Abstract
Value of new drugs are evaluated through HTAs in at least 48 countries. Their influence on evidence-based healthcare decision-making includes determining level of coverage in Europe. The characteristics, attributes and methodologies employed by HTA bodies vary significantly. Navigation through the HTA application process in multiple countries is a challenging endeavor. The objective was to characterize the different HTA methodologies used in major European markets. We conducted a systematic review of HTA bodies’ documentation of 10 markets in Europe (England & Wales, France, Germany, Italy, Netherlands, Poland, Scotland, Spain, Sweden and Switzerland) and on peer-reviewed publications through PubMed. For Italy and Spain, a prominent regional HTA was evaluated, Lombardy and Catalonia respectively. Over 350 HTA characteristics, attributes assessed and methodologies used were assessed. Among 10 HTA systems evaluated, England & Wales (NICE), Netherlands (CVZ) and Poland (AOTM) use explicitly stated incremental cost-effectiveness ratio (ICER) thresholds of £20,000-£30,000/QALY, €40,000/QALY and €26,500/QALY respectively. Three markets use implicit ICER thresholds based on the cost-effectiveness studies of previously approved drugs/technologies. Seven HTA bodies involve the general public, 6 publish reports online, 5 review within 2-6 months, and 3 allow for some form of appeal. We describe the various characteristics, attributes, and methodologies by payer architypes across Europe and discuss the associated pros and cons. Numerous HTA bodies provide support during submission process but others lack important information in the public domain. HTA bodies vary significantly and can be categorized as ones using explicit ICER thresholds and ones using implicit ICER thresholds in addition to other factors. Understanding the nuances related to HTA evaluation processes in multiple countries regarding involvement the general public, duration of review process, and ability to appeal, methods of technology assessment, preference on active controls, or availability of submission support will help manufacturers plan accordingly.
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