PBAC's latest decision on Plitidepsin: Not recommended (2020). Considered for Treatment of relapsed/refractory multiple myeloma in patients refractory to a proteasome inhibitor and an immunomodulatory drug (third-line setting) or in patients who have received at least three prior treatment regimens including both a proteasome inhibitor and an immunomodulatory drug (fourth-line setting).
PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
2
first 2019
Submissions
2
2019 → 2020
Eligible population
Patients with relapsed/refractory multiple myeloma who are refractory to a proteasome inhibitor and an immunomodulatory drug (third-line) or have received at least three prior treatment regimens including both a proteasome inhibitor and an immunomodulatory drug (fourth-line), treated in combination with dexamethasone.
ICER values are redacted (shown as '$''''''''''''') in the public document. The resubmission presented a cost-minimisation analysis (third-line) and cost-utility analysis (fourth-line) with base case ICER redacted.
Risk sharing
Risk-sharing arrangement in place — Special Pricing Arrangements (SPA) acknowledged as may be required; i-access risk management program registration required for continuing treatment.
Why PBAC said no
Reasons cited in the latest PSD: Marginal clinical benefit in PFS (median increase of 0.9-3 months depending on analysis), significant increase in adverse events, uncertain non-inferiority claim against pomalidomide + Dxm, insufficient safety data for comparison with pomalidomide, issues with economic model methodology (crossover adjustment, utility values, time-to-treatment-failure estimation, KM data application), ICER threshold concerns given substantial toxicity and minor additional benefit