Groundbreaking advances in precision medicine promise to change how we approach diseases such as cancer, but the availability of new diagnostics and treatments doesn’t guarantee access to all patients.
To begin, a couple of the biggest challenges standing in the way of widespread adoption is the need to establish clinical utility and forge proven pathways to reimbursement. Healthcare leaders are collaborating with the FDA to create a regulatory framework that allows clinically valid tests to be adopted rapidly in clinical settings.
Precision medicine treatments can come with a higher price tag than traditional therapies and, when one calculates the cost of each individual test, the companion diagnostics approved to match patients with precision therapies are often more expensive than conventional screening.
Looking through the lens of value-based care, however, precision medicine has the potential to lower costs overall by reducing the need for additional testing and enabling physicians to prescribe more effective therapies as a first course of treatment. By replacing a trial-and-error based approach with a targeted approach that has been proven to improve patient outcomes, providers are making the economic case for precision medicine.
Increased access to precision medicine will also require more widespread participation in clinical trials to accelerate the availability of new targeted therapies. Large-scale studies are not feasible with traditional, one-sample, one-biomarker testing.
As the industry moves toward developing drugs in smaller, even individualized batches – drug manufacturing is becoming more complex. To make the process more affordable and accessible to more people, biotech and pharmaceutical companies are starting to collaborate and share resources, expanding the total infrastructure working to speed up drug development.
And importantly, clinicians will need specialized training to increase their comfort level working with new precision medicine tests. Most cancer patients in the United States are treated in community hospitals that typically don’t have the advanced genomic sequencing capabilities of larger medical research centers. Companies such as Thermo Fisher are working to make precision medicine more accessible by developing new technologies that are easier to use and, ideally, more cost-effective, outside of major medical centers.
Learn more about Thermo Fisher precision medicine solutions here.
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