You are here

Managed entry agreements / Coverage with Evidence Development – The new home-run for device, diagnostic and digital health start-ups!?
26 Mar 2019

With the evolving evidence requirements for the introduction of new technologies, I would suggest that we should evaluate how we see a successful journey for a start-up company.

Historically, most of the start-ups we worked with would have the perspective:

  • Identify / create a favorable reimbursement scenario
  • Generate sales
  • ..to hopefully be acquired by the large corporations.

In this perspective, countries like France would be considered less attractive due to the high evidence requirement. Their program to do a clinical study to solve the problem with lack of evidence was many times missed.

High level evidence is the new standard

I am not aware of any country in western Europe that would offer an easy pathway, without high quality of evidence, for a new technology

The exception, which can be very attractive, is if you can provide an obvious benefit within the existing reimbursement framework / DRGs. In this scenario, there may be good opportunities to create a commercial success without high level of evidence.

For most of the disruptive technologies, there will be a long process to develop the required clinical and economical evidence to qualify for reimbursement.

Coverage with evidence solutions are crucial

As we move forward, I believe that start-ups and investors should focus on the ability to find programs and solutions that provide the ability to collaborate with Governments in the execution of the clinical trials while providing partial or full reimbursement.

  • France, which historically would be the difficult country, has a well-established framework to support the evidence development until the decision about reimbursement.
  • The change in Germany with the NUB process, which has been a significant drawback for many companies, also created the opportunity to establish a clinical trial partially funded by the government while the procedure / device is reimbursed.
  • United Kingdom also have a few different programs where the Government will fund clinical research for promising technologies.

If you have a company that aspire to leverage these frameworks it is important to assess the feasibility of these programs early and design the strategy for this.

In the coming months we will be coming out with webinars to talk about this topic, so stay tuned.

Tags: 

Managed entry agreements / Coverage with Evidence Development – The new home-run for device, diagnostic and digital health start-ups!? | Synergus

Error

The website encountered an unexpected error. Please try again later.