Novartis’ Kisqali (ribociclib) has been recommended by the National Institute for Health and Care Excellence (NICE) to treat a broad population of early breast cancer patients.
The health technology assessment agency has recommended in final draft guidance that the drug be used on the NHS in combination with an aromatase inhibitor as an additional treatment option for patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer.
Patients eligible for the combination will have responded to initial treatments including surgery, but will be at high risk of disease recurrence.
The decision significantly expands access to the treatment, which was previously available only for patients whose cancer had spread to nearby lymph nodes.
“We welcome NICE’s recommendation enabling access to [Kisqali] for more patients with early-stage breast cancer. This marks a step forward in expanding treatment options for people diagnosed with HR-positive/HER2-negative early breast cancer,” said Johan Kahlström, president and managing director Novartis UK and Ireland.
The recommendation follows an approval from Medicines and Healthcare products Regulatory Agency in February and was supported by positive results from the late-stage NATALEE trial.
In the study, Kisqali used in combination with an aromatase inhibitor reduced invasive disease-free survival events by 25.1% compared to treatment with an aromatase inhibitor alone.
NICE added that the treatment “has been made cost-effective for the NHS through a confidential discount agreement with Novartis, ensuring patients can access this innovative therapy while maintaining value for the health service”.
Approximately 56,822 people are diagnosed with breast cancer every year in the UK, and HR-positive/HER2-negative is the most common subtype.
Despite current treatment options, patients with HR-positive/HER2-negative early breast cancer remain at risk of experiencing disease recurrence in the long term, often as an incurable disease.
Novartis’ Kisqali is designed to inhibit the CDK4/6 proteins, which play a key role in cancer cell growth and division.
Helen Knight, director of medicines evaluation at NICE, said: “This is fantastic news for the tens of thousands of patients and their loved ones who are now benefiting from access to cutting edge new treatments.
“It is also due in no small part to the willingness of companies to engage with us constructively, as in the case with [Kisqali], to ensure the benefits of their treatments are properly presented and appropriately priced.”