Understanding evidence requirements for the EU reimbursement and HTA submissions
Optimize the investment into evidence generation for medical technologies, increase chances of success with market access and reduce time-to-reimbursement
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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, the Netherlands) and funding (e.g. obtaining coverage in England, Germany 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, 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 on 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 determine clinical and economic evidence requirements, on the basis of 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.

What is included in the analysis?
Our approach is based on the in-depth analysis of the previous reimbursement decisions
1
Evidence base for the technology
Analysis of available and ongoing clinical and economic data. Literature review or provided by the customer
2
Understanding reimbursement and funding pathways
It is essential to understand the specific pathways for technology in scope. Optionally, can include analysis of the current standard of care to determine relevant comparator
3
General requirements of reimbursement pathways
Analysis based on general requirements (processes, templates) of reimbursement and HTA processes
4
Evidence requirements for already reimbursed technologies
The key part of the analysis, includes evidence review from the reimbursement decisions / HTAs
5
General position of authorities in relation to class of technologies
Analysis of general evidence requirements and recommendations in other documents of the same reimbursement stakeholder
6
Interviews with KOLs (optional)
Optional interviews are helpful to get additional insights about specifics of the evidence generation for a particular type of technology

The format of deliverable
The format of deliverable is aligned with the need of the client, but typically focuses on the findings on analysis and specific recommendations about evidence requirements
Number of studies
Number of studies of each design to support reimbursement processes
Design
Design (RCT, case series), population, comparator in each country, duration of follow-up
Outcomes
Specific clinical, economic, quality of life outcomes

Key benefits
Pan-European support
Analysis focuses on multiple European countries
Specialized Med Tech provider
MTRC is one of the leading European medical device consultancies with an expertise in reimbursement strategies
Well-document decisions and report
Details of analysis are well-documented to provide a solid basis for internal decision-making about evidence generation strategy

MTRC has unique insights into evidence requirements of European reimbursement and HTA organizations

About MTRC
A specialized hospital and 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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