A first step has been taken to identify the most critical healthcare services which should be examined as part of a massive national comparative effectiveness study underway. It's designed to eventually rein in the cost of healthcare in the U.S. and insure best use of existing health resources.
The American Recovery and Reinvestment Act of 2009, signed into law in February by President Barack Obama, required the Institute of Medicine (IOM; Washington) to prioritize what would be studied to improve the quality and efficiency of healthcare in America.
"Healthcare decisions too often area matter of guesswork because we lack good evidence to inform them," said committee co-chair Harold Sox, editor, Annals of Internal Medicine, American College of Physicians of Internal Medicine, Philadelphia. "For example, we spend a great deal on diagnostic tests for coronary heart disease in this country, but we lack sufficient evidence to determine which test is best."
Sox co-chaired a committee convened by the IOM to kick off the effort at the request of Congress as part of a $1.1 billion effort to improve the quality and efficiency of healthcare through comparative effectiveness research outlined in the Act. The committee's report provides independent guidance, derived from extensive public input, to Congress and the secretary of the U.S. Department of Health and Human Services on how to spend $400 million on research to compare health services and approaches to care.
A total of 100 healthcare services are included in the group's recommendations. The top 25 run the gamut from the effectiveness of various medical and surgical atrial fibrillation treatments to how Staphylococcus aureus (MRSA) infections are screened, prevented and treated. (See sidebar, above.)
Although the committee didn't rank the 100 health topics, industry analysts have already started to pluck out hot areas that will be affected.
A team led by Morgan Stanley's (New York) David Lewis tackled the medical technology angle:
"Cardio, robotics, spine and anti-tumor necrosis factor are focal areas while joint replacement emerges relatively unscathed in initial comparative effectiveness plans," Lewis wrote in an analysis. "With 20 recommendations, fourth highest among IOM's 29 research areas, cardiology looks to be an unexpected priority. Atrial fibrillation (AF) screens as a top research area amid 20%+ annual market growth and upcoming CABANA trial, which could spur widespread AF utilization as a first-line treatment option. St. Jude Medical (St. Paul, Minnesota) and Hansen Medical (Mountain View, California) are most exposed but Johnson & Johnson (New Brunswick, New Jersey) and Medtronic (Minneapolis) are also levered to AF. Disc replacement and spinal fusion were likewise highlighted on several occasions while hip and knee replacements, surprisingly, ranked among IOM's lowest priorities."
Capping the list of priorities at 100 started by soliciting input via an invitation to the public and key stakeholders to testify at a one-day public meeting in Washington earlier this year at which the committee heard 54 speakers and received additional written testimony, a web-based nomination process through which 1,758 respondents (mostly physicians and representatives of professional organizations, but also many members of the general public) nominated a total of 1,268 unique research topics and the project's web site, which received emails and letters.
"Outcomes comparisons for various surgical techniques, including robotics, where Intuitive Surgical (Sunnyvale, California) is a leader, and minimally invasive surgery, where Covidien (St. Louis) is a leader, will face added scrutiny," Lewis continued. "Autoimmune diseases and psoriasis, collectively $15 billion markets for Abbott Laboratories (Abbott Park, Illinois) and Johnson & Johnson are seen as primary research areas going forward."
The group also set the stage by developing a definition of comparative effectiveness research (CER), which is "...the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care. The purpose of CER is to assist consumers, clinicians, purchasers, and policy makers to make informed decisions that will improve health care at both the individual and population levels."
The general consensus is that CER will yield greater value from the healthcare system and better outcomes for patients. CER weighs the benefits and harms of various ways to prevent, diagnose, treat or monitor clinical conditions to determine which work best for particular types of patients and in different settings and circumstances. It's anticipated that these study results will help patients and their healthcare providers, as well as policymakers and purchasers, to make more informed decisions.
The stimulus funds originally appropriated for CER must be committed by the end of this year, but the IOM reported that House and Senate healthcare reform bills are likely to include provisions for permanent CER, which is seen as attractive to Congress as a $1.3 billion cost saver to offset other reforms, according to Lewis.