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Palbociclib

Ibrance

Extended indication

Patients with HR+/HER2- invasive early breast cancer in combination with standard adjuvant endocrin

Therapeutic value

No judgement
Total cost

€ 117,981,408.00
Registration phase

No registration expected

Product

Active substance

Palbociclib
Domain

Oncology and Hematology
Reason of inclusion

Indication extension
Main indication

Breast cancer
Extended indication

Patients with HR+/HER2- invasive early breast cancer in combination with standard adjuvant endocrine therapy.
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 
Primaire eindpunten van de studie zijn niet gehaald. De fabrikant verwacht op dit moment geen indiening.

Therapeutic value

Current treatment options

Endocriene therapie
Therapeutic value

No judgement
Duration of treatment

Average 2 year / years
Frequency of administration

1 times a day
Dosage per administration

125 mg
References 
NCT02513394
Additional comments 
Addition of 2 years of palbociclib to standard adjuvant endocrine therapy. 
Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle for a total duration of 2 years, in addition to standard adjuvant endocrine therapy for a duration of at least 5 years.

Expected patient volume per year

Patient volume

< 5,006

Market share is generally not included unless otherwise stated.
References 
NKR
Additional comments 
Er waren in 2016 in totaal 5.006 patiënten met stadium II of III HR+/HER2- borstkanker in Nederland. Een gedeelte van deze patiënten komt mogelijk in aanmerking voor deze behandeling.

Expected cost per patient per year

Cost

€ 23,568.00
References 
farmacotherapeutischkompas.nl;
Additional comments 
De gemiddelde prijs per 21 stuks:  
IBRANCE, CDe 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

€ 117,981,408.00

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

Yes
Indication extensions

Non-small cell lung cancer
References 
Adisinsight.
Additional comments 
Fase II/III

Other information

There is currently no futher information available.