Ribociclib with an aromatase inhibitor can be used, within its marketing authorisation, as an option for the adjuvant treatment of hormone receptor-positive, HER2-negative, early breast cancer at high risk of recurrence in adults. Combine the aromatase inhibitor with a luteinising hormone-releasing hormone agonist, unless after menopause.
Ribociclib is recommended only if the company provides it according to the commercial arrangement.
What this means in practice
Ribociclib with an aromatase inhibitor must be funded in the NHS in England for the condition and population in the recommendation, if it is considered the most suitable treatment option. It must be funded in England within 90 days of final publication of this guidance.
There is enough evidence to show that ribociclib with an aromatase inhibitor provides benefits and value for money, so it can be used routinely across the NHS in this population.
NICE has produced tools and resources to support the implementation of this guidance.
Adjuvant treatment aims to reduce the risk of cancer returning after surgery. Usual treatment for hormone receptor-positive, HER2-negative, early breast cancer at high risk of recurrence includes adjuvant endocrine treatment such as aromatase inhibitors. Abemaciclib plus endocrine treatment is also an option when the cancer has spread to the lymph nodes.
Results from a clinical trial suggest that, compared with an aromatase inhibitor alone, ribociclib plus an aromatase inhibitor may increase how long people have before their cancer returns. It is unclear whether ribociclib plus an aromatase inhibitor increases how long people live, because the trial is ongoing.
Ribociclib plus an aromatase inhibitor has not been directly compared in a clinical trial with abemaciclib plus endocrine treatment, but results from an indirect comparison suggest that they work as well as each other.
The cost-effectiveness estimates show that ribociclib plus an aromatase inhibitor is a cost-effective use of NHS resources. So, ribociclib plus an aromatase inhibitor can be used.