Palbociclib

Active substance

Palbociclib

Domain

Oncology and Hematology

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.

Product

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)

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 judgement

Duration of treatment

Not found

Frequency of administration

1 times a day

Dosage per administration

125 mg

References
NCT01864746
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 €1964,52 (excl. BTW). Op jaarbasis komt dit uit op €23.568 exclusief btw.

Potential total cost per year

Total cost

23,261,616

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.