Validating Imaginary Worlds? The AdViSHE Assessment Tool
The publication in April 2016 of the Assessment of the Validation Status of Health-Economic Decision Models (AdViSHE) checklist for decision models raises a number of issues that the health technology assessment literature has yet to address. The principal issue being the role of decision models in generating claims that are evaluable and replicable. Unfortunately, this is not addressed in this new checklist which is intended to address the perceived need for a tradeoff between confidence in a decision model and the need to allocate resources by developers and payers to validating the model. Irrespective of the degree of confidence a developer or payers may have in the sufficiency of the model in representing ‘reality’ unless the model has generated evaluable claims and evidence for those claims in target treating populations, the model fails the standards of normal science. Apart from the absence of a commitment in the AdViSHE checklist to the modeling of claims that are evaluable and replicable, the validation check list makes no allowance for a product pricing strategy that may commits a manufacturer to regular and substantial annual or semi-annual product price increases. Indeed, product pricing assumptions are conspicuous by their absence. The commentary argues that failure to accommodate anticipated pricing behavior renders lifetime cost-per-QALY models and the application of willingness-to-pay thresholds meaningless.