Cost Effectiveness of Paricalcitol Versus Cinacalcet with Low-Dose Vitamin D for Management of Secondary Hyperparathyroidism in Haemodialysis Patients in the USA
The IMPACT SHPT [Improved Management of Intact Parathyroid Hormone (iPTH) with Paricalcitol-Centered Therapy Versus Cinacalcet Therapy with Low-Dose Vitamin D in Hemodialysis Patients with Secondary Hyperparathyroidism] study compared the effectiveness of paricalcitol and cinacalcet in the management of secondary hyperparathyroidism in haemodialysis patients but did not report the costs or cost effectiveness of these treatments.
The aim of this study was to compare the cost effectiveness of a paricalcitol-based regimen versus cinacalcet with low-dose vitamin D for management of secondary hyperparathyroidism in haemodialysis patients from a US payer perspective, using a 1-year time horizon.
This was a post hoc cost-effectiveness analysis of data collected for US patients enrolled in the IMPACT SHPT study—a 28-week, randomized, open-label, phase 4, multinational study (ClinicalTrials.gov identifier: NCT00977080). Patients eligible for the IMPACT SHPT study were aged ≥18 years with stage 5 chronic kidney disease, had been receiving maintenance haemodialysis three times weekly for at least 3 months before screening and were to continue haemodialysis during the study. Only US patients who reached the evaluation period (weeks 21–28) were included in this secondary analysis. US subjects in the IMPACT SHPT study were randomly assigned to receive intravenous paricalcitol, or oral cinacalcet plus fixed-dose intravenous doxercalciferol, for 28 weeks. Patients in the paricalcitol group could also receive supplemental cinacalcet for hypercalcaemia. The primary effectiveness endpoint in the IMPACT SHPT study was the proportion of subjects who achieved a mean intact parathyroid hormone (iPTH) level of 150–300 pg/mL during the evaluation period. In this secondary analysis, we estimated the incremental cost-effectiveness ratio (ICER), comparing paricalcitol-treated patients with cinacalcet-treated patients on the basis of this primary endpoint and several secondary endpoints. Costs were estimated by examining the dosage of the study drug (paricalcitol or cinacalcet) and phosphate binders used by each participant during the trial. Nonparametric bootstrap analysis was used to examine the accuracy of the ICER point estimates.
The percentages of patients achieving the treatment goal of a mean iPTH level between 150–300 pg/mL during weeks 21–28 of therapy were 56.9 % in the paricalcitol group and 34.0 % in the cinacalcet group (a difference of 23 %, p = 0.0235). Paricalcitol was also more effective for each of the secondary endpoints. When annualized, the total drug costs were US$10,153 in the paricalcitol group and US$15,967 in the cinacalcet group, a difference of US$5,814 (57.3 %, p = 0.0053). Because the paricalcitol-based treatment was less expensive and more effective, it was ‘dominant’, compared with cinacalcet, in this cost-effectiveness analyses. In our bootstrap analysis, 99.1 % of bootstrap replicates for the ICER of the primary endpoint fell within the lower right quadrant of the cost-effectiveness plane—where paricalcitol is considered dominant. For all of the other endpoints, paricalcitol was dominant in 100 % of replicates.
On the basis of dosing and effectiveness data from US patients in the IMPACT SHPT study, we found that a regimen of intravenous paricalcitol was more cost effective than cinacalcet plus low-dose vitamin D in the management of iPTH in patients with SHPT requiring haemodialysis.
- Centers for Disease Control and Prevention (CDC). National chronic kidney disease fact sheet: general information and national estimates on chronic kidney disease in the United States, 2010. Atlanta: US Department of Health and Human Services, CDC; 2010.
- Coresh J, Selvin E, Stevens LA, et al. Prevalence of chronic kidney disease in the United States. JAMA. 2007;298(17):2038–47. CrossRef
- Zhang Q-L, Rothenbacher D. Prevalence of chronic kidney disease in population-based studies: systematic review. BMC Pub Health. 2008;8(1):117. CrossRef
- St Peter WL. Chronic kidney disease and Medicare. J Manag Care Pharm. 2007;13(9 Suppl D):S13–8.
