Reducing Medical Costs Through Innovative Treatment for Chronic Kidney Disease

Content sponsored by AstraZeneca Pharmaceuticals LP

Gary A. Singer, MD, FACP, nephrologist, founding partner of Midwest Nephrology Associates and an Assistant Professor of Clinical Medicine at Washington University School of Medicine

As a practicing nephrologist, I have treated many people with chronic kidney disease (CKD). The disturbing reality is that an estimated 37 million American adults are living with CKD¹, yet 9 in 10 people don’t know they have it.² This is due in part to the fact that CKD is a “silent disease,” with symptoms often not appearing until the disease has advanced.¹ When CKD goes undiagnosed and untreated, it tends to progress to advanced stages, leading to end-stage kidney disease (ESKD), requiring a kidney transplant or dialysis for patients to survive.³

People with CKD have a higher risk of heart failure (HF) because their kidneys cannot effectively eliminate salt and water.⁴ Similarly, patients with HF often have reduced blood flow to their kidneys and, therefore, have a higher risk of CKD. Currently, more than 1 million hospitalizations per year are caused by HF⁵, and it is the number one 30-day readmission diagnosis causing rehospitalization within a month.^5-6

For decades, CKD was treated by managing underlying conditions, such as diabetes and hypertension.¹ However, recent advancements in nephrology have led to newer CKD treatments, such as FARXIGA^® (dapagliflozin), which can reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, ESKD, cardiovascular (CV) death, and hospitalization for HF in adults with CKD at risk of progression (see additional Indications and Limitations of Use below).^7-8

FARXIGA is the first sodium-glucose cotransporter 2 (SGLT2) inhibitor proven to significantly reduce the risk of mortality in patients with CKD. ^8-14 The DAPA-CKD Phase III trial showed that, on top of standard of care with an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker, FARXIGA demonstrated a 39% relative risk reduction in the primary composite endpoint of sustained ≥50% eGFR decline, ESKD and CV or renal death compared to placebo (HR 0.61; 95% CI: 0.51-0.72; p<0.0001) in 4,304 patients with CKD (eGFR between 25 and 75 mL/min/1.73m²) and albuminuria (urine albumin creatinine [UACR] between 200 and 5000 mg/g.^7-8 FARXIGA also demonstrated a 29% relative risk reduction in the composite of CV death or hospitalization for HF (HR 0.71; 95% CI: 0.55-0.92; p=0.0089) and a 31% relative risk reduction in all-cause mortality (HR 0.69; 95% CI: 0.53-0.88; p=0.0035). FARXIGA is contraindicated in patients with a prior serious hypersensitivity reaction to FARXIGA. FARXIGA also has several Warnings and Precautions including for ketoacidosis, volume depletion, and urosepsis and pyelonephritis (see Important Safety Information below).

In addition to these advancements, more can be done to ensure regular CKD screening, timely diagnosis and early intervention to slow disease progression.¹⁵ This can help reduce clinical and economic burdens, including hospitalizations.

A retrospective, observational cohort study of real-world data was recently published in Expert Review of Pharmacoeconomics & Outcomes Research, which evaluated the impact of dapagliflozin on short-term medical costs in 1,006 1:1 propensity score matched patients with Stage 3 CKD¹⁶. Patients were identified from the IQVIA PharMetrics Plus US commercial medical and pharmacy claims database as being 18 years or older and diagnosed with Stage 3 CKD between September 2020 and December 2021. The study showed that dapagliflozin was associated with reduced CKD-related medical costs (the sum of claims for inpatient hospitalizations, emergency department (ED) visits, and outpatient visits with a diagnosis code for CKD in any diagnosis position and claims for inpatient hospitalizations with a diagnosis code for HF in any diagnosis position) over 6 months compared with no dapagliflozin treatment in patients with Stage 3 CKD.  

The costs listed below were also analyzed for this population over the course of 6 months:¹⁶

• Patient out-of-pocket (OOP) costs for CKD-related medical claims defined as the sum of deductibles, coinsurances, and copays paid by the patient for CKD-related medical claims (ie, CKD-related inpatient hospitalizations, outpatient visits, and ED visits and HF-related inpatient hospitalizations)
• All-cause medical costs for payers defined as the sum of costs for inpatient hospitalization, ED visits, and outpatient visits
• All-cause pharmacy cost does not exclude rebates and discounts to payers

Analyses found:

• A reduction in the mean per-patient CKD-related medical cost of $3,047.35 (49.0%) for patients treated with dapagliflozin compared to patients not treated with dapagliflozin. Mean per-patient OOP CKD-related medical costs were also reduced by $786.48 or 74.0% between the two groups.¹⁶
• The mean all-cause medical cost per patient, including inpatient hospitalizations, ED visits and outpatient visits, was reduced by $4,151.29 or 34.0% for patients treated with dapagliflozin compared to patients not treated with dapagliflozin.¹⁶
• The mean all-cause pharmacy cost per patient increased by $1,603.75 or 21.5% in the dapagliflozin cohort versus the non-dapagliflozin cohort. However, dapagliflozin was associated with a reduction in CKD-related and all-cause medical costs that exceeded the increase in all-cause pharmacy costs.¹⁶
• The retrospective design of this study and the reliance on claims data introduce potential limitations. Claims data may be susceptible to coding restrictions, which may lead to misclassification of disease status, study outcomes, and covariates. As a non-randomized study, residual confounding is possible and differences in follow-up costs may result from factors other than dapagliflozin treatment.
• Insurance claims data do not include key clinical (eGFR, UACR, or blood pressure) and lifestyle (diet or smoking status) factors to match and adjust for.

