On 29 August 2018, the NICE released Technology appraisal guidance [TA539] on lutetium (177Lu) oxodotreotide (Lutathera) for treating unresectable or metastatic neuroendocrine tumours in adults. Lutetium (177Lu) oxodotreotide is recommended, within its marketing authorisation, as an option for treating unresectable or metastatic, progressive, well-differentiated (grade 1 or grade 2), somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (GEP NETs) in adults. It is recommended only if the company provides it according to the commercial arrangement.
Lutetium is administered as an intravenous infusion. A single cycle consists of 4 infusions of 7.4 gigabecquerels (GBq). The recommended interval between infusions is 8 weeks.
Clinical trial evidence shows that lutetium (177Lu) oxodotreotide is effective for treating somatostatin receptor-positive gastrointestinal and pancreatic NETs. Indirect comparison with everolimus, sunitinib and best supportive care suggests lutetium is effective for treating gastrointestinal and pancreatic NETs in patients with progressive disease.
For treating pancreatic NETs, lutetium meets NICE's end-of-life criteria. Compared with everolimus, sunitinib and best supportive care, the cost-effectiveness estimates are within the range NICE normally considers acceptable. So lutetium can be recommended for treating pancreatic NETs.
For treating gastrointestinal NETs, lutetium does not meet the end-of-life criteria because life expectancy for this form of the disease is between 5 and 6 years. But it can be recommended because the most plausible cost-effectiveness estimate is within what NICE normally considers acceptable and treatment options for gastrointestinal NETs are limited.
The price is 71,500.00 GBP for 4 administrations of 7.4 GBq (excluding VAT; company submission).
The company has a commercial arrangement. This makes lutetium available to the NHS with a discount. The size of the discount is commercial in confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount.