Request for information: Shortage of oestradiol transdermal products
Thank you for your request dated 18 June 2024 under the Official Information Act 1982 (the Act). Please find a response to each part of your request below:
1. What date did Pharmac become aware of the potential shortage of oestrogen patches available to the New Zealand health system?
Oestradiol patches have experienced periods of constrained supply since May 2020. Many occasions of constrained supply with the funded brand Estradot have been effectively managed with the listing of alternative brands. However, demand has continued to increase in the 2020/21 financial year, the annual volume of patches used in New Zealand was approximately 1.27 million patches (across all strengths). In the 2023/24 financial year the annual volume of patches used in New Zealand was approximately 4.04 million patches (across all strengths).
2. Did Pharmac formulate a plan for addressing the shortage of oestrogen patches? If the answer is yes, please supply the plan.
Due to the difficulty in meeting demand, we have continued to actively manage supply constraints with oestradiol patches, via the following mechanisms.
Securing more oestradiol patches
Pharmac has been working closely with suppliers to source alternative brands of patches to try to keep up with demand. We currently have six different brands of oestradiol patches listed on the Pharmaceutical Schedule.
Securing long term supply for oestradiol patches
We recently tendered for the supply of patches. The annual tender invites bids to supply the New Zealand market for a minimum of three years. A key consideration for awarding supply through our annual tender process is the supplier’s ability to meet demand and provide ongoing supply to New Zealand. Pharmac is still working through its tender evaluation process but hopes to notify of a decision later in 2024.
Alternative oestrogen products
We have also sought proposals for supply of an oestradiol gel product, through a competitive procurement process.
Ongoing activities
Alongside the key priorities above, Pharmac has been:
- working with suppliers to review their forecasting and demand planning for the New Zealand market,
- providing support for suppliers to get their product faster into the NZ market to meet increased demand,
- engaging with our expert advisory network to understand our options; and
- updating our website regularly so people impacted by the supply issues have the latest information.
3. Did Pharmac do a risk assessment to the health of women due to the shortage and the possible outcomes? If yes, please supply the risk assessment.
4. At the date of becoming aware of the shortage of oestrogen patches, what assessment was made of other options for women on HRT? Please provide this assessment.
5. Some users are not able to take oral oestrogen (e.g., those who have had a previous blood clot, who are pre- or post-operative, who have liver disease or active cardiovascular disease, or a history of cardiovascular disease). What plan has been put in place knowing these women do not have another funded option available?
We consider continuity of supply for funded medicines to be a high priority and any treatment disruption to medicines present risk to an individual’s wellbeing. We acknowledge that disruption to the treatments people need to live well can be stressful and frustrating. Treatment disruption is never ideal. We work hard with suppliers to avoid this wherever possible.
Pharmac’s Endocrinology Advisory Committee and the Reproductive and Sexual Health Advisory Committee have both provided clinical advice on the global shortage of oestradiol transdermal products. You can find a summary of their advice at:
May 2023 Endocrinology Advisory Committee: Clinical advice summary [PDF, 110 KB]
May 2023 Reproductive and Sexual Health Advisory Committee: Clinical advice summary [PDF, 115 KB]
In response to this advice, on 15 August 2023 we announced that we would be issuing a competitive process for supply of oestradiol transdermal products. You can find more information about this plan, including the Future Procurement Opportunity document at:
Pharmac indicates interest to fund more oestradiol treatments to relieve supply issue
6. Did Pharmac look at the response from other countries and assess if this response was required in New Zealand? EG In 2022 the UK appointed a lead to address the HRT shortage. Was this instituted at Pharmac?
We acknowledge this is a global supply issue and there have similarly been ongoing supply constraints in the UK, Australia and other countries. We appreciate each country has different systems in place to manage supply issues, however we can’t comment on the specifics of these. At any one time New Zealand can be experiencing up to 20 or 30 supply issues with medicines and Pharmac has robust processes to support these. More information on supply management can be found on our website.
7. What support and guidance has been provided to clinicians and pharmacists regarding how to change medications and what side effects should be communicated to consumers regarding change in doses/preparations? Please supply the support and education materials provided and the date and avenue of supply.
8. Does the support include information on how clinicians can support users who have migraines or migraines with aura, which can be sensitive to hormone changes, given the lack of availability of transdermal patches?
Pharmac is responsible for the funding of medicines in New Zealand, while we have a role in supporting the responsible use of medicines, we are unable to comment or provide clinical advice for individual patient circumstance. Prescribers and Pharmacists are best placed to provide accurate and relevant clinical advice on alternative treatment options or dosage changes.
In general, professional bodies that support prescribers include the Medical Council New Zealand and the Royal New Zealand College of General Practitioners.
In general, professional bodies that support pharmacist practice include the Pharmaceutical Society New Zealand and the Pharmacy Guild.
9. What stage is the Requests for Proposals for the supply of Oestrogen gels? e.g. has the RFP closed?
10. When will Pharmac make a final decision on which gel will be supplied?
11. On which date could patients reasonably expect to see gels in pharmacies and will they be funded?
The RFP closed on the 13 May 2024 and Pharmac is evaluating the proposals received. Pharmac aims to provide more information on a selected proposal in July for people’s feedback. More information on the oestradiol gel RFP can be found here: Request for Proposals – Supply of oestradiol gel. General information on RFPs can be found here: Request for Proposals (RFPs).
The Pharmac tender process and oestradiol gel RFP should provide better supply of the treatments people need to live well. Neither the tender nor the RFP are quick solutions and will take time to implement. In the meantime, Pharmac is working closely with many suppliers to find and fund alternative brands of patches.
12. Has Pharmac considered an emergency supply of gels during the RFP process due to the significant shortage of transdermal oestrogen patches as a replacement?
Pharmac has prioritised the potential funding of an oestradiol gel product through a competitive procurement process. This allows us to receive proposals for oestradiol gel products from interested suppliers while adhering to government procurement rules.
13. Due to the patch limits imposed by Pharmac, what funding changes are being put in place to address the cost of patches in different formats due to the shortage?
We are exploring options that could help with supply issues for oestradiol patches, including reviewing the restriction. However, we need to carefully consider this alongside available supply to make sure we don’t do anything that could make the situation worse. We are constantly reviewing and monitoring the situation and working with our suppliers to see what we can do. We consider that removal of the patch restriction, while it may provide a fully funded option for some, it may further exacerbate the limited supply available for everyone.
14. What risk assessment has been done for the supply of alternatives for oestrogen patches? Please provide the risk assessment.
Alternatives to oestradiol transdermal products were evaluated by the Endocrinology Advisory Committee & Sexual Health Advisory Committee, please refer to the summary of their advice provided above.
15. What monitoring process was put in place regarding the number of scripts and what plans were put in place due to the increase in scripts as reported on your website.
Our contracts require suppliers to make sure that there is enough product in the country to supply the market. We work closely with suppliers to review current demand patterns and to understand their forecasts for supply.
Unfortunately, despite working with many different suppliers we have been unable to avoid significant supply shortages. We understand the manufacturing behind HRT is complex(external link) and that there are significant challenges for manufacturers to ramp up supply to keep up with demand.
We trust that this information answers your queries. Please note, you have the right to make a complaint to the Ombudsman about our response to your OIA, under section 28(3) of the OIA. Details of how to make a complaint(external link) are on the Ombudsman’s website.
To make information more freely available, we publish selected OIA responses (excluding personal details) on our website. Please get in touch with us if you have any questions about this.