WHAT IS THE REIMBURSEMENT RECOMMENDATION FOR KEYTRUDA?: Canada’s Drug Agency recommends that Keytruda should be reimbursed by public drug plans for the treatment of patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2) negative gastric or gastroesophageal junction (GEJ) adenocarcinoma if certain conditions are met. WHICH PATIENTS ARE ELIGIBLE FOR COVERAGE? Keytruda should only be covered to treat patients who have not received previous treatment for HER2-negative advanced or metastatic gastric or GEJ cancer and who have good performance status. WHAT ARE THE CONDITIONS FOR REIMBURSEMENT? Keytruda should only be reimbursed if prescribed in combination with fluoropyrimidine- and platinum-containing chemotherapy by a clinician with expertise and experience in treating gastric and GEJ cancer, and the cost of Keytruda in combination with chemotherapy is reduced so that it does not exceed the drug program cost of treatment with nivolumab in combination with chemotherapy. WHY DID WE MAKE THIS RECOMMENDATION? • Evidence from 1 clinical trial demonstrated that patients treated with Keytruda, when added to fluoropyrimidine- and platinum-containing chemotherapy, resulted in improved survival and could delay cancer progression. • Keytruda meets patient needs of delaying disease progression and prolonging survival and was unlikely to worsen health-related quality of life (HRQoL). • Based on our assessment of the health economic evidence, Keytruda 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 greater cost for Keytruda in combination with chemotherapy compared with nivolumab in combination with chemotherapy. • Based on public list prices, Keytruda, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is estimated to cost the public drug plans approximately $2.1 million over the next 3 years.

ADDITIONAL INFORMATION

WHAT IS GASTRIC OR GEJ CANCER? Gastric and GEJ cancers occur in the stomach, where the esophagus and stomach join, respectively. Most gastric and GEJ cancers are adenocarcinomas. The cancer is considered locally advanced if it spreads in the stomach or GEJ and metastatic if it spreads to another part of the body. The 5-year survival rate for patients diagnosed with gastric and GEJ cancer living in Canada is 29%. For patients with metastatic gastric or GEJ cancer, the 5-year survival rate is 6.6%. UNMET NEEDS IN GASTRIC OR GEJ CANCER: Many patients with HER2-negative gastric or GEJ cancer do not respond to available treatment options. Even in patients who do respond to treatment, their survival remains limited. HOW MUCH DOES KEYTRUDA COST? Treatment with Keytruda is expected to cost approximately $11,733 per patient per 28-day cycle.