What Is the CADTH Reimbursement Recommendation for Lutathera?: CADTH recommends that Lutathera should be reimbursed by public drug plans for the treatment of unresectable or metastatic, well-differentiated, somatostatin receptor (SSR)–positive pancreatic neuroendocrine tumours (pNETs) in adults whose disease has progressed after treatment with a somatostatin analogue (SSA), unless there is a contraindication or intolerance, if certain conditions are met.
Which Patients Are Eligible for Coverage?: Lutathera should only be covered to treat adult patients with unresectable or metastatic, well-differentiated, SSR-positive pNETs whose disease has progressed after treatment with a SSA, unless they could not receive an SSA.
What Are the Conditions for Reimbursement?: Lutathera should only be reimbursed if it is prescribed by clinicians who are experts in radiopharmaceuticals, patients are treated in specialized centres with the infrastructure to safely use radiopharmaceuticals, and the cost of Lutathera is reduced.
Why Did CADTH Make This Recommendation?:
No randomized clinical trials evaluating the efficacy or safety of Lutathera in adult patients with pNETs have been conducted.
Evidence from a registry study and 3 observational studies showed that Lutathera controlled disease progression and prolonged survival for patients with pNETs and the benefits were considered clinically meaningful. The indirect evidence also suggested that Lutathera may control disease progression better than other drugs used to treat pNETs.
Treatment with Lutathera may meet some important needs identified by patients, such as controlling disease progression.
Based on CADTH’s assessment of the health economic evidence, Lutathera does not represent good value to the health care system at the public list price. A price reduction is therefore required.
Based on public list prices, Lutathera is estimated to cost the public drug plans approximately $7.9 million over the next 3 years.
What Are pNETs?: pNETs are an uncommon type of cancer that start in hormone-producing cells of the pancreas. Less than 1 in 100,000 people develop pNETs each year.
Unmet Needs in pNETs: pNETs are incurable, and patients with pNETs have a poor prognosis. There is a need for treatments that prolong patients’ lives and improve their quality of life.
How Much Does Lutathera Cost?: Treatment with Lutathera is expected to cost approximately $23,333 per patient per month.
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