Trastuzumab deruxtecan Medicine 08 December 2020 Extended indication Enhertu as monotherapy is indicated for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. Therapeutic value No estimate possible yet Total cost € 2,403,000.00 Registration phase Registered Product Active substance Trastuzumab deruxtecan Domain Oncology Reason of inclusion Indication extension IND Main indication Stomach cancer Extended indication Enhertu as monotherapy is indicated for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. Current proprietary name Already available biosimilars / generics Proprietary name Enhertu Manufacturer AstraZeneca Portfolio holder Mechanism of action Antibody-drug conjugate Route of administration Intravenous Therapeutical formulation Injection / infusion solution Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date October 2021 Expected Registration December 2022 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Broadly excluded Additional remarks Positieve CHMP-opinie november 2022. Registratie december 2022. Dit geneesmiddel is in de sluis geplaatst voor zover verstrekt in het kader van geneeskundige behandelingen. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation In de DESTINY-Gastric02 werd een respons percentage van 38% gevonden. Enhertu is per december 2022 geregistreerd op basis van de DESTINY-Gastric01 en DESTINY-Gastric02 studies. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 6,4mg/kg References Additional remarks Expected patient volume per year Patient volume 40 - 50 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References (1) GIPdatabank (2) expertopinie Additional remarks Uitgaande van 360 patiënten die nu met ramucirumab worden behandeld (1), waarvan 20% een HER2+ expressie heeft, komen er volgens de werkgroep 40 tot 50 patiënten in aanmerking voor Enhertu. Expected cost per patient per year Cost € < 53,400.00 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 CBS; fabrikant Additional remarks Trastuzumab-deruxtecan is beschikbaar in flacons van 100mg. De apotheekinkoopprijs bedraag €1.243 per flacon. De aanbevolen dosering is 6,4 mg per kg per behandelcyclus van 21 dagen. Op basis van een gemiddeld gewicht van 78kg bedragen de kosten van trastuzumab-deruxtecan €6.215 per behandelcyclus (5 flacons van €1.243). De kosten per maand zijn dan €11.595 (365,25/12)*(8.000/21)). De mediane behandelduur is 4,6 maanden; De kosten per patiënt per jaar zijn dan €53.338. Potential total cost per year Total cost € 2,403,000.00 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti HER2 based regimens (NCT03248492). Treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2 therapies (2L) (NCT03529110). Treatment of adult patients with unresectable or metastatic HER2-Low breast cancer. Treatment of adult patients with HER2-mutated, Unresectable and/or Metastatic non-small cell lung cancer (NSCLC) (NCT03505710). References Additional remarks Other information Additional remarks