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Early value dossiers for medical technologies

The essential tool to understand the value proposition for your product and position it well with reimbursement/HTA stakeholders

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?

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.

Burden of disease

Epidemiological analysis to present incidence, prevalence, high-risk groups, mortality, morbidity, impact on quality of life, and cost-of-illness. This section answers the question: why is this specific healthcare problem important? 

Current treatment options and unmet need

Current treatment/diagnostic pathways, based on clinical guidelines and surveys of patients and physicians

Review of limitations of existing treatment methods

This section answers the questions: what are the current treatment options and what are their limitations? 

Presentation of the technology

Technical presentation of the technology in scope, including composition, method of action, description of the procedure, and necessary requirements. This section gives a general overview of the technology

Clinical evidence

Evidence of the safety and efficacy of the technology, based on the systematic literature review. This section answers the question: is this technology safe and effective?

Economic outcomes

Analysis of the cost of the procedure and comparative treatments. Cost-effectiveness and budget impact analysis. This section answers the questions: what are the cost implications for this technology? Does it offer value for money? What is the economic impact of the introduction of this technology? 

What is the difference between an early and full value dossier?

Early and full value dossiers follow the same principal structure and but there are some differences in the content and process of development.

Early value dossier

  • Number of sections is limited. The focus is on epidemiology, current treatment options and unmet clinical need, clinical and core economic evidence for a technology

  • The search is limited to Medline

  • Only key evidence is presented for each research question 

  • For the clinical evidence for a target technology, the search covers all published research, but reporting is limited to key studies

  • The size is limited to between 20 and 25 pages

  • The cost is significantly lower compared to a full value dossier

Core (full) value dossier

  • All necessary sections are present, including organisational impact, size of the population, and patient pathways

  • The search is extended to Medline In-Process, EMBASE, Cochrane Library, and other sources for the target technology

  • For each research question, several key studies are presented (often offering insights from different locations)

  • Unlimited size (usually between 60 and a 100 pages)

Technological coverage of our services

We provide services for major types of medical technologies:

Implantable devices
Interventional procedures
Non-interventional procedures
In-Vitro diagnostics (IVD) tests
Medical aids

Our team has worked on hundreds of reimbursement/HEOR projects within different clinical and technological areas, including heart valve replacement, minimally invasive and open heart surgery, coronary, cerebral and peripheral stenting, coronary diagnostic and imaging techniques (fractional flow reserve, intravascular ultrasound), coronary, cerebral and peripheral vascular thrombectomy, implantable and extracorporeal ventricular assist devices, clinic- and home-based dialysis, extracorporeal membrane oxygenation, apheresis, obesity surgery, hernia and reconstruction surgery, tissue products and skin reconstruction surgery, negative wound pressure therapy and medical bandages, neurostimulators for different indications, cell therapy, rehabilitation devices, devices for minimally invasive and open spine surgery, embolization procedures, glucose monitoring, use of fusidial markers, radiotherapy, and endoscopy, amongst others.

Why partner with MTRC?

Be confident in the results

We are accredited by the United Kingdom Accreditation Service (UKAS) as an ISO 9001:2015 certified vendor, specialised in medical technologies market access. Unlike many of our competitors, we dedicate 100% of our time and focus to the area of medical technologies, so that our clients enjoy higher quality services at a lower cost

Avoid the hassle of working with multiple vendors

We specialize in Pan-European projects and worked in 34 countries in Europe. You can save time, effort and money by working with a single experienced vendor vs contracting several consultants individually

Spend less on consulting

We understand the budgetary challenges of the med tech industry and can therefore offer a cost-effective approach to our specialised services. Thirteen percent (13%) of our current business comes from small to medium-sized enterprises (SMEs) – a testament to our unique and personal approach to solve your budgetary challenges

Direct access to senior leadership

Small enough to ensure significant personal attention, and large enough to address your needs, our boutique consultancy guarantees that each project enjoys the attention it deserves with direct access to our senior leaders

Make decisions and advance your business quickly

We appreciate the time-sensitive nature of market access. Being a flexible team, we are not afraid to go beyond regular working hours to meet the high expectations of our clients. For every type of project, we offer the shortest possible turnaround times

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

Full-time employees
Regular clients from the top 30 med tech companies
Of business comes from Small to Medium-sized Enterprises (SMEs)

Our timelines support your timelines

The value dossier is delivered timely to support your market access activities.

MTRC proposals typically specify a timeline of five to six months for the development of the full value dossier and up to four months for the early value dossier. In order to ensure that the work is completed according to industry standards, it is usually not possible to shorten timelines for the development of a value dossier. 

Get in touch

Contact us to discuss your needs and learn about our services