癌症药物的后审核创新和通货膨胀减缓法案
Henry Grabowski1, Joseph A DiMasi2, Genia Long3
1Henry Grabowski (grabow@econ.duke.edu), Duke University, Chapel Hill, North Carolina.
Health affairs (Project Hope)
|October 7, 2024
概括
减少通货膨胀的法律.
科学领域:
- 药品制造业 药品制造业 药品制造业 药品制造业
- 卫生政策 卫生政策
- 在瘤学瘤学.
背景情况:
- 通货膨胀减缓法案的药物价格谈判计划 (DPNP) 旨在降低处方药的成本.
- 该计划可能会通过改变预期利和药物定价来影响生物制药投资.
- 专注于新药开发,但批准后的活动也令人担忧,特别是在瘤学领域.
研究的目的:
- 评估DPNP对瘤药物批准后活动的潜在影响.
- 为了量化瘤药物对DPNP的暴露,符合条件的日期是FDA批准后的.
主要方法:
- 分析了2000-2021年间批准的155种瘤药物 (112种小分子,43种生物药物).
- 检查食品和药物管理局 (FDA) 批准的标签指示和行业赞助的临床试验.
- 对小分子与生物制剂的DPNP合格日期的批准后暴露的比较.
主要成果:
- 57%的标签指示和68%的临床试验发生在瘤药物的批准后.
- 后审批活动经常发生在DPNP选择资格日期附近或之后.
- 与生物药物相比,小分子瘤学药物面临的DPNP资格日期暴露率是生物药物的两倍多.
结论:
- 瘤学药物,特别是小分子,在批准后表现出相当大的活性,可能会受到DPNP的影响.
- 潜在的影响包括对其他瘤类型的发展的变化,罕见病治疗方法和儿科适应症.
- DPNP可能会显著改变对瘤药物的生物制药部门的后审批投资激励措施.
相关概念视频
Treatment for Pulmonary Arterial Hypertension: Prostacyclin Receptor Agonists
155
Prostacyclin receptor agonists are a class of therapeutic agents integral to managing pulmonary arterial hypertension (PAH). These drugs operate by mimicking the action of prostaglandin I2, or PGI2, a naturally occurring compound in the body.
These agonists bind to the IPR receptor situated on the plasma membrane of the pulmonary artery smooth muscle cells. This binding triggers a cascade of reactions known as the GS-AC-cAMP-PKA pathway. This pathway results in the relaxation of smooth muscle...
These agonists bind to the IPR receptor situated on the plasma membrane of the pulmonary artery smooth muscle cells. This binding triggers a cascade of reactions known as the GS-AC-cAMP-PKA pathway. This pathway results in the relaxation of smooth muscle...
155
Targeted Cancer Therapies
7.5K
The targeted cancer therapies, also known as “molecular targeted therapies,” take advantage of the molecular and genetic differences between the cancer cells and the normal cells. It needs a thorough understanding of the cancer cells to develop drugs that can target specific molecular aspects that drive the growth, progression, and spread of cancer cells without affecting the growth and survival of other normal cells in the body.
There are several types of targeted therapies against...
There are several types of targeted therapies against...
7.5K
Drug Regulation
1.3K
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...
1.3K
Tumor Immunotherapy
489
Immunotherapy is a treatment that boosts or manipulates the immune system to fight diseases, including cancer. For instance, by stimulating an immune response through vaccinations against viruses that cause cancers, like hepatitis B virus and human papillomavirus, these diseases can be prevented. Nonetheless, some cancer cells can avoid the immune system due to their rapid mutation and division. The immune response to many cancers involves three phases: elimination, equilibrium, and escape.
489
Cancer Therapies
7.6K
Cancer therapies are various modes of treatment, such as surgery, radiation therapy, and chemotherapy that are administered to cancer patients.
However, cancer treatments can pose several challenges, as therapies used to kill cancer cells are generally also toxic to normal cells. Moreover, cancer cells mutate rapidly and can develop resistance to chemical agents or radiation therapy. Besides, all types of cancer cells may not respond to the same therapy. Some cancer cells respond to one...
However, cancer treatments can pose several challenges, as therapies used to kill cancer cells are generally also toxic to normal cells. Moreover, cancer cells mutate rapidly and can develop resistance to chemical agents or radiation therapy. Besides, all types of cancer cells may not respond to the same therapy. Some cancer cells respond to one...
7.6K
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


