Novartis’ Kisqali has been recommended for use on the Cancer Drugs Fund (CDF) for second line use in combination with fulvestrant in advanced breast cancer.
The decision represents a change of heart by NICE, which it says was made possible by an improved commercial offer from Novartis.
The ruling is good news for the company, which is vying with two other treatments in the same CDK4/6 inhibitors class, Eli Lilly’s Verzenio and market leader, Pfizer’s Ibrance.
NICE’s positive recommendation puts Novartis’ drug alongside Verzenio, which was recommended for CDF use in April for the same indication.
Ibrance and Kisqali gained NICE approval for first line treatment of hormone receptor (HR) positive, HER2 negative locally advanced or secondary breast cancer in November 2017, while Lilly’s drug only gained NICE approval in this setting in January.
It was able to turn the tables and gain recommendation in this second line use first, but now Novartis’ drug is hot on its heels.
Overall, Ibrance is the clear leader among the trio of competitors, its global revenues growing 46% to $3.1bn last year, with Evaluate predicting peak annual sales of $6bn.
Analysts forecast that both Verzenio and Kisqali will earn $1bn plus in annual revenues year within the next two to three years -though much could depend on long term survival data.
Like its rival, Kisqali has shown significant improvements in progression free survival (PFS) but not overall survival (OS), hence why both will now be used on the CDF to allow subsequent trial results to potentially demonstrate extra months of life added thanks to treatment.
Kisqali with fulvestrant will be available to NHS patients in England immediately. Subject to appeal, NICE’s final guidance will be published next month.
While Pfizer’s Ibrance is the clear leader in the frontline setting, its NICE review is lagging behind its rivals in this indication. England’s cost effectiveness watchdog is due to conclude its already ongoing appraisal of this second line combination use in December this year.