nullius in verba: the university of minnesota social and administrative pharmacy program proposed guidelines for formulary evaluations
Clicks: 81
ID: 221376
2016
Article Quality & Performance Metrics
Overall Quality
Not rated
Combines reader engagement with the AI quality analysis. This
article has not been analysed, so there is no overall score —
reader engagement is measured and shown alongside.
Reader Engagement
Emerging Content
24.0
/100
81 views
2 readers
AI Quality Assessment
Not analyzed
Readership in this journal
EmergingRanked #115 of 122 articles by views in food control
Most read
Least read
Bar heights use a square-root scale. Only the 120 most-read articles are drawn; the journal has 122 in total.
Mint this article as an NFT
Not yet mintedCreate a permanent, verifiable on-chain record of this article on the Scimatic Network. The NFT is held in your Journament account, and you can withdraw it to your own wallet at any time.
5
SUSD
one-off · no wallet required
Abstract
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
None
Type: Commentary
| Reference Key |
langley2016innovationsnullius
Use this key to autocite in the manuscript while using
SciMatic Manuscript Manager or Thesis Manager
|
|---|---|
| Authors | ;Paul C Langley |
| Journal | food control |
| Year | 2016 |
| DOI |
10.24926/iip.v7i2.433
|
| URL | |
| Keywords | Keywords not found |
Citations
No citations found. To add a citation, contact the admin at info@scimatic.org
Comments
No comments yet. Be the first to comment on this article.