PBAC's latest decision on Maribavir: Recommended with restriction (2024). Considered for Acute treatment of post-transplant cytomegalovirus (CMV) infection and disease resistant, refractory or intolerant to one or more prior therapies in adults who have undergone haematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT).
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
2
first 2023
Submissions
2
2023 → 2024
Eligible population
Adults with post-transplant (HSCT and SOT) CMV infection and disease resistant, refractory, or intolerant to one or more prior therapies (ganciclovir, valganciclovir, cidofovir, or foscarnet).
Therapy area
Infectious disease
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
CMV viremia clearance
Key trials
SOLSTICE
Comparator
standard of care (oral valganciclovir, intravenous ganciclovir, intravenous foscarnet, and/or intravenous cidofovir)
Economic model
CUA
ICER note
ICER values are redacted/commercially sensitive. The document states 'The effective DPMQ of maribavir has been reduced by %' and refers to confidential effective prices of '$' for public and private hospitals, indicating the economic model contains commercial-in-confidence data.
Risk sharing
Risk-sharing arrangement in place — Special Pricing Arrangements apply; the maribavir price was reduced compared to the November 2023 submission to reflect uncertainty in clinical data and short duration of efficacy in patients who develop resistance.
Submission history
Nov 2023: Recommended with restriction · Authority Required
Nov 2024: Recommended with restriction · Authority Required