Dataset Information

Cost-effectiveness analysis of cinacalcet for haemodialysis patients with moderate-to-severe secondary hyperparathyroidism in China: evaluation based on the EVOLVE trial.

ABSTRACT: OBJECTIVE:As the cost-effectiveness evaluation of cinacalcet and conventional therapy in China has not been reported, the objective of this study was to make a pharmacoeconomic evaluation of cinacalcet specific to the Chinese healthcare setting in patients with moderate-to-severe secondary hyperparathyroidism (SHPT) undergoing dialysis. DESIGNS:Data from Evaluation of Cinacalcet Therapy to Lower Cardiovascular Events trial were used for this analysis. A semi-Markov model was constructed to estimate quality-adjusted life years (QALYs) and lifetime costs in cinacalcet plus conventional therapy (cinacalcet strategy) compared with conventional therapy (standard strategy), in patients with moderate-to-severe SHPT undergoing dialysis. Treatment effect estimates from the unadjusted intent-to-treat (ITT) analysis and covariate-adjusted ITT analysis were used as the main analyses. Model sensitivity to variations in individual inputs and overall decision uncertainty were assessed through probabilistic sensitivity analyses. PRIMARY AND SECONDARY OUTCOME MEASURES:Incremental cost-effectiveness ratio (ICER) as measured by cost per QALY gained. RESULTS:The ICER for cinacalcet strategy was US$44?400 per QALY gained using the covariate-adjusted ITT analysis. Probabilistic sensitivity analysis suggested a 46.2% chance of the ICER being below a willingness-to-pay threshold of US$26?508. Treatment effects from unadjusted ITT analysis yielded an ICER of US$87?210 per QALY. The model was most sensitive to the treatment effect on mortality. CONCLUSIONS:Existing evidence does not support the cost-effectiveness of cinacalcet strategy in patients with moderate-to-severe SHPT undergoing dialysis when applying a willingness-to-pay threshold of US$26 508 per QALY, whether it is using the treatment effect from covariate-adjusted ITT analysis or unadjusted ITT analysis.

SUBMITTER: Liu L

PROVIDER: S-EPMC7406115 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Cost-effectiveness analysis of cinacalcet for haemodialysis patients with moderate-to-severe secondary hyperparathyroidism in China: evaluation based on the EVOLVE trial.

Liu Lin L Hong Dongsheng D Ma Kuifen K Wu Bin B Lu Xiaoyang X

BMJ open 20200804 8

<h4>Objective</h4>As the cost-effectiveness evaluation of cinacalcet and conventional therapy in China has not been reported, the objective of this study was to make a pharmacoeconomic evaluation of cinacalcet specific to the Chinese healthcare setting in patients with moderate-to-severe secondary hyperparathyroidism (SHPT) undergoing dialysis.<h4>Designs</h4>Data from Evaluation of Cinacalcet Therapy to Lower Cardiovascular Events trial were used for this analysis. A semi-Markov model was const ...[more]

PMID: 32753447

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Project description:BackgroundThe 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.AimThe 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.MethodsThis 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.ResultsThe 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.ConclusionOn 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.

Project description:BackgroundSecondary hyperparathyroidism may lead to increased cardiovascular risk. The use of cinacalcet may improve bone and cardiovascular health with improved parathormone (PTH) and phosphate control.MethodsThis is an open-label prospective randomised controlled trial to compare progression of cardiovascular and chronic kidney disease mineral and bone disorder (CKD-MBD) parameters. Patients were randomised to receive cinacalcet alongside standard therapy or standard therapy alone. Thirty-six haemodialysis patients who had > 90 days on dialysis, iPTH > 300 pg/mL, calcium > 2.1 mmol/L and age 18-75 years were included. Following randomization, all 36 patients underwent an intensive 12-week period of bone disease management aiming for iPTH 150-300 pg/mL. The primary outcome was change in vascular calcification using CT agatston score. Secondary outcomes included pulse wave velocity (PWV), left ventricular mass index (LVMI), carotid intima-media thickness (CIMT), augmentation index (Aix) and bone measurements. The above measurements were obtained at baseline and 12 months.ResultsThere was no evidence of a group difference in the progression of calcification (median change (IQR) cinacalcet: 488 (0 to1539); standard therapy: 563 (50 to 1214)). In a post hoc analysis combining groups there was a mean (SD) phosphate reduction of 0.3 mmol/L (0.7) and median (IQR) iPTH reduction of 380 pg/mL (- 754, 120). Regression of LVMI and CIMT was seen (P = 0.03 and P = 0.001) and was significantly associated with change of phosphate on multi-factorial analyses.ConclusionsWith a policy of intense CKD-MBD parameter control, no significant benefit in bone and cardiovascular markers was seen with the addition of cinacalcet to standard therapy over one year. Tight control of hyperphosphataemia and secondary hyperparathyroidism may lead to a reduction in LVMI and CIMT but this needs further investigation. Although the sample size was small, meticulous trial supervision resulted in very few protocol deviations with therapy.

Dataset Information

Cost-effectiveness analysis of cinacalcet for haemodialysis patients with moderate-to-severe secondary hyperparathyroidism in China: evaluation based on the EVOLVE trial.

Publications

Cost-effectiveness analysis of cinacalcet for haemodialysis patients with moderate-to-severe secondary hyperparathyroidism in China: evaluation based on the EVOLVE trial.

Similar Datasets

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