van Hout B A, Simoons M L
Institute for Medical Technology Assessment, Erasmus University, Rotterdam, The Netherlands.
Eur Heart J. 2001 May;22(9):751-61. doi: 10.1053/euhj.2000.2308.
Treatment guidelines have been developed for both "primary" and "secondary" prevention of coronary heart disease. These should consider both the efficacy as well as the costs of such treatment, particularly the costs of treatment with HMG co-enzyme A reductase inhibitors (statins). In the context of guideline development in The Netherlands, the cost effectiveness of treatment with statins was analysed.
Following a modelling approach, cost effectiveness was analysed as a function of a patient's initial risk for new coronary heart disease events, combining results from 4S, CARE, LIPID, WOSCOPS and AFCAPS with Dutch cost data. For each sex and age group, an estimate was made of the level of cardiovascular risks that might correspond to a cost-effectiveness ratio under NLG 40 000 (Euro 18 151) per life year gained.
If the 10-year risk of myocardial infarction, stroke or cardiovascular death was estimated at 9% (AFCAPS/TexCAPS), 20% (WOSCOPS), 36% (CARE) 36% (LIPID) and 47% (4S), cost effectiveness was estimated at Euro 51 400, Euro 26 013, Euro 9970, Euro 8028 and Euro 6695. The arbitrary threshold of NLG 40 000 (approximately Euro 18 000) was achieved at a 10 year coronary heart disease event risk ranging from 19% to 26% for different age groups. Assuming the effectiveness of statin treatment decreased with age, a 10-year risk, corresponding to Euro 18 000, varied from 11% (under age 30) to 41% (over age 80). Patients at higher risk levels should be considered for statin therapy.
Treatment costs for primary or secondary prevention are determined predominantly by the costs of statin drugs. The developed model allows comparison of cost effectiveness of statin therapy across a wide range of subjects with or without coronary heart disease. The consensus committee in the Netherlands postulated that drug therapy should be considered in subjects with or without coronary heart disease in which cost-effectiveness is similar. Such groups can be identified using the presented model. When cost effectiveness ratios up to Euro 18 000 per life year gained are deemed acceptable, statin treatment should be considered in most patients with known cardiovascular disease (secondary prevention), and in a limited group of subjects who are at high risk of developing coronary heart disease (primary prevention).
已制定了冠心病“一级”和“二级”预防的治疗指南。这些指南应兼顾此类治疗的疗效和成本，尤其是HMG辅酶A还原酶抑制剂（他汀类药物）的治疗成本。在荷兰制定指南的背景下，对他汀类药物治疗的成本效益进行了分析。
采用建模方法，结合4S、CARE、LIPID、WOSCOPS和AFCAPS的结果与荷兰成本数据，将成本效益分析为患者发生新发冠心病事件的初始风险的函数。针对每个性别和年龄组，估计了可能对应于每获得一个生命年成本效益比低于40000荷兰盾（18151欧元）的心血管风险水平。
如果将心肌梗死、中风或心血管死亡的10年风险估计为9%（AFCAPS/TexCAPS）、20%（WOSCOPS）、36%（CARE）、36%（LIPID）和47%（4S），则成本效益估计分别为51400欧元、26013欧元、9970欧元、8028欧元和6695欧元。对于不同年龄组，每获得一个生命年成本效益比低于40000荷兰盾（约18000欧元）的10年冠心病事件风险范围为19%至26%。假设他汀类药物治疗的有效性随年龄降低，对应于18000欧元的10年风险从11%（30岁以下）到41%（80岁以上）不等。应考虑对风险水平较高的患者进行他汀类药物治疗。
一级或二级预防的治疗成本主要由他汀类药物的成本决定。所开发的模型允许比较广泛的有或无冠心病受试者中他汀类药物治疗的成本效益。荷兰的共识委员会假定，对于成本效益相似的有或无冠心病的受试者，应考虑药物治疗。使用所提出的模型可以识别此类人群。当每获得一个生命年的成本效益比高达18000欧元被认为可接受时，大多数已知心血管疾病的患者（二级预防）以及一小部分有患冠心病高风险的受试者（一级预防）应考虑他汀类药物治疗。
