Extended indication Diabetes type 1
Therapeutic value No judgement
Total cost 96,000.00
Registration phase Registration application pending

Product

Active substance Sotagliflozin
Domain Metabolism and Endocrinology
Reason of inclusion New medicine (specialité)
Main indication Diabetes
Extended indication Diabetes type 1
Manufacturer Sanofi
Route of administration Oral
Therapeutical formulation Tablet + chewable tablet
Budgetting framework Extramural (GVS)
Additional remarks Combinatie van Sodium-glucose transport protein 1 en 2 (SGLT-1/SGLT-2) remmers; dit zorgt voor verlaging van de glucoseopname en verhoogt uitscheiding via de urine. Dit heeft als gevolg dat de bloedsuikerspiegel verlaagt.

Registration

Registration route Centralised (EMA)
Submission date March 2018
Expected Registration April 2019
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value No judgement
Frequency of administration 1 times a day

Expected patient volume per year

Patient volume

160

Market share is generally not included unless otherwise stated.

References GIPdatabank; GLP-1-agonisten bij diabetes mellitus type 2, ZIN 2016; Monitor Voorschrijfgedrag Huisartsen 2017
Additional remarks Totaal aantal gebruikers van diabetesmiddelen in 2016 was 814.714. 10% hiervan heeft diabetes mellitus type 1 dus het aantal patiënten in Nederland bedraagt ongeveer 80.000. Verwacht marktaandeel: Uitgaande van 0,6% nieuwe gebruikers op SGLT-2 (480). Gelijke verdeling marktaandeel over 3 SGLT-2's voor DM1 (dapaglizlozine, empagliflozine, sotagliflozine)=0,2% (160 patiënten) .

Expected cost per patient per year

Cost 600.00
References Medicijnkosten.nl
Additional remarks Vergelijkbare prijs met SGLT-2 remmers dapagliflozine en empagliflozine

Potential total cost per year

Total cost

96,000.00

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 Diabetes type 2

Other information

There is currently no futher information available.