NICE Widens Access to Ribociclib for Early Breast Cancer
ribociclib (Kisqali, Novartis) for routine NHS use in adjuvant treatment of hormone receptor-positive, HER2-negative early breast cancer in patients at high risk of recurrence.
The drug is now recommended for use alongside an aromatase inhibitor after initial treatments, such as surgery. In pre-menopausal women, the aromatase inhibitor should be combined with a luteinising hormone-releasing hormone agonist.
Targeted Therapy for Common Breast Cancer Subtype
Ribociclib is a cyclin-dependent kinase (CDK) 4/6 inhibitor. It works by blocking proteins that drive cancer cell growth and division. NICE said the treatment 'represents a significant advance' in managing hormone receptor-positive, HER2-negative early breast cancer.
Breast cancer is the most common cancer in the UK. Hormone receptor-positive, HER2-negative breast cancer is the most common subtype, accounting for about 68% of all UK cases.
Expanded NHS Use Follows Evidence Submission
Until now, NHS access in England was limited to patients whose cancer had spread to nearby lymph nodes. NICE approved this use of ribociclib in April 2025 but asked Novartis for more evidence to justify broader access.
Following further review, NICE concluded in final draft guidance that ribociclib with an aromatase inhibitor offers clinical benefit and value for money. It is now considered a cost-effective use of NHS resources.
Trial Shows Delayed Recurrence
A clinical trial involving more than 5000 patients showed that ribociclib combined with an aromatase inhibitor delayed disease recurrence compared with the aromatase inhibitor alone. The latest analysis, based on a mean of 33 months' follow-up, continued to show improved invasive disease-free survival across key subgroups.
However, NICE said that it remained unclear whether the combination increased overall survival and that more mature data, including predictions of longer-term outcomes, is needed. Further data from the trial are expected in May 2026.
Comparable to Other Options
Indirect evidence suggests that ribociclib plus an aromatase inhibitor is as effective as abemaciclib plus endocrine therapy. Abemaciclib is currently used for node-positive breast cancer.
Ribociclib in combination with fulvestrant is already recommended for treating hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer in adults who have had previous endocrine therapy. This demonstrated 'the drug's versatility across different stages of the disease,', NICE said.
Helen Knight, director of medicines evaluation at NICE, described the latest decision as 'fantastic news for the tens of thousands of patients and their loved ones'. An estimated 5700 people with early breast cancer could benefit from expanded access to the combination treatment.
Relapse after initial treatment occurs in about 30% of people with early breast cancer. Patient experts told the NICE committee that the high risk of recurrence has a considerable impact on quality of life. 'The fear of the cancer returning is a common cause of stress and anxiety for people and their families, affecting physical and psychological wellbeing,' they said.
Treatment options are limited and have unpleasant side effects. Having different options is particularly important because people often choose treatments based on
their side-effect profiles. Both patient and clinical experts emphasised the importance of treatment choice.
Dosage, Side Effects, and Pricing
Ribociclib is taken orally, which may improve convenience and adherence compared with alternatives.
The usual dose of ribociclib is:
400 mg once daily (two 200 mg tablets) for primary breast cancer
600 mg once daily (three 200 mg tablets) for locally advanced or secondary disease
Common side effects include leukopaenia and increased infection risks, anaemia, anorexia, nausea and vomiting, diarrhoea and constipation, abdominal pain, fatigue, sore mouth, shortness of breath, cough, rashes, and hair loss.
The list prices of ribociclib 200-mg tablets are:
£983.33 for 21 tablets
£1966.67 for 42 tablets
£2950.00 for 63 tablets
A simple patient access scheme allows the NHS to purchase the drug at a confidential discount.
Knight said the expanded access was 'also due in no small part to the willingness of companies to engage with us constructively, as in the case with ribociclib, to ensure the benefits of their treatments are properly presented and appropriately priced'.
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