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Published on: May 4, 2017
Differences among formulary submission guidelines: implications for health technology assessment
Josephine Mauskopf1, Jeffrey Walter, Julie Birt
1RTI Health Solutions. jmauskopf@rti.org
Summary
Health technology assessment (HTA) guidelines vary globally, impacting evidence generation for new health technologies. Understanding these differences is crucial for consistent clinical and reimbursement decisions across countries.
Area of Science:
- Health Economics
- Health Technology Assessment
- Pharmaceutical Policy
Background:
- Formulary submission guidelines from health technology assessment (HTA) agencies differ significantly across countries.
- These variations influence the evidence base required for evaluating new health technologies.
Purpose of the Study:
- To analyze and compare formulary submission guidelines from various HTA agencies.
- To illustrate how guideline differences impact the evidence used in HTA.
Main Methods:
- Compiled and summarized evidence generation recommendations from 12 developed HTA systems (Europe, North America, Australia).
- Focused on clinical and economic data requirements, including systematic literature reviews, comparator selection, and data sources.
- Examined differences in methodologies for evidence synthesis and uncertainty analysis.
Main Results:
- Key discrepancies identified in systematic review methods, comparator choice, clinical evidence appraisal, and economic data collection.
- Country-specific requirements necessitate tailored evidence generation, potentially leading to different evidence bases.
- Methods for literature searching and subset creation can facilitate comparative analysis.
Conclusions:
- Adherence to differing international guidelines likely results in country-specific evidence bodies.
- These variations can lead to disparate HTA assessments and recommendations.
- This comparative analysis aids in understanding the drivers of international variations in clinical and reimbursement decisions.
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