Neratinib Medicine 09 January 2018 Extended indication Nerlynx is indicated for the extended adjuvant treatment of adult patients with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab based therapy. Therapeutic value No judgement Total cost € 29,080,000.00 Registration phase Registered Product Active substance Neratinib Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Breast cancer Extended indication Nerlynx is indicated for the extended adjuvant treatment of adult patients with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab based therapy. Current proprietary name Already available biosimilars / generics Proprietary name Nerlynx Manufacturer Puma Portfolio holder Mechanism of action Tyrosine kinase inhibitor Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Tyrosine kinase inhibitor. Adjuvante setting, na trastuzumab. 2-jaars ziekte vrije overleving (DFS; disease-free survival) gepubliceerd, maar commissie BOM eist 5 jaar follow-up voor uitspraak. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date September 2016 Expected Registration August 2018 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Negatieve CHMP opinie februari 2018. Fabrikant heeft een herbeoordeling aangevraagd. Positieve CHMP-opinie in juli 2018. Geregistreerd in augustus 2018. Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Wordt zowel adjuvant als in gemetastaseerde setting onderzocht bij HER2 neu + tumoren. Studieresultaten vooorlopig nog niet verwacht; nog geen schatting mogelijk. Duration of treatment Average 12 month / months Frequency of administration 1 times a day Dosage per administration 240 mg References Additional remarks Expected patient volume per year Patient volume 624 - 830 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks NKR: stadium 2, HER2+ betreft 830 patiënten, hiervan wordt 75% behandeld met een targeted therapy (=trastuzumab) = 624 patiënten. Expected cost per patient per year Cost € 30,000.00 - 50,000.00 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 Additional remarks Lapatinib kost nu maximaal €40.000,00 per patiënt per jaar. Potential total cost per year Total cost € 29,080,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Breast cancer, advanced HER-2-positive - 3rd-line in combination with capecitabine (PhIII). References Additional remarks Other information Additional remarks