Finding a biomarker for central nervous system (CNS) disorders that translates into clinical meaningfulness has been a real challenge for the biomarkers space. Biomarkers will be used more in the future, but limitation and lack of reimbursement for these biomarker tests will affect their use, says GlobalData, a leading data and analytics company.  

According to GlobalData’s latest report, ‘Biomarkers in the Central Nervous System’, Alzheimer’s Disease (AD) is the major indication being targeted for the development of drugs involving biomarkers, with a total of 197 clinical trials conducted in the eight major markets (8MM*). Currently, there are three FDA and EMA approved diagnostic tests for AD, all of which are PET neuroimaging scans capable of detecting beta-amyloid plaques in the brains of living patients.

Alessio Brunello, Pharma Analyst at GlobalData, comments, “Many biofluid biomarkers, particularly blood-based biomarkers, still face numerous challenges in terms of standardization and measurements of these markers have shown variability and inconsistencies when applied in different settings. These biomarkers are important because they could be widely implemented as diagnostic screens for several diseases, as they would be more cost-effective and less invasive for patients.”

Assay technologies are improving and will offer a more convenient and efficient way to test multiple biomarkers, which will become increasingly important as more targeted therapies are approved and the presence of biomarkers impacts clinical decision-making even more widely. Furthermore, physicians would use liquid biopsies more often if they were more reliable, but this is not expected to improve significantly in the next few years.

Biomarkers have a unique set of regulatory challenges and the reimbursement of biomarkers remains a global market barrier as trends across the 8MM are inconsistent. Biomarkers in CNS are used when there is clinical utility and to help decisions regarding a particular drug treatment, and if effective are most likely to receive reimbursement from the regulatory advisor. Reimbursement presents challenges for patients accessing CNS biomarkers, and reforms are crucial to accelerating the adoption of personalized medicine.

Brunello concludes, “Availability of multiple biomarker tests will encourage competition and likely bring prices down, increasing access to biomarker testing. However, one of the major barriers to the widespread use of biomarkers that are available for CNS disorders is the limitation or lack of reimbursement for biomarker tests by public and private health insurance providers.”

* 8MM: US, France, Germany, Italy, Spain, UK, Japan and China