Original Investigation
Dialysis
Cost-Effectiveness of Cinacalcet Hydrochloride for Hemodialysis Patients With Severe Secondary Hyperparathyroidism in Japan

https://doi.org/10.1053/j.ajkd.2011.12.034Get rights and content

Background

Cinacalcet effectively reduces elevated levels of parathyroid hormone (PTH) in patients with secondary hyperparathyroidism (SHPT), even those with severe disease for whom parathyroidectomy can be the treatment of choice. The objective of this study was to estimate the cost-effectiveness of cinacalcet treatment in hemodialysis patients with severe SHPT in Japan.

Study Design

Cost-effectiveness analysis.

Setting & Population

Patients with severe SHPT (intact PTH >500 pg/mL) who were receiving hemodialysis in Japan.

Model, Perspective, & Timeframe

A Markov model was constructed from the health care system perspective in Japan. Patients were followed up over their lifetime. Dialysis costs were not included in the base case.

Intervention

Cinacalcet as an addition to conventional treatment compared to conventional treatment alone. In both arms, patients underwent parathyroidectomy if intact PTH level was >500 pg/mL for 6 months and they were eligible for surgery.

Outcomes

Costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs).

Results

ICERs for cinacalcet for those who were eligible for surgery and those who were not were $352,631/QALY gained and $21,613/QALY gained, respectively. Sensitivity and scenario analyses showed that results were fairly robust to variations in model parameters and assumptions. In the probabilistic sensitivity analysis, cinacalcet was cost-effective in only 0.9% of simulations for those eligible for surgery, but in more than 99.9% of simulations for those ineligible for surgery, if society would be willing to pay $50,000 per additional QALY.

Limitations

Data for the long-term effect of cinacalcet on patient-level outcomes are limited. The model predicted rates for clinical events using data for the surrogate biochemical end points.

Conclusions

The use of cinacalcet to treat severe SHPT is likely to be cost-effective for only those who cannot undergo parathyroid surgery for medical or personal reasons.

Section snippets

Study Design

We constructed a Markov model to estimate quality-adjusted life-years (QALYs) and lifetime costs associated with cinacalcet plus conventional treatment compared with conventional treatment alone for the treatment of severe SHPT. Because no randomized trials have evaluated whether treatment of SHPT with cinacalcet reduces the risk of mortality and CV morbidity, we modeled the effect of cinacalcet on patient-level outcomes using data from observational studies on the risk of clinical events in

Clinical Outcomes

Patient-level outcomes in the economic model for 1,000 patients are listed in Table 5. For patients who are eligible for parathyroidectomy, the addition of cinacalcet to conventional treatment resulted in a marked decrease in the incidence of parathyroidectomy, but there were only slight differences in the incidences of CV events, fracture, and mortality between the arms of the model. In contrast, use of cinacalcet for those ineligible for parathyroidectomy was predicted to result in decreased

Discussion

Many clinical trials have shown that cinacalcet effectively controls biochemical parameters of SHPT.20, 21, 22, 23, 24, 25 However, just a few studies to date have estimated the cost-effectiveness of this agent. Narayan et al26 compared the cost-effectiveness of cinacalcet and parathyroidectomy in patients who were potential candidates for surgery in the United States and showed that long-term use of cinacalcet to treat severe SHPT is unlikely to be cost-effective compared with

Acknowledgements

The authors thank Kyowa Hakko Kirin for providing data for the clinical trials of KRN1493.

Support: This work was funded by a research grant from the Japan Dialysis Outcome Research Group and a Grant-in-Aid for Young Scientists (B) (23790958) from the Ministry of Education, Culture, Sports, Science and Technology, Japan.

Financial Disclosure: Drs Komaba, Taniguchi, and Kakuta have received honoraria from Kyowa Hakko Kirin, Chugai Pharmaceutical, and Bayer Yakuhin. Dr Kamae has received consulting

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    Originally published online March 26, 2012.

    H.K. and K.M. contributed equally to this work.

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