Pegylated Liposomal Doxorubicin

Key Messages

• The Formulary Management Expert Committee (FMEC) recommends that pegylated liposomal doxorubicin be reimbursed for the treatment of advanced soft tissue sarcoma (aSTS) in adults, provided certain conditions are met.
• Pegylated liposomal doxorubicin may be initiated and reimbursed for the treatment of aSTS in adults if 1 of the following conditions is met: cardiac contraindications to conventional doxorubicin, poor performance status, or no progression on conventional doxorubicin and having reached the maximum cumulative dose. Pegylated liposomal doxorubicin should be discontinued if there is evidence of disease progression or significant toxicities. The initial prescribing of pegylated liposomal doxorubicin should be limited to medical oncologists with expertise in the management and diagnosis of soft tissue sarcoma (STS). Pegylated liposomal doxorubicin should be priced no higher than the least costly comparator for this population.
• FMEC reviewed 1 phase II randomized controlled trial (RCT), 1 single-arm phase II trial, 1 retrospective cohort study, and a cost comparison of pegylated liposomal doxorubicin versus other treatments used in Canada. The evidence was insufficient to demonstrate clinically important differences between treatment with pegylated liposomal doxorubicin and conventional doxorubicin for overall survival (OS), progression-free survival (PFS), objective response rate, and stable disease.
• FMEC concluded that there is a significant clinical need arising from aSTS despite available treatments, largely due to the cardiotoxicity associated with conventional doxorubicin and its maximum lifetime cumulative dose. FMEC also concluded that pegylated liposomal doxorubicin demonstrates acceptable clinical value. The reimbursement recommendation also considered distinct social and ethical considerations, economic considerations, and impacts on health systems.