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Radium-223

Xofigo

Extended indication

For the treatment of metastatic castration resistant prostate cancer (mCRPC) in combination with enz

Therapeutic value

No estimate possible yet
Total cost

4,635,750.00
Registration phase

Clinical trials

Product

Active substance

Radium-223
Domain

Oncology
Reason of inclusion

Indication extension
Main indication

Prostate cancer
Extended indication

For the treatment of metastatic castration resistant prostate cancer (mCRPC) in combination with enzalutamide.
Proprietary name

Xofigo
Manufacturer

Bayer
Portfolio holder

Bayer
Mechanism of action

Other
Route of administration

Intravenous
Therapeutical formulation

Injection
Budgetting framework

Intermural (MSZ)

Registration

Registration route

Centralised (EMA)
ATMP

No
Submission date

January 2025
Expected Registration

October 2025
Registration phase

Clinical trials

Therapeutic value

Therapeutic value

No estimate possible yet
Substantiation

De resultaten van de PEACE III(1) studie dienen nog afgewacht te worden. Daarnaast loopt er ook een fase III studie van Radium in combinatie met docetaxel. De combinatie met abiraterone was negatief en voortijdig gestaakt in verband met toename fracturen (2) waarschijnlijk door suboptimaal gebruik van bisfosfonaten. De real-world observationele studie met Ra223/ENZA liet positieve resultaten zien op het gebied van pijn en QoL. (3).
Duration of treatment

Average 6 month / months
Frequency of administration

1 times every 4 weeks
Dosage per administration

55kBq/kg
References 
(1)NCT02194842; (2)Lancet Oncol. 2019 Mar;20(3):408-419 (3) REASSURE ESMO 2021 593P
Additional remarks 
Ra223 will be administered 55kBq/kg standard dose monthly for 6 months and given in combination with enzalutamide at a dose of 160 mg daily.

Expected patient volume per year

Patient volume

< 150

Market share is generally not included unless otherwise stated.
References 
NKR2021(1)
Wallace KL, Landsteiner A, Bunner SH, Engel-Nitz NM, Luckenbaugh AN. Increasing prevalence of metastatic castration-resistant prostate cancer in a managed care population in the United States. Cancer Causes Control. 2021 Dec;32(12):1365-1374. doi: 10.1007/s10552-021-01484-4. Epub 2021 Aug 12. PMID: 34386852 (2)
Additional remarks 
In 2021 waren er 13.548 diagnoses prostaatcarcinoom (1).
Volgens Wallace et al (2021) heeft 1,1% van de patiënten met prostaatkanker mCRPC.  Dit betekent dat er ongeveer 150 patiënten in aanmerkingen zullen komen.

Expected cost per patient per year

Cost

30,905.00
References 
Costs of radium-223 and the pharmacy preparation 177Lu-PSMA-I&T for metastatic castration-resistant prostate cancer in Dutch hospitals. S. W. Quist et al. Maart 2023.
Additional remarks 
Op basis van de studie die hier boven in de bronnen genoemd wordt zijn de verwachte kosten voor een behandeling ongeveer 30.000 per patiënt per jaar.

Potential total cost per year

Total cost

4,635,750.00

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.