通过突破性设备计划,调整美国机构对心血管设备的政策
Osman Moneer1, Vinay K Rathi2, James L Johnston3
1Yale School of Medicine, New Haven, Connecticut.
JAMA cardiology
|October 25, 2023
概括
美国食品和药物管理局 (FDA) 的突破性设备计划 (BDP) 可能会加快使用有限证据的设备的市场授权和医疗保险退款. 这一途径可能会导致更高的成本和未经验证的患者利益.
科学领域:
- 医疗器械监管法规 医疗器械监管法规
- 卫生经济学 卫生经济学
- 临床证据评估临床证据评估
背景情况:
- 美国食品和药物管理局 (FDA) 和医疗保险和医疗补助服务中心 (CMS) 在医疗器械批准和报销方面发挥着不同的作用.
- 美国食品和药物管理局 (CMS) 推出了政策,以加快对FDA指定为"突破性"的设备的覆盖,包括新的新兴技术过渡覆盖途径.
研究的目的:
- 分析FDA的突破性设备计划 (BDP) 对医疗器械市场授权和报销的影响.
- 评估用于BDP指定设备的证据标准及其对Medicare受益人群的代表性.
主要方法:
- 审查关于FDA突破性设备计划的公开信息.
- 研究了通过BDP授权的心血管设备的案例.
- 对所选产品的证据要求,试验设计和市场后研究结果进行分析.
主要成果:
- 该BDP可能允许FDA授权的证据不那么严格,包括单臂试验和代用终点,往往不代表医疗保险受益人.
- 一些通过BDP授权的设备显示了最初的发现,后来未经验证或与市场后研究相矛盾.
- 制造商利用BDP指定提高设备定价,导致CMS和医疗保健系统的成本增加.
结论:
- 尽管临床证据有限或未经验证,但BDP可以为昂贵的设备提供加速报销.
- 建议包括增加FDA对BDP资格的选择性,对指定撤销的客观标准和及时的市场后证据生成.
- CMS应独立审查临床证据,指导制造商制定覆盖标准,并将退款与已证明的临床结果联系起来.
更多相关视频
08:47Evaluation of Cardiac Contractility Modulation Therapy in 2D Human Stem Cell-Derived Cardiomyocytes
Published on: December 16, 2022
2.5K
11:49Autologous Endothelial Progenitor Cell-Seeding Technology and Biocompatibility Testing For Cardiovascular Devices in Large Animal Model
Published on: September 9, 2011
20.5K
相关概念视频
01:18Cardiovascular Drugs: Classification based on Therapeutic Indications
2.9K
Cardiovascular diseases, encompassing a range of conditions, can significantly affect the heart's operations and the overall circulatory system. These conditions impair the heart's ability to pump blood, leading to a deficit in oxygen supply to crucial organs. Anomalies in the heart's electrical system, known as arrhythmias, can cause heartbeats to accelerate or slow down. Usually, heart rates increase during physical activity and decrease while resting or sleeping. However,...
2.9K
01:29Cardiomyopathy V: Interprofessional Care
14
Managing cardiomyopathy involves addressing underlying or precipitating causes, treating heart failure with medications, and implementing dietary changes and a balanced exercise and rest regimen.Lifestyle ModificationsCardiomyopathy patients should adopt a low-sodium diet to reduce fluid retention and manage heart failure. A personalized exercise and rest plan helps maintain physical fitness without overstraining the heart. Avoiding alcohol and tobacco is essential to prevent further damage to...
14
01:30Heart Failure V: Medical Management
9
Medical Management of Acute Decompensated Heart Failure (ADHF)The primary goals of therapy for patients hospitalized with acute decompensated heart failure (ADHF) include:Relieving symptomsOptimizing volume statusSupporting oxygenation and ventilationMaintaining cardiac output (CO) and end-organ perfusionIdentifying and addressing the cause of ADHFPreventing complicationsProviding patient education on factors precipitating HF exacerbationPlanning for dischargeOngoing monitoring and assessment...
9
01:26Drug Administration and Therapy Phases: Overview
486
Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
486
01:02Prescription, Nonprescription and Orphan Drugs
742
Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...
742
01:25Drug Regulation
1.4K
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
1.4K