Mexiletine HCl

Active substance
Mexiletine HCl
Domain
Neurological disorders
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Other muscular diseases
Extended indication
Symptomatic treatment of myotonia in adult patients with non-dystrophic myotonic disorders.

1. Product

Proprietary name
Namuscla
Manufacturer
Lupin
Mechanism of action
Ion channel blocker
Route of administration
Oral
Therapeutical formulation
Capsule
Budgetting framework
Extramural (GVS)
Additional comments
Toedieningsvorm: naast capsules komt mexiletine HCl ook als oplossing beschikbaar (bron EMA).

2. Registration

Registration route
Centralised (EMA)
Type of trajectory
Normal trajectory
Submission date
September 2017
Expected Registration
December 2018
Orphan drug
Yes
Registration phase
Registered
Additional comments
Mexiletine HCl is al op de markt in Frankrijk. Positieve CHMP-opinie oktober 2018. Geregistreerd in december 2018.

3. Therapeutic value

Therapeutic value
No judgement
Frequency of administration
3 times a day
Dosage per administration
150 mg
References
NCT01406873

4. Expected patient volume per year

Patient volume

< 300

Market share is generally not included unless otherwise stated.

References
https://www.radboudumc.nl/nieuws/2019/radboudumc-bezorgd-over-toegankelijkheid-medicijn
Additional comments
Er lijden in Nederland ongeveer 300 patiënten aan niet-dystrofische myotonie

5. Expected cost per patient per year

Cost
80,000
References
https://www.radboudumc.nl/nieuws/2019/radboudumc-bezorgd-over-toegankelijkheid-medicijn
Additional comments
In Duitsland en het Verenigd Koninkrijk kost een behandeljaar €80.000

6. Potential total cost per year

Total cost

24,000,000

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.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

Indication extension
No
References
SPS

9. Other information

There is currently no futher information available.