Key result
Plozasiran lowers fasting triglycerides and acute pancreatitis events versus placebo in adults with FCS.
Why the study?
This review assesses the clinical effectiveness and cost-effectiveness of subcutaneous plozasiran injection to inform nonbinding reimbursement recommendations for Canadian federal, provincial, and territorial governments.
Does subcutaneous plozasiran 25 mg every 3 months reduce fasting triglyceride levels and acute pancreatitis events compared to placebo in adult patients with familial chylomicronemia syndrome?
Does subcutaneous plozasiran 25 mg every 3 months reduce fasting triglyceride levels and acute pancreatitis events compared to placebo in adult patients with familial chylomicronemia syndrome?
In this Canadian health technology assessment, subcutaneous plozasiran 25 mg every 3 months was found to likely reduce fasting triglyceride levels and acute pancreatitis events in adults with familial chylomicronemia syndrome compared to placebo, though with an incremental cost-effectiveness ratio of $1,813,089 per QALY gained.
Questions routine plozasiran adoption in FCS due to high ICER; extends single-trial data for reimbursement decisions.
Reimbursement reviews are comprehensive assessments of the clinical effectiveness and cost-effectiveness, as well as patient and clinician perspectives, of a drug or drug class. The assessments inform nonbinding recommendations that help guide the reimbursement decisions of Canada’s federal, provincial, and territorial governments, with the exception of Quebec. This review assesses plozasiran injection (Redemplo), 25 mg/0.5 mL, sterile solution for subcutaneous use. Indication: As an adjunct to diet to reduce triglyceride levels for adult patients with FCS for whom standard triglyceride-lowering therapies have been inadequate.
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CDA-AMC (2026) conducted a review in Familial chylomicronemia syndrome (FCS) (n=75). Plozasiran vs. Placebo added to standard of care (low-fat diet ≤20 g daily) was evaluated on Change in fasting triglycerides from baseline to 10 months. Plozasiran 25 mg every 3 months likely reduces fasting triglyceride levels at 10 months and acute pancreatitis events at 12 months compared to placebo in adults with FCS, with an ICER of $1,813,089/QALY.
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