NICE recommends routine funding for Novartis’ Kisqali

The UK’s National Institute for Health and Care Excellence (NICE) has recommended routine access to Novartis’ Kisqali in certain advanced breast cancer patients.

NICE’s draft guidance recommends Kisqali (ribociclib) in combination with fulvestrant for the treatment of locally advanced or metastatic breast cancer that is hormone receptor-positive and human epidermal growth factor receptor 2 (HER2)-negative.

It will be routinely available on the NHS for adults who have had previous endocrine therapy and where exemestane plus everolimus is the most appropriate alternative treatment.

Kisqali is taken as a once-daily pill and belongs to a class of drugs known as cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors.

The drug has been available to patients via the Cancer Drugs Fund (CDF) since 2019, while more evidence was collected to address uncertainties around how much it extends overall survival and its cost-effectiveness.

In a statement, NICE said that the new evidence demonstrates that people receiving Kisqali treatment live longer and experience longer periods before disease progression compared to fulvestrant alone.

“We are pleased therefore that our original decision to make Kisqali available through the CDF not only gave people access to it earlier than would otherwise have been possible, but has now, through the data collected during that time, allowed us to recommend it for routine use on the NHS,” said Meindert Boysen, deputy chief executive and director of the NICE Centre for Health Technology Evaluation.

Following the recommendation for routine NHS funding, Kisqali treatment could now be an option for up to 3,300 women.

“It’s fantastic news that NICE has approved [Kisqali] ribociclib with fulvestrant for routine use on the NHS – this life-changing treatment will now bring thousands more women living with incurable secondary breast cancer hope of precious extra time to live well" said Baroness Delyth Morgan, chief executive at Breast Cancer Now.

“As well as offering certain patients with incurable breast cancer extra time with loved ones, this innovative drug combination can help delay the need for chemotherapy and its debilitating side effects," she added.