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Pertuzumab

Medicine

Extended indication Indicated for use in combination with trastuzumab and chemotherapy in the neoadjuvant treatment of adult patients with HER2-positive, locally advanced
Therapeutic value No judgement
Total cost € 48,117,000.00
Registration phase Registered and reimbursed

Product

Active substance Pertuzumab
Domain Oncology and Hematology
Main indication Breast cancer
Extended indication Indicated for use in combination with trastuzumab and chemotherapy in the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence and the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence.
Proprietary name Perjeta
Manufacturer Roche
Mechanism of action Unknown
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Gehumaniseerd IgG1 monoclonaal antilichaam gericht tegen HER2

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity Indication extension
ATMP Unknown
Submission date November 2017
Expected Registration June 2018
Orphan drug No
Registration phase Registered and reimbursed
Additional remarks Positieve opinie CHMP april 2018.

Therapeutic value

Current treatment options Trastuzumab zonder pertuzumab
Therapeutic value No judgement

This assessment does not indicate any potential inclusion in the package.
Substantiation Meerwaarde ten opzichte van standaard behandeling nog onduidelijk.
Duration of treatment Average 12 month / months
Frequency of administration 1 times every 3 weeks
Dosage per administration 420 mg
References Von Minckwitz et al. N Engl J Med 2017; 377:122-131.
Additional remarks Eerste toediening 840 mg

Expected patient volume per year

Patient volume < 1,119

Market share is generally not included unless otherwise stated.
References NKR
Additional remarks Aantal diagnoses stadium 2/3 HER+ in 2016

Expected cost per patient per year

Cost € 43,000.00

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.
References Medicijnkosten.nl
Additional remarks Maximum kosten zijn gebaseerd op een behandelduur van 1 jaar en prijs van €2.360 per flacon pertuzumab.

Potential total cost per year

Total cost € 48,117,000.00

Off label use

Off label use No

Indication extension

Indication extensions No

Other information