Key Insights

• pERC conditionally recommends the reimbursement of inLu-Dotatate (Lutathera) for the treatment of adult patients with somatostatin receptor-positive (SSR+) midgut neuroendocrine tumours (NETs) whose disease has progressed on a somatostatin analogue and is unresectable if the following conditions are met:

1. cost-effectiveness being improved to an acceptable level
2. feasibility of adoption (budget impact) being addressed
3. capacity for jurisdictions to have the infrastructure in place to implement 177 Lu-Dotatate.

• "pERC made this recommendation because it was satisfied that there is a net clinical benefit of 17Lu-Dotatate in adult patients with progressed somatostatin receptor-positive midgut NETs compared with octreotide LAR based on a statistically significant and clinically meaningful improvement in progression-free survival (PFS)"
• "Furthermore, 17Lu-Dotatate is associated with manageable toxicities and no detriment in quality of life (QoL) compared with octreotide LAR"
• Pricing concerns: "pERC noted that at the submitted price, 177Lu-Dotatate cannot be considered cost-effective compared with octreotide LAR in patients with SSR+ midgut NETs"
• Budget impact concerns: "pERC highlighted that the potential budget impact of 17Lu-Dotatate for patients with progressed somatostatin receptor-positive midgut NETs is grossly underestimated and will be substantial due to the high cost of the therapy and the number of eligible patients for this treatment"
• Not recommended for hindgut and foregut: "pERC does not recommend reimbursement of 177Lu-Dotatate in patients with SSR+ foregut and hindgut NETs whose disease has progressed and is unresectable"