The continued development and refinement of personalized medicine (PM) has offered an opportunity to revolutionize medical practice and improve outcomes by providing treatments for patients with the notion that “this drug is for you.” The promise of personalized medicine holds allure for patients, providers, and payers alike by improving quality of care by targeting therapy, predicting disease course, mitigating risk, and reducing waste of scarce resources. However, several barriers remain that hinder adoption of PM across the globe, including industry incentive, regulatory pathways, reimbursement policies, and physician habits. In the U.S. market, there are challenges related to reimbursement, but manufacturers can take steps to overcome these barriers working with fellow stakeholders to unlock the full potential of personalized medicine.
In many cases, PM consists of a pharmaceutical product (or a medical device) coupled with a predictive companion diagnostic to help elucidate the right patient for treatment. The U.S. Food and Drug Administration describes such companion diagnostics as in vitro diagnostic or imaging tools that provide essential information for the safe and effective use of a corresponding therapeutic product1. Diagnostics generally consist of assay tests for molecular or genetic profile of the patient to determine if mutations exist that could have an impact on the efficacy of pharmaceutical treatments. These predictive tests help improve clinical outcomes by focusing treatment on those who benefit most avoiding unnecessary treatment in patients who are unlikely to benefit2. Companion diagnostics are a mainstay of PM. Without accurate diagnostic information to guide treatment, the full potential of the targeted therapy is lost.
All too often patients’ access to the promise of personalized medicine is limited by lack of coverage or affordability. As more targeted drug therapies enter the U.S. market, the level of interest in reimbursing and managing biomarker diagnostics is growing quickly among payers3. But payers may not be prepared to properly evaluate coverage for companion diagnostic tests. Research conducted by Xcenda, a strategic consulting firm that is part of AmerisourceBergen, revealed the following:
So, how can diagnostic manufacturers overcome barriers to access?
While personalized medicine faces hurdles to mainstream adoption, there are solutions to expand access and integrate personalized medicine so it can reach its full potential – improving outcomes for patients while driving efficiency across the healthcare continuum. AmerisourceBergen is committed to advancing the promise of personalized medicine and supports manufacturers, providers and patients in overcoming barriers to access.