Register TodayEarn Free CME Credits by reading the latest medical news in your specialty.Sign UpAn additional 12.8 million Americans ages 40 to 75 are eligible for statin therapy under the latest prevention guidelines from the American College of Cardiology and American Heart Association, researchers estimated.
That represents an increase from about 43.2 million individuals (37.5% of that age group) eligible for statins under the previous guidelines released about a decade ago to about 56 million (48.6%) under the new guidance, according to Michael Pencina, PhD, of the Duke Clinical Research Institute, and colleagues.
Most of the additional coverage would occur in the primary prevention setting and in individuals 60 and older, they reported online in the New England Journal of Medicine.
"I think this current study emphasizes the fact that if we were to fastidiously apply the new guidelines to the current population of patients we should all in our practices be expanding the indication for statins pretty significantly," commented Sahil Parikh, MD, an interventional cardiologist at University Hospitals Harrington Heart & Vascular Institute in Cleveland.
The authors acknowledged, however, that the estimates assumed that everybody eligible for statin therapy under the guidelines would actually receive a prescription even though "the new guidelines call for an informed risk-benefit discussion between the patient and physician before the initiation of statin therapy."
And that's a key consideration because the discussion should include information on lifestyle and other risk factors, potential adverse effects and drug-drug interactions, and patient preferences, Neil Stone, MD, of Northwestern Memorial Hospital's Bluhm Cardiovascular Institute, in Chicago, told MedPage Today.
"In older adults especially, even if they had a [10-year cardiovascular disease] risk of 7.5% or more, the risk estimator doesn't prescribe a statin, the discussion does," said Stone, who served as chair of the expert panel in charge of the cholesterol guidance. "Some patients whose only risk factor is age may decide with their clinician not to pursue statin therapy. Others who are slightly under the 7.5% but have other important factors mentioned in the report may decide to be on a statin."
"We hope, if careful attention is paid to the guidelines, that we're treating those people more likely to benefit," Stone added.
The ACC/AHA prevention guidelines, which were released in November, include guidance on better assessing the risk of atherosclerotic cardiovascular disease and on managing lifestyle, cholesterol, and weight. But the cholesterol guidance received the most attention because it moved away from treating to LDL cholesterol targets and toward treating the level of risk.
Concerns also were expressed about the increase in the number of individuals who would be deemed eligible for statin therapy in the new guidelines compared with the previous recommendations from the Third Adult Treatment Panel (ATP III) of the National Cholesterol Education Program first released in 2001 and then updated in 2004.
To estimate the actual increase, Pencina and colleagues started with data from 3,773 individuals ages 40 to 75 who participated in the National Health and Nutrition Examination Surveys of 2005 to 2010.
Of those individuals, 42% were receiving or would be eligible for statins based on the ATP III criteria, a figure that increased to 56.6% using the criteria from the new guidelines.
That information was then extrapolated to the population of 115.4 million U.S. adults ages 40 to 75 to identify the increase of 12.8 million who would be eligible for statin therapy under the new guidance. Of the newly eligible people, the median age would be 63.4 and 61.7% would be men. Also, the median LDL cholesterol would be 105.2 mg/dL, which is lower than the median of 120.4 mg/dL for those eligible under the ATP-III criteria.
Most of the increase in those deemed eligible for statin therapy (10.4 million) would occur in adults without cardiovascular disease (primary prevention) and in those in the upper end of the age range (60 to 75).
"Since the prevalence of cardiovascular disease rises markedly with age, the large proportions of older adults who would be eligible for statin therapy may be justifiable," the authors wrote.
They also determined that the increases would occur both in adults who would be expected to have future cardiovascular events and those who would not. Thus, sensitivity rises and specificity drops.
Still, they calculated that about 475,000 cardiovascular events would be prevented using the new guidelines instead of the older ones, assuming full adoption and adherence.
"I think what we'll look forward to seeing is what the economic impact of this is," Parikh said. "In the current era of [the] Affordable Care Act and accountable care organizations I think we're all looking very carefully at resource allocation, and we'll have to see -- is it, in fact, worth the extra money on a population basis to expand the indication for statins when it comes to event reduction?"
Pencina and colleagues noted some limitations of their analysis, including the reliance on NHANES data, the extrapolation of data from a relatively small sample to the larger population, the assumption that the new guidelines would be universally adopted and implemented, and the lack of information on treatment adherence.
