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Relugolix

Extended indication Advanced Prostate Cancer.
Therapeutic value No estimate possible yet
Total cost 375,000.00
Registration phase Registration application pending

Product

Active substance Relugolix
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Prostate cancer
Extended indication Advanced Prostate Cancer.
Manufacturer Myovant
Mechanism of action Receptor antagonist
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)
Additional remarks GNRH antagonist.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date March 2021
Expected Registration April 2022
Orphan drug No
Registration phase Registration application pending
Additional remarks SPS UK: "Mar 21 · Considered a potential blockbuster drug for 2021 by analysts".

Therapeutic value

Current treatment options Gosereline en leuproreline.
Therapeutic value No estimate possible yet
Frequency of administration 1 times a day
Dosage per administration 120 mg
References NCT03085095.

Expected patient volume per year

Patient volume

< 500

Market share is generally not included unless otherwise stated.
References Bron: NKR en ARCHES
Additional remarks Totaal aantal nieuwe prostaatkankerpantiënten per jaar is meer dan 12.000. Patiënten geregistreerd in de NKR 2016 met cM0cNX, cM0cN0, cMcN1, cM1, pM1 betreft 8226 in totaal. Maximaal 20% gaat het om gemetastaseerde hormoon gevoelige prostaatkanker (n = 1645). Uitgaande van de ARCHES studie gaat het mogelijk slechts in 5% van de prostaatkanker patiënten om gemetastaseerde hormoon gevoelige prostaatkanker (410). Aantal is afhankelijk van hoe vroeg patiënten zich melden. Uiteindelijke inschatting: max 500 patiënten die reëel gezien in aanmerking zullen komen.

Expected cost per patient per year

Cost 500.00 - 1,000.00
References medicijnkosten.nl; GIPdatabank
Additional remarks Relugolix zal wat kosten betreft vergeleken moeten worden met de depot GnRH agonisten. Huidige behandelopties kosten tussen de €500-€1.000 per behandeling. Ter vergelijking kost Zoladex kost voor 6 spuiten €686,37. De gemiddelde vergoeding voor Zoladex in 2016 is €997,30. Kosten kunnen verder oplopen indien langer gebruik is toegestaan.

Potential total cost per year

Total cost

375,000.00

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 Uterine fibroids, endometriosis-related pain.
References Clinicaltrials.gov.

Other information

There is currently no futher information available.