Evidence generation

In late April, NHS Accelerated Access Collaborative introduced the Health Technology Navigation Pathway Tool to help innovators adopt new technologies into the NHS. The Tool breaks the innovation journey down into 25 steps, themed around the five key phases of the product lifecycle, from creation to commissioning and adoption. For each step, the schematic flowchart outlines key organizations to engage with, regulatory insights, best practice approaches, policies, guidelines, to-do lists, and required outputs.

On December 17, 2021, the Belgian Health Care Knowledge Center (KCE) published a health services research report “Evidence gaps for drugs and medical devices at market entry in Europe and potential solutions”. In this report, KCE examined the lack of comparative evidence health technology assessment (HTA) agencies and payers face in evaluating new medicinal products and high-risk medical devices at market entry.

Using its deep knowledge of market access pathways in Europe and a specific, fact-based, benchmarking approach, MTRC can support the development of reliable clinical and economic evidence generation strategy.

The Institute for Quality and Efficiency in Health Care (IQWiG) has analyzed the applications for approval of clinical trials at the Berlin Ethics Committee. The share of randomized controlled trials (RCTs) had risen to 86% in 2013. This trend is assumed to be an early response to increasing international legal regulations of medical devices requiring manufacturers to present higher standards of evidence.

National Institute for Health and Care Excellence’s Scientific Advice service is launching an online tool to help developers of medical devices and diagnostics understand and generate the evidence needed to show their products are clinically and cost effective. This will help companies prepare for a dialogue with health technology assessment organisations and payers and potentially speed up time to market.

iFR-SWEDEHEART trial gave another example of quick, inexpensive and reliable way to develop comparative effectiveness for medical device and IVD industry.