What is a Value Dossier?
- A Value Dossier presents a summary of the clinical, economic, and humanistic value and supporting evidence (studies) for a new product in a disease area as well as background information on that disease (i.e., burden of illness, epidemiology, etc.)
- The dossier development process involves the creation of value messages, an evaluation of the evidence supporting each of the messages, and identification of evidence GAPs (i.e., need for an economic evaluation).
- The dossier can also act as a guide to inform future research studies, publication strategies, and other evidence generation activities.
What types of Value Dossiers does HEA develop?
- Core Value Dossiers: The Core Value Dossier dossier is a comprehensive information resource which presents all supporting evidence of the clinical, economic, and humanistic value for a new intervention as well as the global burden of illness for that particular therapeutic area. The dossier is developed as an “evolving” document that can serve as a template for customizing submissions to local or national payers (i.e., AMCP dossier, NICE Submission, CADTH submission) and other stakeholders.
- AMCP Dossiers: The Academy of Manged Care Pharmacy (AMCP) Dossier is a pre-specified format for submission of clinical and economic evidence of pharmaceuticals in support of formulary consideration. The evidence requirements are intended for use by manufactuers of pharmaceuticals, biologics, and vaccines who are responding to an unsolicited request from a healthcare system (in the United States) to support reimbursement and/or formulary placement of a new product, new indication, or new formulation of an existing product.
What information is in the Value Dossier?
- Disease Description
- Global Epidemiology and Global Burden of Illness
- Summary of Treatment Pathways, Guidelines, and Competitor Landscape
- Unmet Medical Need and Place of New Product in Clinical Pathway
- Value Story
- Clinical, Economic, and Humanistic Value Messages and Statements
- Summary of Evidence Supporting Product Value
- Clinical Evidence: Summary of Safety and Efficacy Studies
- Humanistic (QOL) Evidence: Summary of Outcomes Studies (Including Quality of Life Studies)
- Economic Evidence: Summary of Cost-Effectiveness Studies, Budget Impact Analyses, and Economic Models
- Our team of medical writers, health economists, and outcomes researchers at Health Economics Associates LLC have developed over a dozen Core Value Dossiers and AMCP dossiers for clients in the pharmaceutical, medical device, and diagnostics industries.
- Clinical areas of dossier development have included diagnostic imaging, nephrology, neurology, obesity, oncology, ophthalmology, orthopedics, and urology.
- Our staff have also supported the development of Health Technology Assessment (HTA) submissions to the Canadian Agency for Drugs in Technology and Health (CADTH) and the UK National Institute of Clinical Excellence (NICE).
- We also conduct trainings through our Core Value Dossier Workshops to help your new staff with dossier development.