015年9月14日 讯 /生物谷BIOON/ --上周三，美国非营利性研究药物成本效益的一项报告草案中指出，两种抗胆固醇药物的高价格或许已经限制了对患者的效益；这两种药物分别为：Praluent和Repatha，其均可以靶向作用PCSK9酶类，当该酶类被抑制后就会导致低密度脂蛋白-胆固醇(LDL-Cholesterol)水平的降低。
FDA在今年早些时候批准了这两种药物的使用，研究者发现，其在不能服用降胆固醇他汀类药物的患者中，可以帮助患者降低55%至60%的胆固醇；而周三来自临床经济研究所（ICER）的草案中表示，相关研究或已提供了适当的确定性，即PCSK9酶类抑制剂疗法或许可以改善患者的预后，而且这两种药物的疗效等同，可以帮助350万至1500万美国人的健康，但如今这些效益或许会因药物价格的上涨而有所限制。
ICER的研究者在一份声明中指出，随着每年药物定价上涨1.4万美元，就会产生许多跟价格相关的严峻问题的产生，但这些药物明显可以给患者及健康护理系统带来合理的价值；而降低67%的药物价格或将给患者使用药物带来全面的健康效益。尽管目前已经有了相当大的折扣，但这些药物对保险业和其它健康护理所带来的累积价值或许会明显拖累药物对社会的益处。
一年一度的药物价格标签小于等于2177美元或许是非常必要的，ICER的研究者表示，当这些药物的价格降低到一定水平后，医生和保险公司就不需要对患者的使用量进行限制了。而如果一年中药物的价格高于2177美元，医药公司、医生、保险公司以及其它参与者或许就需要共同合作来确定如何限制药物的使用，并且采取其它措施来使得患者可以负担得起药物的价格。
高胆固醇往往和心脏疾病发病直接相关，而心脏病是引发美国个体死亡的主要原因，研究者Elizabeth Baxter在一份声明中指出，我们需要更好地理解ICER的分析，尤其是他们的分析模式和方法学，这对于我们后期执行有效的模型来帮助制定更为合适的药物价格而言将非常重要。(生物谷Bioon.com)
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New anti-cholesterol drugs too expensive: report
The high price of two new anti-cholesterol drugs limits the benefits patients may see from them, according to a draft report released Wednesday by a US nonprofit examining drug cost effectiveness.
The new drugs, Praluent, from French pharmaceutical giant Sanofi and Regeneron, and Repatha, from California-based Amgen, both target the enzyme PCSK9, which, when inhibited, can lead to reduced LDL-cholesterol.
The US Food and Drug Administration approved the medications earlier this year, finding they reduced cholesterol by approximately 55-60% in patients who are already on or who cannot take cholesterol-reducing statin drugs.
Wednesday's draft report from the Institute for Clinical and Economic Review (ICER) said those findings "provides moderate certainty that PCSK9 inhibitor therapy improves patient outcomes" and that the two new drugs, which it says are equally effective, may help as many as 3.5 to 15 million Americans.
But those benefits may be limited by the drugs' steep costs.
"With a list price over $14,000 per year there are serious questions regarding the price at which these drugs would represent a sensible value to patients and to the health care system," ICER researchers said in a statement.
They said lowering that list price by 67 percent would best represent the "overall benefits" of the drugs to individual patients.
Even at that steep discount, though, the cumulative costs of those drugs on insurers and others paying for health care would drag down the full benefits of the drugs to society.
An annual price tag at or below $2,177 is needed, ICER researchers said, "for the total costs of these new drugs to come down to a level at which doctors and insurers would not have to try to limit patient use in some way to keep overall health care cost growth within bounds."
"If the cost is more than $2,177 a year, drug companies, doctors, insurers, and other parties may need to work together to determine ways to limit the use of these drugs, find savings in other parts of the health care system, or adopt other measures to help make these drugs more affordable," ICER president Steven Pearson said.
High cholesterol has been tied to heart disease, the most common cause of death in the United States.
Elizabeth Baxter, of Sanofi, said in a statement: "We need to better understand the ICER analysis, particularly their model and methodology, as we performed our own cost effectiveness model to help us determine the appropriate price.
"These calculations are complex and a robust and open peer-review process is essential."
