Objectives
COVID-19 standard of care (SoC) has rapidly evolved, and many treatments are now in development which will require HTA following regulatory approval. Given the evolving COVID-19 treatment landscape, up-to-date evidence synthesis may challenge HTA. The aim of this study was to evaluate the methodological implications of the rapidly evolving evidence base required for HTA.
Methods
A systematic literature review (SLR) in Embase and Medline of published clinical, economic and health-related quality of life (HRQoL) COVID-19 literature was conducted to generate evidence for HTA.
Results
COVID-19 entries have increased exponentially compared to other diseases. A ‘COVID-19’ search in Embase generated 146,882 hits from October 2019-May 2021. Of these, 1,305 (estimated number per week (ENPW): 101) were published in 2019, 88,098 (ENPW: 1,694) in 2020 and 57,479 (ENPW: 2,699) in 2021. In comparison, there were 14,073 entries for multiple myeloma (MM), with 4,322 (ENPW: 333) in 2019, 7,224 (ENPW: 139) in 2020 and 2,527 (ENPW: 119) in 2021. An Embase and Medline search for COVID-19 clinical studies (October 2019 to May 2021), resulted in 7,279 entries, with only 63 (ENPW: 5) in 2019 (October to December), 3,746 (ENPW: 72) in 2020 and 3,470 (ENPW: 163) up to May 2021. In comparison, the MM SLR resulted in fewer clinical publications (1,964 entries, 614/47, 1,056/20 and 294/14 in 2019-2021). Similar trends were observed for economic and HRQoL studies. Overall, the COVID-19 SLR reported >70% clinical and >90% economic and HRQoL studies compared to a MM SLR intended for HTA.
Conclusions
COVID-19 entries in databases are rapidly increasing weekly. Due to the evolving landscape and abundant evidence, challenges remain to synthesise evidence that is current and reflective of SoC. Based on this experience, a six-month time limit is recommended. COVID-19 evidence generation for HTA requires consensus around the requirements to ensure recommendations are based on up-to-date evidence.