Polihexanide

Active substance
Polihexanide
Domain
Neurological disorders
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Eye disorders
Extended indication
Acanthamoeba keratitis in patients aged 13 years and older.

1. Product

Manufacturer
SIFI
Mechanism of action
Disinfectant
Route of administration
Ocular
Therapeutical formulation
Eye drops
Budgetting framework
Extramural (GVS)
Additional comments
Disinfectant that is active against bacteria and acanthamoeba.

2. Registration

Registration route
Centralised (EMA)
Submission date
2019
Expected Registration
2020
Orphan drug
No
Registration phase
Clinical trials

3. Therapeutic value

Current treatment options
De behandeling bestaat uit oogdruppels met een ontsmettende werking, zoals chloorhexidine, brolene of PHMB.
Therapeutic value
No judgement
Substantiation
Het wordt gebruikt als vervanging van chloorhexidine. Maar nog onduidelijk wat de verwachte waarde is t.o.v. chloorhexidine.
Duration of treatment
Not found
References
NCT03274895
Additional comments
Clinical trial: "16 drops each in a day for 5 days,8 drops each in a day for 7 days,6 drops each in a day for 7 days and 4 drops each in a day up to clinical resolution."

4. Expected patient volume per year

Patient volume

< 100

Market share is generally not included unless otherwise stated.

References
SPS, https://www.radboudumc.nl/patientenzorg/aandoeningen/acanthamoebe-keratitis/
Additional comments
SPS: "Acanthamoeba keratitis is a form of keratitis with a fairly low prevalence (7 cases per 1,000,000 in Europe)." Teruggerekend naar Nederland gaat dat om maximaal 119 personen. Op de website van het Radboud UMC is het volgende terug te vinden: in Nederland komt AK weinig voor, 30 tot 40 keer per jaar. Dit aantal lijkt toe te nemen. De inschatting is dat minder dan 100 patiënten per jaar die in aanmerking zullen komen voor dit geneesmiddel.

5. Expected cost per patient per year

There is currently nothing known about the expected cost.

6. Potential total cost per year

There is currently nothing known about the possible total cost.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

Indication extension
No

9. Other information

There is currently no futher information available.