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

Explore Related HEOR by Topic


Your browser is out-of-date

ISPOR recommends that you update your browser for more security, speed and the best experience on ispor.org. Update my browser now

×