GLOBAL EVIDENCE GENERATION - CHALLENGES FOR THE PHARMA INDUSTRY
Author(s)
Mukku SDouble Helix Consulting Group, London, United Kingdom
Presentation Documents
Health technology assessments around the world are changing at a pace that it is becoming extremely difficult for the pharmaceutical companies to keep up to the demands of health authorities around the world. Market access, commercial and more specifically clinical development teams are facing a mamoth task of developing and generating clinical data in a form that will satisfy the increasing expectations of health care systems around the world. Objectives: This research paper analysis the current trends in data expectations from key markets around the world. This specific objective was to develop a matrix that will identify the differences and commonalities in clinical data expectations in selected key markets of US, France, Germany, UK, The Netherlands, Spain, Italy, Poland, China, Australia, Turkey, India, Brazil and Mexico. Methods: A combination of ndepth secondary research followed by interviews with key stakeholders in each market was used to achieve the objectives of the project. Clinical experts who are involved in clinical trial design in key research centres, payers at the national and regional level and executives from pharmaceutical industry were interviewed. Results: It was concluded that there is huge variance in data expectations in the selected markets and for this reason countries could be placed in different buckets. For instance, some countries focus on economic assessment (UK, Australia) while other focus on well designed RCTs against relevant comparator (Germany, France). The 2011 introduction of AMNOG has resulted in deadlock between the manufacturers and the GBA (Joint federal committee) in Germany on the choice of comparator. Similarly the new clinical guidelines that are being introduced in China require data with local/Chinese population. The French Transparency (TC) commission is not considering drugs as valuable (AMSR scoring) if they are not supported with a well designed comparator study. The paper elaborates on such global challenges.
Conference/Value in Health Info
2012-06, ISPOR 2012, Washington, D.C., USA
Value in Health, Vol. 15, No. 4 (June 2012)
Code
PHP111
Topic
Health Policy & Regulatory
Disease
Multiple Diseases