PBAC's latest decision on Vericiguat: Recommended with restriction (2022). Considered for Treatment of symptomatic chronic heart failure (NYHA class II, III or IV) in patients with reduced ejection fraction (LVEF <45%) who are stabilised after a recent decompensation event requiring hospitalisation and/or intravenous diuretic therapy.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
$45k/QALY
Range: $35k/QALY–$45k/QALY
Submissions
2
first 2022
Submissions
2
2022 → 2022
Eligible population
Adults with symptomatic chronic heart failure (NYHA class II, III or IV), reduced ejection fraction (LVEF <45%), stabilised after a recent decompensation event requiring hospitalisation in the past 6 months or intravenous diuretic therapy in the past 3 months, not currently in fluid overload, and on optimal standard heart failure treatment including beta-blocker and ACE inhibitor/ARB/ARNi.
Therapy area
Cardiovascular
Line of therapy
Not applicable
Evidence base
RCT
Primary endpoint
Other
Key trials
VICTORIA
Comparator
placebo plus standard of care
Economic model
CUA
Risk sharing
Risk-sharing arrangement in place — Risk Share Arrangement (RSA) outlined to manage the risk of use in a broader population, with expenditure caps and rebate provisions for expenditure beyond caps.
Submission history
Mar 2022: Recommended with restriction · Authority Required