Austin, Texas—Autosomal dominant polycystic kidney disease (ADPKD) is a progressive genetic kidney disease characterized by enlargement of bilateral renal cysts leading to loss of renal function. The TEMPO 3:4 trial demonstrated the efficacy of tolvaptan, a selective vasopressin V2-receptor antagonist. TEMPO 3:4 was a randomized, placebo-controlled trial involving 1445 patients over 3 years. An analysis of prespecified end points showed a significant reduction in the occurrence of renal pain and a slowing in progression of chronic kidney disease with tolvaptan.
Researchers led by Callum Shephard recently conducted a study designed to assess the impact of tolvaptan compared with placebo on costs associated with renal pain events and CKD progression. Study results were reported during a poster session at the NKF Spring Clinical Meetings 2018 in a poster titled Impact of Tolvaptan on Costs Associated with Renal Pain and Chronic Kidney Disease among Patients with Autosomal Dominant Polycystic Kidney Disease.
The cost-consequence analysis included 1000 patients with ADPKD and was conducted from a payer perspective. Publicaly available sources were utilized to obtain resource use costs, including labor, diagnostic, and pain relief medications and procedures. Costs by CKD stage were gathered from Golestaneh 2017.
Rates of renal pain events and related costs were stratified by pain severity. Renal pain costs were assessed on-treatment: during the 3-year trial study period. Due to the hemodynamic effect of tolvaptan on estimated glomerular filtration rate, costs related to CKD were assessed off-treatment: at baseline prior to treatment and at 2 weeks after treatment withdrawal.
There was an association between tolvaptan and 90 fewer renal pain events over the 3 years. Resulting pain-events related costs were lower with tolvaptan compared with placebo ($98,147 vs $161,299). Baseline total monthly costs related to CKD management were similar between tolvaptan and placebo ($1,419,784 vs $1,406,842). At 2 weeks after tolvaptan withdrawal, the slower rate of CKD progression with tolvaptan was reflected in lower monthly CKD costs compared with placebo ($1,872,196 vs $2,052,792).
In conclusion, the researchers said, “This analysis showed tolvaptan use affects renal pain and CKD costs. Future studies should include the cost of tolvaptan to assess the overall cost impact of tolvaptan.”
Source: Shephard C, Delavelle C, Riemer J, et al. Impact of tolvaptan on costs associated with renal pain and chronic kidney disease among patients with autosomal dominant polycystic kidney disease. Abstract of a poster presented at the National Kidney Foundation Spring Clinical Meetings 2018, April 10-14, 2018, Austin, Texas.