[Limitations of pharmacoeconomics from a clinical-pharmacological point of view].

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.