Patritumab deruxtecan Medicine 03 December 2024 Extended indication Patritumab deruxtecan monotherapy for second line or later treatment of locally advanced or metastatic EGFR-mutated non-small cell lung cancer in adults and elderly after failure of EGFR TKI therapy. Therapeutic value No estimate possible yet Total cost € 26,659,000.00 Registration phase Clinical trials Product Active substance Patritumab deruxtecan Domain Oncology Reason of inclusion New medicine (specialité) Main indication Lung cancer Extended indication Patritumab deruxtecan monotherapy for second line or later treatment of locally advanced or metastatic EGFR-mutated non-small cell lung cancer in adults and elderly after failure of EGFR TKI therapy. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Daiichi Sankyo Portfolio holder Daiichi Sankyo Mechanism of action Antibody-drug conjugate Route of administration Intravenous Therapeutical formulation Powder for injection / infusion solution Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New therapeutical formulation ATMP No Submission date 2026 Expected Registration 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Dit geneesmiddel heeft potentie. Het middel zal niet voor de gehele groep ingezet worden die progressie heeft. Verdere resultaten dienen afgewacht te worden. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 5,6mg/kg References NCT05338970 (HERTHENA-Lung02) Additional remarks 5,6mg/kg iedere drie weken. Expected patient volume per year Patient volume 335 - 670 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2022 (1); Expertopinie (2). Additional remarks In 2022 waren er 9.099 diagnoses NSCLC in Nederland. Dit betrof 1.567 stadium I, 760 stadium II, 2.052 stadium III (waarvan zo'n 55% stadium IIIa en zo'n 45% stadium IIIb), 4.720 stadium IV. Uitgaande van stadium IIIb / IV komt dat neer op zo'n 5.634 patiënten (1). Hier komen nog patiënten bij uit eerdere stadia die verslechteren naar stadium IIIb/IV. Binnen een jaar is de inschatting dat dit 20% van stadium I/II bedraagt (465) en 50% van stadium IIIa (564). In totaal bedraagt deze groep dus zo'n 6.700 patiënten. Het aantal NSCLC patiënten met EGFR betreft zo'n 5 tot 10% van deze patiënten (2). Expected cost per patient per year Cost € < 53,000.00 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 Horizonscan Geneesmiddelen Enhertu (1); Jänne et al. Cancer Discov. 2022 (2). Additional remarks De kosten zullen waarschijnlijk in dezelfde orde van grootte liggen als Enhertu, waarvan de kosten per maand ongeveer €9.276 bedragen (1). In de fase I trial was de median treatment duration 5,7 maanden (2). Uitgaande van deze variabelen kan een voorlopige schatting gegeven worden van €53.000 per patiënt per jaar. Potential total cost per year Total cost € 26,659,000.00 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