Realizing the promise of personalized medicine

Genzyme Genetics, Division of Genzyme Corporation, Westborough, Massachusetts, USA.
Harvard business review (Impact Factor: 1.27). 11/2007; 85(10):108-17, 165.
Source: PubMed


Scientific advances have begun to give doctors the power to customize therapy for individuals. However, adoption of this approach has progressed slowly and unevenly because the trial-and-error treatment model still governs how the health care system develops, regulates, pays for, and delivers therapies. Aspinall, the president of Genzyme Genetics, and Hamermesh, chair of a Harvard Business School initiative to improve leadership in health care organizations, discuss the barriers to personalized medicine and suggest ways to overcome them. The blockbuster model for developing drugs, the authors point out, is still what most major pharmaceutical companies follow, even though its days are numbered. What the industry must embrace in its place is a business model based on a larger portfolio of targeted--and therefore more effective and profitable--treatments, not a limited palette of one-size-fits-all drugs. The current regulatory environment overemphasizes large-scale clinical trials of broad-based therapies. Instead, the focus should be on enrolling subpopulations, based on diagnostic testing, in trials of targeted drug treatments and on monitoring and assessing effectiveness after drugs are approved. A dysfunctional payment system complicates matters by rewarding providers for performance of procedures rather than for accurate diagnosis and effective prevention. Aspinall and Hamermesh call for coordinating regulation and reimbursement so that incentives are provided for the right outcomes. Finally, the authors urge changing physicians' habits through education about genomics, diagnostic testing, and targeted therapies. They say that medical schools and physician organizations must become committed advocates of personalized medicine so that patients and the medical industry can get all the benefits it offers.

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Available from: Mara Aspinall, May 20, 2015
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    • "Stratified medicine can offer the potential to target patient populations who will most benefit from a therapy while reducing unnecessary health interventions associated with side effects and thus, may demonstrate a differential value proposition in order to gain substantial market access. Multiple studies have shown that most drugs prescribed in various diseases are effective in fewer than 60% of treated patients (e.g., oncology only 25–30%) outlining the potential to realize efficiency gains for healthcare systems (Aspinall, 2007). Medical diagnostics is fundamentally about identifying the subgroups of patients, however, in clinical practice, many of the available tests do not demonstrate clinical utility which makes it difficult to demonstrate the value of diagnostics. "
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    ABSTRACT: Stratified Medicine (SM) has the potential to target patient populations who will most benefit from a therapy while reducing unnecessary health interventions associated with side effects. The link between clinical biomarkers/diagnostics and therapies provides new opportunities for value creation to strengthen the value proposition to pricing and reimbursement (P&R) authorities. However, the introduction of SM challenges current reimbursement schemes in many EU countries and the US as different P&R policies have been adopted for drugs and diagnostics. Also, there is a lack of a consistent process for value assessment of more complex diagnostics in these markets. New, innovative approaches and more flexible P&R systems are needed to reflect the added value of diagnostic tests and to stimulate investments in new technologies. Yet, the framework for access of diagnostic-based therapies still requires further development while setting the right incentives and appropriate align stakeholders interests when realizing long-term patient benefits. This article addresses the reimbursement challenges of SM approaches in several EU countries and the US outlining some options to overcome existing reimbursement barriers for stratified medicine.
    Frontiers in Pharmacology 10/2012; 3:181. DOI:10.3389/fphar.2012.00181 · 3.80 Impact Factor
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    • "Interestingly, if drugs are not accounted for inter-individual differences, they are either 'ineffective' or 'not completely effective' in 30-60% of patients.2)3) One tends to scotomize that on average, a drug on the market works for only 50 percent of the people who take it.4) "
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    ABSTRACT: Personalized medicine is a novel medical model with all decisions and practices being tailored to individual patients in whatever ways possible. In the era of genomics, personalized medicine combines the genetic information for additional benefit in preventive and therapeutic strategies. Personalized medicine may allow the physician to provide a better therapy for patients in terms of efficiency, safety and treatment length to reduce the associated costs. There was a remarkable growth in scientific publication on personalized medicine within the past few years in the cardiovascular field. However, so far, only very few cardiologists in the USA are incorporating personalized medicine into clinical treatment. We review the concepts, strengths, limitations and challenges of personalized medicine with a particular focus on cardiovascular diseases (CVDs). There are many challenges from both scientific and policy perspectives to personalized medicine, which can overcome them by comprehensive concept and understanding, clinical application, and evidence based practices. Individualized medicine serves a pivotal role in the evolution of national and global healthcare reform, especially, in the CVDs fields. Ultimately, personalized medicine will affect the entire landscape of health care system in the near future.
    Korean Circulation Journal 09/2012; 42(9):583-91. DOI:10.4070/kcj.2012.42.9.583 · 0.75 Impact Factor
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    • "However, these approaches can suffer from a paucity of data, since all relevant information may not be present (or accessible). For diagnostics , a key issue is the lack of identification of the particular test used, if it is not linked to a particular CPT code (Aspinall and Hamermesh, 2007; Ramsey et al., 2006). In addition, a key disadvantage in these studies is the presence of unmeasured factors that may bias findings (Sox and Greenfield, 2009). "
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    ABSTRACT: Genomic-based diagnostics can play a key role in creating a more efficient healthcare system by directing patients toward beneficial therapies and away from therapies that pose substantial risk or are unlikely to improve outcomes for the patient. We outline how the value provided by diagnostics is closely linked to a range of factors including magnitude of health outcome improvement, avoiding adverse effect, diagnostic parameters, process of care, resource utilization, and costs. Comparative effectiveness approaches to evidence generation, including health outcome measurements, quality of life, economic analyses, decision modeling, and pragmatic clinical trials, can be used to provide stakeholders with a range of information to inform treatment, guidelines, coverage, and reimbursement decisions. Evidence of comparative effectiveness can also help support value-based reimbursement of cancer biomarkers and treatment strategies as means of paying for personalized medicine.
    Molecular oncology 03/2012; 6(2):260-6. DOI:10.1016/j.molonc.2012.02.006 · 5.33 Impact Factor
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