Aumolertinib (mesilate) Medicine 06 June 2023 Extended indication EGFR-mutated non–small cell lung cancer (NSCLC) and locally advanced or metastatic EGFR T790M mutation–positive NSCLC. Therapeutic value Possible equal value Total cost Registration phase Registration application pending Product Active substance Aumolertinib (mesilate) Domain Oncology Reason of inclusion New medicine (specialité) Main indication Lung cancer Extended indication EGFR-mutated non–small cell lung cancer (NSCLC) and locally advanced or metastatic EGFR T790M mutation–positive NSCLC. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer EQRx Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Werkingsmechanisme: EEGFR antagonists. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date December 2022 Expected Registration July 2025 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Verwachte registratie op basis van IHSI-inschatting. Therapeutic value Current treatment options erlotinib, gefitinib, afatinib, dacomitinib en osimertinib Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Er wordt een gelijke waarde met osimertinib verwacht op basis van de non-inferioriteitsstudie. Duration of treatment Frequency of administration 1 times a day Dosage per administration 110mg/55mg References NCT03849768 Additional remarks Klinische studie: The initial dose 110mg once daily can be reduced to 55mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria. Expected patient volume per year Patient volume 210 - 420 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Pakketadvies Atezolizumab; Ned Tijdschr Geneeskd. 2011;155:A2554; expertopinie; PALGA database Additional remarks Jaarlijks presenteren er ongeveer 7.500 patiënten per jaar met NSCLC stadium IIIb/IV. Het aantal NSCLC patiënten met EGFR mutaties in de eerste lijn is ongeveer 5 tot 10% (375 tot 750). In de praktijk zullen niet alle patiënten vanwege co morbiditeit in aanmerking komen voor een behandeling, maar ongeveer 80% (300 tot 600). Verder is het testgehalte voor mutaties volgens de PALGA database 70%. Dit brengt het totale aantal patiënten op 210 tot 420. Expected cost per patient per year Cost References Expertopinie Additional remarks Er wordt verwacht dat de kosten van aumolertinib lager zullen uitvallen dan concurrent osimertinib. 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 Adis Insight Additional remarks Niet op korte termijn, fase 1 studie solide tumoren Other information Additional remarks