Durvalumab (Imfinzi): CADTH Reimbursement Recommendation [Internet]

What Is the CADTH Reimbursement Recommendation for Imfinzi?: CADTH recommends that Imfinzi should be reimbursed by public drug plans for the treatment of locally advanced or metastatic biliary tract cancer (BTC) if certain conditions are met.

Which Patients Are Eligible for Coverage?: Imfinzi in combination with gemcitabine plus platinum-based chemotherapy should only be covered to treat patients with locally advanced or metastatic BTC who have not received prior treatment. Patients receiving Imfinzi should be in relatively good health (i.e., have a good performance status, as determined by a specialist).

What Are the Conditions for Reimbursement?: Imfinzi should only be reimbursed when it is used in combination with gemcitabine and platinum-based chemotherapy, if prescribed by specialists with experience in managing BTC, and if the cost of Imfinzi is reduced. Imfinzi should not be reimbursed if it is used to treat patients with Ampulla of Vater (AoV) cancer.

Why Did CADTH Make This Recommendation?:

1. Evidence from a clinical trial demonstrated that treatment with Imfinzi plus gemcitabine and cisplatin live longer than patients treated with gemcitabine and cisplatin alone.

2. Imfinzi meets some of the needs identified by patients. It is another treatment option that delays disease progression and has manageable side effects.

3. Based on CADTH’s assessment of the health economic evidence, Imfinzi does not represent good value to the health care system at the public list price. A price reduction is therefore required.

4. Based on public list prices, Imfinzi is estimated to cost the public drug plans approximately $1.36 million over the next 3 years.

What Is BTC?: BTCs 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 are approximately 400 new BTC cases diagnosed in Canada each year, though this has increased over the past 20 years.

Unmet Needs in BTC: Treatment for locally advanced or metastatic BTC has not changed in the past 10 years, and there has been no improvement in treatment outcomes. There is a need for new, life-extending treatments that improve quality of life.

How Much Does Imfinzi Cost?: Treatment with Imfinzi is expected to cost approximately $11,733 for per cycle.