Understand What Evidence Reimbursement Bodies Expect - Before You Invest in Studies

When You May Need an Evidence Gap Analysis

Evidence planning is often based on regulatory requirements, clinical advisory boards or general research priorities. These perspectives may not fully reflect what reimbursement authorities, payers and HTA bodies require.

An Evidence Gap Analysis may be helpful when your company is preparing for reimbursement or HTA, planning a clinical study, entering new European markets or deciding how to allocate evidence-generation budgets.

It can also support situations where the team is uncertain about the appropriate comparator, outcomes, sample size, study design, duration of follow-up or need for economic evidence.

What Evidence Is Likely to Be Required?

We analyze relevant reimbursement and HTA pathways and examine previous decisions for comparable technologies.

This helps clarify the likely expectations for:

Study design
Comparator selection
Sample size
Follow-up duration
Clinical outcomes
Health economic outcomes
Local evidence
Support in clinical guidelines

Is Your Current Evidence Sufficient?

We review the available clinical and economic evidence for your technology and compare it with the requirements identified from relevant reimbursement and HTA precedents.

This allows us to determine where the current evidence is strong, where uncertainty remains and which gaps may affect future access.

What Evidence Should You Generate Next?

We translate the identified gaps into practical research recommendations.

These may address study design, outcomes, comparators, follow-up, sample size, local data, economic analysis and the sequence in which evidence should be developed.

Our work helps your team determine:

Whether the existing evidence is likely to support reimbursement or HTA

Which evidence gaps create the greatest access risk

Which clinical and economic outcomes should be prioritized

Whether additional studies are necessary

Which comparator and study design may be most appropriate

Whether local evidence or health economic analysis is required

Where evidence-generation budgets should be focused

What research should be completed first

A Fact-Based Approach to Evidence Planning

MTRC’s approach is based on analysis of real reimbursement and HTA decisions rather than relying only on interviews or general expert opinion.

We examine previous decisions for comparable technologies in the same or a similar clinical field. These reference cases help reveal the evidence that decision-makers previously accepted, challenged or considered insufficient.

The recommendations are also informed by the relevant reimbursement and HTA pathways in each target market.

How MTRC Works

Define the Market Access Objective

We clarify the target countries, reimbursement or HTA processes, technology, indication, care setting and business decision the analysis must support.

Identify the Relevant Access Barriers

We determine whether the main challenge relates to reimbursement, payer coverage, procedure coding, funding, HTA or another decision-making process.

Analyze Relevant Reference Cases

We review previous reimbursement and HTA decisions for comparable technologies to identify the evidence considered necessary for approval or endorsement.

Review the Existing Evidence

We assess the available clinical and economic evidence for the technology in scope.

The review may be based on materials provided by the client or on a targeted literature review performed by MTRC.

Identify the Evidence Gaps

We compare the existing evidence with the requirements identified from relevant reference cases and target processes.

Develop Practical Research Recommendations

We recommend how the most important gaps can be addressed and which evidence-generation activities should be prioritized.

Why MTRC

Market Access-Led Evidence Planning

MTRC evaluates evidence through the perspective of reimbursement, payer and HTA decision-making, not only through regulatory or academic standards.

Analysis of Real Decisions

Our recommendations are based on previous reimbursement and HTA decisions for comparable technologies, helping reveal how decision-makers have evaluated evidence in practice.

MedTech and IVD Expertise

MTRC focuses on medical devices, diagnostic tests and related medical technologies. We understand the evidence challenges associated with procedures, devices, diagnostics and digital technologies.

European Country Know-How

Our team combines evidence assessment with an understanding of country-specific reimbursement and HTA pathways.

Integrated Clinical and Economic Perspective

We consider both clinical and economic evidence where relevant, including the need for health economic modeling, local costing or budget impact analysis.

Practical Recommendations

The final output does not only describe the gaps. It explains what evidence should be generated, why it matters and how it can support future reimbursement or HTA activities.

From Evidence Gaps to Evidence Generation

An Evidence Gap Analysis can provide the foundation for subsequent work such as:

Clinical study protocol review
Systematic literature review
Value dossier development
Health economic modelling
Reimbursement or HTA dossier development
Market access strategy

Discuss Your Evidence Requirements

Tell us about your technology, existing evidence, target markets and the reimbursement or HTA decision you are preparing for.

MTRC will recommend the most appropriate scope and level of analysis.

Discuss Your Evidence Requirements

Understand What Evidence Reimbursement Bodies Expect - Before You Invest in Studies

When You May Need an Evidence Gap Analysis

Three Questions We Help You Answer

What Your Team Will Be Able to Decide

A Fact-Based Approach to Evidence Planning

How MTRC Works

Why MTRC

From Evidence Gaps to Evidence Generation

Discuss Your Evidence Requirements