Services

Value Dossiers

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 is a comprehensive information resource that 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 Managed 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 manufacturers 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 Experience

  • 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.

Health Economic Models

What is a Health Economic Model?

  • A Health Economic Model is a mathematical framework whose purpose is to estimate the effects of an intervention on valued health consequences and costs.
  • Models enable an evaluation to be extended beyond what has been observed in a study and can bring together data from a variety of different sources.
  • Data sources for model parameter estimates may include clinical trials, observational studies, insurance claim databases, case registries, public health statistics, and quality-of-life surveys.

What types of Health Economic Models does HEA develop?

  • Cost-Effectiveness Models:  Cost–Effectiveness Models assess the overall clinical and economic value of a new therapy in relation to therapies in the same class or in relation to other healthcare interventions.  Cost-effectiveness evaluations typically include impacts on patients or populations (i.e., morbidity and mortality) and on healthcare costs. Common approaches for constructing cost-effectiveness models may include decision tree and Markov (cohort) models.
  • Budget Impact Models:  Budget Impact Models estimate the impact of an intervention on drug costs, healthcare cost offsets, and adverse event costs, as well as the expected utilization in the healthcare system.  These models are useful for estimating system wide (i.e., pharmacy and medical) budget impacts, and are commonly used by managed care payers.  Budget impact models may utilize clinical data and have their results projected as cost per member per month.

Our Approach

  • Transparent: We design our models so that all calculations, data sources, and assumptions are clearly presented and described throughout the model.  We also include sensitivity analysis to explore the effects of alternative input values and assumptions on the results.
  • User-Friendly: We design customer-friendly graphical user interfaces (GUIs) for our economic models using a variety of platforms including Excel and Visual Basic for Applications so that the models can be shared externally or used for internal decision-making.
  • Methodologically Sound: We develop and validate our models based on the ISPOR principles of good research practice for modeling in health care evaluation.  Many of our models have been published in peer-reviewed clinical journals and health economics journals.

Our Experience

  • Our team of economic modelers have developed over 50 health economic models for clients in the pharmaceutical, medical device, and diagnostics industries.
  • Clinical areas of model development have included oncology supportive care, diagnostic imaging, nephrology, neurology, obesity, ophthalmology, and orthopedics.
  • Our staff have also supported the global adaptation of models from the Canadian, UK, and Australian payer perspectives.
  • Several of our models have been published in the medical literature, presented at scientific conferences, presented as part of an AMCP value dossier or Core Value Dossier, and submitted as part of an HTA assessment.

Medical Literature Reviews

What types of Medical Literature Reviews does HEA provide?

  • Comprehensive Reviews: Our Comprehensive Literature Reviews identify, appraise, and synthesize all high quality evidence relevant to a research question. Our reviews generally focus on the health economic and humanistic impact of an intervention in a specific therapeutic area, the burden of a particular illness, the epidemiology and current clinical practice patterns (i.e., diagnosis and treatment) for a disease, and/or a summary of an unmet medical need. Our Comprehensive Reviews also include abstraction tables for the key evidence (studies) in the review.
  • Expedited Reviews: Our Expedited Reviews provide quick summaries of what is already known about a specific topic, disease area, or intervention. Expedited Reviews use systematic review methods to search and evaluate the literature, but the comprehensiveness of the search and other review stages may be limited.

What are some benefits of performing Medical Literature Reviews?

  • Understand the epidemiology (incidence and prevalence) of a particular disease
  • Quantify the humanistic and economic burden of illness including the direct and indirect costs
  • Evaluate the competitive landscape and limitations of current interventions
  • Guide the design of clinical-economic studies
  • Identify GAPs in the medical literature on the economic, clinical, and humanistic impact for particular interventions
  • Inform the development of health economic evaluations and model parameter estimates

Our Approach

  • Define the Research Question and Conduct Literature Search
  • Select Relevant Studies, Develop Review Protocol, and Assess Study Quality
  • Synthesize the Results and Prepare Report

Our Experience

  • Our medical writers and health economics researchers have performed medical literature reviews on the costs and outcomes of new interventions, the global epidemiology and burden of illness, the direct and indirect costs of disease, and the competitive landscape and limitations of current interventions in a number of therapeutic areas.
  • Some of the therapeutic areas where we have performed medical literature reviews include age-related macular degeneration, atopic dermatitis, chemotherapy induced anemia, chronic migraine, chronic renal insufficiency, diabetic macular edema, obesity, osteoarthritis, overactive bladder, post-operative pain management, and spinal fusion.
  • Our medical literature reviews have been used by our clients to develop an early understanding of disease landscapes, to support regulatory and reimbursement submissions for new interventions, and to help inform evidence generation activities and publication strategies.