Proposal to fund oestradiol gel and to award Principal Supply Status to Estrogel

Medicines Consultation Closed

What we’re proposing

We’re asking for feedback on a proposal to fund an oestradiol gel product, Estrogel, supplied by Pharmaco from 1 November 2024. This proposal is a result of a Request for Proposals (RFP) for the supply of oestradiol gel. Further details on this proposal can be found below.

We welcome your feedback on this proposal. To submit feedback:

Use our online form

or email consult@pharmac.govt.nz.

Consultation closes at 5 pm, on Thursday, 15 August 2024.

What we’d like to know

Along with general feedback on our proposal we are also particularly interested in feedback on the implementation activities and support people might need. For example:

  • Implementation activities required to support people starting on oestradiol gel.
  • Implementation activities required to support people changing from alternative oestradiol treatment options (such as the patches) to the gel.
  • Support needed to assist health care professionals to prescribe oestradiol gel.
  • Information required to support people using and accessing oestradiol gel, including populations experiencing health disparities.
  • Information required to support people using and accessing oestradiol gel, including women and those from rainbow communities, particularly trans, non-binary, Takatāpui, and Fa’afafine people who may use oestradiol gel, in consultation with their healthcare provider.
  • Information pharmacists need to support the dispensing and patient counselling for oestradiol gel.

What would the effect be?

This proposal would result in oestradiol gel being fully funded without dispensing or eligibility restrictions. This would mean that oestradiol gel would be fully funded when prescribed for anyone who needs it.

This proposal is subject to a final decision from the Pharmac Board (or its delegate) which we expect to take place in September 2024. If approved, we expect over 18,000 people to benefit in the first year of funding.

The Estrogel brand would have Principal Supply Status for the funded oestradiol gel market from 1 November 2024 to 31 October 2027. This means that Estrogel would be the funded oestradiol gel product in the community and bought by Health New Zealand | Te Whatu Ora hospitals. There would be an alternative brand allowance of 5%. This would allow Pharmac to fund an alternative brand for up to 5% of the market if required. We are currently not proposing to fund an alternative brand of oestradiol gel.

We seek to provide more options for people who are prescribed oestradiol products. By funding oestradiol gel, we are aiming to help with the current supply constraints with oestradiol patches. There are no changes proposed to the other forms of oestradiol (eg. tablets and patches) which are currently listed on the Pharmaceutical Schedule.

Who we think will be interested

  • People who use (or may use) medicines containing oestradiol, their whānau and caregivers
  • Endocrinologists, primary care prescribers and health care professionals who support people using oestradiol
  • Health New Zealand | Te Whatu Ora hospitals and other organisations who deliver services and support for people who may use oestradiol
  • Pharmacies and pharmaceutical wholesalers
  • Pharmaceutical suppliers
  • Health advocacy groups

About oestradiol gel

Oestradiol (also called estradiol) gel is used to increase oestradiol levels in your body. Oestradiol gel is applied and absorbed through your skin. Oestradiol gel is approved in Aotearoa New Zealand for:

  • Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women
  • Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are unable to take other types of medicine for the prevention of osteoporosis.

Medsafe datasheet for Estrogel [PDF](external link)

Clinical advice we have received indicates that oestradiol gel may also be used for oestradiol-based gender affirming hormone therapy, and for premature ovarian insufficiency (where people undergo premature menopause eg. because of some treatments for cancers). Use of oestradiol gel outside of approved indications would need to be prescribed and supplied under Section 25 of the Medicines Act 1981(external link).

Endocrinology Advisory Committee - Record of meeting May 2023 [PDF, 110 KB]

Most oestradiol use is in our communities. Currently, there are two presentations of oestradiol funded in the community:

  • Patches
  • Tablets

You can see the current oestradiol products on the Pharmaceutical Schedule.

Oestradiol listings in the community schedule(external link)

Oestradiol listings in the HML(external link)

Why are we proposing this?

Recently, the global demand for oestradiol patches has increased substantially, driven by increasing awareness of the benefits of oestradiol in managing menopausal symptoms. This has led to global supply issues resulting in disrupted treatment, uncertainty and stressful situations for many people requiring oestradiol.

