MTRC can provide support with the development of both early and core value dossiers. Typically, a dossier is developed from either a global or European perspective.
The challenge that every innovative medical technology company faces, is communicating its value of medical technology to different stakeholders: why is this specific health care problem important (mortality, morbidity, impact on quality of life, cost-of-illness)? What are the current treatment options and what are their limitations? What is the size of the population with high unmet needs? What is the proposed novel solution? Is the treatment/diagnostic option safe and effective? What are the economic consequences to the hospital and health care system? What are the organizational requirements for the introduction of a novel method?
Historically, these questions were answered by separate publications in peer-reviewed journals and marketing materials. However, these publications are typically not comprehensive enough, lacking important information, and are too unstructured to support discussion with various stakeholders including clinicians, reimbursement authorities, and payers.
The modern answer to the challenge of summarizing and presenting the value of technology is the value dossier. A value dossier is a document of a certain structure that summarizes in a comprehensive and unbiased way, all value-related messages for medical technology. The document is also used as a source of information for any reimbursement-related activities: from supporting local business cases to applications to the national Health Technology Assessment (HTA).
The value dossier is available in two formats:
- The early value dossier — a relatively short (twenty to twenty-five pages) document, based on a systematic but limited search with a focus on the key messages and data
- The core value dossier is a more comprehensive document (typically about 60 to a 100 pages plus supplements) that covers a larger number of topics
MTRC can provide support with the development of both early and core value dossiers. Typically, a dossier is developed from either a global or European perspective.
What is the typical content of the dossier?
Our approach takes into account both the EUnetHTA Core HTA model, and the format of the typical reimbursement and HTA dossiers in Europe.
Global, European
or country-specific dossiers
Usually, dossiers are developed from a global or European perspective, which means that the selection of epidemiological data, treatment patterns, patient pathways and other data is based primarily on either global or European sources.
Clinical effectiveness data are always based on global evidence.
The scope of the dossier is discussed with the client to adjust the methodological approach. In some cases, MTRC will limit the data to key European markets (e.g., EU5 – France, Germany, Italy, Spain, and the UK).
Our team can apply our deep knowledge of the requirements of different reimbursement and Health Technology Assessment stakeholders in Europe to ensure that our clients receive a truly useful value dossier. MTRC has worked on reimbursement/HTA submission projects in Belgium, France, Germany, Italy, Norway, the Netherlands, Poland, Russia, Sweden, and the UK.
MTRC in numbers
An extremely specialised boutique consultancy with a global impact
The value dossier is delivered timely to support your market access activities
The typical timelines in our proposal are five to six months for the development of the value dossier. Usually, it is not possible to shorten the timelines for value dossier projects to ensure that the work is done according to industry standards.
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