协调HTA证据需求和期望:改善证据生成,确保获取和负担能力的挑战和机会
Sarah K Emond1, Wim G Goettsch2,3, Daniel A Ollendorf1,4
1Institute for Clinical and Economic Review, Boston, Massachusetts, USA.
Clinical pharmacology and therapeutics
|February 19, 2025
概括
高质量的证据对于医疗技术评估至关重要,但对于新药来说往往缺乏. 本综述探讨了证据生成,患者获取和负担能力方面的挑战和政策解决方案.
科学领域:
- 医疗技术评估 (HTA) 是指对医疗技术进行评估.
- 制药政策 制药政策
- 基于证据的医学 基于证据的医学
背景情况:
- 高质量的证据对于有效的医疗技术评估至关重要.
- 不断变化的监管标准加快了药品的批准,往往造成证据缺口.
- 医疗技术从业者面临的挑战是,决策的证据有限.
研究的目的:
- 审查卫生技术评估人员如何管理新药品的证据差距.
- 检查美国和欧洲的各种治疗领域的经验.
- 提出政策解决方案,平衡证据,获取和可负担性.
主要方法:
- 综述文章综合了来自美国和欧洲观点的案例.
- 对大群体 (如阿尔茨海默病) 的治疗方法的经验分析.
- 对超罕见疾病的基因疗法的检查.
主要成果:
- 医疗技术评估人员因药物的快速批准而遇到重大证据限制.
- 案例说明了评估广泛和利基治疗创新的挑战.
- 在快速进入市场和强有力的证据生成之间存在紧张关系.
结论:
- 需要政策解决方案来协调证据要求,患者获取和医疗保健成本.
- 潜在的解决方案包括通过证据开发和管理入口协议进行报销.
- 基于结果的合同为共享风险和价值展示提供了一个机制.
相关概念视频
Hazard Ratio
77
The hazard ratio (HR) is a widely used measure in clinical trials to compare the risk of events, such as death or disease recurrence, between two groups over time. It reflects the ratio of hazard rates—the instantaneous risk of the event occurring—between a treatment group and a control group. This measure provides valuable insights into the relative effectiveness of a treatment by assessing how the risk of an event differs between the two groups.
For example, in a clinical trial...
For example, in a clinical trial...
77
Health Information Technology and Healthcare Information System
790
Health Information Technology (HIT)
Health Information Technology, commonly called HIT, integrates advanced information systems and technology in healthcare settings. Its primary functions include:
Health Information Technology, commonly called HIT, integrates advanced information systems and technology in healthcare settings. Its primary functions include:
790
Issues And Trends In Healthcare Delivery System
5.6K
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...
5.6K
Methods Of Healthcare Delivery System
3.1K
At the different levels of the healthcare system, we see varying methods of healthcare used. These methods include managed care systems, case management, and primary healthcare.
Managed Care System:
The managed care system is designed to control the cost while maintaining the quality of care. The patient's care from admission to discharge is planned by the primary care provider or the case manager, also known as the gatekeeper. In a managed care system, the number of care providers is...
Managed Care System:
The managed care system is designed to control the cost while maintaining the quality of care. The patient's care from admission to discharge is planned by the primary care provider or the case manager, also known as the gatekeeper. In a managed care system, the number of care providers is...
3.1K
Current Trends in Nursing II
1.2K
Trends in nursing are multifactorial and associated with changes in society, within the nursing profession, and in other professions. Notably, telehealth and remote nursing contribute to successful healthcare delivery for numerous patients and help reduce stress for nurses due to nursing shortages. Nurses can reach patients, monitor their conditions, and interact with them using computers, audio, visual accessories, and telephones—for example, remote patient monitoring systems. Likewise,...
1.2K
Documentation in Long-Term and Home Healthcare Setting
868
Documentation in long-term care facilities and home healthcare settings is crucial for ensuring continuous, coordinated, and comprehensive care for patients. Each setting has its specific documentation processes and tools:
Long-Term Care Facilities
Long-Term Care Facilities
868


