GLOBAL EVIDENCE PLATFORM

The GEP Software

The Maimon Research GEP is a unique information management and document creation software system, a platform designed to support health policy decisions as well as supporting pharmaceutical products and devices over their life cycle. As a platform the GEP provides an effective, inexpensive and easy to utilize approach to the management, evaluation and sharing of information. The GEP has three main functions:

1. as a dynamic, MicroSoft SharePoint based document management system, GEP provides a real time, continually updated, single site resource for the storage of all documents created as over the life cycle of a product, to include consultant reports, systematic reviews, quality assessment, text and clinical reports;

2. as a single evidentiary source for identifying and meeting market access reimbursement needs, undertaking information gap analyses, specifyinginformation templates to reimburser specifications and producing draft documentation at a global level to support market access and value propositions; and

3. as a shared information platform, GEP is an ideal vehicle for the creation, processing and dissemination of information, providing feedback in real time to support health policy and health technology assessments

GEP is built upon Microsoft SharePoint (2007 version; currently updating to 2013 version). All of the features of SharePoint are retained. These include transparency, remote access, team communications, document exchange, discussions, audited reviews and access authorization levels.  Clients can have unrestricted access to the GEP as it is being developed. The SharePoint framework allows sections to be reviewed by the client and, for example, legal departments, before being posted for general access. Unless requested by the client, the GEP is hosted on the Maimon Research server with 24/7 technical support. Maimon Research can provide ongoing management and technical support for a client to ensure the integrity of the system is maintained as well as its currency in terms of monitoring the disease area, undertaking systematic reviews and refreshing text and client documentation. If a client wishes to maintain or create their own GEP, an unrestricted software license is available. The license would include ongoing technical support, trouble shooting and training.

The Maimon Research System, utilizing SharePoint capabilities, can host any number of GEPs. If the client had a number of products/devices to be hosted, a separate GEP could be assembled and customized for each. There would be cost savings in hosting, providing technical support, and maintaining each GEP. Permissions could be introduced to restrict access to the various GEP sites, with each site having its own templates, etc. for document creation and information provision.

Structure of the GEP

Inputs to the GEP comprise documents and data.  Folders are created to capture all relevant documents. These are both specific to the product or device as well as those capturing key features of the disease or treatment area. The former would include product descriptions, package inserts, Phase 1 through Phase 4 clinical trial protocols and reports, systematic reviews focusing on product efficacy and effectiveness, adverse event reports, as well as cost-effectiveness models and budget impact assessments. Systematic reviews and gap analyses are an integral part of this process, notably in respect of documenting unmet medical need. The latter documents would include comparator product descriptions, package inserts and met-analyses of treatment effect, network clinical outcomes, patient reported outcomes instruments, comparator reimbursement assessments (e.g., NICE evaluations), comparator cost-effectiveness and comparator budget impact claims. Once again, systematic reviews are an integral part of this process. At the same time clients can request that internal training materials, posters and PowerPoint presentations be included. A separate bibliography is created with references linked to the text sections (see below) of the GEP, with cited references held in PDF format or linked to their respective websites. As a primary focus of the GEP is on meeting reimbursement standards, links are provided to relevant assessment sites (e.g., CADTH, NICE, PBAC).

As well as capturing all relevant documentation, the development of a GEP involves the creation of a detailed table of contents with text entries. These text entries provide a basis for systematic reviews information dissemination, quality controls and feedback as well as inputs to document creation and health care decisions. A standard table of contents would include the following main sections:

• Introduction: GEP structure and site navigation

• Disease area: Definition, diagnosis and treatment

• Epidemiology: prevalence, course of disease, risk factors, comorbidities

• Place of product in therapy

• Treatment patterns, resource utilization and direct medical costs

• Outcomes in disease state and outcomes instruments

• Burden of disease and unmet medical need

• Clinical profile of product: efficacy and effectiveness

• Comparator therapies: efficacy and effectiveness

• Cost-effectiveness and cost-utility claims

• Budget impact claims

• Evidentiary standards and templates for document creation

• Value drivers and value propositions

• Validating product claims

Separate lists comprise, for example, the table of contents that captures text, illustrations, tables, photographs, figures that can be exported via template to produce country and user specific documents. There are also reference lists, template lists (where standard and customized lists for document creation are stored), poster lists and folders. The system can also generate, apart from links between the various sections, ‘quick lists’ to specific documents, templates, etc. to enhance access.