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An analysis of cost-effectiveness using data from SOLOIST-WHF provides insight into the varying cost-effectiveness of the agent as a treatment for worsening heart failure.
Use of sotagliflozin was a cost-effective treatment for heart failure patients at commonly accepted willingness-to-pay thresholds, according to an analysis of phase 3 trial data.
Leveraging data from the SOLOIST-WHF trial, results of the study suggested use of sotagliflozin was associated with an increase in quality-adjusted life years (QALY) and an increase in life-years, with an incremental lifetime cost less than $30,000 and an incremental cost-effectiveness ratio (ICER) of $75,000 per QALY gained.1
“With the prevalence of heart failure rising at an ever-increasing rate and hospitalizations driving a significant majority of healthcare costs relating to heart failure, it is clear that we need to do more,” said Craig Granowitz, MD, MPH, Lexicon’s senior vice president and chief medical officer.2 “We are closer than ever to potentially providing an additional treatment option for heart failure patients transitioning out of the hospital and helping to reduce the financial and physical burdens of rehospitalizations.”
As it approaches a potential approval, sotagliflozin finds itself in a unique situation. Although its one-time bid as a type 1 diabetes agent was unsuccessful3, the SGLT1/2 inhibitor has found new life with Lexicon Pharmaceuticals as a potential therapy for people with worsening heart failure. Now, less than a month from its May 27, 2023 PDUFA date, the agent could be poised to join dapagliflozin and empagliflozin as the third SGLT2 inhibitor to receive an indication for heart failure.
Originally presented alongside the SCORED trial at the American Heart Association’s 2020 annual meeting, SOLOIST-WHF was a phase 3, double-blind, randomized, placebo-controlled trial and enrolled 1222 adult patients recently hospitalized for worsening heart failure. Although the trial was terminated prematurely due to funding during the COVID-19 pandemic, results of the study provided evidence of the benefit from the SGLT1/2 inhibitor on clinical outcomes in this patient population.
Designed with a primary composite endpoint of cardiovascular death, hospitalizations, and urgent visits for heart failure, results suggested use of sotagliflozin was associated with a lower incidence of primary events (51.0 vs 76.3 per 100 patient-years; Hazard ratio [HR], 0.67 [95% Confidence interval [CI], 0.52-0.85]; P < .001), lower rate of death from cardiovascular causes (10.6 vs 12.5; HR, 0.84 [95% CI, 0.58-1.22]), and lower rate of all-cause mortality (13.5 vs 16.3; HR, 0.82 [95% CI, 0.59-1.14]) relative to placebo therapy. Based on results, investigators determined the overall number needed to treat to prevent a primary outcome event was 4.4
In the current study, Granowitz and investigators sought to perform an economic assessment of sotagliflozin use based on data from the SOLOIST-WHF trial. The specific intent of the investigatory team was to explore healthcare resource use, calculate in-trial life years gained and estimated QALY gained, and conduct lifetime cost-effectiveness analysis using a microsimulation model.1
Results of the analysis indicated the average in-trial costs were significantly greater for those in the sotagliflozin group than the placebo therapy group, but investigators pointed out this was driven by the cost of medication. During the 9-month follow-up period, patients in the sotagliflozin arm experienced a mean increase of 0.80 life-years and 0.51 QALYs compared to 0.77 and 0.49, respectively, among the placebo arm.1
Further analysis revealed use of sotagliflozin was associated with increases of 0.39 QALYs (4.43 vs. 4.04), 0.64 life-years (7.12 vs. 6.48) over the lifetime at an incremental lifetime cost of $29,449 (95% CI, 26,610-32,528), for an ICER of $75,510 per QALY gained, which investigators pointed out was less than the threshold of $1000,000 per QALY.1
“I think ultimately, the specific answer to your question will depend on the labeling of the drug. But I think the data from SOLOIST, and for that matter, SCORE really do support the use of sotagliflozin, and patients that have come in with acute decompensated heart failure and then been stabilized, but getting it on board relatively early and prior to their discharge,” said Deepak Bhatt, MD, MPH, principal investigator of SOLOIST-WHF and director of Mount Sinai Heart, when discussing the potential upcoming regulatory decision in an interview.