Financing the Future of Digital Pathology

Pathologists play a pivotal role in precision medicine as they are responsible for the biomarker testing, which will select patients for a targeted treatment. Despite growing demand, the notable shortage of pathologists leads to multiple bottlenecks in the field (commonly illustrated by the graphic from the poster by Dr. Andrey Bychkov ).

Digital pathology, enhanced by AI-powered image analysis, is often regarded as a key solution to address the shortage of pathologists, while supporting them expedite results and improve reproducibility. DxD Hub data shows a 300% increase in European labs using digital pathology in routine from 2020 to 2024. Yet, access to digital pathology still restricted to few, mostly large centers and when asked for some of the barriers of adoption, there is an important common point: cost. This hurdle can be subdivided into three main areas:

1)??????? Cost of acquisition: Significant initial investment is required. It is not only difficult for centers to get the resource for acquiring the infrastructure, but also there is a challenge to understand the platform that will better suit their needs and they would not like to be bound to 3 or 4-year contracts to have access to suboptimal solutions.

2)??????? Cost of implementation: Training is time-consuming and demands significant dedication from lab personnel already under pressure to deliver testing results. In some cases, hiring new personnel might also be necessary, as handling of modern equipment may require a different skill set than the available in the lab to experience the full potential of digital pathology. Additionally, alignment of all lab on the use of digital pathology and transition timelines should not be underestimated.

3)??????? Cost of use: Routine use incurs costs for image interpretation and data storage, among others.

In Europe, acquisition and implementation costs are generally seen as part of infrastructure investments to be done by government and institutions, the cost of use has been expected to be incorporated to the reimbursement system. At a side event during the European Congress of Pathology organized by the European Alliance for Personalised Medicine (EAPM) , representants from the regulatory/payor side were clear positioning the cost of use as part of infrastructure gap from their perspective. Reimbursement for digital pathology would only be considered for reimbursement if it is integral to diagnostics for correctly identifying treatment paths (CDx).

Notably, at the end of the ECP, 阿斯利康 announced the development of a new biomarker based on digital pathology (TROP2-QCS) as part of their development program with Daiichi Sankyo . This new biomarker fulfils the payor requirement for inclusion in the reimbursement system. The next challenge is how to include this solution in the reimbursement system, as currently there is no coding available for liquid biopsy. It will be important for both pharma and Dx companies to start an early conversation with the different HTAs to ensure necessary data will be generated and dossiers timely submitted to enable availability of reimbursement by the launch. Early engagement is crucial to avoid situations like those faced by more innovative tests, as the one of ESR1 by liquid biopsy for mBC patients, where treatment is reimbursed, but the biomarker test is not. In Germany, formal inclusion and coding in the EBM happened almost an year after receiving EMA approval, leading to a major obstacle for patients to get access to treatment.

?As innovative diagnostics such as the TROP2-QCS biomarker progress through clinical trials as potential companion diagnostics (CDx), proactive engagement with Health Technology Assessment (HTA) bodies becomes crucial. This process should be a collaborative effort led by pharmaceutical and diagnostic companies to ensure comprehensive evaluation of the Rx-Dx pair. Joint assessment of the therapeutic and diagnostic elements for reimbursement can prevent delays and ensure seamless access to necessary treatments for patients. Such strategic partnerships are vital to overcoming the hurdles experienced by prior innovative testing scenarios, promoting timely inclusion in reimbursement frameworks.

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