Analysis of INPEFA® (Sotagliflozin) Cost-Effectiveness Published in JACC: Heart Failure, the Peer-Reviewed Journal of the American College of Cardiology

Rhea-AI Summary

Lexicon Pharmaceuticals (Nasdaq: LXRX) has announced that a new analysis published in the Journal of the American College of Cardiology: Heart Failure concludes that INPEFA® (sotagliflozin) is cost-effective for patients with diabetes and recent worsening heart failure. The peer-reviewed study, conducted from a U.S. healthcare perspective, follows Consolidated Health Economic Evaluation Reporting Standards. It reveals that lifetime quality-adjusted life-years (QALYs) were higher for the INPEFA group (4.43) compared to the placebo group (4.04), confirming the drug's economic viability. Another study in the Journal of Comparative Effectiveness Research supports these findings, showing a net QALY gain of 0.425 for INPEFA. Lexicon's senior VP, Craig Granowitz, emphasized the financial and clinical benefits for the U.S. healthcare system.

Positive

• INPEFA (sotagliflozin) demonstrated cost-effectiveness in patients with diabetes and worsening heart failure.
• The study, published in the Journal of the American College of Cardiology: Heart Failure, followed rigorous Consolidated Health Economic Evaluation Reporting Standards.
• Lifetime quality-adjusted life-years (QALYs) were 4.43 for INPEFA versus 4.04 for placebo, confirming the economic value.
• The results were supported by another study in the Journal of Comparative Effectiveness Research, which showed a net gain in QALYs of 0.425.
• Lexicon's senior VP highlighted significant financial value for payors and the U.S. healthcare system.

Negative

• The press release does not provide specific cost figures for INPEFA, which may limit transparency for investors.
• There is no mention of any potential side effects or risks associated with INPEFA, which could be a red flag for cautious investors.
• The studies are based on specific patient populations (diabetes and worsening heart failure), potentially limiting the general applicability of the findings.

Financial Analyst

The publication of cost-effectiveness data for INPEFA® (sotagliflozin) in a high-impact, peer-reviewed journal like JACC: Heart Failure is significant for investors. These clinical findings support the financial viability of INPEFA, emphasizing its economic value to the U.S. healthcare system. From an investor's perspective, this could potentially drive increased adoption among healthcare providers and payors, translating to higher sales and revenue for Lexicon Pharmaceuticals.

In terms of specific metrics, the increase in Quality-Adjusted Life Years (QALYs) indicates that patients not only live longer but also enjoy better quality of life, which is attractive from a cost-benefit standpoint. The net gain in QALYs (0.425) for INPEFA demonstrates a substantial improvement over standard care. Such metrics are often critical in convincing insurance companies to cover new treatments, thereby expanding the market.

However, it's important to consider potential drawbacks. Cost-effectiveness in the U.S. market doesn't necessarily translate internationally due to differing healthcare systems and reimbursement policies. Moreover, the real-world efficacy of INPEFA needs ongoing scrutiny to ensure these findings hold beyond clinical trials.

Medical Research Analyst

The publication highlights that INPEFA® is a cost-effective treatment, a important consideration in modern healthcare where budget constraints are significant. The SOLOIST-WHF trial's findings, which are now validated by a well-respected medical journal, reinforce the clinical and economic benefits of sotagliflozin for patients with diabetes and heart failure.

Cost-effectiveness is assessed using willingness-to-pay thresholds, commonly set by healthcare systems to determine if a treatment provides sufficient value. INPEFA's favorable comparison to these thresholds can significantly influence its uptake among healthcare providers. This suggests that INPEFA is not only clinically beneficial but also a financially justifiable option, likely leading to greater adoption in treatment protocols.

Furthermore, the increase in QALYs points to genuine improvements in patient outcomes, supporting its broader use. Yet, ongoing post-market studies will be essential to confirm these results in day-to-day clinical practice.

While these findings strengthen the case for INPEFA's use, investors should remain aware of the dynamic nature of clinical research and reimbursement landscapes, which could influence long-term prospects.

New analysis of the pivotal Phase 3 SOLOIST-WHF trial demonstrates INPEFA cost-effectiveness

Findings consistent with another study recently published in the Journal of Comparative Effectiveness Research

THE WOODLANDS, Texas, June 18, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that the peer-reviewed Journal of the American College of Cardiology: Heart Failure has published a research paper concluding that INPEFA^® (sotagliflozin) is cost-effective for people with diabetes and recent worsening heart failure using commonly accepted willingness-to-pay thresholds.