The study was supported in part by the Duke Clinical Research Institute's research funds and unrestricted grants from M. Jean de Granpré and Louis and Sylvia Vogel.
Pencina disclosed relevant relationships with McGill University Health Center and AbbVie. One of his co-authors disclosed relevant relationships with Janssen, Eli Lilly, and Boehringer Ingelheim.
From the American Heart Association:
Todd Neale, MedPage Today Staff Writer, got his start in journalism at Audubon Magazine and made a stop in directory publishing before landing at MedPage Today. He received a B.S. in biology from the University of Massachusetts Amherst and an M.A. in journalism from the Science, Health, and Environmental Reporting program at New York University.
By Marla G. Roshkoff and Brian M. PinheiroContinuing with the recent proliferation of guidance on health care reform, the U.S. Departments of the Treasury, Labor, and Health and Human Services have released proposed regulations and requested comments regarding the implementation of a new, simplified benefit summary requirement created by the Patient Protection and Affordable Care Act (the 2010 health care reform legislation).The Affordable Care Act requires group health plans and insurers, beginning March 23, 2012, to provide a summary of benefits and coverage explanation (SBC), in easy to understand language, to plan participants, beneficiaries, and certain individuals who inquire about plan coverage. The SBC is intended to help individuals better understand their health coverage options. The new guidance provides a template for plans to use to create an SBC, instructions for completing the template, sample benefit scenarios, and a uniform term glossary.Content of the SBC. The SBC, which is intended to be a stand-alone document, may be up to four double-sided pages in length in 12-point font. The SBC must include the following:• Uniform definitions of standard insurance and medical terms• A description of coverage, including cost sharing, for certain benefit categories• Exceptions, reductions, and limitations on coverage• Cost-sharing provisions, including deductibles, coinsurance, and copayments• Renewability and continuation of coverage provisions• Coverage examples explaining common benefit scenarios with hypothetical situations• Beginning January 1, 2014, a statement as to whether the plan provides affordable minimum essential coverage (Click here to read our related alert.)• A statement that the SBC is only a summary and the plan documents should be consulted• Contact information, including a Web site• Directions for obtaining a list of network providers, if applicable• Directions for obtaining information about the prescription drug formulary, if applicable• An Internet address for accessing the uniform glossary• Premium information.Distribution of the SBC. An insurer (in an insured plan) or the plan administrator of a group health plan must provide an SBC to a participant or beneficiary as part of written enrollment materials (or if none, upon eligibility for enrollment), upon a change in information included in the SBC, upon a special enrollment event, and within seven days of a request.For an insured plan, the insurer also must provide an SBC to the plan sponsor automatically upon application, when the policy is renewed, upon a change in information included in the SBC, and within seven days of a request.The SBC may be provided by paper copy or electronically in accordance with the Department of Labor’s electronic distribution requirements (certain special distribution procedures apply to plans not subject to ERISA). The SBC must be provided in a “culturally and linguistically appropriate manner” in accordance with the requirements for claim appeal communications under health care reform. (Click here to read our related alert.) A revised SBC must be provided if any material modification is made to the plan that is not reflected in the most recently provided SBC 60 days before the effective date of the change.
A plan (or its administrator) that willfully fails to provide an SBC may be fined up to $1,000 for each failure.Significantly, the proposed regulations do not include an extension of the March 23, 2012, compliance date, even though the Departments are late in issuing SBC guidance. The Departments specifically solicit comments on the new rules and indicate that the guidance will likely be changed before it is issued in final form. Plan sponsors should begin to consider the process by which they will prepare and communicate SBCs by the March 23, 2012, deadline and pay close attention to any changes in the final guidance, which will be issued in the next several months.If you have questions about these guidelines, please contact Marla G. Roshkoff at 215.864.8417 or roshkoff@ballardspahr.com, or Brian M. Pinheiro at 215.864.8511 or pinheiro@ballardspahr.com.As the federal health care reform effort gained steam, Ballard Spahr attorneys formed an initiative to monitor and analyze legislative developments. With federal health care reform now a reality, our attorneys are assisting employers in understanding the relevant changes and planning for the future. For more information on the firm’s Health Care Reform Initiative, please click here.Copyright © 2011 by Ballard Spahr LLP.