Digital Health Market Access - Evidence Requirements and Outcomes

If you are new to the topic of market access, it is important to become familiar with how medical interventions / drugs are typically evaluated prior to establishing reimbursement, Health Technology Assessments (HTA). On a European level there is a methodological collaboration on how these assessments should be carried out. You can read more about this here:

Traditionally the HTA organizations will require so called hard-outcomes from well-designed randomized clinical trials. You can read more about this in this publication:

The challenge for many digital solutions is that they will not be able to fit in the traditional box of the HTA evaluations, for a couple reasons:

  • Compared to traditional trials of interventions (drugs / devices) there is a more significant impact of confounding factors which are difficult to capture in a traditional trial, such as organizational and behavioral aspects.
  • Many times, the value will come from the impact in the disease pathway which will require a more comprehensive data collection of a longer period of time than what typically can be carried out in a traditional clinical trial.

The ability to understand the requirements of clinical and economical evidence by the decision makers / evaluators is crucial to establish reimbursement.

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

The process to develop evidence may be time-consuming and costly and it is essential to develop the right strategy.