Idecabtagene vicleucel Medicine 12 June 2019 Extended indication Abecma is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. Therapeutic value Possible added value Total cost € 16,250,000.00 Registration phase Registered Product Active substance Idecabtagene vicleucel Domain Hematology Reason of inclusion New medicine (specialité) Main indication Multiple Myeloma Extended indication Abecma is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. Current proprietary name Already available biosimilars / generics Proprietary name Abecma Manufacturer BMS Portfolio holder Mechanism of action CAR-T therapy Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise AMC locatie VU Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Accelerated assessment Particularity New medicine with Priority Medicines (PRIME) ATMP Yes Submission date April 2020 Expected Registration August 2021 Orphan drug Yes Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve opinie van de CHMP in juni 2021. Dit middel is voor deze indicatie in de sluis geplaatst. Therapeutic value Current treatment options Chemotherapie combinaties Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Gebruik van ide-cel in de "real world" is vergeleken met standard of care in een populatie van patiënten met een vergelijkbaar profiel (Jagannath et al, JCO mei 2020). Hier wordt een significant betere overall response rate (76 versus 32%) en progressie vrije overleving (11.3 versus 3.5 maanden) gezien. Duration of treatment Frequency of administration Dosage per administration 150 - 450 x 10^6 CAR+ T cells References NCT03361748 Additional remarks Expected patient volume per year Patient volume < 50 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Gezien de vele behandelopties komen naar schatting maximaal 50 patiënten per jaar hiervoor in aanmerking. Naar de toekomst toe kan CAR-T mogelijk naar eerdere behandelrichtlijnen verschuiven, in dat geval zouden meer patiënten in aanmerking komen. Expected cost per patient per year Cost € 320,000.00 - 330,000.00 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 De kosten mogelijk vergelijkbaar met andere CAR-T therapieën tisagenlecleucel en axicabtagene ciloleucel (€320.000-€330.000). Dit middel is voor deze indicatie in de sluis geplaatst tot er een financieel arrangement overeengekomen is. Potential total cost per year Total cost € 16,250,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References AdisInsight. Additional remarks Other information Additional remarks