The Future of Coverage and Payment for Personalized Medicine Diagnostics


The past decade has seen incredible progress for the scope and impact of personalized medicine. Just ten years ago, tamoxifen and trastuzumab were among the few drugs that were routinely paired with a companion diagnostic test. Today, it seems that the FDA approves new precision-targeted therapeutics nearly every month, and the medical development pipeline includes hundreds of targeted therapies to come. Impressive as this is, drugs targeted using combination diagnostic tests are not the only channel through which personalized medicine can become a reality. Genetic tests are increasingly available to diagnose both children and adults with difficult clinical presentations, such as metabolic and mitochondrial diseases. Non-invasive ultrasensitive genomic prenatal testing for trisomy disorders such as Down’s syndrome is also rapidly replacing traditional amniocentesis methods, and amazingly sophisticated cartridge-based kits running on platforms the size of a laser printer can now provide molecular identification of both viral and bacterial diseases. Other technological achievements include the development of multi-analyte assays with algorithms, which help physicians plan the management and in many cases reduce the overtreatment of diseases as diverse as breast, prostate, ovarian, and thyroid cancers. Dozens of papers have surfaced on the potential role of next-generation sequencing in providing a “realtime” genomic map of cancer that could be used to support clinical decision-making.

This has the potential to rapidly facilitate a much deeper understanding of the mechanisms of chemotherapy resistance and point to actionable, effective ways to limit it. The aging of the American population is a stimulus for a longer-term and more progressive approach to decision-making in medical care. Personalized medicine can control costs and improve outcomes, and the increased attention on the future of Medicare will demand creative approaches to accomplishing these goals.

Originally published by Personal Medicine Coalition on July 10, 2014.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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