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: https://www.eunethta.eu/
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:
- Ivandic, Victor. “Requirements for Benefit Assessment in Germany and England – Overview and Comparison.” Health Economics Review 4 (August 28, 2014). https://doi.org/10.1186/s13561-014-0012-8.
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.