Personalized medicine is the customization of healthcare. Already, a suite of molecular approaches is being used to tailor certain medical decisions, practice and products to the individual patient. For example, melanoma, leukemia and metastatic lung, breast and brain cancers can be routinely molecularly diagnosed and treated with medicines that target the specific genetic mutations. These represent a remarkable improvement over trial-and-error medicine.
Other diagnostic tests use the patients DNA sequence to determine drug-metabolizing capabilities. This helps improve dosing of drugs for conditions as wide-ranging as depression, coronary artery disease, inflammatory bowel disease and cancer.
And the scope of personalized medicine has rapidly broadened to encompass all sorts of personalization measures. Among these are tools that will help transform medicine from the treatment of illness to the maintenance of wellness. This not just some future-world vision: personalized medicine is already beginning to happen, and happen quickly. In 2006, there were just 13 prominent examples of personalized drugs, treatments and diagnostics on the market. By 2011, this number had risen to 72, and today there are 113. Thats a 57 percent increase in the last three years. But the introduction of personalized medicine cant happen quickly enough.
The great opportunity for personalized medicine is its potential to introduce new scientific, business, and medical models. Segmenting populations into groups of patients who have a greater likelihood of responding to a particular treatment or avoiding side effects not only can change the dynamic of drug development but also the practice of medicine. Patients can benefit from better drugs, as well as new diagnostic and prognostic tools.
The way forward
As part of the effort to maintain momentum, yesterday a new report was published, titled The Case for Personalized Medicine. This is the fourth version the first version was published in 2006 and it is required because of the speed of progress in personalized medicine since the third edition was published in 2011. The Case is an examination of the opportunities and the challenges that the continued development and adoption of personalized medicine is meeting, set against a backdrop of faster and cheaper genetic sequencing, increase commitment from the pharmaceutical industry and evolution in the public policy landscape.
The Case for Personalized Medicine is published by the Personalized Medicine Coalition (PMC), which represents innovators, scientists, patients, providers and payers. With progress comes a greater responsibility to move personalized medicine forward, says Edward Abrahams, President of PMC. 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, preempt the progression of disease, and, at the same time, increase the efficiency of the health care system by improving quality, accessibility, and affordability. Weve come a long way, but we have a lot to do, especially in education and advocacy.
The report identifies seven major benefits of personalized medicine. These are to:
Team effort required
To achieve the above benefits, the report argues, we need intelligent coverage and payment policies, new regulatory guidelines, and modernized professional education to prepare the next generation of doctors and other health care professionals for personalized medicine. The report pays special attention to the laws and regulations that govern personalized medicine products and services used in clinical practice which are, necessarily, complex. FDA policies pertaining to personalized medicine tests, pharmaceuticals, and companion diagnostics are of particular importance. Likewise, coverage and payment policieswhether in government programs like Medicare or those of private payersplay an essential role. Payers recognize the benefits of personalized medicine products in patient care management, but they increasingly seek additional evidence of their clinical, if not economic, value. In addition, payers are expanding new models for health care payment and delivery that could have a significant impact on the ability of patients to gain access to personalized medicine products and services. Understanding the changes and potential consequences these policies will have on personalized medicine tests, pharmaceuticals, and companion diagnostics is essential to ensure continued progress in the improvements to patient care.
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Making the Case for Personalized Medicine