OBJECTIVES:

To research HTA procedures used to assess COVID-19 technologies in US, Canada, and EU5; to assess whether HTA procedures for COVID-19 technologies differ from established HTA procedures for that country and which COVID-19 monoclonal antibodies (mAb) have been assessed.

METHODS:

Information relating to HTA procedures, mAbs, and outcomes (if available) were identified and extracted from each agency’s website and qualitatively assessed.

RESULTS:

Two countries with decentralized HTA procedures (Italy, Spain) were excluded from analysis. Five countries have HTA agencies assessing COVID-19 technologies. Adapted HTA procedures are used by three (NICE, CADTH, ICER), and procedures are unclear for two (HAS, G-BA) it is unclear what procedures are used.

Of nine mAbs available for treatment and prevention of COVID-19, four are the subject of HTA:

• Casirivimab & Imdevimab: HAS (published; early access granted), CADTH (published; unable to make a decision), NICE (in progress), G-BA (in progress)
• Lenzilumab: NICE (in progress)
• Sotrovimab: HAS (published; opinion in favor of reimbursement), CADTH (published; no decision) NICE (in progress), G-BA (in progress)
• Tocilizumab: NICE (in progress), CADTH (published; no decision)

No HTAs were identified for the remaining five mAbs: bebtelovimab, bamlanivimab & etesevimab, regdanvimab, sarilumab, and tixagevimab & cilgavimab.

CONCLUSIONS:

Agencies are applying HTA procedures to COVID-19 technologies. Assessments, particularly for COVID-19 mAbs, will face challenges. Differing trial designs, definitions and outcomes, and a lack of standard-of-care treatments early in the pandemic may render estimates of comparative effectiveness invalid. Clinical and cost-effectiveness estimates will be affected by a number of other factors, including trial timing, prevalence of variants and their susceptibility to different mAbs, and the proportion of patients remaining vulnerable to severe disease after vaccine rollout. These variables may not be captured in traditional trial-based evidence, rendering HTA reliant on real-world evidence, and HTA decisions may lack longevity and will require frequent updates.