Personalized Medicine Empowers Treatment Decisions

VBCC - June 2012, Volume 3, No 4 - AVBCC Annual Conference
Caroline Helwick

Houston, TX—“Personalized medicine can improve healthcare delivery, improve healthcare outcomes, and help manage healthcare costs and spending,” said Jeffrey Scott, MD, Senior Vice President, General Manager for P4 Healthcare/Cardinal Health Specialty Solutions, at the Second Annual Con ference of the Association for Value-Based Cancer Care.

Figure 1
Personalized Medicine Relevant to All Stakeholders.
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Personalized medicine is integral to all healthcare stakeholders (Figure 1), Dr Scott suggests. Patients need individualized treatment based on their specific diseases. Physicians need more accurate clinical predictors, and payers need better allocation of resources.

However, Dr Scott notes, there are challenges to the broad adoption of personalized medicine, including:

  • Physicians and payers need education in the use and interpretation of new diagnostic tests that individualize treatment planning
  • Reimbursement has traditionally been cost-based rather than valuebased
  • New individualized diagnostics and therapeutics are based on new technologies and innovative test concepts
  • Legacy regulatory frameworks must evolve to accommodate new diagnostic and therapeutic technologies.
Figure 2
Molecular Targets in Non–Small-Cell Lung Cancer.
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The number of potential molecular targets in just 1 solid tumor alone, such as non–small-cell lung cancer (Figure 2), is overwhelming. If drugs in development improve outcomes, this is good news for the patient, but it adds to confusion for clinicians and payers. “Nevertheless, targeted therapy allows me to better understand how to treat a specific patient,” Dr Scott said.

Accuracy and clinical relevance of genomic assays must be assured, Dr Scott emphasized. Ideally, this includes strong analytical performance (quantification of analyte is re - liable and reproducible), clinical va - lidity (test relates to the clinical outcome of interest), clinical utility (information contributes to and improves on current management), and economic value (cost-savings or cost-effectiveness can be assessed). These measures are interrelated. Analytic performance must be evaluated in the context of clinical use, and clinical validity must be assessed in the context of analytic performance, he noted.

Role of Molecular Diagnostics in Evidence-Based Pathways

Molecular diagnostics has a place in evidence-based pathways, because they can optimize patient care and can create value, Dr Scott said. Molecular diagnostic tests contribute to achieving the lowest total or “appropriate” costs of care, to optimization of therapeutic spend, and to providing a coordinated approach to diagnostics. Patients only receive the drugs from which they can benefit, and the lowest cost is achieved where there is no efficacy differential. The coordinated approach allows for more precise stratification to pathways, he said.

Dr Scott suggested that even when molecular diagnostic tests are expensive up front, if test results drive more appropriate treatment, then cost becomes less important.

Finally, when treatment decisions are based on biology and evidence relevant to the individual patient, disease prognosis and prediction of treatment benefit are improved and therefore outcomes are optimized, he concluded.

“It is likely that within the next decade molecular diagnostics and therapeutics will play a role in the diagnosis and treatment of almost all cancers,” Dr Scott predicted, “and we will enter into a new realm of cancer prevention.”

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