Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced
that the Journal of Managed Care + Specialty Pharmacy (JMCP), the
peer-reviewed journal of the Academy of Managed Care Pharmacy, has
published a research paper concluding that the use of INPEFA®
(sotagliflozin) for the treatment of patients hospitalized for
heart failure (HF) and suffering from comorbid diabetes leads to
significant positive impact on provider health system financial
outcomes, largely due to bonus payments through alternative payment
models (APM).
Researchers quantified the one-year financial impact on US
provider health systems of adopting sotagliflozin relative to
standard of care (SoC) across three common APMs, also known as
value-based purchasing agreements: the Bundled Payments for Care
Improvement-Advanced program (BPCI), Medicare Shared Savings
Program for Accountable Care Organizations program (ACO), and the
Hospital Readmissions Reduction Program (HRRP). HRRP is a Medicare
value-based purchasing program designed to encourage hospitals to
reduce the 30-day risk of unplanned readmissions for six procedures
or conditions, including HF.
“Our analysis demonstrated that sotagliflozin use reduced the
frequency of patient hospital readmissions and emergency department
visits, leading providers to receive larger value-based bonus
payments under these alternative payment models,” said Jason
Shafrin, Ph.D., Center for Healthcare Economics and Policy at FTI
Consulting, and the lead author of the research paper.
The study population matched that of the SOLOIST-WHF trial:
adult patients aged 18 to 85 years who had been hospitalized for a
HF event and were also diagnosed with diabetes. Researchers modeled
the total costs of rehospitalization, emergency department visits,
drug costs, and adverse events between sotagliflozin and SoC from
the perspective of a median sized U.S. community hospital and
concluded that substantial positive financial impacts were realized
with sotagliflozin when participating in any of the three studied
APMs. On a per admission basis, sotagliflozin adoption resulted in
a $4,720 margin increase for HRRP, $1,200 margin increase for BPCI,
and $1,078 margin increase for ACO.
Sotagliflozin adoption also produced significant cost savings
when measured on a total health system basis. The model estimated
that a median sized U.S. community hospital would realize a
$305,604 annual margin increase for HRRP, $100,106 margin increase
for BPCI, and $31,029 margin increase for ACO by adopting
sotagliflozin.
“There is a growing body of evidence that the use of INPEFA for
patients hospitalized with heart failure who suffer from diabetes
leads to significant value for payors and clinical institutions,”
said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president
and chief medical officer. “This analysis provides additional
evidence that as more health systems adopt APMs, often more than
one at a time, there is potential to realize important clinical and
financial advantages with the use of INPEFA.”
The Journal of Managed Care + Specialty Pharmacy manuscript can
be accessed here.
These findings are consistent with two peer-reviewed studies
published in June 2024, “Cost-Effectiveness of
Sotagliflozin in SOLOIST-WHF” in the Journal of the
American College of Cardiology: Heart Failure can be accessed here
and “Cost–effectiveness of sotagliflozin for the treatment
of patients with diabetes and recent worsening heart
failure” in the Journal of Comparative Effectiveness
Research 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 INPEFA
(sotagliflozin) and 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
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