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Nivolumab

Opdivo

Extended indication Extension of Indication to include first-line treatment of adult patients with metastatic Non-Small
Therapeutic value No judgement
Total cost 56,071,000.00
Registration phase Registration application pending

Product

Active substance Nivolumab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Lung cancer
Extended indication Extension of Indication to include first-line treatment of adult patients with metastatic Non-Small Cell Lung Carcinoma (NSCLC) in combination with ipilimumab.
Proprietary name Opdivo
Manufacturer BMS
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks PD-1 remmer. Financieel arrangement van toepassing op alle indicaties.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date 2018
Expected Registration November 2019
Orphan drug No
Registration phase Registration application pending
Additional remarks Checkmate 227; met PFS primary endpoint in high tumor burden.

Therapeutic value

Current treatment options Platinum doublet chemo, pembrolizumab (PDL1 ≥ 50%), pembrolizumab + chemo. Binnenkort: atezolizumab + bevacizumab + chemo (PDL1 all comers), atezolizumab + chemo
Therapeutic value No judgement
Substantiation Studieresultaten: wel een verschil in PFS maar geen verschil in OS, biomarker (tumour mutational load) daarnaast nog niet mogelijk in Nederland.
Duration of treatment Not found
Frequency of administration 1 times every 2 weeks
Dosage per administration 3 mg/kg
References https://news.bms.com/press-release/bms/pivotal-phase-3-checkmate-227-study-demonstrates-superior-progression-free-surviva; Hellmann et al. N Engl J Med 2018; 378:2093-2104; NCT02477826
Additional remarks Opdivo 3 mg/kg every two weeks and low-dose Yervoy (1 mg/kg) every six weeks. Median duration of treatment is 4,2 maanden

Expected patient volume per year

Patient volume

< 1,193

Market share is generally not included unless otherwise stated.
References NKR 2016, GIP-databank; Hellmann et al. N Engl J Med 2018; 378:2093-2104
Additional remarks Jaarlijks presenteren er ongeveer 4.500 patiënten per jaar met NSCLC stadium IV. Hiervan zal 60% een eerstelijnsbehandeling krijgen (2.700). Hoog tumor mutational burden (TMB ≥ 10 mutaties per megabase) komt bij 44.2% van patiënten voor. Hierdoor komen 1.193 patiënten in aanmerking voor behandeling met nivolumab in combinatie met ipilimumab. De biomarker die nodig is is echter nog niet overal beschikbaar in Nederland.

Expected cost per patient per year

Cost 47,000.00
References G-standaard, januari 2019; Hellmann et al. N Engl J Med 2018
Additional remarks Ipilimumab 50 mg kost €4.250, ipilimumab 2.000 mg kost €17.000,00. Bij een behandelduur van 4,2 maanden worden 9 toedieningen Opdivo gebruikt: €21.871,00 (9 x €2.430,00) en 3 toedieningen Yervoy: €25.500,00 (3 x €8.500,00). In totaal bedraagt dit €47.371,00. Voor alle indicatie van nivolumab geldt een financieel arrangement die is voortgekomen uit de onderhandelingen in de sluis (lopend tot eind 2019).

Potential total cost per year

Total cost

56,071,000.00

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.