Precision medicine offers the promise of selecting the right drug for the right person in a timely manner, but outside of cancer, trial-and-error prescribing still prevails in many disease areas. This can lead to the waste of healthcare resources as tests exist to differentiate between responders and non-responders, and those susceptible to adverse events. To address this, changes to the reimbursement model aligning price with value could be a solution. Genomic tests can personalize therapy selection by detecting biomarkers, diagnosing specific diseases, and predicting response levels. Tests with clinical utility lead to changes in medical management and improved health outcomes.
Companion diagnostics are widely used in cancer, where tests are a prerequisite for prescribing some therapeutics. For conditions like Alzheimer’s Disease, biomarkers can differentiate between patients based on their responsiveness to medicines and likelihood of adverse events. Brain scans are essential to diagnose the presence of beta amyloid plaque for proper prescription of certain drugs like Leqembi. Medicare has recently started reimbursing for necessary imaging tests to detect plaque in Alzheimer’s patients, highlighting the importance of accurate diagnosis prior to treatment.
Auto-immune disorders like rheumatoid arthritis can benefit from diagnostics to determine whether treatments will be effective. Companies like Scipher Medicine and Mindera Health are developing tests to identify non-responders to specific therapies, reducing trial-and-error prescribing and improving patient outcomes. Reimbursement for these tests remains a challenge, but initiatives by Centers for Medicare and Medicaid Services and partnerships with insurers aim to increase access and utilization.
Non-alcoholic steatohepatitis (NASH) is a growing concern, with new treatments like Rezdiffra available. However, non-invasive tests like FibroScan are essential to identify effective therapies and rule out patients unlikely to have advanced liver disease. Poor reimbursement for these tests could lead to wasteful spending and ineffective treatment. Reform of the pricing and reimbursement model for diagnostic tests is needed to align costs with value and promote the adoption of precision medicine.
Efforts to link diagnostic test prices to their value have been made by public payers, but insurers continue to rely on outdated reimbursement systems. A comprehensive reset of the pricing and reimbursement system for biomarker tests could facilitate greater adoption of precision medicine. Aligning financial incentives with the use of diagnostics that optimize treatment and make care more efficient would lead to better outcomes for patients and more cost-effective healthcare. This shift is crucial to harnessing the full potential of precision medicine and improving patient care across a variety of disease areas.
