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We respond to double SMC drug announcement - adjuvant abemaciclib and alpelisib with fulvestrant

Chief Executive of Breast Cancer Now, Baroness Delyth Morgan, has commented on the double announcement by the Scottish Medicines Consortium.


Chief Executive of Breast Cancer Now, Baroness Delyth Morgan, said:

“It’s fantastic that abemaciclib plus hormone therapy has been approved by the Scottish Medicines Consortium (SMC), as this brings a new effective treatment option for patients with a specific type of primary breast cancer1.

“The fear of breast cancer returning or spreading to other parts of their body, where it becomes incurable, can cause much anxiety for so many women and their loved ones. However, this decision increases treatment options available after surgery, providing women with the chance to further reduce the risk of the disease coming back.

“Alongside welcoming this news however, we’re deeply disappointed that alpelisib with fulvestrant has been rejected for use on the NHS in Scotland, for certain patients with incurable secondary breast cancer2.

“This would have been the first targeted treatment option available for certain patients with a PIK3CA mutation – estimated to be found in around 30-40% of oestrogen receptor positive, HER2 negative breast cancers.

"And evidence suggests not only that it’s more effective than the current standard treatment, but that it could have potentially delayed these patients starting chemotherapy and enduring its often-gruelling side effects. 

“Devastatingly, this rejection of alpelisib with fulvestrant denies women in Scotland a treatment option open to their peers in England and Wales.

"The drug company, Novartis, must now engage with the SMC to address the reasons why their medicine has not been accepted and resubmit it for further assessment as soon as possible.”



  1. Abemaciclib (also known as Verzenios) with hormone (endocrine) therapy is recommended as an option after surgery for the treatment of hormone receptor positive, HER2 negative, node positive primary breast cancer where there is a high risk of recurrence. This high risk is defined as pathological tumour involvement in: At least 4 positive axillary lymph nodes or 1-3 positive axillary lymph nodes, and: Grade 3 disease or primary tumour size of at least 5cm.
  2. Alpelisib (also known as Piqray) with fulvestrant is for patients with hormone receptor positive, HER2 negative, PIK3CA mutated locally advanced or secondary (metastatic) breast cancer after a CDK 4/6 inhibitor plus aromatase inhibitor.

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