PMID- 34950969 OWN - NLM STAT- MEDLINE DCOM- 20220420 LR - 20220811 IS - 1619-7089 (Electronic) IS - 1619-7070 (Print) IS - 1619-7070 (Linking) VI - 49 IP - 6 DP - 2022 May TI - [(177)Lu]Lu-DOTA-TATE versus standard of care in adult patients with gastro-enteropancreatic neuroendocrine tumours (GEP-NETs): a cost-consequence analysis from an Italian hospital perspective. PG - 2037-2048 LID - 10.1007/s00259-021-05656-x [doi] AB - PURPOSE: To 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). METHODS: We 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. RESULTS: In patients with PanNETs, total costs per progression-free month were euro2989 for [177Lu]Lu-DOTA-TATE, euro4975 for originator everolimus, euro3472 for generic everolimus, and euro5337 for sunitinib. In patients with GI-NETs, total costs per progression-free month were euro3189 for [177Lu]Lu-DOTA-TATE, euro4990 for originator everolimus, and euro3483 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. CI - (c) 2021. The Author(s). FAU - Spada, Francesca AU - Spada F AD - Division of Gastrointestinal Medical Oncology and Neuroendocrine Tumors, European Institute of Oncology (IEO), IRCCS, Milan, Italy. FAU - Campana, Davide AU - Campana D AD - Division of Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Via P. Albertoni 15, 40138, Bologna, Italy. FAU - Lamberti, Giuseppe AU - Lamberti G AD - Division of Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Via P. Albertoni 15, 40138, Bologna, Italy. FAU - Laudicella, Riccardo AU - Laudicella R AD - Nuclear Medicine Unit, Department of Biomedical and Dental Sciences and of Morpho-Functional Imaging, University of Messina, Viale Consolare Valeria n.1, Messina, Italy. FAU - Dellamano, Renato AU - Dellamano R AD - ValueVector, Milan, Italy. FAU - Dellamano, Luca AU - Dellamano L AD - ValueVector, Milan, Italy. FAU - Leeuwenkamp, Oscar AU - Leeuwenkamp O AD - Advanced Accelerator Applications/A Novartis Company, Geneva, Switzerland. FAU - Baldari, Sergio AU - Baldari S AD - Nuclear Medicine Unit, Department of Biomedical and Dental Sciences and of Morpho-Functional Imaging, University of Messina, Viale Consolare Valeria n.1, Messina, Italy. sergio.baldari@unime.it. LA - eng PT - Journal Article DEP - 20211224 PL - Germany TA - Eur J Nucl Med Mol Imaging JT - European journal of nuclear medicine and molecular imaging JID - 101140988 RN - 0 (Heterocyclic Compounds, 1-Ring) RN - 0 (Organometallic Compounds) RN - 1HTE449DGZ (1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid) RN - 9HW64Q8G6G (Everolimus) RN - RWM8CCW8GP (Octreotide) RN - V99T50803M (Sunitinib) SB - IM MH - Adult MH - Everolimus/adverse effects MH - Heterocyclic Compounds, 1-Ring MH - Hospitals MH - Humans MH - *Neuroendocrine Tumors/drug therapy/radiotherapy MH - Octreotide/adverse effects MH - *Organometallic Compounds/adverse effects MH - Standard of Care MH - State Medicine MH - Sunitinib/therapeutic use PMC - PMC9016001 OTO - NOTNLM OT - Cost-consequence analysis; Everolimus OT - Gastro-enteropancreatic neuroendocrine tumour OT - Healthcare costs OT - Italy OT - Lutetium OT - Peptide receptor radionuclide therapy OT - Progression-free survival OT - Somatostatin receptor agonists OT - Sunitinib COIS- F.S. has received research support from Ipsen, Novartis, Pfizer, Advanced Accelerator Applications, and Merck for advisory boards and speaking engagements and is a principal investigator in clinical trials funded by GETNE, Incyte, and MSD. Additionally, F.S. has non-remunerated positions on the executive board of ITANET (Italian Neuroendocrine Tumor Society) and as a coordinator of the NEN AIOM guidelines. L.D. and R.D. have been providing consultancy services to Advanced Accelerator Applications/A Novartis Company, Colleretto Giacosa, Italy. O.L. is an employee of Advanced Accelerator Applications/A Novartis Company, Geneva, Switzerland, which funded the study. D.C., G.L., R.L., and S.B. declare no conflicts of interest that are relevant to the present work. EDAT- 2021/12/25 06:00 MHDA- 2022/04/21 06:00 PMCR- 2021/12/24 CRDT- 2021/12/24 05:59 PHST- 2021/07/23 00:00 [received] PHST- 2021/12/12 00:00 [accepted] PHST- 2021/12/25 06:00 [pubmed] PHST- 2022/04/21 06:00 [medline] PHST- 2021/12/24 05:59 [entrez] PHST- 2021/12/24 00:00 [pmc-release] AID - 10.1007/s00259-021-05656-x [pii] AID - 5656 [pii] AID - 10.1007/s00259-021-05656-x [doi] PST - ppublish SO - Eur J Nucl Med Mol Imaging. 2022 May;49(6):2037-2048. doi: 10.1007/s00259-021-05656-x. Epub 2021 Dec 24.