Trastuzumab deruxtecan Medicine 06 June 2023 Extended indication Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment. Therapeutic value No estimate possible yet Total cost € 122,138,000.00 Registration phase Registered Product Active substance Trastuzumab deruxtecan Domain Oncology Reason of inclusion Indication extension IND Main indication Breast cancer Extended indication Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment. Current proprietary name Already available biosimilars / generics Proprietary name Enhertu Manufacturer AstraZeneca Portfolio holder AstraZeneca 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 August 2024 Expected Registration April 2025 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Broadly excluded Additional remarks Therapeutic value Current treatment options SoC chemotherapie Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation In de totale onderzoekspopulatie was de mediane PFS: 13,2 maanden voor T-DXd versus 8,1 maanden voor chemotherapie (HR: 0,63; 95% CI: 0,53-0,75; p < 0,0001). Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 5,4mg/kg References DESTINY-Breast06 (NCT04494425). Additional remarks Expected patient volume per year Patient volume 1,122 - 1,701 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2021 (1); Expertopinie (2) Additional remarks Invasief mammacarcinoom HER2-negatief kwam in 2021 bij 1.022 stadium-3 en 679 stadium-4 patiënten voor (1). Inclusiecriteria van de studie zijn als volgt omschreven: ʼHER2-low or negative expression by local test, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) or HER2 IHC 0 (ISH- or untested)ʼ. Als er uitgegaan wordt dat ongeveer 25 tot 30% van de patiënten HER2-positief is, komt ongeveer tweederde van de patiënten in aanmerking. Potentieel kan de hele groep die negatief is in aanmerking komen, indien er niet op getest wordt (2). Expected cost per patient per year Cost € < 86,500.00 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 5,4mg per kg per behandelcyclus van 21 dagen. Op basis van een gemiddeld gewicht van 72kg bedragen de kosten van trastuzumab-deruxtecan €4.972 per behandelcyclus (vier flacons van €1.243). De kosten per maand zijn dan €7.208 ((365,25/12)*(4.972/21)). De kosten per patiënt per jaar zijn dan €86.496 Potential total cost per year Total cost € 122,138,000.00 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks