Pertuzumab / trastuzumab Medicine 10 June 2020 Extended indication Indicated for use in combination with trastuzumab and chemotherapy in patients with HER2-positive early breast cancer. Therapeutic value Possible equal value Total cost Registration phase Registration application pending Product Active substance Pertuzumab / trastuzumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Breast cancer Extended indication Indicated for use in combination with trastuzumab and chemotherapy in patients with HER2-positive early breast cancer. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Roche Portfolio holder Mechanism of action Antibody-drug conjugate Route of administration Subcutaneous Therapeutical formulation Injection liquid Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory 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 Therapeutic value Current treatment options Pertuzumab en trastuzumab als losse combinatie. Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Er zal substitutie plaatsvinden ten opzichte van de intraveneuze variant van pertuzumab. Duration of treatment Frequency of administration Dosage per administration References NCT03493854 Additional remarks Expected patient volume per year Patient volume < 463 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks In 2015 waren er in totaal 646 patiënten met HER2-positieve borstkanker. Hiervan hadden 463 patiënten een stadium 1 of 2 carcinoom. Er zal substitutie plaatsvinden ten opzichte van de intraveneuze variant van pertuzumab. Er worden echter in de nabije toekomst ook biosimilar varianten van pertuzumab verwacht. Dit zal mogelijk invloed hebben op het patiëntvolume de komende jaren. Expected cost per patient per year Cost References Medicijnkosten.nl Additional remarks De verwachte kosten zullen waarschijnlijk vergelijkbaar zijn met de intraveneuze variant van pertuzumab (dit record betreft de subcutane variant). Deze bedragen per patiënt ongeveer €43.000 gebaseerd op een behandelduur van 1 jaar en prijs van €2.360 per flacon pertuzumab. Er worden echter in de nabije toekomst (2025) ook biosimilar varianten van pertuzumab verwacht. Het is de vraag hoe de markt hierop zal reageren. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References adisinsght Additional remarks Op dit moment zijn er geen andere studies. Other information Additional remarks