Extended indication Early breast cancer (EBC) Phesgo is indicated for use in combination with chemotherapy in: the neo
Therapeutic value Possible equal value
Total cost 58,800,000.00
Registration phase Positive CHMP opinion

Product

Active substance Pertuzumab / trastuzumab
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Breast cancer
Extended indication Early breast cancer (EBC) Phesgo is indicated for use in combination with chemotherapy in: the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence. Metastatic breast cancer (MBC) Phesgo is indicated for use in combination with docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.
Proprietary name Phesgo
Manufacturer Roche
Mechanism of action Combination therapy
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity New therapeutical formulation
Submission date January 2020
Expected Registration January 2021
Orphan drug No
Registration phase Positive CHMP opinion
Additional comments Positieve CHMP-opinie in november 2020.

Therapeutic value

Current treatment options Pertuzumab (IV), trastuzumab (IV/SC), chemotherapie.
Therapeutic value Possible equal value
Substantiation Er zal substitutie plaatsvinden ten opzichte van de beschikbare varianten van pertuzumab en trastuzumab.
Frequency of administration 1 times every 3 weeks
Dosage per administration 600 mg / 600 mg
References NCT03493854
Additional comments Maintenance dose: 600mg pertuzumab; 600mg trastuzumab. A loading dose is applicable at the start of the treatment (1200mg pertuzumab; 600mg trastuzumab).

Expected patient volume per year

Patient volume

< 1,960

Market share is generally not included unless otherwise stated.

References GIP databank
Additional comments Deze nieuwe toedieningsvorm zal een zelfde indicatie krijgen als pertuzumab. Aantal patiënten per jaar die pertuzumab hebben gebruikt in 2019 betrof 1.960. Maximale aantal patiënten dat in aanmerking komt voor deze nieuwe toedieningsvorm betreft dan ook 1.960 patiënten.

Expected cost per patient per year

Cost < 30,000.00
References GIP databank
Additional comments In 2019 betroffen de kosten per patiënt per jaar voor pertuzmab €18.574 en trastuzumab €10.587. Deze nieuwe toedieningsvorm zal naar verwachting maximaal €30.000 gaan kosten. Er worden in de nabije toekomst (2025) ook biosimilar varianten van pertuzumab verwacht. Het is de vraag hoe de markt hierop zal reageren.

Potential total cost per year

Total cost

58,800,000.00

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.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension No
References Adisinsght
Additional comments Op dit moment zijn er geen andere studies.

Other information

There is currently no futher information available.