Extended indication Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Pat
Therapeutic value No estimate possible yet
Total cost 23,261,616.00
Registration phase No registration expected

Product

Active substance Palbociclib
Domain Oncology
Reason of inclusion Indication extension
Main indication Breast cancer
Extended indication Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery.
Proprietary name Ibrance
Manufacturer Pfizer
Mechanism of action CDK4 / 6 tyrosine kinase inhibitor
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Orphan drug No
Registration phase No registration expected
Additional comments De PENELOPE-B Trial heeft de primaire eindpunten niet gehaald.

Therapeutic value

Current treatment options Endocriene therapie
Therapeutic value No estimate possible yet
Frequency of administration 1 times a day
Dosage per administration 125 mg
References NCT01864746 https://investors.pfizer.com/investor-news/press-release-details/2020/PENELOPE-B-Trial-of-IBRANCE-palbociclib-in-Early-Breast-Cancer-Did-Not-Meet-Primary-Endpoint/default.aspx
Additional comments Palbociclib at a dose of 125 mg once daily, day 1 to day 21 followed by 7 days off treatment in a 28-day cycle Other Name: Ibrance

Expected patient volume per year

Patient volume

< 987

Market share is generally not included unless otherwise stated.

References Ned. Kanker registratie 2018; Record abemaciclib.
Additional comments Van het totale aantal patiënten (9.865) zal naar verwachting een klein deel (maximaal 10%) behandeld worden. Er zullen dus maximaal 987 patiënten in aanmerking komen voor palbociclib.

Expected cost per patient per year

Cost 23,568.00
References Farmacotherapeutischkompas.nl;
Additional comments De gemiddelde prijs per 21 stuks: De lijstprijs van Ibrance is €1.964,52 (exclusief BTW). Op jaarbasis komt dit uit op €23.568 exclusief btw.

Potential total cost per year

Total cost

23,261,616.00

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.