Express Scripts has also included the heart failure drug Inpefa on its Medicare formularies.
Express Scripts, Cigna’s PBM, has placed Inpefa (sotagliflozin) on its Basic and High Performance formularies for commercially insured patients beginning Nov. 1, 2023. 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.
Last month, it was announced that Express Scripts had placed Inpefa on its Premier Access and Premier Performance national formularies for Medicare patients.
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.
Inpefa was approved in May 2023, and 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.
Inpefa’s approval was based on two phase 3 cardiovascular outcomes studies. Together, SOLOIST-WHF (Worsening Heart Failure) and SCORED enrolled almost 12,000 patients. 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.
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.
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.