In April 2024, we released a Request for Proposals (RFP) for the supply of oestradiol gel to support the supply issues for oestradiol patches and to provide people who require oestradiol with an additional  treatment option. An RFP invites suppliers to submit proposals for supply of a product. 

More about RFPs

From this RFP, Pharmac has entered into an agreement with Pharmaco New Zealand Ltd for Principal Supply status of oestradiol gel. This would mean that the Estogel brand would be the main funded brand of oestradiol gel in New Zealand. Estrogel would be listed without dispensing or eligibility restrictions. This agreement is provisional on consultation and a final decision from the Pharmac Board (or its delegate).

As part of the RFP process and our evaluation of the proposals received, advice was sought from the Endocrinology, Reproductive and Sexual Health and Tender Clinical Advisory Committees.  The advice received indicated Estrogel would be suitable and clinically appropriate to list on the Pharmaceutical Schedule.  

Details about our proposal

Oestradiol gel, brand name Estrogel, would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 November 2024 as follows:

Chemical and presentation

Formulation

Brand

Pack Size

Oestradiol

Gel (transdermal) 0.6 mg per g

Estrogel

80 g OP

Estrogel would be listed without dispensing or eligibility restrictions.

We are proposing to fund Pharmaco’s Estrogel product as another oestradiol option. This would be funded alongside other oestradiol presentations including patches and tablets.

Estrogel would have Principal Supply Status for the funded oestradiol gel market from 1 November 2024 to 31 October 2027.

Support for people who would use oestradiol gel and health care professionals

We want to support equitable access and use of funded oestradiol gel. We have included some proposed activities below and want to hear your feedback and suggestions.

Support for people using oestradiol gel

We would work alongside the supplier (Pharmaco NZ Limited), support groups for people using oestradiol, and health care professionals to provide information on Estrogel.

We want everyone to have the information they would need about Estrogel, so people are confident about what using oestradiol gel would mean for them. We would work with Pharmaco NZ Ltd to provide specific information for people prescribed Estrogel, including education and support resources with information about the product.

This information would be provided to health care professionals and consumer groups to share with people who would be using this medicine, as well as hosted on a website for people using the product. The website would include product information and guidelines. Education material would be available to download as a PDF in a range of languages including English, Māori, Samoan and Tongan languages. We acknowledge different cultural views of menopause, and we want to ensure that the educational support provided to support the listing of oestradiol gel is culturally appropriate.   

We would also have a dedicated page on the Pharmac website with information for individuals as well as health care professionals. We would also explore working with other educational providers such as Healthify to update their website to include information about oestradiol gel (Estrogel).

Support for health care professionals

We understand health care professionals need information about this so they can support people using oestradiol gel. This may include the following:

  • Information for people starting oestradiol treatment for the first time, as well as for people who have previously used oestradiol patches or other oestradiol products.
  • Access to patient education resources outlined above for people using oestradiol gel.
  • Product training.
  • Online learning resources including clinical and practical information about the prescribing and use of oestradiol gel.
  • Training resource for pharmacists that includes training on correct storage, side effects, and misuse information.

To provide feedback

Submit feedback through our online form or email consult@pharmac.govt.nz by 5 pm, on Thursday, 15 August 2024.

All feedback received before the closing date will be considered by Pharmac’s Board (or its delegate) prior to making a decision on this proposal.

Your feedback may be shared

Feedback we receive is subject to the Official Information Act 1982 (OIA). Please be aware that we may need to share your feedback, including your identity, in response to an OIA request. This applies to anyone providing feedback, whether they are providing feedback themselves or for an organisation, in a personal or professional capacity.

We can only keep feedback confidential as allowed under the OIA and other related laws. If you want any part of your feedback treated as confidential, you need to tell us. Please let us know if you want to keep part of your feedback confidential, and why. Is it commercially sensitive, confidential or proprietary, or personal information? Clearly state this and tell us which parts of your feedback you want to keep confidential for these reasons. We will consider your request under our OIA requirements.