The challenge
Our client, a company focusing on innovative theragnostics, aimed to gain a better understanding of the access landscape for genetic diagnostic tests used to identify responders to a pharmaceutical product, to inform its R&D investment decisions.
There was limited understanding on the access pathway for such a test, and the potential impact on mid- and long-term outcomes on their product, from a pricing and reimbursement standpoint.
As such, the company requested Inbeeo’s support in performing an assessment of the access situation of genetic diagnostic tests across Germany, the US, and Canada.
The approach
Inbeeo captured the reimbursement pathways, evidence requirement, timelines and hurdles for genetic CDx within countries of interest through:
- Assessment of the landscape based on a review of local guidelines and protocols, analysis of reimbursement status and timelines for 20 FDA approved genetic CDx and 68 CDx/drug combinations, and analysis of appraisal outcomes of three analogue genetic CDx
- Pressure-testing of findings through interviews with experts experienced in Dx
- Modelling the pricing impact of changes in the treatment pathway or patient population
The impact
Inbeeo was able to provide clear and market-specific advice on:
- evidence requirements
- the speed and breadth of reimbursement for different types of genetic diagnostic tests
- impact on reimbursement of the drug accompanied by the CDx.
