Palbociclib

Extended indication	Patients with HR+/HER2- invasive early breast cancer in combination with standard adjuvant endocrine therapy.
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 remarks	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 remarks	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 remarks	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.

Patient volume

< 5,006

Market share is generally not included unless otherwise stated.

References

NKR

Additional remarks

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 remarks	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.

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 remarks	Fase 2-3

Other information

There is currently no futher information available.