Inpefa is approved to reduce the risk of cardiovascular death and hospitalization for heart failure in adults. The wholesale acquisition cost is $598 per month.
Beginning Nov. 1, 2023, Express Scripts, Cigna’s PBM, has placed Inpefa (sotagliflozin) on its Premier Access and Premier Performance national formularies for Medicare patients. 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.
About 6.7 million Americans suffer from heart failure, with the prevalence expected to rise to 8.0 million by 2030. Heart failure is the leading cause of hospitalizations for individuals aged 65 and older, triggering about 1.3 million hospitalizations a year. Patients with heart failure are at highest risk of a heart failure event in the first 30 days post-discharge, with 7% dying and 25% being rehospitalized within one month. Diabetes, chronic kidney disease, peripheral vascular disease, and stroke are diseases that increase the risk of heart failure.
The SGLT class, originally approved to treat type 2 diabetes, has revolutionized the oral treatment of chronic heart failure. Two SGLT2 inhibitors are now on the market for patients who have a history of heart failure: AstraZeneca’s Farxiga (dapagliflozin) and Boehringer Ingelheim’s Jardiance (empagliflozin).
Inpefa is an inhibitor of both SGLT2 and SGLT1, which are responsible for glucose regulation in the kidney and gastrointestinal tract, respectively. The wholesale acquisition cost of Inpefa is $598 per month. A $10 copay card for Inpefa is available that would cover up to $2,600 in costs per year.
A Lexicon-sponsored study found Inpefa would likely be cost-effective for commonly accepted willingness-to-pay thresholds in patients with diabetes and worsening heart failure. Conducted by Medstar Health Research, the analysis was based on 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 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.
A post-hoc analysis of data from the SOLOIST-WHF phase 3 outcomes study of found that treatment with Inpefa resulted in significant relative risk reductions of about 50% for readmission for non-fatal heart failure events and for the composite of cardiovascular death and readmission for heart failure at 30- or 90-days following hospital discharge versus placebo. The study was published in August in the Journal of the American College of Cardiology: Heart Failure.
“Our analysis concluded that starting sotagliflozin before discharge in patients hospitalized for worsening heart failure significantly decreased cardiovascular deaths and heart failure events,” Bertram Pitt, M.D., professor of medicine emeritus at the University of Michigan, School of Medicine, and the paper’s lead author, said in a press release. “Hospital readmissions are burdensome, time-consuming, and costly. The results emphasize the importance of beginning SGLT inhibition before discharge.”
Lexicon is also studying sotagliflozin in type 1 diabetes. The FDA, however, had issued a complete response letter for an NDA for this indication in 2019. Company officials said in its second quarter 2023 financial results that a hearing process is ongoing.
Additionally, Lexicon is developing LX9211 to treat patients with diabetic peripheral neuropathic pain. The company has recently begun a phase 2b dose optimization study.