- Schumock GT, Sprague SM. Clinical and economic burden of fractures in patients with renal osteodystrophy. Clin Nephrol. 2007;67(4):201–8. CrossRef
- Rix M, Andreassen H, Eskildsen P, et al. Bone mineral density and biochemical markers of bone turnover in patients with predialysis chronic renal failure. Kidney Int. 1999;56(3):1084–93. CrossRef
- Coco M, Rush H. Increased incidence of hip fractures in dialysis patients with low serum parathyroid hormone. Am J Kidney Dis. 2000;36(6):1115–21. CrossRef
- Tsuchihashi K, Takizawa H, Torii T, et al. Hypoparathyroidism potentiates cardiovascular complications through disturbed calcium metabolism: possible risk of vitamin D(3) analog administration in dialysis patients with end-stage renal disease. Nephron. 2000;84(1):13–20. CrossRef
- Weiner DE, Tighiouart H, Stark PC, et al. Kidney disease as a risk factor for recurrent cardiovascular disease and mortality. Am J Kidney Dis. 2004;44(2):198–206. CrossRef
- Slinin Y, Foley RN, Collins AJ. Calcium, phosphorus, parathyroid hormone, and cardiovascular disease in hemodialysis patients: the USRDS Waves 1, 3, and 4 study. J Am Soc Nephrol. 2005;16(6):1788–93. CrossRef
- National Kidney Foundation. KDOQI clinical practice guidelines for bone metabolism and disease in chronic kidney disease. Am J Kidney Dis. 2003;42(S3):S1–202.
- National Kidney Foundation. Chapter 4.1: treatment of CKD-MBD targeted at lowering high serum phosphorus and maintaining serum calcium. Kidney Int. 2009;76(S113):S50–99.
- Coyne DW, Grieff M, Ahya SN, et al. Differential effects of acute administration of 19-Nor-1,25-dihydroxy-vitamin D2 and 1,25-dihydroxy-vitamin D3 on serum calcium and phosphorus in hemodialysis patients. Am J Kidney Dis. 2002;40(6):1283–8. CrossRef
- Joist HE, Ahya SN, Giles K, et al. Differential effects of very high doses of doxercalciferol and paricalcitol on serum phosphorus in hemodialysis patients. Clin Nephrol. 2006;65(5):335–41. CrossRef
- Teng M, Wolf M, Lowrie E, et al. Survival of patients undergoing hemodialysis with paricalcitol or calcitriol therapy. N Engl J Med. 2003;349(5):446–56. CrossRef
- Dobrez DG, Mathes A, Amdahl M, et al. Paricalcitol-treated patients experience improved hospitalization outcomes compared with calcitriol-treated patients in real-world clinical settings. Nephrol Dial Transplant. 2004;19(5):1174–81. CrossRef
- Sprague SM, Llach F, Amdahl M, et al. Paricalcitol versus calcitriol in the treatment of secondary hyperparathyroidism. Kidney Int. 2003;63(4):1483–90. CrossRef
- Block GA, Martin KJ, de Francisco AL, et al. Cinacalcet for secondary hyperparathyroidism in patients receiving hemodialysis. N Engl J Med. 2004;350(15):1516–25. CrossRef
- Block GA, Zaun D, Smits G, et al. Cinacalcet hydrochloride treatment significantly improves all-cause and cardiovascular survival in a large cohort of hemodialysis patients. Kidney Int. 2010;78(6):578–89. CrossRef
- Ketteler M, Martin KJ, Wolf M, et al. Paricalcitol versus cinacalcet plus low-dose vitamin D therapy for the treatment of secondary hyperparathyroidism in patients receiving haemodialysis: results of the IMPACT SHPT study. Nephrol Dial Transplant. 2012;19(27):3270–8. CrossRef
- Sharma A, Ketteler M, Marshall TS, et al. Comparative cost analysis of management of secondary hyperparathyroidism with paricalcitol or cinacalcet with low-dose vitamin D in hemodialysis patients. J Med Econ. 2013;16(9):1129–36. CrossRef
- Boer R, Lalla AM, Belozeroff V. Cost-effectiveness of cinacalcet in secondary hyperparathyroidism in the United States. J Med Econ. 2012;15(3):509–20. CrossRef
- Shireman TI, Almehmi A, Wetmore JB, et al. Economic analysis of cinacalcet in combination with low-dose vitamin D versus flexible-dose vitamin D in treating secondary hyperparathyroidism in hemodialysis patients. Am J Kidney Dis. 2010;56(6):1108–16. CrossRef
- Ketteler M, Martin KJ, Cozzolino M, et al. Paricalcitol versus cinacalcet plus low-dose vitamin D for the treatment of secondary hyperparathyroidism in patients receiving haemodialysis: study design and baseline characteristics of the IMPACT SHPT study. Nephrol Dial Transplant. 2011;19(27):1942–9.
- Schumock GT, Walton SM, Lee TA, et al. Comparative effectiveness of paricalcitol versus cinacalcet for secondary hyperparathyroidism in patients receiving hemodialysis. Nephron Clin Pract. 2011;117(2):c151–9.
- United States Renal Data System. USRDS 2012 annual data report: atlas of chronic kidney disease and end-stage renal disease in the United States. Bethesda: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2012.
- Cost Effectiveness of Paricalcitol Versus Cinacalcet with Low-Dose Vitamin D for Management of Secondary Hyperparathyroidism in Haemodialysis Patients in the USA
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