Expand all sections

Mepolizumab

Nucala

Extended indication Eosinofile granulomatueze poly angiitis (EGPA) (voorheen Churg Strauss syndroom).
Therapeutic value No judgement
Total cost 127,842,000.00

Product

Active substance Mepolizumab
Domain Lung diseases
Main indication Lung other
Extended indication Eosinofile granulomatueze poly angiitis (EGPA) (voorheen Churg Strauss syndroom).
Proprietary name Nucala
Manufacturer GSK
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional remarks Al geregistreerd voor astma.

Registration

Registration route Centralised (EMA)
Expected Registration 2018
Orphan drug No
Additional remarks Indicatie-uitbreiding

Therapeutic value

Therapeutic value No judgement
Substantiation Wordt off-label al voorgeschreven.
Duration of treatment Not found
Frequency of administration 1 times a month
Dosage per administration 300 mg

Expected patient volume per year

Patient volume

1,000 - 4,500

Market share is generally not included unless otherwise stated.
Additional remarks Lastige indicatiestelling, waardoor patiëntenaantal lastig is te voorspellen, wordt nu off-label bij een paar honderd patiënten voorgeschreven. Schatting: 500 - 1000 patiënten.

Expected cost per patient per year

Cost < 46,488.00
References Medicijnkosten.nl
Additional remarks Meerkosten. per injectieflacon van 100mg FL € 1263,52 (Medicijnkosten.nl) komt op huidige kosten

Potential total cost per year

Total cost

127,842,000.00

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

Off label use Yes
Indications off label use Gezien lastige indicatiestelling - grote kans op off-label gebruik.

Indication extension

Indication extension Yes
Indication extensions Meerdere fase 3 studies

Other information

There is currently no futher information available.