Garside Ruth, Pitt Martin, Anderson Rob, Mealing Stuart, D'Souza Richard, Stein Ken
Peninsula Technology Assessment Group, Peninsula Medical School, University of Exeter, and Noy Scott House, Royal Devon & Exeter Hospital, Barrack Road Exeter, EX2 5DW, UK.
Nephrol Dial Transplant. 2007 May;22(5):1428-36. doi: 10.1093/ndt/gfl774. Epub 2007 Feb 17.
Secondary hyperparathyroidism (SHPT) is a common side effect of end-stage renal disease (ESRD) and is associated with increased risk of fracture and cardiovascular events (CV). Current standard treatment includes dietary control, phosphate binders and vitamin D. However, many patients do not have their parathyroid hormone (PTH), calcium and phosphate levels controlled by this regimen. Cinacalcet is the first of a new class of calcimimetic drugs which suppress PTH production. Although there is convincing evidence of the impact of cinacalcet on serum biomarkers, the long-term clinical implications of treatment are less clear. The aim of this study is to estimate the cost-utility of cinacalcet as an addition to standard treatment of SHPT compared with standard treatment alone.
A Markov model was developed to estimate the incremental cost-utility of cinacalcet. Uncertainty was explored through extensive sensitivity analysis.
Compared with standard treatment, cinacalcet incurs average additional lifetime costs of pound21,167 per person and confers an additional 0.34 quality adjusted life years, resulting in an incremental cost-effectiveness ratio of pound61,890 (approximately euro89,000) per quality-adjusted life-year (QALY). Extensive one-way sensitivity analysis showed that cinacalcet was only likely to be considered cost-effective if the relative risk of mortality for people with very high levels of PTH was 2.2 compared with people whose PTH reached target levels, or if drug costs were considerably reduced. Probabilistic sensitivity analysis showed cinacalcet was very unlikely to be cost-effective at usual levels of willingness to pay in the National Health Service (NHS).
Unless the cost of cinacalcet is considerably reduced, it is unlikely to be considered a cost-effective treatment for people with SHPT.
继发性甲状旁腺功能亢进（SHPT）是终末期肾病（ESRD）的常见副作用，与骨折和心血管事件（CV）风险增加相关。当前的标准治疗包括饮食控制、磷结合剂和维生素D。然而，许多患者的甲状旁腺激素（PTH）、钙和磷水平并未通过该方案得到控制。西那卡塞是一类新型拟钙剂药物中的首个药物，可抑制PTH的产生。尽管有令人信服的证据表明西那卡塞对血清生物标志物有影响，但治疗的长期临床意义尚不清楚。本研究的目的是评估与单独的标准治疗相比，西那卡塞作为SHPT标准治疗补充药物的成本效益。
建立了一个马尔可夫模型来估计西那卡塞的增量成本效益。通过广泛的敏感性分析探讨不确定性。
与标准治疗相比，西那卡塞人均平均额外终身成本为21,167英镑，并带来额外的0.34个质量调整生命年，导致每质量调整生命年（QALY）的增量成本效益比为61,890英镑（约合89,000欧元）。广泛的单向敏感性分析表明，只有当PTH水平非常高的人群与PTH达到目标水平的人群相比，死亡相对风险为2.2时，或者药物成本大幅降低时，西那卡塞才可能被认为具有成本效益。概率敏感性分析表明，在英国国家医疗服务体系（NHS）通常的支付意愿水平下，西那卡塞极不可能具有成本效益。
除非西那卡塞的成本大幅降低，否则它不太可能被认为是SHPT患者具有成本效益的治疗方法。
