Important: these departments might not always agree with each other.

to less healthcare consumption. This is a less solid claim and therefore, the insurer demands that the payback period should not exceed three years. The reduction of care consumption should be proven in a threefold analysis: first, a trial aimed at the efficiency of the innovation and process measure (i.e. adherence to therapy). Second, the translation of this efficiency to final process measure (i.e. decrease in complications) proven with scientific research. Last, the use of own data to calculate the expected cost reduction. Facts and figures carry more weight than opinions and experiences and it is important to be careful with estimations. In the case that an innovation is beneficial for multiple conditions, focus on the one that delivers the most cost reduction in the shortest amount of time (‘pick your battles’).

Fourth, this route is suitable for innovations that change the delivery of care, but not the contents or quality. As the insurer believes that the negotiations should be between insurer and provider, it is very important to include the providers as soon as possible in the development of the innovation. This will create the necessary support and enthusiasm needed to convince the insurer. When the content of care is changed because of the innovation, then additional negotiations have to be held with the NZa. The care provider and insurer can file a motion at the NZa. This organisation will determine if the innovation will become reimbursable. If approved, the innovation gets time to prove its performance.

Last, the biggest pitfall is the lack of support among healthcare providers and experts. Another problem is forgetting the substitution of existing care. It is also possible to surpass the insurer if the innovation has proven to lead to cost reduction for at least a similar quality of care. If the initial costs of the innovation are more expensive, but lead to a better quality of care, than the insurer should be involved and the support for this innovation should be bigger.

6.5 GOVERNMENTAL ROUTE

The NZa is the organisation that is responsible for most of the governmental tasks concerning healthcare. Therefore, when taking the governmental route, the NZa is the main stakeholder to take in account.

First, the NZa is responsible for guarding the managed competition market of the Dutch healthcare

Figure 14. The insurer route.

Which step 7 and 8 occur, dependent on which stakeholder delivers the innovation to the consumer/patient. Either the company provides the solution, and the ACM monitors that delivery, or the professional provides the solution, and the ACM monitors that delivery. When the innovation is delivered by the professional, it will most likely be used in a hospital or specialists centre. When the company delivers the situation, most likely a more complex cooperation will be in place.

system. The NZa is also the responsible organisation that can decide if an innovation is applicable for reimbursement and thus, if the insurer can reimburse this care product. The ZiNL (Zorginstituut Nederland) supervises and manages the basic insurance packages. This organisation determines what belongs to the basic package35 _{and so, if the innovation has the potential to be used for the entire Dutch population,}

then the ZiNL should be contacted as well. Second, the NZa is only interested in innovations with broad support from both providers and insurers, as those two are the only stakeholders that can request a new care product. To convince the ZiNL, two criteria must be met (Janssen et al., 2014): (1) the medical experts must accept this type of innovation and it should conform to established guidelines (ZiNL, 2018) for effective and quality care, and (2) the innovation must be clinically validated to provide supporting scientific evidence of its performance. This evidence should be ‘fitting’: the evidence should fit the type of care related to the innovation. The proof does not always have to be delivered through a clinical trial (ZiNL, 2015). The ZiNL has provided guidelines to determine which type of evidence collecting is suitable (Heymans, Kleijnen , & Verstijnen, 2013). Third, this route is applicable if the innovation delivers a new type of care in both content and delivery. Therefore, the solution should be analysed to figure out if both aspects of care change because of the solution design. To speed up the innovation research and development, the government has instituted two regulations: through the ‘beleidsregels innovatie’ regulation it is possible to define a temporary care product so that an innovation can be tested in the proper medical context on small scale for a few years. Through the ‘facultatieve prestaties’ it becomes possible for providers and insurers to file a motion for a new care product at the NZa. Last, this route is similar to the insurer route, and therefore, the same pitfalls exist. However, it is often underestimated how much time and effort this route asks. Most importantly, if the innovation is not used in practice and reimbursable, then no revenue is made from the innovation. Which requires a lot of external financing to gap the years of development and the reimbursement trajectory. Therefore, it is advised to contact the ZiNL early on in development to assess if this route is applicable.

Usually, these types of innovation are developed by medical specialists in combination with companies and researchers.

Figure 15. The governmental route.

35 _{This is determined based on four principles: necessity (do enough people in the Dutch population benefit from this innovation?),}