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Neuroendocrine tumours: NICE appraisal of lutetium

A NICE appraisal committee has published a final appraisal determination (FAD) on lutetium (177Lu) oxodotreotide for treating unresectable or metastatic neuroendocrine tumours (NETs) in patients with progressive disease.

The committee has recommended lutetium (177Lu) oxodotreotide as an option for treating unresectable or metastatic, progressive, well-differentiated (grade 1 or grade 2), somatostatin receptor-positive gastroenteropancreatic NETs in adults.

The committee acknowledged that for treating pancreatic NETs, the drug met NICE’s end-of-life criteria, and compared with everolimus, sunitinib, and best supportive care, the cost-effectiveness estimates were within the required range.

Although it does not meet the end-of-life criteria because of life expectancy for gastrointestinal NETs, the committee recommended lutetium for this indication based on cost-effectiveness and the dearth of treatments for these tumours.

The phase 1 and phase 2 single-arm ERASMUS trial reported median progression-free survival (PFS) of 30.3 (95% CI 24.3-36.3) months and overall survival (OS) of 66.4 (57.2 to 80.9) months.

The phase 3, open-label, randomized, controlled NETTER-1 trial compared lutetium plus long-acting release octreotide 30 mg with long-acting release (LAR) octreotide 60 mg. Median PFS was 28.4 months vs 8.5 months (HR 0.214; 95% CI 0.139-0.331; P<.0001). At the cut-off date 30 June 2016, median OS was 27.4 months with octreotide LAR and had not been reached in the lutetium arm (HR 0.54; 95% CI 0.33-0.86; P=.0094).

The decision is dependent on a commercial arrangement between NICE and the pharmaceutical company on the cost of treatment.


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