What Is the CADTH Reimbursement Recommendation for Lorbrena?: CADTH recommends that Lorbrena should be reimbursed by public drug plans for the treatment of adult patients with ALK-positive locally advanced or metastatic non–small cell lung cancer (NSCLC) if certain conditions are met.

Which Patients Are Eligible for Coverage?: Lorbrena should only be covered to treat adult patients with ALK-positive NSCLC who are diagnosed when their cancer has spread to lymph nodes (locally advanced disease) or other parts of the body (metastatic disease) and who have had no prior systemic treatment for advanced or metastatic NSCLC.

What Are the Conditions for Reimbursement?: Lorbrena should only be reimbursed by public drug plans when used as a single drug. It should be prescribed by an oncologist with experience in the treatment of ALK-positive NSCLC although thereafter it can be given in an outpatient clinic by the patient’s health care team. The cost of Lorbrena should not be higher than the cost of treatment with alectinib or brigatinib for these patients.

Why Did CADTH Make This Recommendation?:

1. Evidence from a clinical trial demonstrated that Lorbrena delayed disease progression when compared with crizotinib in patients with metastatic ALK-positive NSCLC. Evidence suggested that Lorbrena was effective in treating and preventing brain metastases in patients with ALK-positive NSCLC.

2. Lorbrena meets patient needs of improving disease control by delaying progression and having manageable side effects.

3. Based on CADTH’s assessment of the health economic evidence, Lorbrena does not represent good value to the health care system at the public list price. The committee determined that there is not enough evidence to justify a higher price for Lorbrena than alectinib and brigatinib.

4. Based on public list prices, Lorbrena is estimated to cost the public drug plans approximately $8 million over the next 3 years; however, the actual budget impact is uncertain.

What Is Metastatic : ALK-positive NSCLC is a subtype of lung cancer that is caused by a mutation in the ALK gene, which accounts for approximately 5% of NSCLC cases. Patients with an ALK gene mutation tend to have a poor life expectancy and a high chance of developing brain metastases.

Unmet Needs in Metastatic : Treatments that improve the survival of patients, are less toxic, and are better at treating brain metastases are needed.

How Much Does Lorbrena Cost?: The sponsor estimated that treatment with Lorbrena would cost approximately $8,982 per 28-day cycle.