Extended indication Treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma, 2L
Therapeutic value No judgement
Registration phase Registration application pending

Product

Active substance Duvelisib
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication CLL
Extended indication Treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma, 2L
Proprietary name Copiktra
Manufacturer Verastem
Mechanism of action Serine / threonine kinase inhibitor
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)
Additional comments Selective PI3K δ/γ inhibitor

Registration

Registration route Centralised (EMA)
Submission date December 2019
Expected Registration January 2021
Orphan drug Yes
Registration phase Registration application pending
Additional comments DUO trial: improved progression free survival (PFS).

Therapeutic value

Therapeutic value No judgement
Substantiation Momenteel te weinig informatie beschikbaar voor opname in de richtlijn.
Duration of treatment Median 11.6 month / months
Frequency of administration 2 times a day
Dosage per administration 25 mg
References NCT02004522; https://www.targetedonc.com/conference/soho-2019/dose-modifications-to-duvelisib-do-not-compromise-outcomes-in-rr-cllsll
Additional comments De werkgroep ziet voorlopig geen indicatie voor duvelisib.

Expected patient volume per year

References NKR
Additional comments Aantal diagnoses CLL en SLL in 2016: 781 en 139 respectievelijk. Nog te weinig bekend over de mogelijke plaatsbepaling om een goede inschatting te kunnen doen van het patiëntvolume.

Expected cost per patient per year

Cost < 160,000.00
References https://www.drugs.com/price-guide/copiktra
Additional comments In de Verenigde Staten is een prijs bekend van ongeveer $13,000 (~€12.800) voor 56 orale capsules van 25 mg. Bij en behandelduur van 11,6 maanden zou dit neerkomen op een inname van 706 capsules en dus ongeveer €160.000 per patiënt per jaar.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Non-Hodgkin's Lymphoma
References adisinsight; clinicaltrials.gov
Additional comments Lopende fase 3 studie

Other information

There is currently no futher information available.