从医疗保险谈判中豁免唯一孤儿药物的成本
Matthew Vogel1, Olivia Zhao2, William B Feldman3,4,5
1John F. Kennedy School of Government, Harvard University, Cambridge, Massachusetts.
JAMA internal medicine
|November 27, 2023
概括
通货膨胀减缓法案唯一的孤儿药物豁免不包括数十亿美元的医疗保险支出. 这些药物实现了高的全球收入,这表明豁免可能是不必要的财务成功.
科学领域:
- 卫生经济学和政策
- 制药政策 制药政策
- 罕见疾病 药物开发 罕见疾病 药物开发
背景情况:
- "通货膨胀减缓法案" (IRA) 要求医疗保险公司对高开支药品进行药品价格谈判.
- 在IRA中,一个关键的豁免是将仅用于治疗单一罕见疾病的药物排除在谈判之外.
- 这种豁免影响了医疗保险支出和孤儿药物的财务成功.
研究的目的:
- 估计2012年至2021年期间可能免于谈判的药物的医疗保险支出和全球收入.
- 分析IRA下唯一的孤儿药物豁免的财务影响.
主要方法:
- 一项横截面研究分析了符合IRA谈判门的药物 (>每年2亿美元的医疗保险支出).
- 药物根据其"孤儿药物法案"的名称和批准历史 (单独孤儿,多孤儿,孤儿第一,非孤儿第一) 来分类.
- 医疗保险支出和全球收入估计为2012年至2021年的唯一孤儿药物.
主要成果:
- 在282种药物中,95种 (34%) 有罕见疾病的征兆;25种 (26%) 是唯一的孤儿药物.
- 医疗保险对孤儿药物的支出从34亿美元增加到10亿美元 (2012-2021年).
- 由于唯一的孤儿豁免,每年估计有25亿美元的医疗保险支出中位数被排除在外;全球收入中位数为110亿美元.
结论:
- 唯一的孤儿豁免显著减少了医疗保险药品价格谈判的范围,排除了数十亿美元的支出.
- 独一无二的孤儿药物获得了大量的全球收入,这表明豁免可能对其财务可行性不至关重要.
- 国会可以重新考虑唯一的孤儿豁免,以增加储蓄,并可能鼓励更广泛的药物指示开发.
相关概念视频
Prescription, Nonprescription and Orphan Drugs
740
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...
740
Drug 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
Drug Elimination: Non-Renal Routes
2.3K
The liver plays a pivotal role in eliminating drugs and their metabolites, primarily through a process known as biliary excretion. This process involves the hepatocytes, the primary cells in the liver that generate bile. A range of transporters actively expels polar drugs or hydrophilic drug metabolites into the bile, which transports the drugs and metabolites into the small intestine. From here, they are eventually expelled from the body through feces. In some instances, the original drug or a...
2.3K
Drug Dosage Regimen: Overview
3.6K
A drug dosage regimen describes the specific instructions and schedule for administering a drug to a patient. It considers factors such as drug dosage, frequency, route of administration, and duration of treatment. Designing an appropriate dosage regimen for a patient aims to achieve a target drug concentration at the site of action.
Typically, the starting dose and dosing interval are guided by the manufacturer's recommendations based on clinical trials conducted during and after drug...
Typically, the starting dose and dosing interval are guided by the manufacturer's recommendations based on clinical trials conducted during and after drug...
3.6K
Drug Classes and Categories
2.0K
Drugs can be classified according to their chemical composition or their intended therapeutic application. For instance, anti-infective agents that possess the ability to eliminate pathogens or suppress their growth and reproduction can be grouped based on the organisms they target or their chemical structure. Furthermore, drugs can be divided into prescription, nonprescription, or controlled substances. Prescription medications, such as antibiotics, require oversight from a licensed healthcare...
2.0K
Bioequivalence: Overview
1.1K
Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
1.1K


