Since its introduction in 2000, the AMCP Format for Formulary Submissions has evolved quite a bit, and is now in its fourth iteration (version 3.0, introduced in 2010).  Along with the changes to the Format and content of the dossiers, a major change has been the introduction of the AMCP eDossier System, also introduced in 2010.  The eDossier System allows manufacturers to present the evidence in support of their product via an easy-to-use, centralized system, and allows Health Care Decision Makers (HCDMs) to request and review this evidence at their convenience.  From my perspective, the AMCP eDossier platform offers several advantages over other methods for disseminating dossiers. With these recent advances in dossier development and dissemination, it is more critical than ever that the content of the dossier is accurate and on-target to meet the needs of the HCDMs who are using the dossiers for evidence-based decision making.

The following tips will help manufacturers develop content that allows their customers to have the best evidence available for decision making:

• Plan ahead!  Developing and finalizing content for a typical dossier takes a good 6 months. If you are planning to use the eDossier platform, plan on an extra 3 weeks for the conversion process (after all the content is finalized).
• Involve all relevant internal colleagues who will have a stake in the dossier, so there are no surprises when you route the dossier content for final review.
• Section 1 (Executive Summary) is your primary opportunity to "put your best foot forward". This section is meant to be brief (2-3 pages). Do not summarize information in this section that is not otherwise presented in the dossier. The Executive Summary should be an easy to read format, using bullet points when possible.
• Section 2 (Product Information and Disease Information) is key for presenting a solid comparison of the prescribing information for the target product and its key comparator products. Consider carefully the products you will present as key comparators to your product. In most cases, the comparators you select should also be key comparators for your economic model.
• Section 3 (Supporting Clinical Evidence) should be presented carefully to make evidence review manageable. While all clinical evidence in support of the product should be presented here, this section can become quite large. Consider presenting text summaries of only your pivotal trials that were part of your FDA submission package and limiting presentation of other studies to evidence tables only. Links and graphics within detailed evidence tables sometimes require sophisticated editing and formatting, but can help present the information more clearly, which is critical given how extensively decision makers use these tables. When using the AMCP eDossier System platform, links to actual primary resources can point your customer to additional, more detailed information, which is very effective.
• Section 4 (Economic Value and Modeling Report) must be completely transparent if you want your customers to use the information in the decision making process.
• Section 5 (Other Supporting Evidence) offers the opportunity to highlight evidence from additional studies. Again, if you have a large amount of evidence to present for this section, consider using the evidence table only format.