WHAT IS THE REIMBURSEMENT RECOMMENDATION FOR ALECENSARO?: Canada’s Drug Agency (CDA-AMC) recommends that Alecensaro should be reimbursed by public drug plans for adjuvant treatment following tumour resection for patients with stage IB (tumours ≥ 4 cm) to IIIA (according to American Joint Committee on Cancer [AJCC] , seventh edition) -positive non–small cell lung cancer (NSCLC) if certain conditions are met. WHICH PATIENTS ARE ELIGIBLE FOR COVERAGE? Alecensaro should only be covered to treat adult patients (≥ 18 years) who have stage IB (tumour ≥ 4 cm) to stage IIIA (per the AJCC seventh edition) positive NSCLC, have had complete tumour resection, and are in relatively good health. WHAT ARE THE CONDITIONS FOR REIMBURSEMENT? Alecensaro should only be reimbursed if it is prescribed by clinicians with expertise in managing NSCLC and the cost of Alecensaro is reduced. Alecensaro should be discontinued if a patient’s cancer grows or spreads, if treatment is unacceptably toxic to the patient, or the patient has completed 2 years of therapy with Alecensaro. WHY DID CDA-AMC MAKE THIS RECOMMENDATION? • Evidence from a clinical trial demonstrated that adjuvant treatment with Alecensaro was better than adjuvant chemotherapy in prolonging life without disease recurrence and delaying the spread of cancer to the brain in adult patients who had complete resection of their stage IB (tumour ≥ 4 cm) to stage IIIA positive NSCLC (stages per AJCC seventh edition). • Based on the CDA-AMC assessment of the health economic evidence, Alecensaro may represent good value to the health care system at the public list price. Price reductions would reduce the uncertainty of this assessment. • Based on public list prices, Alecensaro is estimated to cost the public drug plans approximately $36 million over the next 3 years.

ADDITIONAL INFORMATION

WHAT IS ALK-POSITIVE NSCLC? Lung cancer is the most commonly diagnosed cancer and the leading cause of cancer deaths in Canada. Approximately 88% of lung cancer cases in Canada are NSCLC. Patients with -positive NSCLC (i.e., tumours with gene rearrangement) are at a higher risk of the cancer spreading to the brain or spinal cord compared to those with -negative NSCLC. UNMET NEEDS IN ALK-POSITIVE NSCLC: There is a need for an effective treatment following tumour resection that can prolong survival, delay recurrent disease, and is less toxic than chemotherapy. HOW MUCH DOES ALECENSARO COST? Treatment with Alecensaro is expected to cost approximately $9,918 per patient per 28-day cycle.