New drug regulations in France: what are the impacts on market access? Part 2 - impacts on market access and impacts for the pharmaceutical industry [0.03%]
法国新药政法规对市场准入的影响(二)——对市场准入及医药行业之影响
Cécile Rémuzat,Mondher Toumi,Bruno Falissard
Cécile Rémuzat
Access to the French drug market is being impacted by an ongoing dramatic shift in practice as well as by two laws that came into force in December 2011. This new environment has been described and analyzed in two separate articles. This se...
Benefits of probabilistic sensitivity analysis - a review of NICE decisions [0.03%]
概率敏感性分析的优势——NICE决定的回顾性研究
Erpur Adalsteinsson,Mondher Toumi
Erpur Adalsteinsson
Objective: Since 2004, the National Institute of Health and Clinical Excellence (NICE) has required manufacturers to conduct a probabilistic sensitivity analysis (PSA) in their technology appraisals. The objective of this...
Mondher Toumi
Mondher Toumi
Drug reformulations and repositioning in pharmaceutical industry and its impact on market access: reassessment of nomenclature [0.03%]
制药行业中的药物改剂型和再定位及其对市场准入的影响：重新评估命名法
Susana Murteira,Zied Ghezaiel,Slim Karray et al.
Susana Murteira et al.
Background: Medicinal products that have been developed and approved for one disease may be the object of additional clinical development in other disease areas or of additional pharmaceutical development for new and diff...
New drug regulations in France: what are the impacts on market access? Part 1 - Overview of new drug regulations in France [0.03%]
法国新药政法规对市场准入的影响（一）—— 法国新药政法规概览
Cécile Rémuzat,Mondher Toumi,Bruno Falissard
Cécile Rémuzat
Access to the French drug market is being impacted by an ongoing dramatic shift in practice as well as by two laws that came into force in December 2011. This new environment has been described and analyzed in two separate articles. The fir...
Delay and restricted access of new molecules in Turkey compared to the United States and European Union [0.03%]
与美国和欧盟相比，土耳其在新分子药物的获取和使用方面存在延迟及受限问题
Toros Şahin,Atakan Yeşil,Türker Topcu
Toros Şahin
Objective: This study compares the performances of new-molecule (NM) launches in Turkey with those in the European Union and United States for the years 2007-2013. ...
Eve Hanna,Cécile Rémuzat,Pascal Auquier et al.
Eve Hanna et al.
Background: Advanced therapy medicinal products (ATMPs) are innovative therapies that encompass gene therapy, somatic cell therapy, and tissue-engineered products. These therapies are expected to bring important health be...
Santiago G Moreno,Joshua A Ray
Santiago G Moreno
Objective: The role of cost-effectiveness analysis (CEA) in incentivizing innovation is controversial. Critics of CEA argue that its use for pricing purposes disregards the 'value of innovation' reflected in new drug deve...
Drug pricing reform in China: analysis of piloted approaches and potential impact of the reform [0.03%]
中国药品定价改革：试点方法分析及改革潜在影响评估
Yixi Chen,Shanlian Hu,Peng Dong et al.
Yixi Chen et al.
Objectives: In 2009, the Chinese government launched a national healthcare reform programme aiming to control healthcare expenditure and increase the quality of care. As part of this programme, a new drug pricing reform w...
A comparison of HAS & NICE guidelines for the economic evaluation of health technologies in the context of their respective national health care systems and cultural environments [0.03%]
HAS与NICE指南比较：在各自国家医疗卫生体系和文化环境下的卫生技术经济评估标准之比较研究
Marc Massetti,Samuel Aballéa,Yann Videau et al.
Marc Massetti et al.
Background: Health technology assessment (HTA) has been reinforced in France, notably with the introduction of economic evaluation in the pricing process for the most innovative and expensive treatments. Similarly to the ...