Expand all sections

Emicizumab

Hemlibra

Extended indication Prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in adults and children
Therapeutic value Possible added value
Total cost 19,492,500.00

Product

Active substance Emicizumab
Domain Oncology and Hematology
Main indication Haemophilia
Extended indication Prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in adults and children with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors.
Proprietary name Hemlibra
Manufacturer Roche
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Centre of expertise Hemofilie Behandel Centra

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date August 2017
Expected Registration March 2018
Orphan drug Yes

Therapeutic value

Current treatment options FEIBA en recombinant factor VIIa
Therapeutic value Possible added value
Duration of treatment continuous
Frequency of administration 1 times a week
Dosage per administration 3 mg/kg
Additional remarks Fabrikant: Chronische behandeling. Dosering is conform klinische studie, kan volgens officiële SmPC nog veranderen. Week 1-4: 3 mg/kg; week ≥ 5: 1,5 mg/kg

Expected patient volume per year

Patient volume

13 - 100

Market share is generally not included unless otherwise stated.
Additional remarks Emicuzumab onderhoud is aangewezen voor deel van patienten bij wie remmer niet verdwijnt na ITI. Percentage patiënten is waarschijnlijk lager dan 20% (formele registratie ontbreekt nog), dan zou het totaal aantal maximaal uitkomen op 100, en het aantal dat daadwerkelijk behandeld zal worden op 25-50.

Expected cost per patient per year

Cost 170,000.00 - 520,000.00
References Medicijnkosten.nl
Additional remarks Berekend obv de prijs voor octocog alfa en behandelschema beschreven in het farmacotherapeutisch kompas voor een patient van 70 kg langetermijnprofilaxe: €170.000-520.000. schatting gedaan op basis van de huidige behandelopties waarmee het moet concurreren.

Potential total cost per year

Total cost

19,492,500.00

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

Off label use No

Indication extension

Indication extension No

Other information

There is currently no futher information available.