WHAT IS THE REIMBURSEMENT RECOMMENDATION FOR KEYTRUDA?: CADTH recommends that public drug plans reimburse Keytruda for the treatment of locally advanced unresectable or metastatic biliary tract carcinoma (BTC) if certain conditions are met. WHICH PATIENTS ARE ELIGIBLE FOR COVERAGE? Keytruda in combination with gemcitabine-based chemotherapy should only be covered to treat patients with locally advanced unresectable or metastatic BTC who have not received prior treatment or who have completed treatment with nongemcitabine-based neoadjuvant or adjuvant therapy more than 6 months ago. Patients receiving Keytruda should be in relatively good health (i.e., have a good performance status, as determined by a specialist). WHAT ARE THE CONDITIONS FOR REIMBURSEMENT? Keytruda should only be reimbursed if it is used in combination with gemcitabine-based chemotherapy if prescribed by specialists with experience in managing BTC and if the cost of Keytruda does not exceed the cost of durvalumab. Keytruda should not be reimbursed if it is used to treat patients with ampulla of Vater cancer. WHY DID CADTH MAKE THIS RECOMMENDATION? Evidence from a clinical trial demonstrated that patients treated with Keytruda plus gemcitabine and cisplatin live longer than those treated with gemcitabine and cisplatin alone. Keytruda meets some of the needs identified by patients. It is another treatment option that may prolong life and has manageable side effects. Based on CADTH’s assessment of the health economic evidence, Keytruda represents good value to the health care system at the public list price. The committee determined that there is not enough evidence to justify a more significant cost for Keytruda compared with durvalumab throughout treatment. Based on public list prices, Keytruda is estimated to save the public drug plans approximately $20 million over the next 3 years. However, the actual budget impact is uncertain.

ADDITIONAL INFORMATION

WHAT IS BTC? Biliary tract cancers are rare cancers that occur in the bile duct system, which includes the bile ducts within the liver and outside of the liver, as well as in the gallbladder. There will be 1,263 new cases of locally advanced unresectable or metastatic BTC diagnosed in Canada in 2025. The length of survival for patients living in Canada with unresectable BTC is approximately 6 to 12 months. UNMET NEEDS IN BTC: Limited currently available treatment options are identified as a significant unmet need for patients with advanced BTC. New, life-extending treatments that improve quality of life are desired. HOW MUCH DOES KEYTRUDA COST? Treatment with Keytruda is expected to cost $9,034.30 for the first 8 of the 21-day cycles and $9,018.70 for every cycle after that.