WHAT IS THE CADTH REIMBURSEMENT RECOMMENDATION FOR TRECONDYV?: CADTH recommends that Trecondyv in combination with fludarabine should be reimbursed by public drug plans as part of conditioning treatment before allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) at increased risk for standard conditioning therapies if certain conditions are met. WHICH PATIENTS ARE ELIGIBLE FOR COVERAGE? Trecondyv in combination with fludarabine should only be covered to treat adult patients with AML or MDS who are eligible for alloHSCT, are at least 50 years old at transplant, and/or have a Hematopoietic Cell Transplantation-Comorbidity Index score greater than 2. Patients should have good performance status. WHAT ARE THE CONDITIONS FOR REIMBURSEMENT? Trecondyv should only be reimbursed in combination with fludarabine if prescribed by clinicians with appropriate training and experience in transplant centres with alloHSCT programs and if the cost of Trecondyv is not more than the least costly alternative conditioning treatment. WHY DID CADTH MAKE THIS RECOMMENDATION? Evidence from a clinical trial demonstrated that treatment with Trecondyv in combination with fludarabine resulted in similar chances of cancer returning within 2 years after alloHSCT as compared with busulfan in combination with fludarabine. Based on CADTH’s assessment of the health economic evidence, Trecondyv 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 Trecondyv compared with other conditioning treatments for adult patients with AML or MDS who are considered ineligible for standard conditioning therapies. Trecondyv in combination with fludarabine may meet patients’ needs to reduce transplant-related complications and prolong survival. Based on public list prices, Trecondyv is estimated to cost the public drug plans approximately $650,000 over the next 3 years. However, the actual budget impact is uncertain and will depend on the market uptake of Trecondyv.
WHAT IS AML AND MDS? AML is a blood and bone marrow cancer that leads to fewer mature blood cells. AML causes weakness, infection, bleeding, and other symptoms and complications. There were 1,090 new cases of AML in Canada in 2016 and 1,184 deaths from AML in 2017. MDS is a group of blood cancers in which the bone marrow makes faulty blood cells that can lead to infections, anemia, or bleeding. Approximately one-quarter to one-third of patients with MDS will progress to AML. The estimated incidence rate of MDS is approximately 4.3 cases per 100,000 people per year. UNMET NEEDS IN AML AND MDS: Improved conditioning regimens are needed that reduce the risk of transplant-related mortality without increasing the chances that cancer returns after the transplant and have fewer side effects compared with current treatment options. HOW MUCH DOES TRECONDYV COST? Treatment with Trecondyv is expected to cost $8,316 per patient per course of treatment.
