Extended indication Replacement therapy in adults, children and adolescents (0‑18 years) in: Secondary immunodeficiencie
Therapeutic value No estimate possible yet
Total cost 2,250,000.00
Registration phase Registered and reimbursed

Product

Active substance Human normal immunoglobulin
Domain Infectious diseases
Reason of inclusion Indication extension
Main indication Other infectious diseases
Extended indication Replacement therapy in adults, children and adolescents (0‑18 years) in: Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF) or serum IgG level of <4 g/l.
Proprietary name HyQvia
Manufacturer Takeda
Mechanism of action Immunostimulation
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date March 2020
Expected Registration September 2020
Orphan drug No
Registration phase Registered and reimbursed
Additional comments Positieve CHMP-opinie in juli 2020.

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation De verwachting is dat dit geneesmiddel een meerwaarde zal hebben voor een kleine groep patiënten.
References NCT03054181
Additional comments Zie de huidige behandeling volledig uitgeschreven in het Farmacotherapeutisch Kompas. https://www.farmacotherapeutischkompas.nl/bladeren/preparaatteksten/n/normaal_immunoglobuline__im_en_sc_

Expected patient volume per year

Patient volume

< 100

Market share is generally not included unless otherwise stated.

References GIP databank
Additional comments Meer dan 1.000 gebruikers per jaar van normaal immunoglobuline subcutaan en meer dan 1.600 gebruikers normaal immunoglobuline IV. Met de aanpassing van de indicatie zal mogelijk een deel van de patiënten die nu intraveneus behandeld wordt subcutaan worden behandeld. De inschatting is dat er maximaal 100 patiënten in aanmerking zullen komen voor deze nieuwe toedieningsvorm.

Expected cost per patient per year

Cost 20,000.00 - 25,000.00
References GIP databank
Additional comments Kosten in 2019 zo'n €20.000-€25.000 per patiënt per jaar. Geen Budget impact, daar deze patiënten nu al met intraveneuze immuunglobulinen worden behandeld.

Potential total cost per year

Total cost

2,250,000.00

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 Yes
Indication extensions Chronic inflammatory demyelinating polyradiculoneuropathy
References fase 3 studie Adis Insight

Other information

There is currently no futher information available.