The quicker this state is obtained, the shorter the road to reimbursement — the gateway to monetisation paradise.
The ultimate component of the Monetisable State is the quantified and/or clinically validated PVP. The clinical proof requirements depend on the medical device classification. As Digital Health Applications (“DiGa’s” according to the German Digital Care Act) generally bear lower risk and are less costly, there is often no need for a genuine clinical trial. Instead, companies have to conduct a comparative study, including case reports, expert opinions and comparable evidence, to prove clinical efficacy.
There are two ways to conduct large scale data collection facilitating the quantification and (clinical) validation of value proposition. While both of them act as enablers for reimbursement, they often simultaneously demonstrate a viable business model even before qualifying for reimbursement, assuming that a PVP has been obtained.
1) B2C: Generating a willingness to pay for DTx on an end-user level is deemed challenging, especially in Europe where users are not used to paying for health-related services. However, assuming that a PVP is obtained, why shouldn’t they pay as much as other personal wellbeing enhancing solutions?
2) B2B2C (Corporate Health Management): B2B2C models provide an attractive gateway to larger user groups, because they act as an effective way of “outsourcing” sales and adoption. The inherent alignment of interests for all stakeholders (employer, employee and health insurances, if applicable) contributes to the viability of this approach. Ideally, the pricing for B2B2C models is based on a combination of usage and fixed pricing, incentivising employers to assure usage. However, low usage rates due to stigmatisation, i.e. employees not willing to reveal their health issues to their employers, often lead to challenging unit economics. Different user progress tracking initiatives often including a gamification element followed by an intact reward system have proven to be successful.
This quantification process is deemed rather challenging because feedback cycles on sufficient positive effects in patient care are often very long. Also, note that real world data is often regarded as noisy data, especially with small sample sizes. Early adopters tend to have a higher propensity to use the product in the right manner, leading to a sample bias.
Putting the different components of commercialisation together, we obtain a so-called “Road to DTx monetisation”: