Key Messages
- Canada’s Drug Agency (CDA-AMC) recommends that Lyvdelzi be reimbursed by public drug plans for the treatment of primary biliary cholangitis (PBC), in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA alone, or as monotherapy in adults unable to tolerate UDCA if certain conditions are met.
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The Canadian Drug Expert Committee (CDEC) determined that Lyvdelzi demonstrates acceptable clinical value versus Iqirvo and Ocaliva in patients with PBC. Lyvdelzi, elafibranor (Iqirvo), and obeticholic acid (Ocaliva) are used in combination with UDCA in adults whose PBC has an inadequate response to UDCA alone or as monotherapy in adults with UDCA intolerance. This determination alone was sufficient for CDEC to recommend that Lyvdelzi be reimbursed. Given that Lyvdelzi is expected to be an alternative to Iqirvo or Ocaliva, acceptable clinical value refers to at least comparable value versus Iqirvo or Ocaliva.
Evidence from 1 clinical trial demonstrated that treatment with Lyvdelzi (in combination with UDCA in patients whose PBC has an inadequate response to UDCA or as monotherapy in those with UDCA intolerance) resulted in improved response to treatment (alkaline phosphatase [ALP] < 1.67 × upper limit of normal [ULN], normal total bilirubin level, and a decrease in ALP ≥ 15% from baseline) and improved pruritus after 1 year of treatment when compared with placebo. Although evidence from 1 indirect treatment comparison for Lyvdelzi versus Iqirvo or Ocaliva was associated with methodological limitations and showed imprecise results, CDEC felt the results did not demonstrate significant differences in outcomes comparing the treatments and found it reasonable to consider them similar in efficacy and safety.
Lyvdelzi meets some important patient needs by offering an additional treatment option that could improve treatment response and normalize ALP levels.
- Lyvdelzi should only be covered to treat adult patients who have a diagnosis of PBC that has either not responded adequately to UDCA treatment after treatment for at least a year (with a stable dose maintained for a minimum of 3 months), or who have intolerance to UDCA treatment, and who have a total bilirubin level of no higher than 2 times the ULN. In addition, patients should have no history or current evidence of other liver diseases. Initial coverage for Lyvdelzi should not exceed 12 months.