11 November 2019

The Scottish Medicines Consortium (SMC) has today (11 November 2019) announced its decision to approve ribociclib in combination with hormone therapy fulvestrant for routine use on Scotland’s NHS.

This combination will offer a new treatment option for patients with hormone receptor positive, HER2 negative locally-advanced or metastatic breast cancer after prior hormone therapy. 

Ribociclib (Kisqali, Novartis) is one of a new class of drugs known as CDK4/6 inhibitors, which work by targeting two crucial cell division proteins called CDK4 and CDK6. Two similar drugs called abemaciclib and palbociclib are already available in combination with fulvestrant on the NHS in Scotland for treating this patient group. Today’s decision will now see a third option made available to patients and their doctors.

For patients who have received prior hormone therapy, a major trial (MONALEESA-3) has shown that ribociclib in combination with fulvestrant extends the time before the disease progresses (progression-free survival) by 7.7 months on average, compared to fulvestrant alone. In addition, new results from the trial last month  showed this treatment combination could also extend patients’ lives. As these results are new they did not form part of the SMC’s assessment. 

This combination is already available in England, Wales and Northern Ireland following approval by the National Institute for Health and Care Excellence in July 2019.  

Baroness Delyth Morgan, Chief Executive at Breast Cancer Now, the research and care charity, said:

We are delighted that ribociclib with fulvestrant will now provide a new option for hundreds of people living with incurable breast cancer in Scotland who have already had hormone therapy.

Compared with fulvestrant alone, this combination treatment can offer patients invaluable extra time to live well before their disease progresses - time to live well and continue with day-to-day activities such as working for as long as possible. This treatment option could also help delay the need for chemotherapy and the often debilitating side effects it can bring, which is incredibly important for patients.

The addition of ribociclib to NHS care, alongside similar drugs abemaciclib and palbociclib, will now improve patient choice in Scotland, and help give women more control over their quality of life. These treatments are just as effective but can come with different side effects, so it’s now vital that all patients are fully informed of the benefits and risks and are supported to make the decision that’s right for them.

Ribociclib is already recommended by the SMC for use in combination with an aromatase inhibitor for patients with previously untreated hormone positive, HER2 negative locally-advanced or metastatic breast cancer.