years to treat menopause symptoms.

If Medsafe approval occurs within the timeframes Viatris and Pharmac are aiming for, this decision means that:

• everyone who uses funded oestradiol patches will need to move to the Estradiol TDP Mylan brand between 1 July 2025 and 1 December 2025
• Estradiol TDP Mylan will be the only funded brand of oestradiol patches from 1 December 2025.

In 2023/24 approximately 85,000 people used oestradiol patches, many of whom used the Estradiol TDP Mylan brand, as it is one of several brands currently funded.

We have made this decision with the aim to secure supply of oestradiol patches. We have heard from people using oestradiol patches that the supply issues have caused significant impact to them, their loved ones and communities. Over the last 2 years, people have had to change brands and, at times, may have run out of oestradiol patches completely. This decision means people will have certainty that the patches they need will be available.

Further detail about this decision:

Why we are doing this

Details about this decision

Implementation activities

Additionally, we have a page on our website which we will keep updated with key information and resources throughout 2025 to support implementation of this decision.

Pharmac website – Oestradiol patches: Estradiol TDP Mylan to be the funded brand

Who we think will be interested

• People who use (or may use) medicines containing oestradiol, their whānau, family, friends and caregivers.
• Endocrinologists, gynaecologists, primary care prescribers, and other health care professionals who support people using oestradiol, including Māori health and Whānau Ora providers.
• Groups who support and advocate for people who use oestradiol.
• Health New Zealand I Te Whatu Ora hospitals and other organisations who deliver services and support for people who may use oestradiol.
• Pharmacies and pharmaceutical wholesalers.
• Pharmaceutical suppliers.

Why we are doing this

Current supply of oestradiol patches

Demand for oestradiol patches has increased substantially over recent years, from 1.3 million patches dispensed in 2020/21 to over 4.7 million patches dispensed in 2023/24. The increase in demand represents growing awareness of the benefits of oestradiol treatment in helping with symptoms of menopause and other conditions related to low or a lack of oestrogen (such as gender affirming care).

Over the last two years there have been significant supply issues for oestradiol patches. To help mitigate the impact of this supply issue, over this time, Pharmac has funded multiple brands of oestradiol patches. However, there have been periods of low or no supply, and people have needed to change brands, use different patch strengths or not been able to access treatment at all.

What we have heard

We have heard about the impacts that supply constraints for oestradiol patches have had on people’s health and wellbeing.

We understand throughout these supply shortages, changing between different brands of oestradiol patches has been challenging. We appreciate that people can have different experiences with different brands of oestradiol patches.

People have highlighted:

• the negative impact the supply issues have had on treatment outcomes, ability to work and effects on family and whānau.
• the stress and frustration with inconsistent availability of patch brands and/or patch strength impacting treatment.
• the financial strain of additional medicine costs, pharmacy visits and doctor consultations.

We have also heard from health care professionals about the significant time and resource required to support people throughout the supply challenges.

Inclusion of oestradiol patches in the Annual Tender to ensure long term supply

To help limit the likelihood of supply issues for oestradiol patches, we included them in the 2023/24 Invitation to Tender (ITT). The aim was to secure long-term supply of oestradiol patches, ensuring consistent supply and access for those who need this medicine.

We consulted on the draft 2023/24 ITT list in July 2023 and asked for feedback from health care professionals and consumers on:

• including oestradiol patches in the 2023/24 ITT and whether a brand change would be clinically appropriate
• whether Principal Supply Status (PSS) was appropriate for this market.

We did not receive any feedback about oestradiol patches during this consultation period.

Prior to the release of the 2023/24 ITT, we sought advice from our Tender Clinical Advisory Committee (made up of expert pharmacists, doctors, and nurses) They told us that a brand change would be clinically appropriate and highlighted the importance of securing adequate supply of oestradiol patches. They also considered that awarding Principal Supply Status would be appropriate.

Awarding the Tender to Viatris for its brand of oestradiol patches

The Estradiol TDP Mylan is currently provisionally approved by Medsafe and is undergoing Medsafe evaluation for full approval. A link to the current datasheet for Estradiol TDP Mylan, is available on the Medsafe website [PDF](external link).

This brand is approved for use in the United States. Estradiol TDP Mylan is currently listed on the Pharmaceutical Schedule, however its listing will be amended as described below from 1 July 2025 if Medsafe approval is granted.

Pharmac has worked closely with Viatris to understand its ability to meet the demand for oestradiol patches in New Zealand, and to ensure Viatris understands its obligations for supply, before making a decision.

