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

Oncology and 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.