Expand all sections

Blinatumomab

Blincyto

Extended indication Blincyto is indicated as monotherapy for the treatment of adults with Philadelphia chromosome negati
Therapeutic value Possible added value
Total cost 2,625,000.00
Registration phase Registered and reimbursed

Product

Active substance Blinatumomab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication ALL
Extended indication Blincyto is indicated as monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive B-precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.
Proprietary name Blincyto
Manufacturer Amgen
Mechanism of action Immunostimulation
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Expected Registration January 2019
Orphan drug Yes
Registration phase Registered and reimbursed
Additional remarks Negatieve CHMP-opinie juli 2018. De fabrikant heeft een herbeoordeling aangevraagd in september 2018. Positieve CHMP-opinie november 2018. Geregistreerd in januari 2019. Sinds 1 maart 2019 opgenomen in de G-standaard.

Therapeutic value

Current treatment options Diverse chemo-schema's
Therapeutic value Possible added value
Dosage per administration 15 μg/m2
References Gökbuget et al. ASH 2014; Abstract 379 and oral presentation.
Additional remarks Behandelduur is max. 4 cycli indien response. Cyclus: 4 weken continue infusie (cIV) daarna behandelingsvrij interval van 2 weken.

Expected patient volume per year

Patient volume

20 - 30

Market share is generally not included unless otherwise stated.
References Fabrikant
Additional remarks NKR: b-ALL in totaal 165 patiënten, hiervan hebben 40 patiënten b-ALL met cytogenetische afwijkingen. Inschatting fabrikant 20-30.

Expected cost per patient per year

Cost 70,000.00 - 140,000.00
References Medicijnkosten.nl; Fabrikant
Additional remarks €2.750,67 per blinatumomab infpdr flacon 38,5 μg + solv 10 ml (uitgaande van 1,7m2). zo'n 50.000 euro per cyclus. Fabrikant (nov 2017): Behandelduur van 1-2 cycli (28 behandeldagen, 28 μg/dag). Uitgaande van 1 behandeling per patiënt jaar: €70.000 - €140.000 p.p.p.j.

Potential total cost per year

Total cost

2,625,000.00

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 Yes
Indication extensions alle indicaties in de Horizonscan Geneesmiddelen en nu ook een fase III studie gestart voor DLBCL.
References clinicaltrials.gov

Other information

There is currently no futher information available.