What Is the CADTH Reimbursement Recommendation for Imcivree?: CADTH recommends that Imcivree be reimbursed by public drug plans for weight management in adult and pediatric patients 6 years of age and older with obesity due to Bardet-Biedl syndrome (BBS) if certain conditions are met.
Which Patients Are Eligible for Coverage?: Imcivree should only be covered for patients who are aged 6 years and older and have a clinically or genetically confirmed diagnosis of BBS and obesity.
What Are the Conditions for Reimbursement?: Imcivree should only be reimbursed if prescribed by an endocrinologist, pediatric endocrinologist, and/or specialist in weight management or obesity and the cost of Imcivree is reduced. When first prescribed, Imcivree should only be reimbursed for 26 weeks. Reimbursement may be renewed on a yearly basis for patients who experience a clinically meaningful decrease in body weight or body mass index (BMI).
Why Did CADTH Make This Recommendation?:
In 1 clinical trial, treatment with Imcivree reduced body weight in patients with BBS who were at least 6 years of age and who were obese. The results of this study also suggested that Imcivree may reduce hunger.
Patients identified reductions in body weight and hunger as important outcomes. Based on the evidence reviewed, Imcivree may meet these needs.
Based on CADTH’s assessment of the health economic evidence, Imcivree 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, Imcivree is estimated to cost the public drug plans approximately $23 million over the next 3 years.
What Is BBS?: BBS is a rare, incurable genetic disease that causes many symptoms, including hyperphagia, the inability to feel full, and early onset obesity. The prevalence of BBS is estimated to be 1 in 100,000 to 160,000 in North America and Europe, but the disorder occurs with greater frequency in certain regions, such as in Newfoundland and Labrador (where the prevalence is 1 in 16,000 to 18,000).
Unmet Needs in BBS: There are no other therapies available that are indicated for the treatment of BBS. Unrelenting hunger, hyperphagia, and obesity are identified by patients as 3 of the most distressing and impactful symptoms of the disease.
How Much Does Imcivree Cost?: At the maximum recommended dose in pediatric patients aged 17 or younger, treatment with Imcivree is expected to cost $294,172 per patient per year. In adults aged 18 years and older, treatment is expected to cost $441,258 per patient per year.