Levoketoconazole

Active substance
Levoketoconazole
Domain
Metabolism and Endocrinology
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Hormonal disorders
Extended indication
Endogenous cushing syndrome, first or subsequent lines for persistent or recurrent disease, in patients aged ≥18 years if not suitable for surgery

1. Product

Proprietary name
Recorlev
Manufacturer
Strongbridge
Mechanism of action
Enzyme inhibitor
Route of administration
Oral
Therapeutical formulation
Tablet
Budgetting framework
Extramural (GVS)
Additional comments
(2S,4R)-ketoconazole steroïdogeneseremmer

2. Registration

Registration route
Centralised (EMA)
Submission date
2020
Expected Registration
2021
Orphan drug
Yes
Registration phase
Clinical trials
Additional comments
Twee fase 3 studies hebben hun primary completion date respectievelijk in april 2018 en mei 2019

3. Therapeutic value

Current treatment options
pasireotide, ketoconazol, mitotane, metyrapone, mifeproston.
Therapeutic value
No judgement
Substantiation
Mogelijk minder bijwerkingen dan bij een behandeling met ketoconazol. Zal met name gebruikt worden als bridging therapie na radiotherapie.
Frequency of administration
1 times a day
Dosage per administration
1200 mg
References
NCT01838551; NCT03277690; Scrip, 13 augustus 2018
Additional comments
SONICS trial met efficacy primary endpoint and is well tolerated

4. Expected patient volume per year

Patient volume

20 - 100

Market share is generally not included unless otherwise stated.

References
Nederlandse Hypofyse Stichting
Additional comments
Naar schatting wordt deze diagnose in Nederland bij ongeveer 50 mensen per jaar gesteld. Levoketoconazole zal de markt moeten delen met pasireotide en mogelijk osilodrostat. Geschat marktaandeel bedraagt 40%. Echter bij Cushing's syndroom mogelijk 60-100 patiënten. Exact aantal patiënten is dus afhankelijk van de precieze indicatiestelling.

5. Expected cost per patient per year

Cost
20,000 - 35,000
References
GIPdatabank; fabrikant osilodrostat (Novartis)
Additional comments
Pasireotide en osilodrostat zijn geprijst in de range €20.000-€35.000. Afhankelijk van de therapeutische waarde zal levoketoconazole vergelijkbaar zijn.

6. Potential total cost per year

Total cost

1,650,000

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

9. Other information

There is currently no futher information available.