Claire McKenna1, Marta Soares2, Karl Claxton3, Laura Bojke2, Susan Griffin2, Stephen Palmer2, Eldon Spackman2. 1. Centre for Health Economics, University of York, York, North Yorkshire, UK. Electronic address: claire.mckenna@york.ac.uk. 2. Centre for Health Economics, University of York, York, North Yorkshire, UK. 3. Centre for Health Economics, University of York, York, North Yorkshire, UK; Department of Economics and Related Studies, University of York, York, North Yorkshire, UK.
Abstract
BACKGROUND: The key principles regarding what assessments lead to different types of guidance about the use of health technologies (Only in Research, Approval with Research, Approve, or Reject) provide an explicit and transparent framework for technology appraisal. OBJECTIVE: We aim to demonstrate how these principles and assessments can be applied in practice through the use of a seven-point checklist of assessment. METHODS: The value of access to a technology and the value of additional evidence are explored through the application of the checklist to the case studies of enhanced external counterpulsation for chronic stable angina and clopidogrel for the management of patients with non-ST-segment elevation acute coronary syndromes. RESULTS: The case studies demonstrate the importance of considering 1) the expected cost-effectiveness and population net health effects; 2) the need for evidence and whether the type of research required can be conducted once a technology is approved for widespread use; 3) whether there are sources of uncertainty that cannot be resolved by research but only over time; and 4) whether there are significant (opportunity) costs that once committed by approval cannot be recovered. CONCLUSIONS: The checklist demonstrates that cost-effectiveness is a necessary but not sufficient condition for approval. Only in Research may be appropriate when a technology is expected to be cost-effective due to significant irrecoverable costs. It is only approval that can be ruled out if a technology is not expected to be cost-effective. Lack of cost-effectiveness is not a necessary or sufficient condition for rejection.
BACKGROUND: The key principles regarding what assessments lead to different types of guidance about the use of health technologies (Only in Research, Approval with Research, Approve, or Reject) provide an explicit and transparent framework for technology appraisal. OBJECTIVE: We aim to demonstrate how these principles and assessments can be applied in practice through the use of a seven-point checklist of assessment. METHODS: The value of access to a technology and the value of additional evidence are explored through the application of the checklist to the case studies of enhanced external counterpulsation for chronic stable angina and clopidogrel for the management of patients with non-ST-segment elevation acute coronary syndromes. RESULTS: The case studies demonstrate the importance of considering 1) the expected cost-effectiveness and population net health effects; 2) the need for evidence and whether the type of research required can be conducted once a technology is approved for widespread use; 3) whether there are sources of uncertainty that cannot be resolved by research but only over time; and 4) whether there are significant (opportunity) costs that once committed by approval cannot be recovered. CONCLUSIONS: The checklist demonstrates that cost-effectiveness is a necessary but not sufficient condition for approval. Only in Research may be appropriate when a technology is expected to be cost-effective due to significant irrecoverable costs. It is only approval that can be ruled out if a technology is not expected to be cost-effective. Lack of cost-effectiveness is not a necessary or sufficient condition for rejection.
Keywords:
cost-effectiveness; coverage with evidence development; health technology assessment; only in research; reimbursement decisions; research decisions
Authors: Anna Heath; Mark Strong; David Glynn; Natalia Kunst; Nicky J Welton; Jeremy D Goldhaber-Fiebert Journal: Med Decis Making Date: 2021-08-13 Impact factor: 2.749
Authors: Mathyn Vervaart; Mark Strong; Karl P Claxton; Nicky J Welton; Torbjørn Wisløff; Eline Aas Journal: Med Decis Making Date: 2021-12-30 Impact factor: 2.749