Abstract
OBJECTIVES: To develop best-practice guidance for health technology assessment (HTA) agencies when appraising diagnostic tests for SARS-CoV-2 and treatments for COVID-19.
METHODS: We used a policy sandbox approach to develop best-practice guidance for HTA agencies to approach known challenges associated with assessing tests and treatments for COVID-19. The guidance was developed by a multi-stakeholder workshop of twenty-one participants representing HTA agencies, clinical and patient experts, academia, industry, and a payer, from across Europe and North America. The workshop was supported by extensive background work to identify the key challenges, including: targeted reviews of existing COVID-related methods guidance for assessing interventions and clinical guidelines, engagement with clinical experts, a survey and workshop of HTA agencies, a systematic review of published economic evaluations, and a workshop of health economic modelers.
RESULTS: We suggest HTA agencies should consider using other types of evidence (e.g., real world) where high-quality randomized controlled trials may be lacking and healthcare systems would value timely HTA outputs. A "living" HTA approach may be useful, given the context of an evolving disease, scientific understanding and evidence base, allowing for decisions to be efficiently revisited in response to new information; particularly, if supported by a common "disease model" for COVID-19. Innovative ways of engaging with the public and clinicians, and early engagement with regulators and payers, are recommended.
CONCLUSIONS: HTA agencies should consider the elements of this guidance that are most suited to their existing processes to enable them to assess the effectiveness and value of interventions for COVID-19.
| Original language | English |
|---|---|
| Article number | e24 |
| Number of pages | 6 |
| Journal | International Journal of Technology Assessment in Health Care |
| Volume | 39 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 24 Apr 2023 |
Bibliographical note
Publisher Copyright:© The Author(s), 2023. Published by Cambridge University Press.
Funding
This work was supported by the European Union’s Horizon 2020 research and innovation program (Grant Agreement No. 825162). This dissemination reflects only the authors’ views and the European Commission is not responsible for any use that may be made of the information it contains. The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. The guidance has been developed as part of Next Generation Health Technology Assessment (HTx). HTx is a Horizon 2020 project supported by the European Union lasting for 5 years from January 2019. Its main aim is to create a framework for the next generation of HTA to support patient-centered, societally oriented, real-time decision making on access to and reimbursement for health technologies throughout Europe.
| Funders | Funder number |
|---|---|
| Horizon 2020 Framework Programme | 825162 |
| European Commission | |
| Horizon 2020 |
Keywords
- Coronavirus
- biomedical
- cost effectiveness
- pandemics
- technology assessment
