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Giving hope to those affected
by secondary breast cancer

Research. Support. Education.

Elacestrant Rejected by Scottish Medicines Consortium

10th November 2025 by Sarah Thomas Education

We are deeply saddened to share the news that the Scottish Medicines Consortium (SMC) has decided not to approve Elacestrant for use on the NHS in Scotland.

Elacestrant is a targeted treatment for postmenopausal women and men with hormone receptor positive, HER2 negative, secondary breast cancer who have an ESR1 mutation, with disease progression after hormone therapy, including a CDK 4/6 inhibitor.

This decision means that people in Scotland will not have access to a treatment that is already available in England, Wales, and Northern Ireland - leaving Scottish patients once again without a targeted option for this subtype of secondary breast cancer.

We know how devastating this news will be. For many, treatments like Elacestrant offer hope of slowing disease progression and maintaining quality of life for longer. It is especially difficult following the rejection of Capivasertib, another targeted treatment for hormone receptor positive secondary breast cancer on 13 October, just a few weeks ago.

At Make 2nds Count, we will continue to push for fair access to new and effective treatments in Scotland. Together with Breast Cancer Now and METUPUK, we will be writing to the SMC to share our concerns about the rejection of both Elacestrant and Capivasertib, and the impact this has for patients.

We’re also bringing together people living with secondary breast cancer in Scotland to help shape fairer access to new treatments. If you’d like to have your say and stay informed about the latest drug decisions in Scotland, you can register to join our Scottish Access to Medicines Forum using this form.

 

Elacestrant Decision - Frequently Asked Questions

1. What has the SMC decided?

The Scottish Medicines Consortium (SMC) has decided not to approve Elacestrant for use on the NHS in Scotland. This means the drug will not be routinely available for people with secondary (metastatic) breast cancer in Scotland at this time.

2. What is Elacestrant?

Elaecstrant is a targeted treatment for people with hormone receptor positive, HER2 negative breast cancer that has spread after earlier treatment. It’s designed for patients whose cancer has specific changes in the ESR1 genes - found in 30-40% of people with this form of breast cancer.

3. What are the key factors which would justify this medicine being approved in Scotland?

  • Secondary breast cancer is an incurable, life-limiting condition and the leading cause of death for young women aged between 25 and 54 in Scotland. The average life expectancy with the hormone receptor positive, HER2 negative subtype is 3 to 5 years. Patients are often independent, with careers and caring responsibilities for children, grandchildren or parents. Diagnosis, symptoms of disease and treatment can have a major impact on quality of life and physical and mental wellbeing.

  • There are currently no targeted treatments available in Scotland for secondary breast cancer patients with an ESR1 mutation. Current treatment options, such as chemotherapy or further hormone therapy, have limited efficacy and are often associated with debilitating side effects. Toxicities can limit the patient’s ability to contribute to family life, continue working and to live life as fully as possible. 

  • Elacestrant is the first targeted treatment for the ESR1 mutation. The improved progression-free survival shown in clinical trials could provide meaningful benefits to patients, with the potential to maintain physical health by delaying the symptoms of disease. It could give patients the opportunity to continue normal life for longer and spend more quality time with their family and friends.

  • Elacestrant is a well-tolerated oral therapy. It offers fewer hospital visits than other therapies. This could reduce travel and time commitments, which may be less disruptive to family and work life.

4. Why was Elacestrant not approved?

The SMC reviews new medicines based on evidence of their effectiveness, safety, and cost-effectiveness for NHS Scotland. While Elacestrant showed clear benefits in clinical trials, the SMC concluded that the company did not present enough evidence on the medicine’s value for money.

5. Is Elacestrant available elsewhere in the UK?

Yes. Elacestrant has been approved for use on the NHS in England, Wales and Northern Ireland. This means patients in Scotland currently do not have the same access to this targeted treatment.

6. What treatment options are available in Scotland?

At the moment, there are no targeted treatments for hormone receptor positive, HER2 negative secondary breast cancer in Scotland. Patients will continue to receive standard treatments such as hormone therapy or chemotherapy recommended by their clinical team.

7. Can my doctor still apply for me to get Elacestrant?

In some cases, your oncologist may be able to apply for access through an Individual Patient Treatment Request (IPTR) if they believe Elacestrant would provide significant benefit in your specific situation. Your healthcare team can advise you on whether this may be possible.

8. Can I get Elacestrant if I move to England?

Elacestrant is available on the NHS in England, Wales and Northern Ireland. However, moving to another part of the UK specifically to access treatment can be complicated and may not guarantee immediate access.

If you move to England and register with a GP there, you would come under the care of the NHS in England. Your new oncology team would then review your treatment options, including whether Elacestrant is suitable for you.

It’s important to consider the practical and emotional impact of relocating - including the need to transfer your care, find new clinicians, and potentially move away from your existing support network.

If you are thinking about this option, speak to your current clinical team before making any decisions. They can help you understand what’s involved and what other options may be available.

9. What is being done to challenge this decision?

We are deeply disappointed by the outcome and will continue to advocate for patients in Scotland to have fair access to the same treatments available elsewhere in the UK. We will be writing to the SMC to share the impact of this decision on patients and families.

Following the SMC decision, we are teaming up with Breast Cancer Now and METUPUK to raise our concerns with the SMC and the pharmaceutical company, Menarini Stemline. We are hopeful that with further dialogue, a review of the data, and continued advocacy from patients and clinicians, Elacestrant can be reconsidered for approval in the future.

We are committed to making sure that the lived experience of people with secondary breast cancer in Scotland is at the heart of any future discussions and we will continue to work closely with the community on medicine approvals. If you are interested in sharing your views, join our Scottish Access to Medicines Forum.

10. What can patients and families do now?

  • Speak to your oncologist about what other treatments might be suitable for you.

  • If you’re struggling with this news, please reach out to our support team - we’re here to listen.

  • Consider sharing your story to help raise awareness of the impact of treatment access in Scotland.

11. Where can I find support?

Our support services are here for anyone affected by the decision. Make 2nds Count offers peer-to-peer in-person and online friendship support groups and wellbeing activities. View our support programme here.