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New HTA Decisions in France
March 2021
Drug name
PIQRAY® (alpelisib)
Company
Novartis Pharma
Decision date
20/01/2021
Therapeutic area
Cancer
Therapeutic sub area
Breast cancer
Official notice date
22/01/2021
Reimbursement %
Decision (SMR)
Insufficient to justify reimbursement
Decision (ASMR)
Indication
PIQRAY® is indicated in combination with fulvestrant for the treatment of men and postmenopausal women with locally advanced or metastatic HR+/HER2- breast cancer, showing a PIK3CA mutation which has progressed after hormone therapy as monotherapy.
Decision Type
New technology assessment
Summary
The committee consider that the actual benefit of PIQRAY® is 'insufficient' to justify reimbursement in the indication of the Marketing Authorisation.