Extended indication IMCIVREE is indicated for the treatment of obesity and the control of hunger associated with genetic
Therapeutic value No estimate possible yet
Registration phase Registered and reimbursed

Product

Active substance Setmelanotide
Domain Metabolism and Endocrinology
Reason of inclusion Indication extension
Main indication Other metabolism and Endocrinology
Extended indication IMCIVREE is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed Bardet‑Biedl syndrome (BBS), loss-of-function biallelic pro-opiomelanocortin (POMC), including PCSK1, deficiency or biallelic leptin receptor (LEPR) deficiency in adults and children 6 years of age and above.
Proprietary name Imcivree
Manufacturer Rhythm
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date October 2021
Expected Registration September 2022
Orphan drug Yes
Registration phase Registered and reimbursed
Additional comments Positieve CHMP opinie ontvangen juli 2022.

Therapeutic value

Therapeutic value No estimate possible yet
Frequency of administration 1 times a day
Dosage per administration 3 mg
References NCT03746522

Expected patient volume per year

Patient volume

< 300

Market share is generally not included unless otherwise stated.

References www.orpha.net
Additional comments In de Verenigde Staten wordt de prevalentie geschat op 1/100.000. Epidemiologische gegevens zijn beperkt in Europa, maar in Denemarken werd de prevalentie geschat op 1/59.000, en op Réunion, Frankrijk, op 1/45.000-66.000 (als gevolg van een stichter effect). Dit zou voor Nederland betekenen dat er maximaal 300 patiënten met deze ziekte leven.

Expected cost per patient per year

References Goodrx;
Additional comments De prijs in de Verenigde Staten is gemiddeld $1,935.63 voor 4 prefilled 0,25mg pens of 0,25mg/0,5ml. De prijs in Nederland zal mogelijk lager zijn.

Potential total cost per year

There is currently nothing known about the possible total cost.

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.