Archive for December, 2010

The Value of Innovation: The Case for Personalized Medicine

December 10th, 2010

This post was 1st featured on the Disruptive Women in Health Care blog and will be part of an upcoming e-book on Innovation.

There are countless articles and books on innovation – incremental innovation, radical innovation, disruptive innovation.   However, I would argue that, with a nod to the authors of Blue Ocean Strategy, that unless innovation is value innovation, providing some deliberate and distinguished combination of factors or service to improve the experience or effectiveness for relevant stakeholders while reducing costs it is not innovation at all, but simply something new.

That said, the case for personalized medicine as a value innovation, a valuable innovation, is one I am eager to make. The most common definition of personalized medicine is genomic-based risk assessment, diagnosis, treatment.  Personalized medicine broadly construed also comprises technology-supported medical practice able to aggregate data on a population level to a degree that positive or adverse outcomes can be spotted in sub-populations of patients, and patient-centered medical practice that provides care in the context of an individual’s culture, values, and health literacy levels.  The uniting concept is a healthcare framework that gets the right treatment for the right patient at the right time, creating a safer, more effective, more cost-efficient healthcare system.  Think of personalized medicine as producing Me drugs rather than Me-too drugs.

The value of personalized medicine is best perceived using a systems view of cost and experience across identification, diagnosis, and treatment of a disease.  Imagine oncology today without personalized medicine.  A woman would not know at a young age that she has a genetic predisposition to a cancer, despite no family history that would raise no red flags. She and her physician do not start an early or aggressive schedule of mammography or other screening. A lump in her early 30s is dismissed. When she does develop cancer, there is no way of determining what type of specific cancer, she is given a treatment that she does not respond to, other treatments are attempted, but ultimately she dies.  The cost of her care is needlessly expensive and the clinical outcome is tragic.

The reason that that does not happen today, at least for certain cancers and other conditions is that a financial and regulatory system supported the development and access to early personalized medicine products. The greatest threat to continued value innovation in personalized medicine is lack of a coherent financial and regulatory framework that recognizes the value of the genomic-based diagnostics and therapies and reimburses appropriately.

A personal example – as a liver transplant I have blood analysis done several times a year to review my liver enzymes, levels of medication, and other markers. Recently, my physician and I have added a test called Immuknow® that provides an assessment of my immune system’s individualized response to the immunosuppressive medications prescribed.    This test gave unique information that despite my dosage, my immune system was still very active putting me at possible risk for rejection of my organ.  Where traditional tests would have led to reduction of my immunosuppression given my apparent stability using traditional tests, the personalized test compelled a different treatment decision. Without this test it was likely that, as in the past, I (and my insurance company) would have incurred tens of thousands of dollars for liver biopsy; greatly increased dosages and numbers of medications usually delivered by IV not orally; hospitalization; and in extreme but foreseeable possibility, rejection or retransplantation which would put the figure then in the hundreds of thousands.  Avoidable for about $600.

Immuknow® is FDA-cleared to be conducted in a complex manner to produce clinically valid results, yet current CMS determinations under the constraints of the laboratory fee schedule processes of cross walks, gap fills, or code-stacking, basically attempts to match new technology to old payment systems, have resulted in a level of reimbursement that does not even cover the costs of performing the test correctly, let alone reflecting its value.  The likely consequence is that hospitals will stop performing the test in an environment where they lose money each time they perform it, and patients and physicians will lose access to this test and the important clinical decision support it provides.

The Bible warns against pouring new wine into old wineskins as unworkable.  Our current system for determining the reimbursement for personalized therapies is just as unsustainable.

Resource: The Personalized Medicine Coalition