VericiguatVerquvo
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.
Decisions on record
- Meeting Jul 2022 Recommended Chronic heart failure with reduced ejection fraction after decompensation event
- Meeting Mar 2022 Not recommended Chronic heart failure
Access path
- TGA registered · Verquvo
TGA label narrower than the PBS population
- Mar 2022Not recommended
vs placebo plus standard of care
- ↻ resubmittedJul 2022Recommended · restricted
- PBS listing · Authority Required
From the public summary
5.1 The PBAC recommended listing of vericiguat as an Authority Required (telephone/online PBS Authorities system) for the initial restriction and an Authority Required (Streamlined) for the continuing restriction, for the treatment of symptomatic (NYHA class II, III or IV) chronic heart failure in patients with a reduced ejection fraction (left ventricular ejection fraction less than 45%) and who are stabilised after a recent decompensation heart failure …PSD · Jul 2022
5.2 The PBAC was satisfied that vericiguat, with concomitant use of standard of care therapies, provides for some patients, a significant improvement in efficacy over standard of care in high-risk patients in a late-line of therapy.PSD · Jul 2022
4.6 Compared with the previous submission, the only changes to the economic model were:PSD · Jul 2022
• use of the ITT population results from the VICTORIA trial; andPSD · Jul 2022
4.4 In March 2022, the PBAC considered that the claim of superior comparative effectiveness was reasonable although the magnitude of the treatment effect was modest and may have been overestimated in the trial.PSD · Jul 2022
4.5 In March 2022, the PBAC considered that the claim of comparable safety was likely reasonable but noted that vericiguat was associated with a slight increase in drug- related adverse events compared with placebo (14.6% versus 11.7%, respectively).PSD · Jul 2022
6.2 The PBAC noted and welcomed the input from an individual whose comments described the importance, to patients and their families, of access to therapies that may reduce the risk of re-hospitalisation.PSD · Mar 2022
4.20 In March 2022, the PBAC considered “that given the overall uncertainty with the economic model a risk sharing arrangement (RSA) would be required to manage the risk of use outside the narrow restriction in a less responsive patient group, given clinical judgement will be required to identify stable patients” (paragraph 7.17, vericiguat PSD, March 2022 PBAC Meeting).PSD · Jul 2022
Cost-effectiveness
Decision context
PopulationAdults 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.
Risk sharingRisk 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
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2022 | Recommended · restricted | placebo plus standard of care | $35k–45k | RCT · Other |
| Mar 2022 | Not recommended | placebo plus standard of care | — | RCT · Composite outcome of cardiovascular death and hospitalisation for heart failure |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| VICTORIA | Ph 3 | 5,050 | Time to First Occurrence of Composite Endpoint of Cardiovascular (CV) Death or Heart Failu… | completed |
Consumer voice
No consumer comments were received for this item.
The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC adds specific NYHA class (II-IV), LVEF threshold (<45%), recent decompensation timing (6 months/3 months), and mandatory baseline standard therapy requirements.