Extended indication Breast cancer, advanced, HR+ en HER2-, 1L or 2L.
Therapeutic value No judgement
Total cost 11,836,250.00
Registration phase Registration application pending

Product

Active substance Abemaciclib
Domain Oncology and Hematology
Main indication Breast cancer
Extended indication Breast cancer, advanced, HR+ en HER2-, 1L or 2L.
Proprietary name Verzenio
Manufacturer Eli Lilly
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional remarks CDK4/6 remmer

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity New medicine
Submission date July 2017
Expected Registration November 2018
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value No judgement

Expected patient volume per year

Patient volume

50 - 507

Market share is generally not included unless otherwise stated.

References NKR
Additional remarks NKR 2015: Mammacarcinoom HR+, HER-, stadium 4: 507 diagnoses. Van max. naar realistisch patiëntenaantal: waarschijnlijk zeer klein aantal patiënten ivm standaard inductie postmenopausale status (met LHRH of via ovariële ablatie).

Expected cost per patient per year

Cost 35,000.00 - 50,000.00
References Medicijnkosten.nl; FiercePharma
Additional remarks Prijsrange geschat nav prijs en behandelschema Ibrance en Kisqaly bij borstkanker. Kisqali (ribociclib) kost €60,70 per tablet van 200 mg; Ibrance (palbociclib) is €163,54 voor een capsule van 100 mg. Prijs range pppj anders dan de kosten per behandeling gezien deze langer dan een jaar duurt. prijs per behandeling geschat op €63.000-76.000.

Potential total cost per year

Total cost

11,836,250.00

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 neoMONARCH: postmenopausal women with previously untreated early stage HR+, HER2- breast cancer; MonarchE: abemaciclib in the adjuvant setting in patients with high-risk, early breast cancer.
References NCT02441946; NCT03155997

Other information

There is currently no futher information available.