从美国食品和药物管理局的授权到新技术的医疗保险覆盖的时间
Zachary A Sexton1, Juliana R Perl1, Henry R Saul1
1Stanford Byers Center for Biodesign, Stanford University, Stanford, California.
JAMA health forum
|August 4, 2023
概括
新型医疗技术在FDA授权后平均需要5.7年才能获得医疗保险覆盖. 许多新技术面临偿还延迟,影响患者获得创新的诊断和设备.
科学领域:
- 医疗保健服务研究 医疗服务研究
- 医疗技术评估 医疗技术评估
- 卫生经济学 卫生经济学
背景情况:
- 美国食品和药物管理局 (FDA) 每年批准许多新的医疗诊断和设备.
- 关于医疗保险为这些新技术建立覆盖范围所需的持续时间的证据有限.
- 及时的医疗保险覆盖对于患者获得和技术采用至关重要.
研究的目的:
- 量化从FDA授权到实现至少名义上的医疗保险覆盖新技术的时间.
- 确定与新医疗技术的医疗保险覆盖时间相关的因素.
主要方法:
- 一项利用公共数据库的横截面研究,将FDA授权的技术与计费代码和覆盖决定联系起来.
- 分析包括通过市场前批准,de novo或突破性指定途径 (2016-2019) 授权的技术.
- 覆盖范围被定义为明确的 (国家/地方覆盖范围的确定) 或隐含的 (与新的计费代码一致).
主要成果:
- 在分析的64种新技术中,只有28种 (44%) 实现了明确或隐含的医疗保险覆盖.
- 至少获得名义医疗保险覆盖的中位时间是5.7年.
- 公司规模和产品类型是与覆盖率实现相关的重要因素;证据水平不是.
结论:
- 在FDA授权和新医疗技术的医疗保险覆盖之间存在很大的延迟.
- 观察到的覆盖时间表明目前的医疗保险退款流程可能存在效率低下.
- 这些延迟可能会阻碍患者及时获得创新的医疗进展.
![Technical Aspect of the Automated Synthesis and Real-Time Kinetic Evaluation of [11C]SNAP-7941](/_next/image?url=https%3A%2F%2Fcloudfront.jove.com%2FCDNSource%2Fteasers%2F59557.jpg&w=3840&q=50)
相关概念视频
01:11Clinical Trials: Overview
3.0K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
3.0K
01:26Drug Administration and Therapy Phases: Overview
535
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...
535
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
01:02Prescription, Nonprescription and Orphan Drugs
765
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...
765
01:17Drug Nomenclature
1.8K
During the development of a new pharmaceutical, the manufacturer initially assigns a code name to the drug. Once approved, the drug receives a United States Adopted Name (USAN)—a generic, nonproprietary designation. Upon being listed in the United States Pharmacopeia, this nonproprietary name becomes the drug's official name. Additionally, the manufacturer assigns a proprietary name or trademark, which serves as the brand name under which the drug is marketed. It is worth noting that...
1.8K
01:29Issues And Trends In Healthcare Delivery System
5.7K
The issues and trends in healthcare delivery are constantly changing. The COVID-19 pandemic is one recent issue that wreaked havoc on healthcare systems, causing a shortage of healthcare workers, high demand for medicines and supplies, and increased medical expenditure due to a lack of insurance. Other issues include rising healthcare costs and care fragmentation.
Cost Containment
Payment for healthcare services has historically promoted adoption of costly and often unnecessary or inefficient...
Cost Containment
Payment for healthcare services has historically promoted adoption of costly and often unnecessary or inefficient...
5.7K