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Mepolizumab

Nucala

Extended indication Eosinofile granulomatueze poly angiitis (EGPA) (voorheen Churg Strauss syndroom).
Therapeutic value No judgement
Total cost 3,450,000.00

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)
Particularity Indication extension
Expected Registration 2018
Orphan drug No

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 Fabrikant: 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 45,000.00 - 47,000.00
References Medicijnkosten.nl
Additional remarks Per injectieflacon van 100mg €1.257,16. Komt bovenop huidige kosten.

Potential total cost per year

Total cost

3,450,000.00

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.