“Our research team believes that this study is an important contribution to the economic evaluation of sotagliflozin, a novel SGLT inhibitor, from the perspective of the U.S. healthcare system. Our results demonstrated that in people with diabetes and recent worsening heart failure, sotagliflozin is cost-effective at commonly accepted willingness-to-pay thresholds,” said William S. Weintraub, MD, MACC, FAHA, FESC, director of Population Health Research at MedStar Health Research Institute, and the lead author of the research paper.

The analysis was conducted from a U.S. healthcare sector perspective, in accordance with Consolidated Health Economic Evaluation Reporting Standards. Results from this study showed that lifetime quality-adjusted life-years (QALYs) were 4.43 and 4.04 in the INPEFA and placebo groups, respectively.

In another study, “Cost-effectiveness of sotagliflozin for the treatment of patients with diabetes and recent worsening heart failure,” recently published in the Journal of Comparative Effectiveness Research, the research team used published real-world data to derive baseline event frequencies and SOLOIST-WHF study data to estimate the efficacy of INPEFA. According to the research results, the use of INPEFA led to a net gain in QALYs of 0.425 for INPEFA versus standard of care. The investigators concluded that INPEFA is a cost-effective addition to standard of care for patients hospitalized with heart failure and comorbid diabetes.

“The data published in these two peer-reviewed journals reinforce our position that in addition to providing meaningful clinical benefits to heart failure patients, INPEFA provides significant financial value for payors and the U.S. healthcare system,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer.

The Journal of the American College of Cardiology: Heart Failure manuscript can be accessed here.

About Lexicon Pharmaceuticals 

Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through the Genome5000™ program, Lexicon’s unique genomics target discovery platform, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to treat disease safely and effectively. Lexicon has commercially launched one of these medicines, INPEFA^® (sotagliflozin) in the United States, and has a pipeline of other promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, diabetes and metabolism and other indications. For additional information, please visit www.lexpharma.com. 

About INPEFA^® (sotagliflozin) 

Discovered using Lexicon’s unique approach to gene science, INPEFA^® (sotagliflozin) is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible for glucose and sodium reabsorption by the kidney and SGLT1 is responsible for glucose and sodium absorption in the gastrointestinal tract. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients.

INDICATION 

INPEFA is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with: 

• heart failure or 
• type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors 
  

IMPORTANT SAFETY INFORMATION

Dosing: Assess renal function and volume status and, if necessary, correct volume depletion prior to initiation of INPEFA. INPEFA dosing for patients with decompensated heart failure may begin when patients are hemodynamically stable, including when hospitalized or immediately upon discharge. 

Contraindications: INPEFA is contraindicated in patients with hypersensitivity to INPEFA or any of its components. 

Ketoacidosis: INPEFA increases the risk of ketoacidosis in patients with type 1 diabetes mellitus (T1DM).  Type 2 diabetes Mellitus (T2DM) and pancreatic disorders are also risk factors.  The risk of ketoacidosis may be greater with higher doses.  There have been postmarketing reports of fatal events of ketoacidosis in patients with type 2 diabetes using sodium glucose transporter 2 (SGLT2) inhibitors.  Before initiating INPEFA, assess risk factors for ketoacidosis. Consider ketone monitoring in patients with T1DM and consider ketone monitoring in others at risk for ketoacidosis and educate patients on the signs/symptoms of ketoacidosis.  Patients receiving INPEFA may require monitoring and temporary discontinuation of therapy in clinical situations known to predispose to ketoacidosis.  INPEFA is not indicated for glycemic control. 

Assess patients who present with signs and symptoms of metabolic acidosis or ketoacidosis, regardless of blood glucose level.  If suspected, discontinue INPEFA, evaluate, and treat promptly.  Monitor patients for resolution of ketoacidosis before restarting INPEFA. 

Volume Depletion: INPEFA can cause intravascular volume depletion which may sometimes manifest as symptomatic hypotension or acute transient changes in creatinine.  There have been post-marketing reports of acute kidney injury, some requiring hospitalization and dialysis, in patients with type 2 diabetes mellitus receiving SGLT2 inhibitors.  Patients with impaired renal function (eGFR < 60 mL/min/1.73 m2), elderly patients, or patients on loop diuretics may be at increased risk for volume depletion or hypotension.  Before initiating INPEFA in patients with one or more of these characteristics, assess volume status and renal function, and monitor for signs and symptoms of hypotension during therapy. 

Urosepsis and Pyelonephritis: Treatment with SGLT2 inhibitors, including INPEFA, increases the risk for urinary tract infections.  Serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalization have been reported. Evaluate patients for signs and symptoms of urinary tract infections and treat promptly. 

Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues: Insulin and insulin secretagogues are known to cause hypoglycemia.  INPEFA may increase the risk of hypoglycemia when combined with insulin or an insulin secretagogue.  Therefore, a lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used with INPEFA. 

Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): Reports of Fournier’s Gangrene, a rare but serious and life-threatening necrotizing infection requiring urgent surgical intervention, have been identified in post-marketing surveillance in patients with diabetes mellitus receiving SGLT2 inhibitors.  Assess patients who present with pain, tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise. If suspected, start treatment immediately with broad-spectrum antibiotics and, if necessary, surgical debridement.  Discontinue INPEFA, closely monitor patient signs and symptoms, and provide appropriate alternative therapy for heart failure. 

Genital Mycotic Infections: INPEFA increases the risk of genital mycotic infections.  Monitor and treat as appropriate. 

Urinary Glucose Test and 1,5-anhydroglucitol (1,5-AG) Assay: these are not reliable for patients taking SGLT2 inhibitors.  Use alternative testing methods to monitor glucose levels.  

Common Adverse Reactions: the most commonly reported adverse reactions (incidence ≥ 5%) were urinary tract infection, volume depletion, diarrhea, and hypoglycemia. 

Drug Interactions: 

• Digoxin: Monitor patients appropriately as there is an increase in the exposure of digoxin when coadministered with INPEFA 400 mg.
• Uridine 5'-diphospho-glucuronosyltransferase (UGT) Inducer: The coadministration of rifampicin, an inducer of UGTs, with sotagliflozin resulted in a decrease in the exposure of sotagliflozin.  
• Lithium: Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations.  Monitor serum lithium concentration more frequently during INPEFA initiation and with dosage changes. 
  

Use in Specific Populations: 

• Pregnancy and Lactation: INPEFA is not recommended during the second and third trimesters of pregnancy, nor while breastfeeding. 
• Geriatric Use: No INPEFA dosage change is recommended based on age.  No overall differences in efficacy were detected between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.  Elderly patients may be at increased risk for volume depletion adverse reactions, including hypotension. 
• Renal Impairment: INPEFA was evaluated in patients with chronic kidney disease (eGFR 25 to 60 mL/min/1.73 m²) and in patients with heart failure with eGFR < 60 mL/min/1.73 m².  The safety profile of INPEFA across eGFR subgroups in these studies was consistent with the known safety profile.  There was an increase in volume-related adverse events (e.g., hypotension, dizziness) in patients with eGFR < 30 mL/min/1.73m² relative to the overall safety population.  Efficacy and safety studies with INPEFA did not enroll patients with an eGFR less than 25 mL/min/1.73 m² or on dialysis.  After starting therapy in the studies, patients were discontinued if eGFR fell below 15 mL/min/1.73 m² or were initiated on chronic dialysis. 
• Hepatic Impairment: INPEFA is not recommended in patients with moderate or severe hepatic impairment. 

Click here for full Prescribing Information. 

https://www.lexpharma.com/inpefa-US-PI.pdf 

Safe Harbor Statement 

This press release contains “forward-looking statements,” including statements relating to Lexicon’s financial position and long-term outlook on its business, growth and future operating results, discovery, development and commercialization of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, successfully commercialize INPEFA in heart failure, conduct preclinical and clinical development and obtain necessary regulatory approvals of sotagliflozin (in other indications), LX9211, LX9851 and its other drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its products and drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2023 and other subsequent disclosure documents filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise. 

For Investor Inquiries: 

Lisa DeFrancesco
Lexicon Pharmaceuticals, Inc.
lexinvest@lexpharma.com 

For Media Inquiries: 

Alina Cocuzza 
Lexicon Pharmaceuticals, Inc. 
acocuzza@lexpharma.com 

FAQ

What is the cost-effectiveness of INPEFA (sotagliflozin) according to recent studies?

Two recent studies conclude that INPEFA is cost-effective for patients with diabetes and recent worsening heart failure, showing higher QALYs compared to standard care.

What are the findings of the INPEFA cost-effectiveness study published in the Journal of the American College of Cardiology: Heart Failure?

The study found that lifetime QALYs were 4.43 for INPEFA and 4.04 for placebo, confirming its economic value for the U.S. healthcare system.

How does the Journal of Comparative Effectiveness Research support INPEFA's cost-effectiveness?

The Journal of Comparative Effectiveness Research found a net gain in QALYs of 0.425 for INPEFA, supporting its cost-effectiveness as an addition to standard care.

What is the impact of INPEFA on the U.S. healthcare system according to Lexicon Pharmaceuticals?

Lexicon Pharmaceuticals states that INPEFA provides significant financial value to payors and the U.S. healthcare system, in addition to clinical benefits.

What is the stock symbol for Lexicon Pharmaceuticals?

The stock symbol for Lexicon Pharmaceuticals is LXRX.