Duvelisib

Active substance

Duvelisib

Domain

Oncology and Hematology

Reason of inclusion in Horizonscan Geneesmiddelen

New medicine (specialité)

Main indication

CLL

Extended indication
Treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma, 2L

1. Product

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

2. 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).

3. 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.

4. 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.

5. Expected cost per patient per year

Cost

< 160,000

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.

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

Yes

Indication extensions

Non-Hodgkin's Lymphoma

References
adisinsight; clinicaltrials.gov
Additional comments
Lopende fase 3 studie

9. Other information

There is currently no futher information available.