An analysis estimated the clinical and economic impact of Inpefa using inputs from a phase 3 trial of the heart failure drug.
Use of the heart failure drug Inpefa (sotagliflozin) led to decreases in hospitalizations, emergency department visits, and produced significant financial benefits for health systems. This is the finding of a new poster presented at the American Heart Association Scientific Sessions meeting in Philadelphia.
Developed by Lexicon Pharmaceuticals, Inpefa was approved in May 2023 to treat patients with heart failure. Inpefa is an inhibitor of SGLT2 and SGLT1 and is a once-daily oral tablet that reduces the risk of cardiovascular death and hospitalization for heart failure in adults.
Heart failure is the leading cause of hospitalizations for individuals aged 65 and older, triggering about 1.3 million hospitalizations a year. A literature review published last year in the Journal of Managed Care & Specialty Pharmacy found that the mean costs per hospitalization for heart failure ranged from $10,737 to $17,830 (mean).
"Heart failure remains a major cost driver in the healthcare system, particularly among Medicare patients," Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer, told Managed Healthcare Executive. "In addition to the significant medical benefits provided by treatment with sotagliflozin, the large reduction in re-hospitalizations for heart failure could result in significant cost reductions to payers that participate in Medicare alternative payment models."
In an analysis sponsored by Lexicon, researchers aimed to quantify the economic impact of the adoption of Inpefa on healthcare systems. This study created a decision tree model and estimated the clinical impact of Inpefa use relative to standard of care from the SOLOIST-WHF trial. Results from SOLOIST-WHF showed that Inpefa significantly reduced risk of the composite of hospitalizations for heart failure, urgent visits for heart failure, and cardiovascular death by 33% compared with placebo in patients who had been recently hospitalized for worsening heart failure.
Researchers in this analysis assessed adults who had been recently hospitalized for heart failure and received treatment with intravenous diuretic therapy. The model, which was validated by researchers at Stanford University, assessed the costs to healthcare systems adopting traditional fee-for-service structure. Built into the model were the results of from the SOLOIST-WHF phase 3 trial to determine changes to healthcare utilization from adopting Inpefa. Researchers also included clinical inputs such as safety and efficacy data, and financial inputs, including costs of healthcare utilization.
The model assessed how the magnitude of changes in healthcare utilization affects health systems’ finances under three alternative payment models: the Hospital Readmissions Reduction Program (a Medicare value-based purchasing program), Bundled Payments for Care Improvement Advanced (which includes financial and performance accountability) and an Accountable Care Organization (a coordinated care model).
Researchers found that the probability of hospitalizations, emergency department visits and deaths decreased: 29% for hospitalizations, 38.5% for emergency department visits, and 17.8% for deaths.
Additionally, the model found that financial returns increased for healthcare systems, by $4,720 per person through the Hospital Readmissions Reduction Program; by $1,200 per person under the Bundled Payments for Care Improvement Advanced; and by $1,078 per person under an Accountable Care Organization. Margins also increased by $1,576 per person under an alternative payment model.
Limitations include the fact that the model did not assess indirect costs and non-cost outcomes (such as patient loss of productivity) and also only assessed the three payment scenarios, which can vary by payer.
Earlier this year, a separate analysis of Inpefa demonstrated that it was cost-effective in treating patients with heart failure. This analysis was conducted by Medstar Health Research and sponsored by Lexicon. This analysis was based nine-month median follow-up data from the 1,222 patients enrolled in the phase 3 SOLOIST-WHF trial and designed to extrapolate costs, life expectancy, and quality-adjusted life expectancy.
The researchers determined that Inpefa is cost-effective at commonly accepted willingness-to-pay thresholds in patients with diabetes and worsening heart failure. The analysis used a base price of $450 for a month’s supply, and but researchers also found that that Inpefa was cost-effective at about $1,000 a month.
Compared with the placebo group, Inpefa added 0.39 quality of life years at an incremental lifetime cost of $29,449 for an incremental cost-effectiveness ratio of $75,510 per quality-of-life year gained, which was lower than the threshold of $100,000.