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Jun 25, 2014

Making the Case for Personalized Medicine

Making the Case for Personalized Medicine

Source: © Alexander Raths - Fotolia.com

  • Personalized medicine is gaining momentum, but it needs yet more impetus to break into the healthcare mainstream, argues a new report. Released on June 25 by the Personalized Medicine Coalition (PMC), the report examines opportunities for the continued development and adoption of personalized medicine as the cost of genetic sequencing declines, the pharmaceutical industry increases its commitment to personalized treatment, and the public policy landscape evolves.

    According to the report, personalized medicine is poised to:

    • Shift the emphasis in medicine from reaction to prevention.
    • Direct the selection of optimal therapy and reduce trial-and-error prescribing.
    • Help avoid adverse drug reactions.
    • Increase patient adherence to treatment.
    • Improve quality of life.
    • Reveal additional or alternative uses for medicines and drug candidates.
    • Help control the overall cost of health care.

    The report, which is entitled “The Case for Personalized Medicine,” strikes a confident tone, citing progress along scientific, technological, and commercial fronts. Advances include a more than 16,000-fold decrease in sequencing costs over the past 10 years, a 57% increase in products the last three years, and a steadily growing number of drugs with labels that include pharmacogenomic information. In 2006, there were 13 prominent examples of personalized drugs, treatments, and diagnostics on the market. In 2011, there were 72, and today there are 113.

    Despite these advances, the report soberly notes that technological changes need to be accompanied by cultural and institutional changes: “Such rapid developments … make it imperative for us to encourage the development and adoption of personalized medicine. It is essential to have appropriate coverage and payment policies, as these will encourage continued investment in new molecular diagnostics. We need regulatory guidelines that adapt to and encourage the coupling of diagnostics and medicines that target genetically defined populations. And professional education must be modernized to prepare the next generation of doctors and other health care professionals for personalized medicine.”

    The report, now in its fourth edition, is scheduled to debut later today at The Personalized Medicine and Diagnostics Forum at the 2014 BIO International Convention in San Diego. “BIO is very pleased to co-host [the forum] with the PMC,” said Paul Sheives, director of BIO’s diagnostics and personalized medicine policy. “PMC’s The Case for Personalized Medicine defines the field and contributes to our understanding of how developments in science and technology are creating new opportunities to address unmet patient needs.”

    “In a time of unprecedented scientific breakthroughs and technological advancements, personalized health care has the capacity to detect the onset of disease at its earliest stages, pre-empt the progression of disease, and, at the same time, increase the efficiency of the health care system by improving quality, accessibility, and affordability,” said Edward Abrahams, president of the PMC. “We’ve come a long way, but we have a lot to do, especially in education and advocacy.”

    The PMC’s report offers these conclusions: “Personalized medicine offers significant short- and long-term benefits, especially for chronic and complex diseases. Payment and reimbursement policies should not discourage interventions that may raise short-term costs but improve clinical/cost value over time. Policies that recognize the principles of personalized medicine will allow physicians to individualize treatment plans for patients through the early diagnosis of disease, target treatments to optimize clinical outcomes, and prevent unnecessary hospitalizations and care, thus reducing long-term costs.

    “Innovators are responsible for developing the collective evidence to justify the contention that personalized medicine can improve outcomes while controlling costs. Except in the case of some individual products, to date they have not proven that contention. When they do, our argument will be more compelling.”


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