Extended indication

Breast cancer; HER2-negative metastatic or locally advanced unresectable BRCA-associated - first to

Therapeutic value

No judgement

Total cost

8,505,000.00

Registration phase

Clinical trials

Product

Active substance

Veliparib

Domain

Oncology and Hematology

Reason of inclusion

New medicine (specialité)

Main indication

Breast cancer

Extended indication

Breast cancer; HER2-negative metastatic or locally advanced unresectable BRCA-associated - first to third-line in combination with carboplatin and paclitaxel.

Manufacturer

Abbvie

Mechanism of action

PARP inhibitor

Route of administration

Oral

Therapeutical formulation

Capsule

Budgetting framework

Intermural (MSZ)

Additional comments
PARP-remmer

Registration

Registration route

Centralised (EMA)

Submission date

July 2020

Expected Registration

August 2021

Orphan drug

No

Registration phase

Clinical trials

Therapeutic value

Current treatment options

Concurrentie van alle parp-remmers.

Therapeutic value

No judgement

Expected patient volume per year

Patient volume

< 189

Market share is generally not included unless otherwise stated.

References
NKR
Additional comments
NKR 2015: 1.885 mammacarcinomen HER- stadia 3 en 4. 5-10% van borstkankers wordt veroorzaakt door BRCA mutaties.

Expected cost per patient per year

Cost

30,000.00 - 60,000.00

Additional comments
Afhankelijk van de behandelduur vergelijkbaar met olaparib en rucaparib. Inschatting €30.000-€60.000.

Potential total cost per year

Total cost

8,505,000.00

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

References
adisinsight
Additional comments
Buiten de indicaties in de Horizonscan geen nieuwe indicatie-uitbreidingen.

Other information

There is currently no futher information available.