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Hydrocortisone

Chronocort

Extended indication Replacement therapy for congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over a
Therapeutic value No judgement
Total cost 2,340,000.00
Registration phase Registration application pending

Product

Active substance Hydrocortisone
Domain Metabolism and Endocrinology
Reason of inclusion New medicine (specialité)
Main indication Metabolic diseases
Extended indication Replacement therapy for congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults.
Proprietary name Chronocort
Manufacturer Diurnal
Mechanism of action Receptor agonist
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Extramural (GVS)
Additional remarks Hydrocortisone extended release glucocorticoid receptor agonist.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity New therapeutical formulation
Submission date March 2020
Expected Registration February 2021
Orphan drug Yes
Registration phase Registration application pending

Therapeutic value

Current treatment options Standaard glucocorticoid therapie: hydrocortisone, prednisone, prednisolone, dexamethasone.
Therapeutic value No judgement
Substantiation Het voordeel van Chronocort ten opzichte van Plenadren is de mooiere release en langdurige werking van het geneesmiddel.
Frequency of administration 1 times a day
Dosage per administration 5mg, 10mg of 20mg
References NCT03062280; NCT02716818

Expected patient volume per year

Patient volume

468

Market share is generally not included unless otherwise stated.
References ntvg;
Additional remarks De prevalentie van de klassieke vorm van AGS is ongeveer 1:12.000 pasgeborenen. Dit betekent dat er in totaal 1.417 patiënten in Nederland zijn. De verwachting is dat ongeveer 1/3 deel van de patiënten over zal stappen op Chronocort. Dit zal leiden tot een mogelijk patiëntvolume van 468 patiënten.

Expected cost per patient per year

Cost 5,000.00
References https://www.hardmanandco.com/wp-content/uploads/2020/02/Diurnal-Interim-update-28-Feb-2020.pdf
Additional remarks Krijgt een benchmark price van $6,000 per patiënt per jaar (~€5.000)

Potential total cost per year

Total cost

2,340,000.00

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 Adrenal insufficiency
References NCT01735617
Additional remarks Indien chronocort ook voor bijnierinsufficiëntie ingezet gaat worden zal het patiëntvolume vele malen hoger zijn.

Other information

There is currently no futher information available.