Extended indication Talzenna is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2 mutat
Therapeutic value Possible added value
Total cost 9,305,800.00
Registration phase Registered and reimbursed


Active substance Talazoparib
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Breast cancer
Extended indication Talzenna is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2 mutations, who have HER2-negative locally advanced or metastatic breast cancer. Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy.
Proprietary name Talzenna
Manufacturer Pfizer
Mechanism of action PARP inhibitor
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)
Additional comments Poly(ADP-ribose) polymerase (PARP) inhibitor


Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date May 2018
Expected Registration June 2019
Orphan drug No
Registration phase Registered and reimbursed
Additional comments Fase 3 studie (NCT01945775, EMBRACA : PFS extended). Fabrikant verwacht registratie in Q3 2019. Positieve CHMP-opinie april 2019. Geregistreerd in juni 2019.

Therapeutic value

Current treatment options Capecitabine, Eribulin, Gemcitabine en Vinorelbine
Therapeutic value Possible added value
Substantiation Significante PFS verlenging ten opzichte van behandelopties Capecitabine, Eribulin, Gemcitabine or Vinorelbine.
Duration of treatment Median 8.6 month / months
Frequency of administration 1 times a day
Dosage per administration 1 mg
References NCT01945775; Litton en al. N Engl J Med 2018; 379:753-763

Expected patient volume per year

Patient volume

< 200

Market share is generally not included unless otherwise stated.

References NKR, Pakketadvies palbociclib, 2017
Additional comments Incidentie invasieve borstkanker 14.497 patiënten (cijfersoverkanker.nl). Ongeveer 5% (725 patiënten) worden met een stadium IV tumor gediagnosticeerd (IKNL 2014,Pakketadvies palbociclib (Ibrance®)). Vervolgens zal naar schatting ongeveer 10% gBRCA positief zijn (72 patiënten). Van de patiënten met een stadium I-IIIB tumor, zal ongeveer 20% uiteindelijk metastases (2.754 patiënten) krijgen (Pakketadvies palbociclib (Ibrance®), waarvan naar schatting 5% gBRCA positief zijn (137 patiënten). Dit komt neer op maximaal 200 patiënten die voor deze behandeling in aanmerking kunnen komen. Aangezien niet elke patiënt genetisch getest zal worden komt slechts een deel van deze patiënten in aanmerking voor de behandeling.

Expected cost per patient per year

Cost 46,529.00
References Fabrikant; SmPC Talzenna; Z-Index (Taxe van mei 2020)"
Additional comments Behandeling met talazoparib (1mg eenmaal daags of 0,75mg eenmaal daags) kost per dag €177,86 en kost met een gemiddelde behandelduur van 8,6 maanden €46.529,56 per patiënt per jaar. Per 1 mei 2020 heeft Talzenna de add-on vergoedingsstatus toegekend gekregen.

Potential total cost per year

Total cost


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

Off label use No

Indication extension

Indication extension Yes
Indication extensions Prostate cancer; Ovarian cancer; Squamous Cell Lung Carcinoma
References clinicaltrials.gov; adisinsight
Additional comments Lopende fase 3 studies.

Other information

There is currently no futher information available.