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.