What Is the CADTH Reimbursement Recommendation for Libtayo?: CADTH recommends that Libtayo should be reimbursed by public drug plans for the first-line treatment of adult patients with non–small cell lung cancer (NSCLC) expressing programmed death ligand 1 (PD-L1) with a Tumour Proportion Score (TPS) of 50% or greater, as determined by a validated test, with no epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) translocation, or c-Ros oncogene 1 (ROS-1) aberrations, who have locally advanced NSCLC and who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC if certain conditions are met.

Which Patients Are Eligible for Coverage?: Libtayo should only be covered to treat patients who have metastatic NSCLC or locally advanced NSCLC that cannot be treated with surgery or chemoradiation, whose tumours have high levels of PD-L1 protein, whose tumours do not have abnormal EGFR, ALK, or ROS1 genes, and who have no prior systemic treatment for advanced or metastatic NSCLC.

What Are the Conditions for Reimbursement?: Libtayo should be prescribed by clinicians with expertise and experience in treating NSCLC and treatment should be supervised and delivered in outpatient specialized oncology clinics. The price of Libtayo should be negotiated so that it does not exceed the cost of treatment with pembrolizumab.

Why Did CADTH Make This Recommendation?:

1. Evidence from a clinical trial demonstrated that treatment with Libtayo improved survival compared with platinum-doublet chemotherapy.

2. Libtayo meets patient needs of improving survival and having manageable side effects.

3. Based on CADTH’s assessment of the health economic evidence, Libtayo does not represent good value to the health care system at the public list price. The Committee determined that there is not enough evidence justify a greater cost for Libtayo compared with pembrolizumab over the duration of treatment.

4. Based on public list prices, Libtayo is estimated to cost the public drug plans approximately $13 million over the next 3 years. However, the actual budget impact is uncertain.

What Is NSCLC?: Lung cancer is the most diagnosed cancer and the leading cause of cancer deaths in Canada. It is estimated that in 2021, 29,600 Canadians were diagnosed with lung cancer and 21,000 Canadians died from lung cancer. Approximately 19% of patients in Canada diagnosed with lung cancer survive for at least 5 years. NSCLC accounts for approximately 85% of lung cancer cases in Canada.

Unmet Needs in NSCLC: Not all patients have a response to currently available first-line treatments for NSCLC and most patients will experience disease progression.

How Much Does NSCLC Cost?: Treatment with Libtayo is expected to cost approximately $11,956 per patient per month.