Initiation of Somatostatin analogues for neuroendocrine tumor patients: a cost-effectiveness analysis.

BACKGROUND & AIMS: Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are heterogeneous neoplasms. Although some have a relatively benign and indolent natural history, others can be aggressive and ultimately fatal. Somatostatin analogues (SSAs) improve both quality of life and survival for these patients once they develop metastatic disease. However, these drugs are costly and their cost-effectiveness is not known. METHODS: A decision-analytic model was developed and analyzed to compare two treatment strategies for patients with Stage IV GEP-NETs. The first strategy had all patients start SSA immediately while the second strategy waited, reserving SSA initiation until the patient showed signs of progression. Sensitivity analysis was performed to explore model parameter uncertainty. RESULTS: Our model of patients age 60 with metastatic GEP-NETs suggests empiric initiation of SSA led to an increase 0.62 unadjusted life-years and incremental increase in quality-adjusted life years (QALYs) of 0.44. The incremental costs were $388,966 per QALY and not cost-effective at a willingness-to-pay threshold of $100,000. Death was attributed to GEP-NETs for 94.1% of patients in the SSA arm vs. 94.9% of patients in the DELAY SSA arm. Sensitivity analysis found that the model was most sensitive to costs of SSAs. Using probabilistic sensitivity analysis, the SSA strategy was only cost-effective 1.4% of the time at a WTP threshold of $100,000 per QALY. CONCLUSIONS: Our modeling study finds it is not cost-effective to initiate SSAs at time of presentation for patients with metastatic GEP-NETs. Further clinical studies are needed to identify the optimal timing to initiate these drugs.

Lutetium oxodotreotide (177Lu-Dotatate) for the treatment of unresectable or metastatic progressive gastroenteropancreatic neuroendocrine tumors: a cost-effectiveness analysis for Scotland.

BACKGROUND: Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) represent a heterogenous group of tumors. Findings from the phase III NETTER-1 trial showed that treatment of unresectable/metastatic progressive gastrointestinal (GI) NETs with 177Lu-Dotatate resulted in a significant improvement in progression-free survival (PFS) and overall survival (OS) compared with best supportive care (BSC) with high dose octreotide long-acting repeatable (LAR) 60 mg. A health economic analysis was performed using input data from clinical studies and data derived from an indirect comparison to determine the cost-effectiveness of 177Lu-Dotatate in the treatment of GI-NETs and pancreatic NETs (P-NETs) in Scotland. METHODS: Cost-effectiveness analysis was performed from the payer perspective using a three-state partitioned survival model. In the base case 177Lu-Dotatate was compared with BSC in gastrointestinal (GI)-NETs using clinical data from the NETTER-1 trial. A secondary analysis comparing 177Lu-Dotatate with BSC, everolimus or sunitinib in patients with P-NETs was also performed using hazard ratios inferred from indirect comparisons. The base case analysis was performed over a 20-year time horizon with an annual discount rate of 3.5% for both costs and clinical outcomes. RESULTS: For unresectable/metastatic progressive GI-NETs treatment with 177Lu-Dotatate led to a gain in quality-adjusted life expectancy of 1.33 quality-adjusted life years (QALYs) compared with BSC due to extended PFS and OS. Mean total lifetime costs were GBP 35,701 higher with 177Lu-Dotatate, leading to an incremental cost-effectiveness ratio (ICER) of GBP 26,830 per QALY gained. In analyses in patients with P-NETs 177Lu-Dotatate was associated with ICERs below GBP 30,000 per QALY gained in comparisons with BSC, sunitinib and everolimus. CONCLUSIONS: Cost-effectiveness analyses demonstrated that, in Scotland, from the payer perspective, 177Lu-Dotatate at the set acquisition cost is a cost-effective treatment option for patients with unresectable or metastatic progressive GI-NETs or P-NETs.

Insurance status is related to overall survival in patients with small intestine adenocarcinoma: A population-based study.

BACKGROUND: Our goal was to investigate the effect of insurance status on the overall survival (OS) in cases of small intestine adenocarcinoma. METHODS: The SEER (Surveillance, Epidemiology, and End Results) database was used to identify 3822 patients who were diagnosed with small intestine adenocarcinoma between 2007 and 2015. The proportional hazard ASSUMPTION was evaluated by proportional-hazards assumption test and Schoenfeld residual test. The Kaplan-Meier method and Cox proportional-hazards regression analysis were performed to evaluate the association between insurance status and OS. RESULTS: We found that the insurance status at the time of diagnosis affected OS at the population level, both in those aged <65 and ≥65 years. Cox multivariate analysis of patients aged <65 years revealed that the hazard of death was greater in the Medicaid group (hazard ratio [HR] = 1.641, 95% confidence interval [CI] = 1.299-2.073, P < 0.001] and uninsured group (HR = 1.472, 95% CI = 1.095-1.979, P = 0.010) compared with the insured group, while the OS did not differ significantly between the Medicaid and uninsured groups. Similarly, the hazard of death among patients aged ≥65 years was higher in the Medicaid than the insured group (HR = 1.403, 95% CI = 1.136-1.733, P = 0.002). CONCLUSION: Our results suggest that patients with small intestine adenocarcinoma with insurance coverage have a significantly better OS than patients who have Medicaid or are uninsured, while the OS does not differ between Medicaid and uninsured patients.

