Extended indication Patients with HR+/HER2- invasive early breast cancer in combination with standard adjuvant endocrin
Therapeutic value No estimate possible yet
Total cost 117,981,408.00
Registration phase No registration expected

Product

Active substance Palbociclib
Domain Oncology
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)
Orphan drug No
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 estimate possible yet
Duration of treatment Average 2 year / years
Frequency of administration 1 times a day
Dosage per administration 125 mg
References NCT02513394 https://investors.pfizer.com/investor-news/press-release-details/2020/Pfizer-Provides-Update-on-Phase-3-PALLAS-Trial-of-IBRANCE-palbociclib-Plus-Endocrine-Therapy-in-HR-HER2--Early-Breast-Cancer/default.aspx
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 €1.964,52 (exclusief 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 2-3

Other information

There is currently no futher information available.