Digital Health Market Acccess - Evidence Strategy and Development

The process to develop the required evidence to establish reimbursement for the digital solutions is one of the most critical issues for the success of a company. A mistake in this process may lead to years of delay and significant unnecessary cost. Consequently, it is of utmost important to do a thorough homework to ensure that you make the right decisions.

For the markets of interest, the following should be understood:

  • What are the clinical and economical outcomes that the decision maker will require?
  • What study design will they require to demonstrate the benefit?

In some countries there are programs that will enable a government sponsored clinical trial, where you as a company only pay a portion of the overall cost of the trial. If you can utilize such program, this can be very cost-effective.

There are other countries, which allows continued development of evidence during the initial use on the market. This may be a very important opportunity to improve speed to market, but it is essential to understand what the requirements will be at the end of this evaluation period.

For some digital solutions, the most appropriate method may be to evaluate the effect using the real-world data already being generated in the health care, maybe together with specific registries in combination with the data from the digital solutions. The ability to do such studies vary significantly across the countries. Through our knowledge about real world data evidence opportunities we can help you make the right strategic decision and help you carry out the analysis of the study.

One you have the required data, it is time to initiate the application for reimbursement in the individual countries.