History and Goals • Why Choose SPI • Clients • Services • Graphics and Design • Contact Us • Links SPI Dossiers: Effectively Communicating the Clinical Value of Drug and Device Products D.S. Pete Fullerton, PhD, RPh was one of the developers of the dossier formulary submission process in 1998, adopted by AMCP in 2000. These formulary submission guidelines allow manufacturers to submit a standardized set of clinical and economic evidence to payers in response to an unsolicited request. This information enables payers to make informed decisions about the value of a medication or device, and allows manufacturers to provide all relevant data on their product. Our dossiers provide an unmatched opportunity to forge and clarify product value messages, distilled from a large volume of published and unpublished data, reviews, graphics, and SPI's extensive clinical and dossier expertise. We work cooperatively with the experts in our client's company--including medical communications, clinical development, marketing, health outcomes, and regulatory staff. We believe our dossiers are the best in the industry. The SPI team of clinical pharmacists writes all of our dossiers, working in close partnership with technical experts at our pharmaceutical company client. Our clinical talent, coupled with our managed care expertise, gives SPI the edge in communicating the value of drug and device products. Our goals are to 1. Summarize a large amount of clinical data, current literature, posters, manuscripts, and review articles with balance and brevity. 2. Clearly communicate the value of pharmaceutical and medical device products to managed care decision makers. Mark McClellan emphasized the importance of value in March 2004: “What matters in drug coverage is the value of the drug – how effective it is in improving health, and potentially in reducing the costs of disease…”
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