Decision to brand change fulvestrant through the 2024/25 Invitation to Tender

Concerns about a brand change

Efficacy, tolerability and side effects:

Patients stable on current treatments fear that switching to other brands may lead to intolerable side effects or reduced efficacy.

Oncology patients are particularly vulnerable due to heightened sensitivity and narrow therapeutic margins.

Minor differences in formulation, excipients, or bioavailability can result in subtherapeutic or toxic effects. Any of these differences may result in adverse reactions.

Repeated use of injectable medicines can cause significant pain and recovery issues. Any change that worsens local impacts would be unacceptable.

Respondents emphasised the importance of ensuring patients can return to the existing funded brand with no restrictions or costs if the alternative is found to be ineffective, sub-standard, or the side effects intolerable

We acknowledge and appreciate the concerns raised regarding the potential impact of brand changes on efficacy, tolerability, and side effects – particularly for oncology patients, who may be more vulnerable due to the nature of their treatment.

Pharmac takes these matters seriously. Our decisions are guided by clinical advice, international evidence, and where possible real-world experience. We understand that even minor differences in formulation or excipients can be significant for some individuals, especially in medicines with narrow therapeutic margins.

As part of our tender process, all medicines must be Medsafe approved. The new brand, Fulvestrant EVER Pharma, is approved and widely used in Australia. It is Medsafe approved and meets internationally agreed standards for safety, quality, and efficacy.

We also recognise that past experiences with brand changes may influence current perceptions. To address this, our implementation planning includes clear communication, and clinical support, to ensure patients and prescribers feel confident and supported throughout the transition.

Given the feedback, we have engaged with Australian clinicians and consumer groups to understand the Australian experience with generic fulvestrant. This has highlighted several key themes that we have considered as part of this process, and we understand that Fulvestrant EVER Pharma is widely used in Australia.

This decision allows people to potentially access a different brand if their prescriber considers Fulvestrant EVER Pharma to be clinically unsuitable for their health needs. The funding of this would be managed via Pharmac’s Exceptional Circumstances framework. This would require an individual’s prescriber to provide information about why the funded brand (Fulvestrant EVER Pharma) is not clinically appropriate.

Pharmac would work closely with clinicians, advocacy groups, and stakeholders to ensure any changes are implemented with care, transparency, and responsiveness to patient needs.

Trust and confidence

Patients and advocacy groups expressed scepticism due to previous poor experiences with brand changes and the lack of transparency.

Alternatives need to be proven to be safe and effective in other countries such as Australia and the UK.

The brand that is currently funded is working well, so there is a strong preference to retain the existing medicine.

Reduced confidence may lead to a perceived loss of efficacy due to nocebo effects.

Pharmac acknowledges the concerns raised by patients and advocacy groups regarding previous experiences with brand changes and the importance of transparency in decision-making.

We understand that trust is built over time and that past experiences can shape current perceptions.

We also recognise that the currently funded brand is working well for many people. Any decision to change brands is made with the goal of maintaining or improving health outcomes while ensuring long-term sustainability of access to medicines. Patients will have a five-month transition period to move to the new brand. We will ensure that robust implementation support is in place to support the change.

As part of this decision-making process, Pharmac engaged with Australian oncologists, pharmacists, and representatives from breast cancer groups in Australia to gain insights into the use of generic fulvestrant products. This engagement helped confirm that the generics currently in use in Australia, including Fulvestrant EVER Pharma, are clinically appropriate and suitable for patients during administration. This has helped us to ensure that there is a high likelihood of Fulvestrant EVER Pharma being able to be implemented effectively in NZ.

Comments on implementation activities

Respondents submitted a range of suggestions to ensure effective implementation of the brand change. These were primarily around communications and included:

Prescriber-Patient Communication

Recommended that Pharmac emphasise the importance of the relationship between the prescriber and patient when managing brand changes. Practitioners support patients in understanding their treatment options, managing side effects and avoiding fear-based reactions or nocebo effects through clear, empathetic communication.

Professional Communication:

Clear, thoughtful communication is essential to reduce psychological impacts and ensure safe switching.

Public Communication:

Communications should be simple, reassuring, and explain the rationale for the change.

We are committed to implementing a comprehensive communication strategy that reflects the suggestions received, including:

Implementation activities

As part of our implementation activities, we will inform people that the new product, Fulvestrant EVER Pharma, is approved and widely used in Australia. It is Medsafe approved and meets internationally agreed standards for safety, quality, and efficacy. We will communicate about the advice received, share information that provides confidence on the introduction and experience of the same product in Australia, the improved suitability expected with the change in storage requirements (no refrigeration needed), and information on Pharmac’s Exceptional Circumstances framework, allowing people to potentially access a different brand if their prescriber considers Fulvestrant EVER Pharma to be clinically unsuitable for their health needs.

Communication channels

Pharmac will ensure awareness of this brand change through ensuring communication as follows:

• Email updates to consumer advocacy groups, educational resources eg. NZF and health professionals including prescribers, PHOs, pharmacists, nurses, oncology nurses
• Webpage update including graphics for comparison and a downloadable patient information leaflet
• A patient focused Healthify consumer fact sheet, on the Healthify website.

Impact to pharmacies

Pharmacies (particularly rural pharmacies) may incur a financial loss if they are left to write off residual stock of delisted brands, particularly concerning slow-moving, high-cost medicines like fulvestrant.

A five-month transition period would be in place from 1 December 2025 until 1 May 2026 before the delisting of Faslodex occurs, allowing sufficient time to adjust stock levels and dispensing practices.