title: A role for two-stage pharmacoeconomic appraisal? Is there a role for interim approval of a drug for reimbursement based on modelling studies with subsequent full approval using phase III data?
abstract: Healthcare decision makers and pharmaceutical companies are increasingly using techniques of economic evaluation, particularly modelling, to assist them in their decisions about drug purchasing and drug development. The use of models in other types of policy decisions is also well established. One option, to shorten the time to a purchasing decision, would be for an interim decision for approval for reimbursement to be based on an economic model. Such a system would mainly benefit the drug development process and thus the pharmaceutical industry; however the approach could also lead to poor decision making, unethical marketing and withdrawal of drugs from the consumer. In this article, we consider the option of a two-stage economic appraisal process from the point of view of the seller, the purchaser and the patient and public. Although a two-stage process may offer some advantages in terms of early return on investment and access, there are significant disadvantages in terms of certainty about effects and public policy and expenditure. Until there are better methods of predicting the effectiveness of a new product, it is unlikely that interim decisions can be seen as a reasonable health policy alternative, although it seems likely that industry may continue to lobby for such an approach.
authors.affiliation: Clinical Pharmacology, School of Medical Practice and Population Health, Faculty of Health, Newcastle University, Newcastle, Australia. hillsu@mail.newcastle.edu.au
authors.forename: Suzanne
authors.initials: S
authors.lastname: Hill
authors.forename: Nick
authors.initials: N
authors.lastname: Freemantle
mesh_terms: D001315:Australia; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D003659:Decision Making, Organizational; D017277:Drug Approval / Q000191:economics*; D004345:Drug Industry / Q000191:economics*; D017850:Economics, Pharmaceutical; D005569:Formularies as Topic; D006801:Humans; D007349:Insurance, Health, Reimbursement; D007356:Insurance, Pharmaceutical Services; D018803:Models, Economic; D006113:United Kingdom