Nephrologists and primary care physicians play critical roles in helping to ensure a healthy future for those living with CKD. I’m excited by this real-world data, which supports the findings from the DAPA-CKD study, anticipating reductions in personal and system-wide medical costs for those treated with FARXIGA, and the potential benefit of this medicine for CKD patients.^7,16 By diagnosing and treating CKD early, we can help delay dialysis allowing our patients to live longer lives.^17-18

For additional information on FARXIGA, visit farxiga-hcp.com.

IMPORTANT SAFETY INFORMATION for FARXIGA® (dapagliflozin)

Contraindications

Prior serious hypersensitivity reaction to FARXIGA

Warnings and Precautions

• Ketoacidosis: FARXIGA significantly increases the risk of diabetic ketoacidosis in patients with type 1 diabetes mellitus. Type 2 diabetes mellitus and pancreatic disorders are also risk factors. There have been postmarketing reports of fatal events of ketoacidosis in patients with type 2 diabetes mellitus using SGLT2 inhibitors, including FARXIGA. Consider ketone monitoring in patients with type 1 diabetes mellitus and in others at risk for ketoacidosis. Assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose levels. If suspected, discontinue FARXIGA, evaluate and treat promptly. Withhold FARXIGA, if possible, in temporary clinical situations that could predispose patients to ketoacidosis. Resume FARXIGA when the patient is clinically stable and has resumed oral intake
• Volume Depletion: FARXIGA can cause intravascular volume depletion, which may manifest as symptomatic hypotension or acute transient changes in creatinine. Acute kidney injury requiring hospitalization and dialysis has been reported in patients with type 2 diabetes mellitus receiving SGLT2 inhibitors, including FARXIGA. Patients with impaired renal function (eGFR less than 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 FARXIGA in these patients, assess volume status and renal function. After initiating therapy, monitor for signs and symptoms of hypotension and renal function
• Urosepsis and Pyelonephritis: SGLT2 inhibitors increase the risk for urinary tract infections (UTIs) and serious UTIs have been reported with FARXIGA. Evaluate for signs and symptoms of UTIs and treat promptly
• Hypoglycemia: FARXIGA can increase the risk of hypoglycemia when coadministered with insulin and insulin secretagogues. Consider lowering the dose of these agents when coadministered with FARXIGA
• Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): Rare but serious, life-threatening cases have been reported in patients with diabetes mellitus receiving SGLT2 inhibitors, including FARXIGA. Cases have been reported in females and males. Serious outcomes have included hospitalization, surgeries, and death. Assess patients presenting with pain or tenderness, erythema, swelling in the genital or perineal area, along with fever or malaise. If suspected, institute prompt treatment and discontinue FARXIGA
• Genital Mycotic Infections: FARXIGA increases the risk of genital mycotic infections, particularly in patients with prior genital mycotic infections. Monitor and treat appropriately

Adverse Reactions

In a pool of 12 placebo-controlled studies, the most common adverse reactions (≥5%) associated with FARXIGA 5 mg, 10 mg, and placebo, respectively, were female genital mycotic infections (8.4% vs 6.9% vs 1.5%), nasopharyngitis (6.6% vs 6.3% vs 6.2%), and urinary tract infections (5.7% vs 4.3% vs 3.7%).

Use in Specific Populations

• Pregnancy: Advise females of potential risk to a fetus especially during the second and third trimesters
• Lactation: FARXIGA is not recommended when breastfeeding

INDICATIONS AND LIMITATIONS OF USE for FARXIGA

FARXIGA is indicated:

• as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
• to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular (CV) disease or multiple CV risk factors
• to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure
• to reduce the risk of sustained eGFR decline, end‑stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression

FARXIGA is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus.

FARXIGA is not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m². FARXIGA is likely to be ineffective in this setting based upon its mechanism of action.

FARXIGA is not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease. FARXIGA is not expected to be effective in these populations.

DOSING

To improve glycemic control, the recommended starting dose is 5 mg orally once daily. Dose can be increased to 10 mg orally once daily for additional glycemic control.

For all other indications, the recommended dose is 10 mg orally once daily.

Please see accompanying US Full Prescribing Information for FARXIGA.

[References]

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