Cost-of-illness of metastatic gastroenteropancreatic neuroendocrine tumours in Sweden-A population-based register-linkage study.

The objective was to estimate the cost-of-illness of grades 1 and 2 metastatic gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in Sweden in 2013 in a population-based study including all patients diagnosed between 2005 and 2013. Data were obtained from national registers, and patients who utilised healthcare resources due to metastatic GEP-NETs in 2013 were included. The study included 478 patients (mean age 64 [SD=11] years, 51% men). The majority (80%) had small intestinal NET, 10% had pancreatic NET, and 41% had carcinoid syndrome. The total cost-of-illness was €12,189,000 in 2013, of which direct costs constituted 77% and costs from production loss constituted 22%. The largest contributor to the direct medical costs was prescription drugs (54%; primarily somatostatin analogues [91% of the total drug cost]). Production loss due to sickness absence constituted 52% of the total costs of production loss. The total annual cost per patient was €25,500. By patient group, the cost was €24,800 (95% CI €21,600-€28,100) for patients with small intestinal NET, €37,300 (95% CI €23,300-€51,300) for those with pancreatic NET and €18,600 (95% CI €12,600-€24,500) for patients with other GEP-NETs. To conclude, the total annual cost of grades 1 and 2 metastatic GEP-NETs in Sweden was €25,500 per patient and year.

Hegemony and cost-effectiveness of endoscopic ultrasound (EUS) in the field of gastroenteropancreatic-neuroendocrine tumors (GEP-NETs).

Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are a group of neoplasms arising from the diffuse neuroendocrine system of the gastrointestinal (GI) tract. They often represent a diagnostic challenge because of their little dimensions, the deep localization into the retroperitoneum or in extramucosal sites, the possibility to be multilocated and the heterogeneous patterns of presentation. Endoscopic ultrasound (EUS) is a cost-effective technique that enables to look very definitely at a suspicious mass and at the surrounding area both within the GI wall and in the pancreas, allowing to precisely assess T and N stage. Under EUS-guidance it is possible to obtain tissue samples in order to reach a definitive diagnosis and to establish the tumor grade. In the therapeutic field, EUS is crucial to assess the safety and the feasibility of resective endoscopic techniques for the GI-wall NETs and it can guide local ablative techniques for pancreatic NETs. After treatment, EUS can be successfully useful to assess complete endoscopic resection and to follow-up resected or ablated patients. It is so evident that EUS has a role in the whole route of NETs management, from diagnosis, evaluation, grading and staging assessment, to therapy and consequent follow-up.

The influence of a Federal comprehensive health care system on the detection and outcome of primary small bowel malignancies.

Twenty-one cases of primary small bowel malignant tumors treated at our institution from 1983 to 1993 were reviewed. The mean age at diagnosis was 51.6 +/- 16.8 years. Twelve patients (57%) reported symptoms of less than 1 month duration. Diagnosis was made at laparotomy in 13 patients (62%), and nine patients (43%) had three or more preoperative studies. Five patients (24%) presented with abdominal emergencies. The 5-year survival rate for the series was 19 per cent. This study was performed at a tertiary care military hospital where patients and physicians are not subjected to the financial constraints of civilian health care. This system should eliminate delays in seeking medical care and expedite diagnosis. Despite almost immediate medical attention for a majority of the patients, overall survival is not significantly different from that in previous reviews. This study emphasizes that the presentation of small bowel malignancies is indolent and difficult to diagnose. Prognosis remains poor despite the patient cost-free system and almost immediate medical attention. This study suggests that a high index of suspicion and a thorough evaluation, including laparotomy, are required to improve outcome.

Economic aspects of endoscopic screening for intestinal precancerous conditions.

The relationship of costs to effectiveness in endoscopic screening depends on the incidence rate of cancers arising from precancerous lesions, the sensitivity and specificity rates of endoscopic screening, and the effectiveness of timely diagnosis and surgery in preventing death. Because all these parameters, which enter a medical decision analysis, have a relatively large margin of error, it is not possible to resolve the issue whether a screening should be performed based on economic analyses alone. A crude "back of the envelope" comparison of different screening programs suggests that colonoscopy in ulcerative colitis would result in the highest yield and gastroscopy of the gastric stump in the lowest yield.

[Viscerosynthesis in laparoscopic interventions--concepts and cost benefit relations]. / Viszerosynthesen bei laparoskopischen Eingriffen--Konzepte und Kosten-Nutzen-Relation.

Viscerosyntheses represent an unrenouncable component of several endoscopic procedures. The extra cost for a laparoscopic viscerosynthesis of approximately 2000 DM in the year 1994 are economically well invested with regard to a reduced postoperative pain, a reduced amount of postoperative analgesics, a faster recovery, and most of all drastically reduced morbidity of the abdominal wall. The unfortunate structure of the healthcare system burdens the hospital with additional financial expenditures, thus shifting the profits to the insurance companies. A change in this profit structure would allow for a faster spread of efficient and promising therapies. Economical studies including patients, physicians, hospital administrations and insurance companies are considered to be imperative in order to promote the development of efficient therapies.