Package Insert Directory:  We have added links to over 600 product package inserts (PIs) to the Resource Center.  Registered users can browse by drug name or manufacturer and quickly find the PI they need to review.  The AMCP eDossier System Team continues to reach out to manufacturers to obtain updated information, but please feel free to contact us directly for more information.

Reference Library:  Based on HCDM feedback we have also started to integrate supplemental scientific resources into the AMCP eDossier System.  The new Reference Library will continue to grow based on user feedback and needs.  Information selected for inclusion on the System will be carefully determined as we are completely dedicated to keeping the AMCP eDossier System free of any promotional or marketing materials.  

In collaboration with the Agency for Healthcare Research and Quality (AHRQ), we are pleased to now offer registered HCDM users direct access to some targeted AHRQ Comparative Effectiveness Research (CER) Reviews via the System's new Reference Library!    

New Content Added to Resource Center for Registered HCDMs!

The Manufacturer Review Site (MRS) is a secure site for manufacturers to review their product eDossiers prior to them being published on the live AMCP eDossier System.  Manufacturers with product eDossiers on the System are provided protected access to their company-specific MRS.

The MRS will continue to evolve to meet manufacturer needs.  Based on feedback from participating manufactures, the following enhancements are on the horizon:

File Manager: To minimize the use of email to transfer confidential information (e.g., product dossiers) during the eDossier Implementation Process, we have created a File Manager tool that allows authorized manufacturer representatives to upload, download, and replace documents associated with the product eDossier.  The use of this tool is simple and secure; however, our dedicated Client Managers will be working with already participating manufacturers to provide any necessary training and instruction guides.

eRequest Manager:  To add further efficiency when fulfilling requests for product eDossiers generated by registered HCDMs, an eRequest Manager will be added to the MRS for participating manufacturers.  This eRequest Manager will allow manufacturers to approve or deny requests for product eDossiers within their secure MRS.  We will be working with participating manufactures to ensure that this enhancement meets their needs and continues to simplify the already streamlined process throughout 2011.

Bob Martin, MS, RPh

Director, Customer Engagement, HE&OR

Novartis Pharmaceuticals Corporation

The development of guidelines for formulary submissions to health care systems since the mid to late 90's, which eventually led to the AMCP Format for Formulary Submissions in 2000, has continued to evolve to the current AMCP eDossier System platform (introduced in January 2010).  Pharmaceutical manufacturers wishing a fair evaluation of their product evidence for formulary review may now collaborate with their customers by disseminating requested product dossiers via this centralized System.

Health Care Decision Makers (HCDMs) and the industry have similar goals, including informed, evidence-based decisions and the best possible outcomes for patients receiving pharmacotherapy.  The industry needs to collaborate with decision makers by providing adequate clinical trial, health economic and outcomes research information with modeling, and other tools for decision makers to evaluate and decide which products will provide the best patient outcomes, in a clinical and cost-effective manner.

From the industry's standpoint, dossiers offer us the opportunity to pull together a fully comprehensive document that focuses on the evidence supporting a product's value.  Decision makers have been very clear regarding the need for manufactures to reference the inclusion and exclusion criteria for evidence cited, as well as be transparent about any model assumptions.  As an industry, we must strive to deliver on these requests.  We need to continue to focus on including quality information in the dossiers that we create or they will become useless to our customers.  If we don't focus on quality, we risk having product dossiers completely disregarded in the decision making process.

When thinking of how the value of dossiers can be specifically expanded, the entire industry must recognize the impact that the delivery mode has on the formulary review process.  The inefficiencies and cost burden of producing paper dossiers and PDF files decreases the overall utility for the HCDM reviewing this material.  The AMCP eDossier System provides an efficient, comprehensive resource that allows for easy extraction of information to fit into multiple formulary presentation media (e.g., monographs, slides).

The AMCP eDossier System isn't something that should be embraced by a handful of manufacturers.  If we, as an industry, want to truly support the decision making process, then this is one simple step in that direction.  And, we must continue to evolve with the process as the next generation of dossier guidelines come to fruition (e.g., outcomes-based dossiers).

Manufacturers participating in the AMCP eDossier System to date have had great experiences.  There have definitely been learnings along the way, especially related to how we need to more effectively and efficiently organize and communicate within our own teams (e.g., internal, departmental cross-functional collaboration for developing dossiers).

The industry has spent the last 10+ years getting used to responding to requests from decision makers for product dossiers.  It took a while for us to embrace the guidance put forth in the AMCP Format, but we have seen the value that this has brought to the decision making process over the years. 

My hope is that manufacturers don't spend the next 10+ years waiting to see if this System will be of value to their customers.  If we all participate and truly make it a centralized resource for decision makers to access product dossiers that they request, the value to all of our customers won't be missed.

Summing it up... the System works and it really does streamline things.  

How can the AMCP eDossier System help HCDMs communicate their information needs to manufacturers?

The AMCP eDossier System offers a directory for locating contact information for manufacturers.  It also provides registered HCDMs with a user-friendly, regulatory-compliant eRequest Tool.  The eRequest Tool allows HCDMs to select the manufacturer that they wish to receive information from and then independently formulate their request in an efficient, concise manner - based on their own specific needs.  Product eDossiers can also accommodate a more customer-specific Contact Center.  Participation on the System's eRequest Tool is free for all manufacturers.  Contact us for more information.

• Click here to watch a video demonstration, which provides an overview of the entire request and fulfillment process.
• Click here to access a Quick Guide for HCDMs to register and/or use the System's eRequest Tool.

What sections of a dossier do HCDMs value most?

When asked in an eSurvey to value the dossier sections that are most useful to them during the formulary review process, registered HCDMs rated all aspects of the dossier fairly high, with the Supporting Clinical Information, Executive Summary, and Product & Disease Information areas the most valuable.