By Gerry McDougall and Matthew Rosamond
The announcement of the sequencing of the human genome some 10 years ago drove expectations of a rapid advancement in care and the dawning of the age of personalized medicine. While the subsequent decade has seen many false starts and false hopes, the age of personalized medicine now appears to be upon us. There is an ever-increasing number of examples of drugs and diagnostics treatment decisions being guided by a patient’s unique circumstances and characteristics, including individual gene and protein configurations. Science fiction? Not anymore. But as providers, practitioners, and patients cautiously embrace the brave new world of customized healthcare through personalized medicine, they are weighing the potential of better treatment and lower costs against a formidable set of challenges.
Personalized medicine—that is, medicine tailored to a patient’s genetic and other unique characteristics—is at the core of customized healthcare. This major shift in care will touch everyone: not just patients, providers, and payers but also industries and economic sectors that traditionally have not been associated with healthcare. Personalized medicine will revolutionize the practice of medicine, as clinicians and consumers work together to guide individual behavior and treatment decisions before, during, and after an illness occurs.
Personalized medicine is often described as the right treatment for the right person at the right time. This emerging science has the potential to truly customize healthcare to the patient, enabling providers to match drugs to patients based on their genetic profiles, to identify which health conditions an individual is susceptible to, and to determine how a given patient will respond to a particular therapy. As a result, personalized medicine can eliminate unnecessary treatments, minimize the potential for adverse events, and, ultimately, improve patient outcomes.
But what exactly is personalized medicine? PwC takes a broad view, defining it as consisting of products and services that directly or indirectly leverage the science of genomics (the study of an organism’s genes) and proteomics (the study of the proteins that genes create, or express) and that capitalize on the trends toward wellness and consumerism in order to facilitate tailored approaches to prevention and care. As we see it, personalized medicine encompasses everything from high-tech diagnostics to functional foods, to technologies that enable the storage, analysis, and linking of patient and scientific data.1 For example, personalized medicine may mean either a biologic that targets specific cells or an interactive technology that allows diabetic patients and their physicians to develop customized food plans and exercise regimes.
Many in the healthcare industry are wondering whether personalized medicine has reached the tipping point of mainstream medicine and at what point it deserves serious attention from clinicians.
A few health systems are forging ahead and making personalized medicine available to their patients—health systems like El Camino Hospital in Silicon Valley, which last year opened its Genomic Medicine Institute. The institute provides genomic testing covering some 40 conditions and offers genetic counseling services to help patients make informed decisions about treatment. The institute’s programs will also provide access to genomicsbased clinical trials as they become available.2
But outside these pioneers and the largest academic medical centers, most health systems have not yet embraced the practice. However, we see encouraging signs of change: From recent conversations we’ve had with providers both in the US and internationally, we’re seeing an excitement and an urgency about how to integrate personalized medicine into a new era of customized care and treatments.3 As health systems move ahead, it will be essential for medical practice and medical research to work together.
Such collaborations are already occurring in some areas. For example, oncologists and clinical research professionals are experimenting with clinical trial pilot projects to accelerate the process of more quickly applying research findings to patients. Those pilots are guiding doctors in the design of personalized treatment regimens for cancer patients. When health providers partner with scientists and research institutes, they can translate scientific discoveries into more-customized—and more-effective—treatments for patients.
Before such changes can occur, though, clinicians and the organizations where they practice will need to overcome significant challenges in the areas of education, business, and regulation.
One of the fundamental challenges for both providers and patients involves simply keeping up with all the advancements that are occurring. Health providers will have to build expertise in personalized medicine if they want to succeed in the new era of customized healthcare delivery. The rapid growth of research in this field is making it difficult for even the most dedicated clinicians to understand and apply new findings or to interpret diagnostic test results. Ambitious physicians will educate themselves in genomics and proteomics as well as gain knowledge from experts in the field. Health systems will need to recruit physicians and genetic counselors who can interpret the results of sophisticated genetic tests and translate them into effective prevention and treatment strategies. Providers must also communicate to medical colleges the need for more education in the field of genomic and proteomic science.
At the same time, healthcare providers have an important role to play in teaching patients to be co-managers of their own health and wellness. In an era of individualized care, educational efforts that target patients will help raise awareness of and demand for new, personalized therapeutics. The dynamics of the doctor-patient role will change. Physicians will no longer be the sole sources of knowledge, and educated patients will participate more in medical decision making and choice. Providers, for instance, will counsel patients on the benefits of contributing genetic information for research, participating in clinical trials, using health-oriented social networking sites, and donating biospecimens for biobanks.
Health systems also need to better understand how the new approach would change the way they conduct business— from the services they provide to the way healthcare decisions are made and paid for. For example, offering personalized approaches may be a competitive advantage. A cancer center that integrates molecular medicine into patient care might be viewed as a leader in the field, thereby attracting more patients than would other providers that offer only traditional therapies.
In addition, reimbursement decisions may become more complex. When it comes to genetic-based tests or therapies, subjectivity on a case-by-case basis may be required, calling for far greater collaboration among payers, providers, and the makers of drugs, diagnostics, medical devices, and therapeutics. Moreover, healthcare providers must also consider how personalized medicine will affect their technology capabilities and infrastructures. Today, a vast amount of healthcare information is already being collected, including patient histories, diagnostic reports, and clinical research findings. The increasing levels of adoption of electronic health records (EHRs) by hospitals and health systems will ramp up the collection of health data exponentially over the next few years. And this is on top of a growing body of genomic data that ultimately will evolve into billions of data points on every individual, as powerful analytical tools are being developed.
The value of the genomic, proteomic, and other health data being collected becomes greater as it gets shared among research organizations and mined to become more predictive. How well providers manage, share, and make use of that data will be crucial to their ability to provide coordinated care and give broad-based clinical decision support for individualized patient management. As personalized medicine becomes a reality, provider systems, payers, and the pharmaceutical industry will be working together to create a new data architecture that will enable interoperability among information technology systems to facilitate the linking and analysis of health data across the country.
When it comes to personalized medicine, employers are beginning to take an active role. First, they’re becoming educated about the science and benefits of personalized medicine by consulting with experts and institutions at the forefront of advancement of the new science. Employers are also working with pharmaceutical and diagnostics companies to maintain current, accurate information on the clinical efficacy of personalized-medicine tests and treatments and using the information to inform benefits policies and reimbursement decisions. For example, looking at just one diagnostic tool—Genomic Health’s Oncotype DX® breast cancer test—illustrates the potential for cost savings and the ability to spare patients unnecessary treatments. Genomic Health estimates that by identifying those who would not benefit from treatment, the test can reduce chemotherapy use by 20 to 35 percent and yield a savings of approximately $1,900 per patient tested.4
At the same time, employers are working with insurers in the analysis of claims data to identify unmet needs that personalized medicine could address. And they’re looking at redesigns of reimbursement models to focus on pay for performance.
As more and more companies embrace these practices, the road to full execution of personalized medicine becomes far easier to travel. And from where we sit, that’s an inevitability that’s bound to occur and will benefit everyone.