PBAC's latest decision on Daratumumab: Recommended with restriction (2025). Considered for Treatment of transplant ineligible, newly diagnosed multiple myeloma in combination with lenalidomide and dexamethasone.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
9
first 2017
PBS spend
$335M
46,891 scripts · 2024
Eligible population
Patients with transplant ineligible, newly diagnosed multiple myeloma, receiving daratumumab in combination with lenalidomide and dexamethasone.
Therapy area
Haematology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
PFS
Key trials
MAIA, SWOG s0777, MRDR
Comparator
lenalidomide and dexamethasone (Ld); bortezomib, lenalidomide and dexamethasone (BLd)
Economic model
CUA
ICER note
ICER not stated in the public text; redacted or confidential
Risk sharing
Risk-sharing arrangement in place — A combined Risk Share Arrangement for daratumumab across the TI NDMM (DLd) and second line MM (DBd) populations is proposed, accounting for utilisation of DLd in the TI NDMM population and DBd for second line MM.
PBS expenditure
The Australian government paid $335M in PBS benefits for Daratumumab in 2024 across 46,891 scripts, at $7,152 per script.
Submission history
Nov 2017: Recommended with restriction · Restricted
Mar 2019: Recommended with restriction · Authority Required
Nov 2019: Recommended with restriction · Restricted
Jul 2020: Recommended with restriction · Authority Required
Jul 2021: Recommended with restriction · Authority Required
Nov 2021: Recommended with restriction · Authority Required
Nov 2021: Recommended with restriction · Authority Required
Mar 2023: Recommended with restriction · Authority Required
Mar 2025: Recommended with restriction · Authority Required