Pertuzumab / trastuzumab

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.
Therapeutic value	Possible equal value
Total cost	98,000,000.00
Registration phase	Registered

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	Registered
Additional remarks	Positieve CHMP-opinie in november 2020. Dit middel is voor deze indicatie in de sluis geplaatst.

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.
Duration of treatment	Average 12 month / months
Frequency of administration	1 times every 3 weeks
Dosage per administration	600 mg / 600 mg
References	NCT03493854
Additional remarks	Maintenance dose: 600mg pertuzumab; 600mg trastuzumab. A loading dose is applicable at the start of the treatment (1.200mg 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 remarks	Er waren 2.060 HER2+ patiënten met mammacarcinoom in 2018. Deze nieuwe toedieningsvorm zal een zelfde indicatie krijgen als pertuzumab. Aantal patiënten per jaar die pertuzumab hebben gebruikt in 2019 betrof 1.960.

Patient volume

< 1,960

Market share is generally not included unless otherwise stated.

References

GIP databank

Additional remarks

Er waren 2.060 HER2+ patiënten met mammacarcinoom in 2018. Deze nieuwe toedieningsvorm zal een zelfde indicatie krijgen als pertuzumab. Aantal patiënten per jaar die pertuzumab hebben gebruikt in 2019 betrof 1.960.

Expected cost per patient per year

Cost	30,000.00 - 70,000.00
References	EPAR Phesgo; NCT03493854 (FeDeriCa), medicijnkosten.nl, Farmacotherapeutisch Kompas; fabrikant
Additional remarks	De gemiddelde behandelduur in de FeDeriCa studie bedraagt ongeveer een jaar (gemiddeld 51,8 weken). De kosten voor de huidige behandeling van een jaar met pertuzumab bedragen ongeveer €47.000 en voor trastuzumab €23.000. In totaal kost de huidige behandeling met pertuzumab en trastuzumab gedurende een jaar dus ongeveer €70.000. In 2019 betroffen de kosten per patiënt per jaar voor pertuzumab €18.574 en trastuzumab €10.587 (bron GIP databank). Dit zijn gemiddelden over alle indicaties en zouden in totaal ongeveer €30.000 bedragen. De verwachting is dat de daadwerkelijke kosten zich in deze range bevinden. De fabrikant geeft aan dat Phesgo voor beide indicaties kostenneutraal ten opzichte van de combinatie pertuzumab en trastuzumab geïntroduceerd zal worden. De precieze kosten per patiënt per jaar hangen af van in welke indicatie Phesgo wordt ingezet. 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	98,000,000.00 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.

Total cost

98,000,000.00

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 remarks	Op dit moment zijn er geen andere studies.

Other information

There is currently no futher information available.