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New HTA Decisions in France
March 2021
Drug name
KISQALI® (ribociclib)
Novartis Pharma SAS
Decision date
Therapeutic area
Therapeutic sub area
Breast cancer
Official notice date
Reimbursement %
Decision (SMR)
Decision (ASMR)
Minor improvement (IV)
KISQALI® in combination with fulvestrant is indicated for the treatment of postmenopausal women with locally advanced or metastatic RH + / HER2 - breast cancer without symptomatic, short-term, life-threatening visceral involvement as initial treatment with hormone therapy or after previous treatment with hormone therapy.
Decision Type
SMR and ASMR reassessment
There was no change from the previous opinion of the commission on 22nd July 2020; the actual benefit remains 'important' but with a minor improvement of actual benefit (ASMR IV) in the indication of the Marketing Authorization considering: • the demonstration of the superiority of the addition of KISQALI® to fulvestrant compared to fulvestrant alone in terms of overall survival (relative reduction in the risk of death of 28%; HR = 0.724; 95% CI [0.568; 0.924]) after a median follow-up of 39.4 months, with an unquantifiable absolute gain, in a randomised double-blind study which included a heterogeneous population of postmenopausal patients (approximately 30% of patients naive to hormone therapy, 50% in the first line and 20 % in the second line); but taking into account: • increased toxicity with in particular a frequency of grade ≥3 adverse events of 81.8% versus 34.4% with hormone therapy alone, as well as hepatobiliary and hematological toxicity and more marked cardiotoxicity; • the absence of robust quality of life data. The committee proposed 100% reimbursement.