Cost-effectiveness of cinacalcet in secondary hyperparathyroidism in the United States.
OBJECTIVE
Cinacalcet has been used in controlling secondary hyperparathyroidism (SHPT) in dialysis patients since 2004, but its full economic evaluation has not been conducted from the US perspective. This study assesses the cost-effectiveness of cinacalcet and low-dose vitamin D for the treatment of SHPT in dialysis patients compared with flexible vitamin D.


METHODS
A lifetime patient-level simulation model was developed using ADVANCE trial data, including biomarker levels: parathyroid hormone, calcium, and phosphorus. The impact of the biomarkers on mortality, cardiovascular events, fractures, and parathyroidectomy were estimated from literature: Block, an observational study; Cunningham, a combined analysis of four randomized trials of cinacalcet; and Danese, a study investigating the effect of duration in recommended targets. Baseline event rates were derived from the large dialysis organizations registries. One-way and probabilistic sensitivity analyses (PSA) were conducted.


RESULTS
The cost-effectiveness ratio for cinacalcet compared with standard of care (vitamin D and phosphate binders) was $54,560 and $72,456/quality-adjusted-life-year (QALY) gained or an incremental cost of $3155 and $2638 per year alive for the Block and Danese variants, respectively. In the Cunningham variant, cost-effectiveness ratio for cinacalcet was $5064/QALY gained or a cost saving of $1068 per year. The difference in the results of the Cunningham variant vs other variants can be explained by the favorable impact of cinacalcet on outcomes, specifically cardiovascular events observed in the Cunningham study. The PSA showed 98% likelihood for cinacalcet to be cost-effective at $100,000/QALY threshold.


CONCLUSIONS
Observational data assessing effects on clinical outcomes, trial restriction to use calcium-containing phosphate binders, no utility data in SHPT dialysis population, and insufficient evidence on long-term impact of cinacalcet and vitamin D on biochemical markers.


CONCLUSIONS
Cinacalcet treatment is cost-effective for treatment of SHPT in the US. Due to cost offsets, cinacalcet can reduce annual costs in some scenarios.
Cerner LifeSciences, Beverly Hills, CA, USA. rob.boer@cerner.com
Rob
R
Boer
Anjana M
AM
Lalla
Vasily
V
Belozeroff
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015415:Biomarkers; D000069449:Cinacalcet; D003362:Cost-Benefit Analysis; D005260:Female; D006801:Humans; D006962:Hyperparathyroidism, Secondary / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D018803:Models, Economic; D009281:Naphthalenes / Q000191:economics* / Q000627:therapeutic use; D019057:Quality-Adjusted Life Years; D014481:United States / Q000453:epidemiology; D055815:Young Adult
D015415:Biomarkers; D009281:Naphthalenes; D000069449:Cinacalcet