Reed Shelby D, Shea Alisa M, Schulman Kevin A
Center for Clinical and Genetic Economics, Duke Clinical Research Institute, PO Box 17969, Durham, NC 27715, USA.
J Gen Intern Med. 2008 Jan;23 Suppl 1(Suppl 1):50-6. doi: 10.1007/s11606-007-0246-9.
To evaluate the impact of regulatory scenarios on the financial viability of medical device companies.
We developed a model to calculate the expected net present value of a hypothetical product throughout preclinical development, clinical testing, regulatory approval, and postmarketing. We tested 3 scenarios: (1) the current regulatory environment; (2) a scenario in which medical devices are subject to the same evidence standards required for pharmaceuticals; and (3) a scenario consistent with the Coverage with Evidence Development: Coverage with Study Participation (CSP) policy proposed by the Centers for Medicare and Medicaid Services, whereby Medicare will pay for beneficiaries to receive new devices that are not currently determined to be "reasonable and necessary" if the patients participate in clinical studies or registries.
When applying assumptions consistent with the implantable cardioverter-defibrillator market, the net present value at the start of development was an estimated $553 million in the current regulatory environment, $322 million in the pharmaceutical scenario, and $403 million in the CSP scenario. Sensitivity analyses showed that the device industry would likely be profitable in all 3 scenarios over a range of assumptions.
The environment in which the medical device industry operates is financially attractive. Furthermore, when compared with the alternative of applying the same evidence standards for pharmaceuticals to medical devices, the CSP policy offers improved financial incentives for medical device companies.
评估监管方案对医疗器械公司财务生存能力的影响。
我们开发了一个模型，用于计算假设产品在临床前研发、临床试验、监管批准及上市后整个过程中的预期净现值。我们测试了三种方案：（1）当前的监管环境；（2）医疗器械需遵循与药品相同证据标准的方案；（3）与医疗保险和医疗补助服务中心提出的“证据支持下的覆盖：参与研究的覆盖”（CSP）政策一致的方案，即如果患者参与临床研究或登记，医疗保险将为受益人支付使用目前尚未被认定为“合理且必要”的新设备的费用。
在应用与植入式心脏复律除颤器市场一致的假设时，在当前监管环境下，研发开始时的净现值估计为5.53亿美元，在药品方案中为3.22亿美元，在CSP方案中为4.03亿美元。敏感性分析表明，在一系列假设下，医疗器械行业在所有三种方案中都可能实现盈利。
医疗器械行业的运营环境在财务方面具有吸引力。此外，与对医疗器械采用与药品相同证据标准的替代方案相比，CSP政策为医疗器械公司提供了更好的财务激励。
