HTA Policy--International Affairs, Pfizer Inc., Surrey, United Kingdom.
Value Health. 2012 Mar-Apr;15(2):381-8. doi: 10.1016/j.jval.2011.08.1736. Epub 2011 Oct 19.
When comparators' prices decrease due to market competition and loss of exclusivity, the incremental clinical effectiveness required for a new technology to be cost-effective is expected to increase; and/or the minimum price at which it will be funded will tend to decrease. This may be, however, either unattainable physiologically or financially unviable for drug development. The objective of this study is to provide an empirical basis for this discussion by estimating the potential for price decreases to impact on the cost-effectiveness of new therapies in hypertension.
Cost-effectiveness at launch was estimated for all antihypertensive drugs launched between 1998 and 2008 in the United Kingdom using hypothetical degrees of incremental clinical effectiveness within the methodologic framework applied by the UK National Institute for Health and Clinical Excellence. Incremental cost-effectiveness ratios were computed and compared with funding thresholds. In addition, the levels of incremental clinical effectiveness required to achieve specific cost-effectiveness thresholds at given prices were estimated.
Significant price decreases were observed for existing drugs. This was shown to markedly affect cost-effectiveness of technologies entering the market. The required incremental clinical effectiveness was in many cases greater than physiologically possible so, as a consequence, a number of products might not be available today if current methods of economic appraisal had been applied.
We conclude that the definition of cost-effectiveness thresholds is fundamental in promoting efficient innovation. Our findings demonstrate that comparator price attrition has the potential to put pressure in the pharmaceutical research model and presents a challenge to new therapies being accepted for funding.
当竞争和失去专有权导致对照剂价格下降时,新技术具有成本效益所需的额外临床效果预计会增加;和/或它将获得资金的最低价格可能会下降。然而,这可能在生理上无法实现,或者从药物开发的经济角度来看是不可行的。本研究的目的是通过估计价格下降对高血压新疗法成本效益的潜在影响,为这一讨论提供实证依据。
使用英国国家卫生与临床优化研究所(NICE)采用的方法学框架内的假设增量临床效果,估算了 1998 年至 2008 年间在英国推出的所有降压药物在推出时的成本效益。计算增量成本效益比并与资助门槛进行比较。此外,还估算了在特定价格下达到特定成本效益阈值所需的增量临床效果水平。
现有药物的价格出现了显著下降。这表明这将极大地影响进入市场的技术的成本效益。在许多情况下,所需的增量临床效果大于生理上可能的效果,因此,如果采用当前的经济评估方法,许多产品今天可能就不会出现。
我们的结论是,成本效益阈值的定义对于促进高效创新至关重要。我们的研究结果表明,对照剂价格下降有可能对制药研究模式施加压力,并对新疗法获得资金的接受提出挑战。