PBAC's latest decision on Letermovir: Recommended with restriction (2019). Considered for Prophylaxis of cytomegalovirus (CMV) infection or disease in CMV seropositive patients who have received an allogeneic haematopoietic stem cell transplant (HSCT).
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
2
first 2018
Submissions
2
2018 → 2019
Eligible population
Adult CMV-seropositive recipients of an allogeneic HSCT, aged 18 years or older, who commence treatment within 28 days of transplant.
Therapy area
Infectious disease
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
CMV infection
Pivotal trial size
565 patients
Key trials
P001
Comparator
placebo
Economic model
CUA
ICER note
ICER values are redacted in the PSD (indicated by '***' and '''''''' placeholders in financial sections); economic model was modified but specific ICER figures not published.
Submission history
Jul 2018: Recommended with restriction · Authority Required
Mar 2019: Recommended with restriction · Authority Required