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Mepolizumab

Nucala

Extended indication Eosinofile granulomatueze poly angiitis (EGPA) (voorheen Churg Strauss syndroom).
Therapeutic value No judgement
Total cost 3,300,000.00
Registration phase Clinical trials

Product

Active substance Mepolizumab
Domain Lung diseases
Reason of inclusion Indication extension
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 2019
Orphan drug No
Registration phase Clinical trials
Additional remarks Goedgekeurd door de FDA in december 2017

Therapeutic value

Current treatment options Corticosteroiden, cyclofosfamide, azathioprine
Therapeutic value No judgement
Substantiation Wordt off-label al voorgeschreven.
Frequency of administration 1 times a month
Dosage per administration 300 mg
References Wechsler et al. N Engl J Med. 2017 May 18;376(20):1921-1932

Expected patient volume per year

Patient volume

50 - 100

Market share is generally not included unless otherwise stated.
References Fabrikant; Martin et al, Drug Saf 1999;8(3):179-89; Cottin, et al. Eur Respir J 2016; 48: 1429–41
Additional remarks De prevalentie van EGPA is geschat op 6,8 per miljoen inwoners. Nucala wordt onderzocht in relapsing/refractory EGPA wat ongeveer de helft van de patiënten betreft, daarom zou op basis van bovenstaande een realistisch patiëntvolume enkele tientallen (rond de 50) zijn en het maximale patiëntvolume ongeveer 100 patiënten.

Expected cost per patient per year

Cost 44,000.00
References G-standaard
Additional remarks 39 flacons van 100 mg kosten €43.906,59

Potential total cost per year

Total cost

3,300,000.00

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.