Blog: Project ideas: What HEOR projects are requested by our clients? Part 2

Market access is a challenging field. Multiple priorities have to be managed within a limited budget. We would like to share the anonymized outlines of the projects in the HEOR and market access fields commissioned to MTRC to inspire our clients. 

The next example is the adaptation of the global models to settings of European countries. 

European adaptation of the model turned into a de novo model

Situation: 

Our client (a large multinational corporation) was promoting a novel diagnostic test in Italy. They were able to establish dedicated reimbursement only in one or two regions; in other regions, only limited/insufficient reimbursement was available. 

The Italian marketing team was engaging with regional health authorities about the introduction of the test but needed data about the economic consequences of the test in Italian settings. 

The situation was complicated by the fact that there are many potential competitors and very different diagnostic sequences/pathways globally. Italy had a specific standard of care (different from many countries) and a high prevalence of the disease in some sub-populations. 

Initially, the client came to us with an idea to adapt a model developed independently by researchers in Asia. The client did not have access to this model, but the idea was to reproduce the model in Italian settings to reduce the budget of the project. 

Who was involved: 

On the client’s side, the project was commissioned/supervised by the Global Manager of Health Economics and Market Access with the involvement of two marketing specialists in Italy. Several KOLs in Italy were consulted as well.  

The solution: 

The project started with the client defining the clinical and diagnostic pathway in Italy. 

It became immediately apparent that the Asian model could not be adapted to Italian settings, as pathway and clinical inputs were different. The project shifted from the adaptation of the model to the development of a de novo model in Italian settings. 

The client saw the value in that shift, as they did not have health economic data for such a pathway anywhere in the world; this would have brought the client to the next level of understanding of economic consequences for their product globally. 

With the health economic analysis for diagnostic test, there were several methodological challenges that had to be solved:

• Adjustment of the inputs to the sequential use of the tests (results of the previous test changes the probability of positive/negative result for the next time in sequence);
• Identifying clinical inputs so similar populations in different studies, as operational characteristics of the tests (sensitivity/specificity) change radically in different populations;
• Incorporating the effectiveness of the test at different cut-off points (six cut-off points were used in the model).

The project took about 2.5 months to complete, including the time for consultations with the Italian marketing team and clinicians. 

The results of the project were eye-opening and changed the initial understanding of the value and target population for the test by the client. The initial understanding was that the test would be most valuable at high cut-off points; however, the analysis indicated the opposite. 

There were additional insights about the most optimal population for the test (defined by the prevalence of the disease). 

At certain cut-off points, the test was found dominant in Italian settings (leading to greater clinical benefits at a lower cost than the standard of care). This could be the driver for the adoption of the test in Italy, Europe and globally. 

The client is planning to use the model to support market access activities in Italy at a regional level, eventually present the results at international conferences, and publish an article in a peer-reviewed journal. 

We hope this overview was useful. If you have any needs in the field of market access, health economics, and evidence review and synthesis, do not hesitate to book a call with us to discuss your situation.