NICE recommends Novartis' Kisqali for NHS use in certain patients with advanced or metastatic breast cancer

The UK National Institute for Health and Care Excellence (NICE) issued draft guidance Wednesday recommending Novartis' CDK4/6 inhibitor Kisqali (ribociclib) for use on the NHS, in combination with fulvestrant, to treat women with HR+/HER2- locally advanced or metastatic breast cancer who have received prior endocrine therapy. "This now means [Kisqali] is available in multiple indications through the NHS which, coupled with the recent ASCO data demonstrating increased survival for pre-menopausal women with HR+/HER2- breast cancer, offers real hope to patients," said Mari Scheiffele, general manager at Novartis Oncology for the UK and Ireland. 

Data from the placebo-controlled Phase III MONALEESA-3 trial unveiled last year showed that Kisqali in combination with fulvestrant was associated with a median progression-free survival (PFS) of 20.5 months, versus 12.8 months for fulvestrant alone in the overall study population of first- and second-line post-menopausal patients with HR+/HER2- advanced breast cancer. According to Novartis, the NICE recommendation is based on the second-line subpopulation of MONALEESA-3, where Kisqali plus fulvestrant demonstrated a median PFS of 14.6 months, compared with 9.1 months for fulvestrant alone.

NICE noted that the recommendation comes after Novartis agreed to a scheme to improve patient access to the once-daily oral treatment. Meindert Boysen, director of the NICE Centre for Health Technology Evaluation, commented "we are pleased...that the company has agreed a commercial arrangement for [Kisqali] that will allow it to be made available to people with this type of breast cancer." The agency estimated that Kisqali could be an option for up to 5300 women who have already had endocrine treatment and where exemestane plus everolimus, which Novartis markets as Afinitor, would be the most appropriate alternative to a CDK 4/6 inhibitor.

Kisqali gained expanded European approval in December 2018 for the treatment of women with HR+/HER2- locally advanced or metastatic breast cancer in combination with fulvestrant as initial endocrine-based therapy and in women who have received prior endocrine therapy. In 2017, NICE recommended routine NHS funding of the drug for patients with HR+/HER2- locally advanced or secondary breast cancer. Meanwhile, the FDA expanded Kisqali's label last year to also include its use in combination with fulvestrant for HR+/HER2- advanced or metastatic breast cancer as initial endocrine-based therapy or following disease progression on endocrine therapy. 

Sales of the treatment more than doubled in the first quarter to $91 million.  

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