REVIEW OF FRANCE'S TRANSPARENCY COMMITTEE'S 2011-2012 ASSESSMENTS
Author(s)
Aggarwal S*;Topaloglu H, Kumar S Novel Health Strategies, Bethesda, MD, USA
OBJECTIVES: In France assessments by the Transparency Committee (TC) plays a significant role in pricing and market access of new products. TC evaluates clinical efficacy and safety data of new interventions, and compares it to current standard of care. TC’s assessments are made using ASMR ratings ranging from I to V (major innovation to no improvement). The objective of this study was to understand trends in TC’s assessments for new products approved by the EMA between 2011-2012. METHODS: TC’s assessments for 11 products approved by the EMA between 2011-2012 were analyzed for their ASMR ratings. Analysis was conducted to identify new trends and compare them for products based on their indications, comparators, and launch timing. RESULTS: Analysis of 2011-2012 assessments by TC shows that the majority of products (73%) received an ASMR rating of IV (minor improvement). Approximately 27% of the products received an ASMR rating of III and V. A new trend in TC’s assessment is the assignment of two ASMR ratings for one product for different subgroups or patient line of treatment. During last one year 3 out of 11 products received two ASMR ratings. None of the products received ASMR ratings of I and II. The products that received ASMR rating of V (no improvement) were indicated for cardiovascular, epilepsy, and bone metastases. All assessments included analysis of intervention’s data versus one or more comparators. CONCLUSIONS: France TC’s assessments trends show a need for robust comparative effectiveness data to obtain better ASMR ratings, which affects both pricing and market access of new products. Future products would need subgroup analysis to obtain high ASMR ratings for all patient populations.
Conference/Value in Health Info
2013-05, ISPOR 2013, New Orleans, LA, USA
Value in Health, Vol. 16, No. 3 (May 2013)
Code
PHP139
Topic
Health Policy & Regulatory
Topic Subcategory
Approval & Labeling
Disease
Multiple Diseases