Abstract

PurposeTo assess and compare clinical outcomes and costs, to the Italian healthcare system, of three therapeutic options approved in the management of adult patients with gastro-enteropancreatic neuroendocrine tumours (GEP-NETs).MethodsWe compared the efficacy, safety, and costs of [177Lu]Lu-DOTA-TATE, everolimus (both originator and generic products), and sunitinib in patients with advanced GEP-NETs (NET G1 and G2) that had progressed following treatment with somatostatin analogs (SSAs). A cost-consequence model was developed and validated by a panel of clinical experts from three NET reference centres in Italy. The clinical outcomes included in the model were median progression-free survival and the incidence of grade 3 or 4 adverse events (AEs), as reported in pivotal clinical trials. The costs for acquisition and administration of each treatment, and of managing AEs, were calculated from the perspective of the Italian national health service. Treatment costs per progression-free month were calculated separately for patients with NETs of pancreatic (PanNETs; all three treatments) and gastrointestinal (GI-NETs; [177Lu]Lu-DOTA-TATE and everolimus only) origin.ResultsIn patients with PanNETs, total costs per progression-free month were €2989 for [177Lu]Lu-DOTA-TATE, €4975 for originator everolimus, €3472 for generic everolimus, and €5337 for sunitinib. In patients with GI-NETs, total costs per progression-free month were €3189 for [177Lu]Lu-DOTA-TATE, €4990 for originator everolimus, and €3483 for generic everolimus.Conclusions[177Lu]Lu-DOTA-TATE was associated with lower costs per progression-free month versus relevant treatment options in patients with GI-NETs or PanNETs (NET G1–G2; progressed following SSA treatment), although acquisition and administration costs are higher. These findings provide further economic arguments in the overall context of treatment decision-making.

Highlights

  • Neuroendocrine neoplasms (NENs), better known as neuroendocrine tumours (NETs), arise from the diffuse neuroendocrine system, which is distributed throughout the human body

  • For [177Lu]Lu-DOTA-TATE, the median progression-free survival (PFS) used in the model was 28.4 months in patients with GI-NETs and 30.3 months in patients with pancreatic NETs (PanNETs) [14]

  • Safety data were not available for patients with PanNETs who received [177Lu]Lu-DOTA-TATE in the Erasmus phase I/ II study, so the available data for GI-NETs from NETTER-1 were extrapolated to both indications

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Summary

Introduction

Neuroendocrine neoplasms (NENs), better known as neuroendocrine tumours (NETs), arise from the diffuse neuroendocrine system, which is distributed throughout the human body. NETs can originate in any part of the body, but most commonly arise in the gastro-enteropancreatic (GEP) tract. GEP-NETs accounted for 3.56 cases per 100 000 in the Surveillance, Epidemiology, and End Results (SEER) 18 registry [1]. Even though they are still considered rare, the incidence of NETs has risen markedly in recent decades. In the UK, the age-standardised incidence rate of GEP-NETs in 2013–2015 has been reported as 4.6 per 100 000 [2]. In Italy, there were an estimated 2700 new cases of NETs in 2015, of which 1242 (46%) were GEPNETs; the crude rate of GEP-NETs for 2000–2010 was approximately 1.9 per 100 000 [3]

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