PBAC's latest decision on Pomalidomide: Recommended (2023). Considered for Treatment of multiple myeloma in patients requiring dose adjustments due to haematological toxicities. The submission was for the addition of 1 mg and 2 mg capsule strengths to support dose reductions and interruptions during treatment.
PBAC outcome
Recommended
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
8
first 2014
Submissions
8
2014 → 2023
Eligible population
Adults with multiple myeloma requiring dose adjustments (interruptions and reductions) due to haematological toxicities such as thrombocytopenia and neutropenia
Therapy area
Oncology
Line of therapy
Not applicable
Evidence base
Cost-minimisation
Primary endpoint
Cost-minimisation
Key trials
CC-4047-MM-003
Comparator
Pomalyst (pomalidomide 1 mg and higher strengths of pomalidomide)
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated as drugs are therapeutically equivalent on a per mg basis
ICER (historical)
$45k/QALY–$75k/QALY across 2 submissions (2014–2017) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Risk sharing
Risk-sharing arrangement in place — Patients receiving pomalidomide under the PBS listing must be registered in the risk management program relevant for the brand being prescribed: Pomolide - Juno's Pregnancy Prevention Program; Pomalyst - i-access program; Pomalidomide Sandoz - Pregnancy Prevention Program
Submission history
Jul 2014: Recommended with restriction · Restricted
Nov 2014: Recommended with restriction · Authority Required — ICER $75k/QALY
Mar 2016: Not recommended · Restricted
Mar 2017: Not recommended · Restricted
Nov 2017: Recommended with restriction · Restricted — ICER $75k/QALY
Jul 2019: Recommended with restriction · Authority Required
Nov 2019: Recommended with restriction · Authority Required