Version 2

177Lu-PSMA-617

Medicine

Extended indication 177Lu-PSMA-617 is indicated for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistan
Therapeutic value Possible equal value
Total cost € 139,825,000.00
Registration phase Clinical trials

Product

Active substance 177Lu-PSMA-617
Domain Oncology and Hematology
Reason of inclusion Indication extension IND
Main indication Prostate cancer
Extended indication 177Lu-PSMA-617 is indicated for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy (ARDT) and taxane-based chemotherapy.
Manufacturer Advanced Accelerator Applications
Mechanism of action Other
Route of administration Intravenous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional remarks RadioLigandTherapy (RLT)

Registration

Registration route Centralised (EMA)
Type of trajectory Unknown
Particularity Unknown
ATMP Yes
Submission date August 2021
Expected Registration June 2022
Orphan drug Yes
Registration phase Clinical trials

Therapeutic value

Current treatment options mCRPC (Metastatic disease treatment) treatments currently available in third line and beyond: abiraterone acetate, enzalutamide, radium-233 dichloride, cabazitaxel.
Therapeutic value Possible equal value

This assessment does not indicate any potential inclusion in the package.
Substantiation Resultaten van de VISION trial laten dat behandeling met 177Lu-PSMA de OS en PFS significant verbeterenn. 177Lu-PSMA kan momenteel zelf door ziekenhuizen bereid worden.
Frequency of administration 1 times every 6 weeks
Dosage per administration 7.4GBq (200 mCi)
References NCT03392428; NCT03511664.
Additional remarks The first dose will be administered at 8.5GBq, reducing by 0.5GBq with every cycle given (i.e. to 6.0GBq on the sixth cycle, if reached).

Expected patient volume per year

Patient volume < 1,645

Market share is generally not included unless otherwise stated.
References bron: NKR en Zinnige Zorg verbetersignalement: Zinnig gebruik van geneesmiddelen bij patiënten met castratie refractair prostaatcarcinoom.
Additional remarks Totaal aantal nieuwe prostaatkankerpatiënten per jaar is meer dan 12.000. Patiënten geregistreerd in de NKR 2016 met "cM0cNX, cM0cN0, cMcN1, cM1, pM1" betreft 8.226 in totaal. Na starten van anti hormonale therapie zal maximaal 20% van de patiënten binnen vijf jaar CRPC ontwikkelen (1645 patiënten). Hiervan zal een deel in aanmerking komen voor deze behandeling.

Expected cost per patient per year

Cost € 80,000.00 - 90,000.00

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 Horizonscan Geneesmiddelen Lutathera.
Additional remarks De kosten zullen waarschijnlijk vergelijkbaar zijn met Lutetium (177Lu) oxodotreotide €83.000. Fabrikant geeft aan dat de verwachte kosten niet per jaar maar voor een 1-malig behandeltraject dat ook over meerdere kalenderjaren kan plaatsvinden loopt in verband met de 6 weken tussen verschillende behandelcycli. Tevens is de vraag hoe lang de OS is na één behandeltraject.

Potential total cost per year

Total cost € 139,825,000.00

Off label use

Off label use Unknown

Indication extension

Indication extensions Yes
Indication extensions 1) PSMAfore 2) PSMAddition
References 1) https://www.clinicaltrials.gov/ct2/show/NCT04689828 2) https://clinicaltrials.gov/ct2/show/NCT04720157

Other information