Buparlisib Medicine 03 December 2024 Extended indication Buparlisib in combination with paclitaxel for second line or later treatment of refractory, recurrent, or metastatic squamous cell carcinoma of head and neck in adults and elderly after treatment with PDL1/PD1-based therapy. Therapeutic value No estimate possible yet Total cost Registration phase No registration expected Product Active substance Buparlisib Domain Oncology Reason of inclusion New medicine (specialité) Main indication Head and neck cancer Extended indication Buparlisib in combination with paclitaxel for second line or later treatment of refractory, recurrent, or metastatic squamous cell carcinoma of head and neck in adults and elderly after treatment with PDL1/PD1-based therapy. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Adlai Nortye Portfolio holder Mechanism of action Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks PI3K-remmer. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date Expected Registration Orphan drug No Registration phase No registration expected Reimbursement Medicine sluice Additional remarks De studie voldeed niet aan het primaire eindpunt van verbetering van de totale overleving in vergelijking met paclitaxel alleen. Therapeutic value Current treatment options Andere immunotherapiën en PD1/PDL1-remmers. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times a day Dosage per administration 100mg References NCT04338399 (BURAN) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2021 (1). Additional remarks In 2021 werden er 8.943 patiënten met plaveiselcelcarcinoom van de huid van hoofd en hals gediagnosticeerd, waarvan 149 stadium III en IV (1). Gezien dit een tweedelijnsbehandeling is zal het verwachte patiëntvolume lager liggen. Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks