Tiragolumab

Extended indication	In combination with atezolizumab for first line treatment of locally advanced, unresectable stage III Non-small cell lung cancer in adults and elderly who have no progression during or following concurrent platinum-based chemoradiotherapy.
Therapeutic value	No estimate possible yet
Total cost	65,000,000.00
Registration phase	Clinical trials

Product

Active substance	Tiragolumab
Domain	Oncology
Reason of inclusion	New medicine (specialité)
Main indication	Lung cancer
Extended indication	In combination with atezolizumab for first line treatment of locally advanced, unresectable stage III Non-small cell lung cancer in adults and elderly who have no progression during or following concurrent platinum-based chemoradiotherapy.
Manufacturer	Roche
Mechanism of action	PD-1 / PD-L1 inhibitor
Route of administration	Intravenous
Budgetting framework	Intermural (MSZ)

Registration

Registration route	Centralised (EMA)
ATMP	No
Submission date	July 2025
Expected Registration	November 2026
Orphan drug	Yes
Registration phase	Clinical trials
Additional remarks	Indieningsdatum en verwachte registratie op basis van informatie fabrikant.

Therapeutic value

Therapeutic value	No estimate possible yet
Substantiation	Nog geen resultaten bekend.
Frequency of administration	1 times every 4 weeks
Dosage per administration	840 mg
References	NCT04513925 (SKYSCRAPER-03)

Expected patient volume per year

Patient volume	< 1,300 Market share is generally not included unless otherwise stated.
References	NKR2021 (1); Expertopinie (2); Declaratiedata. 2023 (3).
Additional remarks	In 2021 waren er 10.096 diagnoses NSCLC in Nederland. Dit betrof 1.727 patiënten in stadium I, 822 patiënten in stadium II, 2.231 patiënten in stadium III, 5.247 patiënten in stadium IV (1). Deze combinatie zal waarschijnlijk ingezet worden als subsitutie van durvalumab na chemo/radiotherapie (<1.300 gebruikers) (2,3).

Patient volume

< 1,300

Market share is generally not included unless otherwise stated.

References

NKR2021 (1); Expertopinie (2); Declaratiedata. 2023 (3).

Additional remarks

In 2021 waren er 10.096 diagnoses NSCLC in Nederland. Dit betrof 1.727 patiënten in stadium I, 822 patiënten in stadium II, 2.231 patiënten in stadium III, 5.247 patiënten in stadium IV (1). Deze combinatie zal waarschijnlijk ingezet worden als subsitutie van durvalumab na chemo/radiotherapie (<1.300 gebruikers) (2,3).

Expected cost per patient per year

Cost	40,000.00 - 60,000.00
Additional remarks	Er is nog niks bekend over de prijs. Het is waarschijnlijk dat de prijs in lijn is met andere PD-1/PD-L1 remmers.

Potential total cost per year

Total cost	65,000,000.00 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

65,000,000.00

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.