Real-World Evidence for Reimbursement and Market Access

Payers, providers, and health systems need evidence that helps them judge not only whether a technology works, but how it performs in routine care, what resources it uses, and where it creates value. Market-access RWE should be designed around those coverage, reimbursement, and adoption decisions.
Real world evidence (RWE) has applications in both regulatory and reimbursement decisions and can be used to inform clinical guidelines. It can be used to identify unmet needs, gain an understanding of patient characteristics, diagnostic markers and disease progression, address evidence gaps when randomized control trials (RCTs) are not feasible, bolster value propositions, and more.
As a result of advances in technology (e.g., remote monitoring technologies) and analytical capabilities – especially those employing artificial intelligence (AI) over recent years, there are large, diverse health-related datasets readily available, and the use of RWE in decision-making is therefore increasing.

Real-world studies can use data generated in routine care through registries, claims, electronic health records, pragmatic studies, observational studies, and other sources to address evidence needs tied to coverage, reimbursement, utilization, and adoption.
RWD can help answer practical questions that traditional trials may not be designed to address, including patterns of use, resource utilization, outcomes in broader populations, and evidence gaps relevant to payer and provider decisions.
FDA has issued guidance describing how real-world data and real-world evidence may be used to support regulatory decision-making for medical devices. Whether RWE is fit for a particular purpose depends on the question, data quality, study design, and the context in which the evidence will be used.

TTi helps MedTech teams define the market-access question first, then select the study approach and evidence plan needed to address it. That can include questions about coverage, reimbursement, utilization, comparative value, and facility adoption.
We identify RWD sources based on whether they can reliably measure the population, utilization, outcomes, costs, comparators, and follow-up needed for the decision at hand.
Leveraging data from disease registries, device and medication registries, patient reported outcomes, insurance and billing claims, electronic health records, biometric monitoring devices, and more, our experts can help generate the evidence your stakeholders need.

Insights

TTi Health Research & Economics2026-08-10T12:43:41-04:00August 10, 2026|Blog, Featured|

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