The Evolution of HTA in Emerging Markets Health-Care ... - TREE
The Evolution of HTA in Emerging Markets Health-Care ... - TREE
The Evolution of HTA in Emerging Markets Health-Care ... - TREE
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OHE Consult<strong>in</strong>g Report for PhRMA<br />
5 January 2011<br />
Table 1: A characterization <strong>of</strong> <strong>HTA</strong> systems<br />
<strong>HTA</strong> governance and organization • Institutions/committees<br />
• Entities responsible for review<strong>in</strong>g <strong>HTA</strong> evidence for priority sett<strong>in</strong>g and decision-‐mak<strong>in</strong>g<br />
• <strong>HTA</strong> agenda-‐sett<strong>in</strong>g body<br />
• Reimbursement requirements and limitations<br />
• Stakeholder <strong>in</strong>volvement<br />
• International collaboration<br />
<strong>HTA</strong> topic selection and analytical design • Governance <strong>of</strong> topic selection<br />
• Criteria for topic selection<br />
• Criteria for assessment<br />
• Criteria outl<strong>in</strong>ed or publicly available<br />
• Analysis perspective<br />
• Duration required to conduct assessments<br />
Evidence requirements and assessment<br />
methods<br />
• Documents required from manufacturer<br />
• Systematic literature review and synthesis<br />
• Unpublished data/grey literature<br />
• Preferred cl<strong>in</strong>ical study type/evidence<br />
• Type <strong>of</strong> economic assessment preferred or required<br />
• Availability <strong>of</strong> guidel<strong>in</strong>es outl<strong>in</strong><strong>in</strong>g methodological requirements<br />
• Methodological requirements cover<strong>in</strong>g issues such as choice <strong>of</strong> comparator, specification <strong>of</strong><br />
(preferred) outcome variable, subgroup analyses, type <strong>of</strong> costs (direct or <strong>in</strong>direct), <strong>in</strong>cremental<br />
analysis required, time horizon, equity issues, discount<strong>in</strong>g, modell<strong>in</strong>g, sensitivity analyses, CE or<br />
WTP threshold, sensitivity analyses, miss<strong>in</strong>g or complete data and support for methodological<br />
development<br />
<strong>HTA</strong> dissem<strong>in</strong>ation and implementation • Channels for <strong>HTA</strong> dissem<strong>in</strong>ation<br />
• Use <strong>of</strong> <strong>HTA</strong> results<br />
• Evidence considered <strong>in</strong> decision-‐mak<strong>in</strong>g<br />
• Any reported obstacles to effective implementation such as legal proceed<strong>in</strong>gs etc.<br />
• Formal processes to measure impact<br />
• Process for re-‐evaluation or appeals<br />
• Accountability for stakeholder <strong>in</strong>put<br />
• Transparent/public decision-‐mak<strong>in</strong>g process<br />
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