Tucatinib Medicine 10 December 2019 Extended indication Tucatinib, in combination with trastuzumab and capecitabine, for the treatment of adult patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received at least two prior anti-HER2 treatment regimens. Therapeutic value No judgement Total cost € 21,850,000.00 Registration phase Registration application pending Product Active substance Tucatinib Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Breast cancer Extended indication Tucatinib, in combination with trastuzumab and capecitabine, for the treatment of adult patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received at least two prior anti-HER2 treatment regimens. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Seattle Genetics Portfolio holder Mechanism of action Receptor antagonist Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks ERBB 2 receptor antagonists. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date February 2020 Expected Registration March 2021 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Fase 3 studie. Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Average 7.3 month / months Frequency of administration 2 times a day Dosage per administration 300 mg References Meerdere fase 2 studies (zie clinicaltrials.gov), zie onder andere NCT02614794, fase 3 studie nu ook gestart: NCT03975647 Additional remarks Expected patient volume per year Patient volume < 230 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References IKNL 2018 Additional remarks Er zijn zo'n 230 patiënten per jaar met stadium IV HER+ invasief mammacarcinoom, een deel hiervan zal in de 2e lijn of daarop volgende behandeling in aanmerking komen voor dit geneesmiddel. Aantal patiënten in de tweede lijn zal naar verwachting wel toe gaan nemen door betere overleving. Expected cost per patient per year Cost € < 95,000.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References https://pharmaphorum.com/news/fda-approves-seattle-genetics-advanced-breast-cancer-drug/ Additional remarks Prijs in Nederland nog onbekend, wel is er al een Amerikaanse prijs bekend: "This is Seattle Genetics‘ first approval in breast cancer, and the drug will reportedly cost $18,500 for a 30-day supply with an average cost for a course at around $111,000 per patient". Omgerekend zou dit om zo'n €95.000 per patiënt per jaar gaan. Potential total cost per year Total cost € 21,850,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions colorectaal carcinoom References AdisInsight, clinicaltrials.gov Additional remarks Other information Additional remarks