Extended indication Abecma is indicated for the treatment of adult patients with relapsed and refractory multiple myelom
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.
Proprietary name Abecma
Manufacturer BMS
Mechanism of action CAR-T therapy
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Centre of expertise AMC locatie VU

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
Additional comments 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
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 one-off
Dosage per administration 150 - 450 x 10^6 CAR+ T cells
References NCT03361748

Expected patient volume per year

Patient volume

< 50

Market share is generally not included unless otherwise stated.

Additional comments 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
Additional comments 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

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.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension No
References AdisInsight.

Other information

There is currently no futher information available.