Palbociclib

Extended indication	Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery.
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.

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.

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.