Extended indication Eosinophilic esophagitis
Therapeutic value No judgement
Total cost 10,625,000.00

Product

Active substance Budesonide
Domain Chronic immune diseases
Main indication Other chronic immune diseases
Extended indication Eosinophilic esophagitis
Manufacturer Dr. Falk
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Accelerated assessment
Submission date July 2017
Expected Registration January 2018
Orphan drug Yes
Additional remarks Positieve CHMP-opinie november 2017

Therapeutic value

Therapeutic value No judgement
Duration of treatment continuous
Frequency of administration 2 times a day
Dosage per administration 2 mg

Expected patient volume per year

Patient volume

< 8,500

Market share is generally not included unless otherwise stated.

References EMA
Additional remarks EMA Orphan designation: 'eosinophilic oesophagitis affected less than 5 in 10,000 people in the European Union (EU).'

Expected cost per patient per year

Cost 1,000.00 - 1,500.00
References Medicijnkosten.nl
Additional remarks €3,25 voor een dagelijkse dosis

Potential total cost per year

Total cost

10,625,000.00

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.