Guidselines, Credibility, AMCP, science vs. pseudoscience


The University of Minnesota Social and Administrative Pharmacy Program proposed Guidelines for Formulary Evaluations (GFE) are designed to focus on the credibility of clinical and cost-outcomes claims in formulary decision making. The last few years have witnessed increasing concern over the credibility of trial based efficacy claims, with a surprisingly high proportion of claims falling short. At the same time cost-outcomes claims, where comparative clinical claims are a key input, have been presented where the claims made are not open to experimental or observational assessment. This follows from standards recommended for modeled and simulated claims. In the absence of cost-outcomes claims being presented in an evaluable form, it is impossible not only to replicate the claim or to judge whether or not it is credible. Claims for product value based on such claims are unacceptable. The guidelines proposed here are designed to overcome these limitations and support an evidence base that is both credible and replicable for formulary decisions. This is achieved by focusing on short-term modeled or simulated claims for cost-effectiveness. The requirement for modeled or simulated claims that are evaluable within a time frame that is meaningful for formulary decisions marks a major departure from format submissions already in play, not only in the US but in other developed economies. Rather than subscribing to the gold standard of long term or lifetime cost-per-QALY claims a short-term time horizon of no more than 2-years is recommended. This allows products to be provisionally placed on formulary but subject to a protocol that supports an evaluation to be reported back to a formulary committee as part of ongoing disease area or therapeutic class reviews. The place of the product and its contracted price can then be reviewed.

Conflict of Interest