Extended indication

Endogenous cushing syndrome, first or subsequent lines for persistent or recurrent disease, in patie

Therapeutic value

No estimate possible yet

Total cost

1,650,000.00

Registration phase

Clinical trials

Product

Active substance

Levoketoconazole

Domain

Metabolism and Endocrinology

Reason of inclusion

New medicine (specialité)

Main indication

Metabolic diseases

Extended indication

Endogenous cushing syndrome, first or subsequent lines for persistent or recurrent disease, in patients aged ≥18 years if not suitable for surgery

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

Registration

Registration route

Centralised (EMA)

Submission date

2022

Expected Registration

2023

Orphan drug

Yes

Registration phase

Clinical trials

Additional comments
Twee fase 3 studies hebben hun primary completion date gehad in april 2018 en mei 2019. In maart 2021 ingediend bij de FDA.

Therapeutic value

Current treatment options

Pasireotide, ketoconazol, mitotane, metyrapone, mifeproston.

Therapeutic value

No estimate possible yet

Substantiation

Mogelijk minder bijwerkingen dan bij een behandeling met ketoconazol. Zal met name gebruikt worden als bridging therapie na radiotherapie.

Duration of treatment

continuous

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.

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.

Expected cost per patient per year

Cost

20,000.00 - 35,000.00

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

Potential total cost per year

Total cost

1,650,000.00

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

No

Other information

There is currently no futher information available.