Evidence gap analysis

Evidence gap analysis helps to optimize the investment into evidence generation for medical technologies, increase chances of success with market access, and reduce time to reimbursement.

Clinical and economic evidence is essential for obtaining market access for innovative technologies in Europe.

Evidence is required to assist reimbursement (e.g. creation of procedure code in Austria, Belgium, France, and the Netherlands) and funding (e.g. obtaining coverage in England and Switzerland) for hospital and ambulatory technologies.
In some countries, only clinical evidence is required, while in others, economic data is required as well (Belgium, England, the Netherlands, and Switzerland).

Companies struggle to understand what kind of data is required to support reimbursement processes. How many studies are necessary? What should be the duration of follow-up? What outcomes should be considered? What comparator should be selected?

Often, a clinical strategy is developed on the basis of the recommendations of the Clinical Advisory Boards, however, they do not take into account the position of the reimbursement decision-makers. Real decision-makers are almost impossible to get for the meeting about the evidence requirements. They are busy and most importantly, don't have a particular topical knowledge of a specific clinical field. In the projects, they are often replaced by proxies with not enough insights into the real drivers of decision-making.

MTRC offers a fact-based, unbiased approach to determining clinical and economic evidence requirements, based on the benchmarking to the prevision reimbursement decisions of reimbursement authorities and HTA organizations. Recommendations are also based on an in-depth understanding of the reimbursement pathways in individual markets.

How does it work?

Our fact-based approach focuses on an in-depth analysis of the previous reimbursement/HTA recommendations

Determining market access barriers

The first step in the project is understanding the market access barriers. This can include the creation of the procedure code, DRG change, add-on reimbursement, obtaining coverage decision by the payer, or recommendation by the health technology assessment (HTA) organization. Different processes could have very different evidence requirements

Determining evidence requirements for target processes

This is one of the key steps in the process and it includes an in-depth analysis of evidence requirements for several (4-5) technologies in a similar clinical field, which already obtained reimbursement or endorsement by HTA. Four-five cases are analyzed per process (e.g. NICE HTA or French HAS review). Information is extracted about the number of studies required for approval, design, need for systematic review, need for RCT/controlled studies, desired outcomes, duration of follow-up, sample size, need for local studies

Analyzing evidence for the technology in scope

Our team performs quick but solid analysis of evidence situation for the target technology. Both clinical and economic evidence is considered. A literature review is performed by our team or provided by the customer

Determining evidence gaps

In this step, the existing evidence for the technology is compared with the general evidence requirements for each target process (based on analysis of reference-benchmark cases) to identify the gaps

Formulating research recommendations

If evidence gaps are determined, our team develops holistic recommendations to bridge existing evidence gaps. This includes general recommendations and details about the design of the study (including outcomes, duration of follow-up, etc.)

Types of evidence gap analysis

Depending on your needs and budget available, MTRC can offer two formats of support

Basic Evidence Gap Analysis

High-level review of evidence for target technology (1-page summary)
MTRC uses pre-selected reference cases from the internal research program
Summary of evidence requirements per reimbursement/HTA process
Limited information about the selection of clinical outcomes
Less expensive

Advanced Evidence Gap Analysis

In-depth review of evidence for target technology
De novo analysis of reference cases from the same clinical field for more detailed insights
Details of evidence requirements per reimbursement/HTA process
Details about the selection of clinical outcomes
More expensive

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