title: [Limitations of pharmacoeconomics from a clinical-pharmacological point of view].
abstract: Pricing decisions for pharmaceuticals usually follow a two-step process. A final economic evaluation needs to be based on a prior clinical-pharmacological evaluation of a new drug in light of therapeutic alternatives. However, major limitations for this evaluation process may be encountered. Most notably a lack of (1) evidence-based data, (2) clinical endpoint data, (3) direct comparator studies or (4) an impaired "assay sensitivity" may cause uncertainty about the appropriate value of a new drug. Moreover situations with (5) incremental, small benefit, (6) lack of precedents in case of innovations or (7) obvious "efficacy-effectiveness gaps" may pose challenges in the pricing decision process for pharmaceuticals.
authors.affiliation: Universitätsklinik für Klinische Pharmakologie, Medizinische Universität Wien, Wien, Osterreich. markus.mueller@meduniwien.ac.at
authors.forename: Markus
authors.initials: M
authors.lastname: Müller
mesh_terms: D001317:Austria; D002986:Clinical Trials as Topic; D003362:Cost-Benefit Analysis; D016527:Drug Costs; D004341:Drug Evaluation; D017850:Economics, Pharmaceutical; D005252:Fees, Pharmaceutical; D006801:Humans; D007349:Insurance, Health, Reimbursement / Q000191:economics; D010601:Pharmacology, Clinical; D013810:Therapeutic Equivalency; D035703:Therapies, Investigational