NICE Approves Novartis’ Kisqali for Broader Early Breast Cancer Treatment

The National Institute for Health and Care Excellence (NICE) has recommended Novartis’ breast cancer treatment, Kisqali (ribociclib), for a broader population of early breast cancer patients in the United Kingdom. The recommendation, issued in a final draft guidance, allows Kisqali to be used in conjunction with an aromatase inhibitor for patients classified as having hormone receptor-positive (HR-positive) and human epidermal growth factor receptor 2-negative (HER2-negative) early breast cancer. This decision marks a significant expansion from its previous restriction, which limited the drug's availability to patients whose cancer had metastasized to nearby lymph nodes.

NICE's recommendation follows an approval from the Medicines and Healthcare products Regulatory Agency (MHRA) in February 2025, bolstered by positive results from the NATALEE trial. This late-stage clinical trial demonstrated that the combination of Kisqali and an aromatase inhibitor reduced invasive disease-free survival events by 25.1% compared to treatment with an aromatase inhibitor alone (NATALEE Trial, 2025).

Johan Kahlström, President and Managing Director of Novartis UK and Ireland, expressed gratitude for NICE's endorsement, stating, "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."

The treatment's cost-effectiveness for the NHS has been secured through a confidential discount agreement with Novartis, facilitating access to this cutting-edge therapy while ensuring fiscal responsibility for the healthcare system.

Breast cancer remains a pressing health issue in the UK, with approximately 56,822 new cases diagnosed annually. Notably, HR-positive/HER2-negative is the most prevalent subtype, yet patients remain at risk of disease recurrence, often resulting in severe health outcomes. The introduction of Kisqali is expected to provide a vital new option for patients whose initial treatments, including surgery, have not fully mitigated risks of recurrence.

Helen Knight, Director of Medicines Evaluation at NICE, remarked, "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 to ensure the benefits of their treatments are properly presented and appropriately priced."

The approval of Kisqali not only signifies a milestone in breast cancer treatment but also reflects the evolving landscape of cancer therapies and the importance of collaborative efforts between pharmaceutical companies and health regulators. As treatment options expand, ongoing research and clinical trials will play a crucial role in providing innovative solutions for cancer patients, thereby improving survival rates and quality of life for those diagnosed with this pervasive disease.