Extended indication

177Lu-PSMA-617 is indicated for the treatment of adult patients with prostate-specific membrane anti

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

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 comments
RadioLigandTherapy (RLT)

Registration

Registration route

Centralised (EMA)

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

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 comments
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 comments
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

References
Horizonscan Geneesmiddelen Lutathera.
Additional comments
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

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

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

There is currently no futher information available.