Cost-Effectiveness Analysis of Nefecon versus Best Supportive Care for People with Immunoglobulin A Nephropathy (IgAN) in the United States

Ramjee, Lauren; Vurgun, Nesrin; Ngai, Chris; Patel, Mit; Tremblay, Gabriel

doi:10.2147/ceor.s389456

Cited by 3 publications

(4 citation statements)

References 38 publications

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“…Annually, the predicted dialysis cost per patient is USD 98.410 in the United States [ 51 ]. The total budesonide treatment with Nefecon is estimated to be USD 14.160 USD for a single patient per cycle [ 52 ]. Each cycle has a mean duration of 9 months [ 52 ].…”

Section: Recent Clinical Trialsmentioning

confidence: 99%

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Diagnosing and Treating IgAN: Steroids, Budesonide, or Maybe Both?

Keskinis,

Moysidou,

Christodoulou

et al. 2024

Diagnostics

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IgA nephropathy (IgAN), the most common primary glomerulonephritis worldwide, is characterized by a mesangial IgA deposit and a variety of histological lesions, as described by the Oxford classification system. Despite the well-described “four-hit hypothesis”, there are still plenty of less or undescribed mechanisms that participate in the disease pathogenesis, such as B-cell priming, which seems to be initiated by different antigens in the intestinal microbiota. Diagnosis of the disease is currently based on kidney biopsy findings, as the sensitivity and specificity of the many serum and urinary biomarkers described so far do not seem to have diagnostic accuracy. Therapeutic strategies consist of the initial step of non-immune medication, aiming to reduce both the intraglomerular pressure and proteinuria to below 0.5 g/day, followed by systemic corticosteroid administration in patients who remain at high risk for progressive chronic kidney disease despite the maximum non-immune treatment. The 6-month systemic corticosteroid treatment reduces proteinuria levels; however, the increased possibility of adverse events and increased relapse rate after treatment raises the need for a new therapeutic approach. Targeted-release budesonide is a therapeutic modality that aims to inhibit disease pathogenetic pathways at early stages; it has minor systemic absorption and proven beneficial effects on renal function and proteinuria. In the present systemic review, the benefits and adverse events of steroids and budesonide are described, and the possibility of combined treatment is questioned in selected cases with active histologic lesions.

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Section: Recent Clinical Trialsmentioning

confidence: 99%

“…The total budesonide treatment with Nefecon is estimated to be USD 14.160 USD for a single patient per cycle [ 52 ]. Each cycle has a mean duration of 9 months [ 52 ]. Moreover, when a patient experiences advanced kidney disease; then they also have increased morbidity, which means increased costs for the health system.…”

Section: Recent Clinical Trialsmentioning

confidence: 99%

Diagnosing and Treating IgAN: Steroids, Budesonide, or Maybe Both?

Keskinis,

Moysidou,

Christodoulou

et al. 2024

Diagnostics

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“…Treatment-related side effects were mild, although signs of systemic corticosteroid exposure were noted in up to 41% of patients in the NEFIGAN study. 56 A major constraint to the widespread use of TRF-budesonide is its economic cost ($14,160 for 1 month of treatment 61 ). It should be noted that the postulated selective effect of TRF-budesonide on the Peyer patches has not been directly demonstrated.…”

Section: Therapies That Target the Formation Of Gd-iga1 And Anti-gd-i...mentioning

confidence: 99%

“…A major constraint to the widespread use of TRF-budesonide is its economic cost ($14,160 for 1 month of treatment 61 ). It should be noted that the postulated selective effect of TRF-budesonide on the Peyer patches has not been directly demonstrated.…”

Section: Therapies That Target the Formation Of Gd-iga1 And Anti–gd-i...mentioning

confidence: 99%

Treatment of IgA Nephropathy: A Rapidly Evolving Field

El Karoui,

Fervenza,

De Vriese

2023

JASN

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The pivotal event in the pathophysiology of IgA nephropathy is the binding of circulating IgA-containing immune complexes to mesangial cells, with secondary glomerular and tubulointerstitial inflammation and fibrosis. The paramount difficulty in the management of IgA nephropathy is the heterogeneity in its clinical presentation and prognosis, requiring an individualized treatment approach. Goal-directed supportive care remains the bedrock of therapy for all patients, regardless of risk of progression. SGLT2 inhibitors and sparsentan should be integral to contemporary supportive care, particularly in patients with chronic kidney damage. Pending the development of reliable biomarkers, it remains a challenge to identify patients prone to progression due to active disease and most likely to derive a net benefit from immunosuppression. The use of clinical parameters, including the degree of proteinuria, the presence of persistent microscopic hematuria and the rate of eGFR loss, combined with the MEST-C score, is currently the best approach. Systemic glucocorticoids are indicated in high-risk patients, but the beneficial effects wane after withdrawal and come at the price of substantial treatment-associated toxicity. Therapies with direct impact on disease pathogenesis are increasingly becoming available. While targeted release budesonide has garnered the most attention, anti-B cell strategies and selective complement inhibition will most likely prove their added value. We propose a comprehensive approach that tackles the different targets in the pathophysiology of IgA nephropathy according to their relevance in the individual patient.

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