Principal Supply Status for Estradiol TDP Mylan is conditional on it receiving Medsafe approval by 1 July 2025. If this occurs:

• From 1 July 2025 the current Estradiol TDP Mylan listing on the Pharmaceutical Schedule will be amended as described below (under ‘Detail about this decision’). While no changes will be made to other brands of oestradiol patches until 1 December 2025, people will need to start transitioning to the Estradiol TDP Mylan brand from 1 July 2025.
• From 1 December 2025, Estradiol TDP Mylan will be awarded Principal Supply Status and will be the main funded brand of oestradiol patches. This means that everyone prescribed oestradiol patches will need to use the Estradiol TDP Mylan brand from 1 December 2025 onwards.
• To support this decision, we have a range of implementation activities planned, outlined in further detail below.

This decision coincides with our recent decision to fund oestradiol gel and to award Principal Supply Status (PSS) to Estrogel(external link). These decisions form part of our wider work in this area to ensure continuity of supply and ongoing access to oestradiol for those who need it.

Expert advice to support this award

We understand that people have different experiences with different brands of oestradiol patches.

Our Tender Clinical Advisory Committee considered the suitability aspects of the Estradiol TDP Mylan brand of oestradiol patches. The Committee considered the packaging, adhesiveness, size and presentation of Estradiol TDP Mylan to be acceptable.

We also sought clinical advice from our Endocrinology Advisory Committee to understand whether secure supply of the Estradiol TDP Mylan brand of patches would meet the health need for people who require oestradiol. The Committee told us that:

• consistent access to the Estradiol TDP Mylan brand of oestradiol patches, and access to other oestradiol presentations, such as the gel (funded from 1 November 2024) or tablet, would meet the health needs of people who require oestradiol.
• stable supply of oestradiol patches would allow more effective treatment monitoring and dose changes, to improve people’s experience on treatment.

Following this process, we are pleased to announce a decision to conditionally award Principal Supply Status for oestradiol patches to Viatris for its brand of oestradiol patches.

Detail about this decision

Should Medsafe approval be granted, the current Estradiol TDP Mylan (supplied by Viatris) listing will be amended in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 July 2025 as follows:

Chemical	Formulation	Brand (Supplier)	Pack size	Current price and subsidy	New Price and subsidy
Oestradiol	Patch 25 mcg per day	Estradiol TDP Mylan (Viatris)	8	$9.85	$8.89
Oestradiol	Patch 50 mcg per day	Estradiol TDP Mylan (Viatris)	8	$10.75	$9.26
Oestradiol	Patch 75 mcg per day	Estradiol TDP Mylan (Viatris)	8	$11.88	$10.33
Oestradiol	Patch 100 mcg per day	Estradiol TDP Mylan (Viatris)	8	$12.95	$10.59

Should Medsafe approval be granted, the following changes will apply:

• all patch strength presentations of the following brands of oestradiol patches will remain listed until 1 December 2025 – Estradot, Estraderm MX, Lyllana, Estradiol Viatris and Estradiol Sandoz
• from 1 December 2025 until 28 February 2026 a brand switch fee will apply at the pharmacy level to support this transition
• Estradiol TDP Mylan (supplied by Viatris) will be the Principal Supply Status brand of oestradiol patches from 1 December 2025 until 30 June 2027. This means that it will be the only listed brand of oestradiol patch during this time.

Implementation activities

We anticipate the transition to the Estradiol TDP Mylan brand of oestradiol patches will be led by pharmacists; however, prescribers, pharmacists and individuals receiving treatment will need to work together to manage this transition.

We plan to undertake the following implementation activities to assist and support people with this change, the use of oestradiol patches and use of the Estradiol TDP Mylan brand of oestradiol patches:

For people using oestradiol patches transitioning to the Estradiol TDP Mylan brand

We will work with the supplier to provide:

• educational resources, including supplier resources, with step by step instructions to enhance understanding of its use
• consumer medicine leaflets about Estradiol TDP Mylan in multiple languages including Te Reo Māori and Pacific languages

We will work with Healthify to update their information on oestradiol patches and information on transitioning to another brand.

We will update the Pharmac website to include information on transitioning to another brand of oestradiol patch, Q and A’s, and point them towards Healthify for more information.

For health care professionals

To support prescribers, we will work to:

• ensure Health Pathways and the New Zealand Formulary is updated to reflect Estradiol TDP Mylan having Principal Supply Status from 1 December 2025
• communicate widely with primary care and pharmacists about the change through our prescriber updates and email
• commission an educational piece on managing the change (eg. with NZ Doctor or BPAC)
• a brand switch fee will be payable for Estradiol TDP Mylan from 1 December 2025 until 28 February 2026, to recognise pharmacist time to support this decision.

If there are additional activities that you think would help people with this change, please contact us through our enquiries inbox below.

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz; or call our toll-free number (9 am to 5 pm, Monday to Friday) on 0800 660 050.