WHAT IS THE CADTH REIMBURSEMENT RECOMMENDATION FOR KEYTRUDA?: CADTH recommends that Keytruda should be reimbursed by public drug plans for the treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2) positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours express programmed cell death-ligand 1 (PD-L1) if certain conditions are met. WHICH PATIENTS ARE ELIGIBLE FOR COVERAGE? Keytruda should only be covered to treat adult patients who have not received previous treatment for advanced or metastatic esophageal or GEJ cancer and have good performance status. WHAT ARE THE CONDITIONS FOR REIMBURSEMENT? Keytruda should only be reimbursed if prescribed in combination with trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy by a clinician with expertise and experience in treating gastric and GEJ cancer. WHY DID CADTH MAKE THIS RECOMMENDATION? Evidence from 1 clinical trial demonstrated that patients treated with Keytruda, when added to trastuzumab and 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 CADTH’s assessment of the health economic evidence, Keytruda 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, Keytruda, in combination with trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy, is estimated to cost the public drug plans approximately $38.1 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: Patients diagnosed with HER2-positive gastric or GEJ cancer have more aggressive disease, and many patients do not respond to available treatment options. Even in patients who do respond to treatment, their survival is quite limited. HOW MUCH DOES KEYTRUDA COST? Treatment with Keytruda is expected to cost approximately $11,733 per patient per cycle when used in combination with trastuzumab and fluoropyrimidine- and platinum-containing chemotherapy.