HEALTH TECHNOLOGY ASSESSMENT IN CHRONIC HEPATITIS C- ASSESSMENT OF DECISION LANDSCAPE AND MANUFACTURER INPUTS IN SIX AGENCIES
Author(s)
Mazumder D1, Kapoor A1, Gwatkin N2, Medeiros C3
1Optum Global Solutions, Noida, India, 2Geni Biopharma, Hampshire, UK, 3Optum Life Sciences, Minneapolis, MN, USA
OBJECTIVES: To evaluate the landscape of health technology assessment (HTA) decisions for chronic hepatitis C (CHC) therapies in Canada (CADTH), Australia (PBAC), England and Wales (NICE), Scotland (SMC), Germany (IQWiG), and France (HAS). METHODS: Selected HTA agency websites were searched for submissions made in the CHC therapy area. Submissions were searched for following information: clinical and economic input provided in the submission, recommendations from HTA agencies, and drivers of HTA decisions. RESULTS: Victrelis®, Daklinza®, Roferon A®, Intron A®, Harvoni®, Viekirax®, Pegasys RBV®, PegIntron®, Rebetol®, Olysio®, Sovaldi®, and Incivo® were the pharmacotherapies for which manufacturer submissions were available across selected agencies. The number of HTA submissions with completion status ranged from 6-12. The percentage recommendation ranged from 43% in Australia to 100% in France and Canada. The number of clinical studies supporting the manufacturer submission ranged from 2-12. The quality of clinical evidence originating from same studies has been rated differentially by different agencies. The economic evidence in this area was primarily based on cost-effectiveness/cost utility analysis (CEA/CUA), comprising ~95% of studies (time horizon 50 years to lifetime). The incremental cost-effectiveness ratios (ICER) ranged USD15000-200000 in PBAC, USD1246-376723 in NICE, USD750-45200 in SMC, and USD11000-75000 in CADTH. More than 90% of the decisions based on ICER values were positive, with restriction being focused on cost negotiations. The primary driver of positive decisions was majorly economic analysis in NICE, PBAC, and SMC, while clinical evidence drove positive recommendations in CADTH, IQWiG, and HAS. CONCLUSIONS: Current landscape of CHC treatments in Canada, Australia, UK, Scotland, Germany, and France is majorly dominated by positive recommendations, considering the high unmet in this area. Most of the restrictions were around cost negotiations. The drivers of decisions fit with agency priorities, with economic analysis being the key driver in agencies with pharmacoeconomic analysis, and clinical evidence in agencies without pharmacoeconomic analysis.
Conference/Value in Health Info
2015-11, ISPOR Europe 2015, Milan, Italy
Value in Health, Vol. 18, No. 7 (November 2015)
Code
PGI58
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
Gastrointestinal Disorders