Changing Regulations, Changing Care?

Changing Regulations, Changing Care?

EDITORIAL Changing Regulations, Changing Care? Donald E. Stull, Jr., PhD Editor-in-Chief RTI HEALTH SOLUTIONS, HEALTH OUTCOMES RESEARCH IN MEDICINE, ...

129KB Sizes 0 Downloads 111 Views

EDITORIAL

Changing Regulations, Changing Care? Donald E. Stull, Jr., PhD Editor-in-Chief RTI HEALTH SOLUTIONS, HEALTH OUTCOMES RESEARCH IN MEDICINE, MANCHESTER, UK

As

we complete our third year of publication, we can reflect on many changes in health care and evidencebased medicine that have occurred worldwide. In the United States alone, the passage of the Patient Protection and Affordable Care Act in March 2010 has the potential to change American health care to a greater extent than anything since the passage of Medicare and Medicaid in 1965. The Affordable Care Act (ACA) was designed to implement policies related to fair health insurance premiums, guaranteed availability and renewability, risk pools, and catastrophic plans, thus increasing access to health insurance for the more than 45 million uninsured Americans. Numerous other notable outcomes of the passage of this bill resulted. For example, the Patient-Centered Outcomes Research Institute was authorized by Congress to conduct research that provides the best available evidence to help patients and their health care providers make more informed decisions about treatments and treatment options. The ACA encourages improvements in health care information technology infrastructure to make the most of available data and improve data collection on health care. In addition, there is explicit emphasis on comparative effectiveness research. In other countries, such as the UK, Germany, and Australia, health technology assessment entities have taken an increasing role in determining the benefits and cost effectiveness of innovative drugs, diagnostics, and medical technologies (respectively, National Institute for Health and Clinical Excellence, Instituts für Qualität und Wirtschaftlichkeit im Gesundheitswesen/Arzneimittelmarktes e Neuordnungsgesetz, and Pharmaceutical Benefits Advisory Committee). Unlike the US, where the US Food and Drug Administration makes decisions about drug approval based on efficacy and safety, these other entities also consider cost. In emerging pharmaceutical markets, such as those in Asia-Pacific, different decision-making processes are evident. In some cases, these are hybrids of those in the US and Europe.

That these issues are of interest worldwide and represent a continual evolution is clear from recent research. For example, a survey of primary care physicians in 10 countries found that there have been improvements in the use of health information technology in health care practices.1 This same survey, however, found that information sharing with specialists and hospitals is often less than timely. Increasing emphasis is being placed on moving toward personalized medicine in which treatments are targeted to individual patients based on their genetic profile or propensity to respond to a particular treatment. Comparative effectiveness research can provide a more formal process of hypothesis generation and testing to rule out treatments that are less effective for some patients yet more effective for others. This effort can go hand-in-hand with current biomarker development and statistical identification of subsets of patients who are more responsive to particular treatments.2,3

See funding, conflict of interest, and authorship disclosures at the end of this article. Ó 2012 Elsevier Inc. All rights reserved  Health Outcomes Research in Medicine (2012) 3, e181-e182

e182

Editorial

The articles in our last issue of 2012 cover some of these topics and their findings have implications for decision-making in the new regulatory and reimbursement climates. It is exciting to be a part of the publication of evidence that can shape the decisions made about health care in these changing regulatory environments.

R E F E R E N CE S 1. Schoen C, Osborn R, Squires D, et al. A survey of primary care doctors in ten countries shows progress in use of health information technology, less in other areas. Health Aff (Millwood). 2012 Nov 15. [Epub ahead of print]. 2. Doyle JJ. The effect of comparative effectiveness research on drug development innovation: a 360 value appraisal. Comp Eff Res. 2011;1:27-34.

3. Ramsey SD, Veenstra D, Tunis SR, Garrison L, Crowley JJ, Baker LH. How comparative effectiveness research can help advance ‘personalized medicine’ in cancer treatment. Health Affairs (Millwood). 2011;30(12): 2259-2268.