OBJECTIVES: Development of a cost-consequences model to assess and compare specific clinical data and costs of three therapeutic options used in adult patients with gastro-enteropancreatic tumours (GEP-NETs). Adaptation of the model to the Italian hospital context and validation by a panel of clinical experts.

METHODS: Products evaluated were lutetium (177Lu) oxodotreotide, sunitinib and everolimus (both originator and generic). Progression-free survival (PFS) and incidence of grade 3-4 adverse events were analyzed, with clinical data derived from pivotal clinical trials used for regulatory approvals. Acquisition and administration costs of the medicinal products and adverse event costs were calculated for all products by assuming an Italian NHS perspective (i.e. prices at ex-factory level; DRG tariffs). Overall treatment costs were calculated and expressed as treatment costs per PFS month for all products, separately for adult patients with neuroendocrine tumours of pancreatic origin (panNET) and neuroendocrine tumours of gastrointestinal origin (giNET). GEP-NETs clinical experts from three different Italian centers of excellence were involved in the assessment and validation of model, adverse event data and analyses.

RESULTS: In panNET patients, PFS was 30.30 months for lutetium (177Lu) oxodotreotide, 11.40 for sunitinib and 11.04 for everolimus, resulting in total costs/PFS month gained of €2,989.18 for lutetium (177Lu) oxodotreotide, €3,781.20 for generic everolimus, €4,975.33 for originator everolimus and €5,336.66 for sunitinib. In giNET patients, PFS was 28.40 months for lutetium (177Lu) oxodotreotide and 11.01 for everolimus, with total costs/PFS month being €3,189.16 for lutetium (177Lu) oxodotreotide, €3,792.62 for generic everolimus and €4,990.00 for originator everolimus (sunitinib not authorized for this indication).

CONCLUSIONS: From an Italian NHS perspective, in both panNET and giNET adult patients, lutetium (177Lu) oxodotreotide provides more PFS months gained, highly compensating the drug acquisition and administration costs, as revealed by the lower costs/PFS ratio compared with the other therapeutic options.