Low rates of patient-reported outcome claims for orphan drugs approved by the us food and drug administration [0.03%]
美国食品药品监督管理局批准的罕见病药物患者报告结果赔偿率较低
Szymon Jarosławski,Pascal Auquier,Borislav Borissov et al.
Szymon Jarosławski et al.
Background: Claims included in package inserts (PIs) for medicinal products approved by the US Food and Drug Administration (FDA) constitute the regulatory definition of drugs' benefits and risks. Objective: We sought to assess the usage of...
Baudouin Standaert,Rino Rappuoli
Baudouin Standaert
In two previous papers we argued on current vaccines economic assessment not fully comprehensive when using the incremental cost-utility analysis normally applied for treatments. Many differences exist between vaccines and drug treatments m...
Baudouin Standaert,Rino Rappuoli
Baudouin Standaert
This paper describes how the economic assessment of vaccines is performed today. It discusses why it may be incomplete and explores potential approaches to adjust the analysis to be more comprehensive. Besides helping protect against seriou...
Towards a more comprehensive approach for a total economic assessment of vaccines?: 1. The building blocks for a health economic assessment of vaccination [0.03%]
迈向全面的疫苗经济评估方法：健康经济效益评估的基础要素？
Baudouin Standaert,Rino Rappuoli
Baudouin Standaert
Since we were born, we all take preventative actions to avoid unpredictable adverse conditions. Some actions are done automatically. Others require a conscious choice , either for personal or social benefit. A distinction can therefore be...
Pharmaceutical Market Access: current state of affairs and key challenges - results of the Market Access Launch Excellence Inventory (MALEI) [0.03%]
医药市场准入：现状与主要挑战——基于市场准入启动卓越调查(MALEI)的结果分析
Marcus A Koch
Marcus A Koch
Objectives: To take inventory of the current state of affairs of Market Access Launch Excellence in the life sciences industry. To identify key gaps and challenges for Market Access (MA) and discuss how they can be addres...
Conflict of interest in Health Technology Assessment decisions: case law in France and impact on reimbursement decisions [0.03%]
法国卫生技术评估决策中的利益冲突案例法及其对报销决定的影响
Sandrine Frybourg,Cécile Remuzat,Åsa Kornfeld et al.
Sandrine Frybourg et al.
The slow reaction of French authorities to the so-called Mediator® saga in 2009 in France led to investigations that questioned the way conflicts of interest are reported. France implemented the Loi Bertrand ('Bertrand Law') in May 2013, k...
Using multicriteria decision analysis during drug development to predict reimbursement decisions [0.03%]
利用多标准决策分析预测药物研发中的报销决定
Paul Williams,Josephine Mauskopf,Jake Lebiecki et al.
Paul Williams et al.
Background: Pharmaceutical companies design clinical development programs to generate the data that they believe will support reimbursement for the experimental compound. ...
Amélie Dubromel,Loïc Geffroy,Gilles Aulagner et al.
Amélie Dubromel et al.
Background: In France, a significant part of health expenditure is publicly funding. This put a heavy burden on society. In an economic context requiring tight control of public spending, it seems relevant to control the diffusion of medica...
Cost-effectiveness of solifenacin compared with oral antimuscarinic agents for the treatment of patients with overactive bladder in the UK [0.03%]
与口服抗胆碱能药物相比，索利那新治疗英国过度活动膀胱患者的成本效益分析
Zalmai Hakimi,Con Kelleher,Samuel Aballéa et al.
Zalmai Hakimi et al.
Objective: To evaluate the cost-effectiveness of solifenacin 5 mg/day versus other oral antimuscarinic agents used for overactive bladder (OAB) from a UK National Health Service (NHS) perspective. Study design: In a Markov model, hypothetic...
Sales promotion by wholesalers affects general practitioners' prescription behaviours in Japan [0.03%]
日本批发商的促销活动影响了英国普通医生的处方行为
Hirohisa Shimura
Hirohisa Shimura
Background: One method for promoting drugs in Japan has been utilizing wholesalers for promotion; however, the effectiveness of the sales promotion has been brought into question. Methods: A total of 74,552 responses were collected from an ...