PBAC's latest decision on Sacubitril/valsartan: Recommended with restriction (2020). Considered for Extension to existing listing for chronic heart failure with reduced ejection fraction (LVEF <50%), allowing initiation without prior ACE inhibitor/ARB treatment and broadening LVEF threshold from ≤40% to <50%.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2020
Submissions
1
2020 → 2020
Eligible population
Adults with chronic heart failure and reduced LVEF <50% (broadened from ≤40%), with or without prior stabilisation on ACE-inhibitors or ARBs, receiving concomitant optimal standard chronic heart failure treatment including maximum tolerated dose of a beta-blocker.
Therapy area
Cardiovascular
Line of therapy
Any
Evidence base
RCT
Primary endpoint
Composite of cardiovascular death or heart failure hospitalisation
Pivotal trial size
887 patients
Key trials
PIONEER-HF, TRANSITION, Tan 2020, PARADIGM-HF
Comparator
enalapril
Economic model
Cost-minimisation
ICER note
No ICER calculated; cost-effectiveness was assumed unchanged from previous listing based on acceptance that the cost effectiveness in the expanded population is unchanged from the current PBS population.
Risk sharing
Risk-sharing arrangement in place — A special pricing arrangement is already in place for sacubitril/valsartan; the expansion to the PBS listing would form part of this special pricing arrangement with the same effective price (adjusted for dispensing fees and pharmacy mark-ups).