Cost Effectiveness of Vericiguat for the Treatment of Chronic Heart Failure with Reduced Ejection Fraction Following a Worsening Heart Failure Event from a US Medicare Perspective

Abstract

Objective Given the high economic burden of disease among adult patients with chronic heart failure with reduced ejection fraction (HFrEF) following a worsening heart failure event in the US, this study aimed to estimate the cost effectiveness of vericiguat plus prior standard-of-care therapies (PSoCT) versus PSoCT alone from a US Medicare perspective. Methods A four-state Markov model (alive prior to heart failure hospitalization, alive during heart failure hospitalization, alive post-heart failure hospitalization, and death) was developed to predict clinical and economic outcomes, based on the results of the VICTORIA trial, in which patients with chronic HFrEF following a worsening heart failure were randomized to placebo or vericiguat, in addition to PSoCT, which consisted of β-blockers, renin-angiotensin-aldosterone inhibitors, mineralocorticoid receptor antagonists, and the angiotensin receptor-neprilysin inhibitor sacubitril/valsartan. Risks of heart failure hospitalization and cardiovascular mortality were based on multivariable regression models derived from VICTORIA data. Utilities were derived from VICTORIA EQ-5D data and the literature. Costs included drug acquisition, heart failure hospitalization, routine care, and terminal care. Primary outcomes included heart failure hospitalization, cardiovascular mortality, life-years, quality-adjusted life-years (QALYs), and incremental costs per QALY gained over a 30-year lifetime horizon, discounted at 3.0% annually. Results For the VICTORIA overall intent-to-treat population, compared with PSoCT, vericiguat plus PSoCT resulted in 19 fewer heart failure hospitalizations and 13 fewer cardiovascular deaths per 1000 patients, as well as 0.28 QALY gained per patient at an incremental cost of $23,322, leading to $82,448 per QALY gained. Conclusions Based on the results of VICTORIA, patients treated with vericiguat had lower rates of heart failure hospitalization and cardiovascular death. The addition of vericiguat to PSoCT was estimated to increase QALYs and to be cost effective at a willingness-to-pay threshold of $100,000 per QALY gained.

Sacubitril-valsartan for the treatment of hypertension in China: A cost-utility analysis based on meta-analysis of randomized controlled trials

“…Due to the differences in economic development between various countries or regions, the WTP threshold varies a lot in different countries, especially between developed countries and developing counties. The WTP threshold in China is 242,928 CNY/QALY, equal to 37,655 US$/QALY, and the value is 5,089 US$/QALY in Thailand ( 27 ), 45,500 in Japan ( 38 ), 79,241 in Germany ( 39 ), and 100,000 in the USA ( 40 ). Given the differences in WTP among countries, the price of sacubitril-valsartan varies among countries.…”

Comment on “Cost Effectiveness of Vericiguat for the Treatment of Chronic Heart Failure with Reduced Ejection Fraction Following a Worsening Heart Failure Event from a US Medicare Perspective”

“…Total hospitalizations for heart failure were reduced by 4.1% ( = 42.4-38.3%) in VICTORIA, yielding savings of US$427 per patient. 1 Considering that the cost of background therapy is the same in both arms and thus cancels out (disregarding an uncertain period of extended survival), vericiguat does not lead to a net saving. It can be safely assumed that extending vericiguat treatment and its effect beyond the trial period does not change this conclusion, that is, the total drug acquisition cost is projected to remain higher than savings from averted hospitalizations.…”

“…A recent publication in PharmacoEconomics presents a decision model evaluating the “[c]ost effectiveness of vericiguat for the treatment of chronic heart failure with reduced ejection fraction following a worsening heart failure event from a US Medicare perspective” [ 1 ]. The model shows that the probability of vericiguat being cost effective was 88% at a willingness-to-pay (WTP) threshold of US$150,000 per quality-adjusted life year (QALY) gained.…”

“…To stay below the willingness-to-pay (WTP) threshold of US$150,000 per QALY gained, the QALY gain thus needs to be at least 0.03 [(4786–427)/150,000]. The modelled disutility of a heart failure hospitalization is 0.077 but lasts only for a maximum of 30 days [ 1 ]. Therefore, vericiguat cannot be considered a cost-effective treatment based on its impact on hospitalizations for heart failure alone.…”

“…As an unrelated point, the authors report that they “did not model any numeric differences in adverse events, given that the VICTORIA trial did not show statistically significant differences in the safety profiles of the vericiguat plus PSoCT [prior standard-of-care therapies—author's note] and placebo plus PSoCT arms” [ 1 ]. However, this conclusion seems inconsistent with the approach of incorporating an insignificant survival benefit.…”