Coronavirus Disease 2019: Considerations for Health Technology Assessment From the National Centre for Pharmacoeconomics Review Group

• Published in: Value in health Vol. 23; no. 11; pp. 1423 - 1426
• Main Authors: Leahy, Joy, Hickey, Conor, McConnell, David, Cassidy, Owen, Trela-Larsen, Lea, Barry, Michael, Tilson, Lesley, McCullagh, Laura
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.11.2020; Elsevier Science Ltd; ISPOR-The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc
• Subjects: Advisory Committees; Applicants; Betacoronavirus; budget impact; Budgets; Clinical assessment; Clinical research; Clinical trials; Coronavirus Infections - drug therapy; Coronaviruses; cost-effectiveness; COVID-19; Discontinued; Economics; Economics, Pharmaceutical; evidence synthesis; Extrapolation; Health care expenditures; Health technology assessment; Humans; Internal Medicine; Medical technology; Medical treatment; Pandemics; Patients; Pharmacoeconomics; Pharmacology; Pneumonia, Viral - drug therapy; Public Health; Quality of Life; SARS-CoV-2; Sensitivity analysis; Technology assessment; Technology Assessment, Biomedical; Themed Section: COVID-19; treatment discontinuation; treatment effect; Treatment Outcome; Uncertainty; Withholding Treatment; COVID-19; health technology assessment; cost-effectiveness; extrapolation; treatment effect; treatment discontinuation; evidence synthesis; budget impact
• ISSN: 1098-3015; 1524-4733; 1524-4733
• DOI: 10.1016/j.jval.2020.09.003

It is expected that the coronavirus disease 2019 (COVID-19) pandemic will leave large deficits in the budgets of many jurisdictions. Funding for other treatments, in particular new treatments, may become more constrained than previously expected. Therefore, a robust health technology assessment (HTA) system is vital. Many clinical trials carried out during the pandemic may have been temporarily halted, while others may have had to change their protocols. Even trials that continue as normal may experience external changes as other aspects of the healthcare service may not be available to the patients in the trial, or the patients themselves may contract COVID-19. Consequently, many limitations are likely to arise in the provision of robust HTAs, which could have profound consequences on the availability of new treatments. Therefore, the National Centre for Pharmacoeconomics Review Group wishes to discuss these issues and make recommendations for applicants submitting to HTA agencies, in ample time for these HTAs to be prepared and assessed. We discuss how the pandemic may affect the estimation of the treatment effect, costs, life-years, utilities, discontinuation rates, and methods of evidence synthesis and extrapolation. In particular, we note that trials conducted during the pandemic will be subject to a higher degree of uncertainty than before. It is vital that applicants clearly identify any parameters that may be affected by the pandemic. These parameters will require considerably more scenario and sensitivity analyses to account for this increase in uncertainty. •The coronavirus disease 2019 pandemic may affect many ongoing clinical trials and leave large deficits in the budgets of many jurisdictions.•This article discusses potential difficulties with data from these trials, such as excess deaths; issues with extrapolation and evidence synthesis; and lack of generalizability of cost, utility, and discontinuation data.•We conclude with recommendations for those submitting health technology assessments.