Value dossiers for the Med Tech companies
Early and core value dossiers to support market access activities for medical devices and in-vitro diagnostic tests
Every innovative technology has the challenge to communicate its value to different stakeholders. Why this health care problem is important (mortality, morbidity, impact on the 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 it 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, they are typically not comprehensive enough, lack important information, and are too unstructured to support discussion with clinicians, reimbursement authorities, and payers.

The modern answer to the challenge of summarizing and presenting the value of the 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 application to the national HTA.

There are two formats of the value dossier: early dossier - a relatively short (15-20 pages) document, based on a systematic but limited search with a focus on the key messages and data; core value dossier is a more comprehensive document (typically about 60-100 pages plus supplements) that covers a larger number of topics.

MTRC can provide support with development of both early and core value dossiers. Typically, dossier is developed either from a global or European perspective.

What is the typical content of the dossier?
Our approach takes into account EUnetHTA Core HTA model and the format of the typical reimbursement and HTA dossiers in Europe
1
Burden of disease
Epidemiological analysis to present incidence, prevalence, high-risk groups, mortality, morbidity, impact on quality of life, cost-of-illness. This section answers the question: why this disease is a serious problem that requires attention?
2
Current treatment options and unmet need
Current treatment pathways, based on clinical guidelines and surveys of patients and physicians. Review of limitations of existing treatment methods. This section answers the questions: how the condition is currently treated and what is the problem with existing treatments? Why the problem is unsolved?
3
Presentation of the technology
Technical presentation of the technology in scope, including composition, method of action, description of the procedure, necessary requirements. This section gives a general overview of the technology
4
Clinical evidence
Evidence of safety and efficacy of the technology, based on the systematic literature review. This section answers the question: is this technology safe and effective?
5
Economic outcomes
Analysis of the cost of the procedure and comparative treatments. Cost-effectiveness, budget impact analysis. This section answers the questions: what are the cost implications for this technology? Does it offer good value for money? What is the budget impact of the introduction of the technology?
6
Size of the eligible population and patient pathway
Calculation of the size of the eligible population, based on bottom-up and top-bottom approaches. Presentation of patient pathway before and after introduction of the technology. This section answers the questions: how many patients are eligible for this treatment? How will the pathway look like after introduction of the technology?
7
Organizational implications
Organizational requirements for the novel technology. This section answers the question: what is required from the organization to introduce a technology (e.g. other equipment, training etc.)?
8
Reimbursement landscape
Coding, payment mechanism, reimbursement tariffs and policy restrictions for the technology in key European countries. This section answers the question: what is the reimbursement of the technology? Will our hospital be adequately reimbursed for performing it?

Key benefits
Dossier suitable for use with different EU stakeholders
MTRC has in-depth understanding of requirements for data presentation of key stakeholders in Europe
Specialized Med Tech provider
MTRC is one of the leading European medical device consultancies with an expertise in reimbursement strategies
Systematic approach for data gathering
MTRC uses multiple focused systematic reviews to answer the research questions in each chapter. All decisions are well-documented and referenced. MTRC also has access to multiple databases to inform development of the dossier

About MTRC
A specialized Med Tech consultancy
17 out of top-30 global Med Tech companies routinely use reimbursement services of MTRC

Coverage of 19 European markets

>120 reimbursement projects per year

15 full-time employees, located in six European countries. In-house coverage of key languages (French, German, Italian, Spanish, Polish, Russian, Turkish)

ISO 9001:2015 certified with the United Kingdom Accreditation Service, UKAS

Main web-sites: Med Tech, Online school in market access
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