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

Oestradiol

Gel (transdermal) 0.06% (750 microgram/ actuation)

Estrogel

80 g OP

$14.25

Listing of oestradiol gel

We received many responses from people who were supportive of the proposal to fund oestradiol gel.

We are pleased to progress a proposal that would improve the health outcomes of New Zealanders.

Many responses detailed the significant impact the supply constraints with oestradiol patches have had on people’s wellbeing.

We acknowledge the stress, frustration and impact of the ongoing supply issues with oestradiol patches has caused.

We consider that the funding of oestradiol gel will help support access to an oestradiol treatment for people who need it. Alongside this, we will continue to work to help ensure that there is sufficient supply of funded oestradiol patches.

Some responders requested that the list date proposed for oestradiol gel be earlier than 1 November 2024

We appreciate people would like access to oestradiol gel as soon as possible. 

We work closely with suppliers to understand their lead time for supply of any new product into the New Zealand market. To ensure sufficient supply is available to support access to oestradiol gel, the earliest possible listing date is 1 November 2024.

A few responders highlighted that Estrogel needs to be available as a fully Medsafe approved product to avoid any additional access challenges.

Estrogel is Medsafe approved and we are pleased that this would help support access for people.  

Some responders considered that having multiple brands of oestradiol gel funded would be beneficial, in particular for those who need high doses of oestradiol.

We acknowledge that there may be individual preferences for specific brands of medicines.

Pharmac operates within a fixed budget, which means we need to make difficult decisions to ensure that we can achieve the best health outcomes for all New Zealanders from within this fixed budget. As a result of this competitive process, we have been able to fully fund an oestradiol gel product.

Our clinical advisors have told us that the Estrogel brand would be suitable for people who need treatment with oestradiol gel.

We understand from our clinical advisors that people who require high doses of oestradiol may prefer to use patches.

Some responders considered that a low dose testosterone gel/cream that is indicated for the management of menopause symptoms should be funded.

We appreciate this feedback. Testosterone gel was outside of the scope of the competitive process for oestradiol gel and therefore cannot be considered as part of this decision.

We have received a funding application for a testosterone gel product indicated for the treatment of hypoactive sexual desire dysfunction in postmenopausal women. The next step for this application is for us to seek expert clinical advice about this application from our Pharmacology and Therapeutics Advisory Committee (PTAC).

You can track the progress of the testosterone gel application on the Pharmac Application Tracker(external link).

Some responders considered the amount of oestradiol gel dispensed would be difficult to fit into a three-month prescription dispensing.

Oestradiol gel will be dispensed as whole bottles.

The amount you are prescribed over a three-month period will be rounded up so you always receive full bottles.

A respondent noted the product label does not align with NZULM generic medicine information and that the spelling in the Pharmaceutical Schedule, (oestradiol) is different to that of the datasheet and product label for Estrogel (estradiol).

We have amended the presentation description of Estrogel in the Pharmaceutical Schedule to align with the NZULM’s recommendation.

However, the product label for Estrogel supplied in New Zealand is harmonised with Estrogel supplied in other international markets. A harmonised pack has significant supply benefits for New Zealand. As a result, the medicine name on the product label will remain as ‘estradiol’.

Implementation support activities

A number of responders provided feedback in relation to information and activities needed to support the implementation of oestradiol gel. These included the following implementation initiatives:

• Information and resources, to support training and education for health professionals.
• Information and resources in various formats for consumers to support responsible use of oestradiol gel.
• Promoting awareness of menopause, women’s health and available treatment options for health care professionals and consumers.
• Importance of education about the impact of hormone replacement therapy on the health and wellbeing for women and support for its inclusion in the national health plan. 

We would like to thank the responders for providing feedback on what would support implementation of this funding decision.

We have incorporated this feedback into our implementation plan activities. As a result of the feedback we plan to:

• Work with the supplier to ensure availability of resources and education for consumers and health care professionals.
• Work with Healthify, Health Pathways and the New Zealand Formulary to provide information to support prescribers and people who would benefit from oestradiol gel. We will also provide this information on the Pharmac website.
• Ensure implementation activities are communicated widely to promote greater awareness of the treatment options available.
• We intend to share feedback about the impact of hormone replacement therapy on women’s health with agencies, such as the Ministry of Health to consider as part of its women’s health strategy.

Some responders requested that access to treatment be made easier. Specifically, highlighting that:

• accessing treatment requires a prescriber appointment, which can be costly and can have significant wait times.
• the funding of prescriber appointments would support access.

We appreciate that it can be difficult arranging an appointment with your prescriber.

Oestradiol gel is a prescription only medicine and to access it, it will require a prescription from a health care professional. We are unable to cover the cost of prescriber appointments to support the listing of oestradiol gel. Funding for health services would need to be considered by Health NZ.

Some responders considered that the ability to change presentations of oestradiol at a pharmacy without the need for a new prescription would be helpful.

Oestradiol gel is different from oestradiol patches. They are applied at a different frequency and have different daily dosages. Any change between presentations of oestradiol (i.e. from patch to a gel) will require a prescription and people would need to talk to their prescriber about this.

A respondent considered hormone testing should be available in primary care, including saliva testing.

We understand laboratory testing of serum oestradiol is funded by Health NZ. We intend to share this feedback regarding the need for saliva hormone testing with Health NZ for its consideration.

Some responders raised the following regarding access to oestradiol gel:

• considered that dispensing oestradiol gel in three monthly quantities would support access
• highlighted challenges faced by rural communities when accessing medicines.

Oestradiol gel will be listed on the Pharmaceutical Schedule from 1 November 2024 and will be dispensed monthly for those who need it.

We appreciate that three monthly dispensing may contribute to better patient access. We intend to monitor uptake of oestradiol gel and work with the supplier to consider whether it would be appropriate to implement three monthly dispensing for oestradiol gel in the future.

We acknowledge the unique access challenges faced by rural communities and that these challenges are exacerbated when there are supply issues with medicines. We are pleased to be funding oestradiol gel, as this would improve access to oestradiol treatment options for people living in rural communities.

While oestradiol gel will be dispensed in monthly amounts, there are circumstances in which a prescription can be dispensed all at once. This includes when an individual lives and works more than 30 minutes from the nearest pharmacy by their normal form of transport. Please see the Pharmaceutical Schedule Rules for further information about this

A respondent considered it would be appropriate to include a brand switch fee for pharmacists supporting people transitioning between funded oestradiol presentations.

Brand switch fees are intended to recognise pharmacist time spent supporting the implementation of Pharmac decisions in which there is a potentially difficult brand change for a currently funded medicine.

We consider that as oestradiol gel is a new medicine option for people and a prescriber appointment is required for someone starting treatment it would not be eligible for a Brand Switch Fee.

More information on when brand switch fees are considered necessary