Health technology assessment of tests for SARS-CoV-2 and treatments for COVID-19: A proposed approach and best-practice recommendations. (24th April 2023)

• Record Type: Journal Article
• Authors: Elvidge, Jamie; Summerfield, Ashley; Knies, Saskia; Németh, Bertalan; Kaló, Zoltán; Goettsch, Wim; Dawoud, Dalia M.
• Is Part Of: International journal of technology assessment in health care. Volume 39:Number 1(2023)
• Publication Date: 2023-04-24
• Subjects: Coronavirus -- technology assessment -- biomedical -- cost effectiveness -- pandemics; Medical technology -- Periodicals; Technology assessment -- Periodicals; 610.28
• DOI: 10.1017/S0266462323000223
• Languages: English
• ISSNs: 0266-4623

Abstract

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.