Blog: Project ideas: What HEOR projects are requested by our clients? Part 1

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 first example is the evidence gap analysis and evidence generation strategy. 

Evidence gap analysis and recommendations for a clinical study

Situation

Our client (a large multinational corporation) was considering the acquisition of a manufacturer of novel digital diagnostic technology. The technology was being used to replace a physical procedure. The space was crowded with a number of manufacturers of devices for physical (manual) procedure and several (six) players in a digital space. 

Research question

The client was interested in understanding the market access barriers and required investment in clinical research to obtain reimbursement and funding. Specific recommendations about the design of the required studies were also necessary.

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 the European HEMA counterparts. 

The solution

Our project had three steps. 

First, we studied the current reimbursement landscape and determined the gaps in the reimbursement. Reimbursement was lacking in several countries, and HTA and funding was a challenge in the UK.

Second, we developed a market access strategy in core markets. The strategy mainly required an application for a procedure/reimbursement code, health technology assessment in several countries, and a funding decision in two markets. 

Third, we performed an evidence gap analysis and provided recommendations for evidence generation. Due to budget limitations, the project was limited to EU3 countries only. 

In the evidence gap analysis, we:

• Reviewed five cases of similar reimbursement/HTA reports in target countries (NICE and NHS England in the UK, HAS in France, G-BA and IQWiG in Germany) to understand evidence requirements of these organizations in relation to similar technologies;
• Performed review of available and ongoing/planned studies for a target technology and competitors (there were multiple ongoing RCTs);
• Identified gaps in evidence;
• Provided recommendations about overall evidence generation strategy, and recommendations for a study design (design, comparator, population, primary and secondary clinical and health economic outcomes, specifics of the statistical analysis and reporting).

At the end of the project (four months in total), the client had a complete understanding of the current and future market access situation and challenges for the product, the necessity of investment in clinical research, and the specifics of the required studies. The report helped the client to inform the decision about the acquisition of the target company. 

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. 

MTRC Team