Heart Drugs Skewing Younger
More people aged 20–44 years are taking prescription medications for cardiac conditions—and their ranks are growing faster than those age 45 or older who use the therapies, according to Medco Health Solutions. Extrapolating data from 2.5 million Medco drug benefit users, the company estimated that nationally, 4.2 million patients aged 20–44 years took lipid-lowering drugs in 2006—a 68% increase from 2001—and 8.5 million took antihypertensives, a 21% rise from 2001. The rate of increase for new users of lipid-lowering drugs was 37% higher for the under 45 group than for patients 45–64 years, and 31% higher than for those 65 and older. Medco chief medical officer Dr. Robert Epstein said in a statement that it's heartening that more young people are taking medications to control these conditions. “The bad news is that these conditions are showing up in patients at younger ages, which could be the result of the growing obesity epidemic and various lifestyle factors.”
SPECT Appropriateness Pilot
The American College of Cardiology, with the assistance of UnitedHealthcare, is starting a pilot program to help physicians implement appropriateness criteria for the use of Single-Photon Emission Computed Tomography Myocardial Perfusion Imaging (SPECT MPI). The criteria were published jointly by the ACC and the American Society of Nuclear Cardiology in 2005. Physicians at 10 UnitedHealthcare practice sites will participate. The pilot will develop a Web-based tool for data collection, examine utilization patterns, give confidential feedback to physicians on their appropriateness patterns, and assess outliers and changes in patterns over time. “We are confident that cardiologists will use the insights from this initiative to help maximize their skills and effectiveness,” said Dr. Jack Lewin, CEO of the ACC, in a statement.
Grassley Seeks Device Prices
Are Medicare, Medicaid, and the State Children's Health Insurance Program paying too much for medical devices? Sen. Chuck Grassley (R-Iowa) wants to know. He and Sen. Arlen Specter (R-Penn.) have introduced the Transparency in Medical Device Pricing Act of 2007 (S. 2221), which would require device makers to submit to the government quarterly data on average and median sales prices for implantable devices used in outpatient and inpatient procedures. The price data would also be made public on the Centers for Medicare and Medicaid Services' Web site; penalties for failure to report would range from $10,000 to $100,000. Lack of price disclosure means some hospitals pay more than others for the same devices, and also means higher co-pays for Medicare recipients, said Sen. Grassley. “Taxpayers need confidence that they're getting the most bang for their buck,” said the Senator in a statement.
Wash. to Evaluate Off-Label Stent Use
The Washington State Health Care Authority is starting to collect data on the off-label use of cardiac stents with an eye toward a full systematic review. The agency will look at safety, efficacy, and cost, and whether or when stenting is appropriate instead of medical therapy. There is also some concern about stents being used in multiple vessels, according to WSHCA. The Society for Cardiovascular Angiography and Interventions has been providing information to WSHCA, and notes that the organization's effort may have broader implications, as Washington is part of a 12-state consortium that conducts technology assessments. The WSHCA is also looking at contrast-enhanced CT angiography as a screen for coronary artery disease.
Data on Elderly Glossed Over
Food and Drug Administration regulations for drug makers conducting clinical trials encourage the inclusion of elderly participants and the reporting of data by age, but the agency is not effective in getting its medical officers to include data on elderly patients in their new drug application (NDA) reviews, according to a report by the Government Accountability Office. The report, requested by Rep. Henry Waxman (D-Calif.) and Sen. Ted Kennedy (D-Mass.), was based on a review of 36 NDAs submitted by manufacturers from January 2001 to June 2004 for drugs to treat diseases that could affect patients aged 65 years and older. All of the NDAs had at least one trial that included elderly participants, but a third of the agency's NDA reviews had no documentation on safety or efficacy for that age group. In addition, the GAO noted that reviewers are not required to establish whether there was a sufficient number of elderly participants in a trial, and if they do address sufficiency, they do not have to document their methods. Sufficiency was addressed in about a quarter of the reviews, none of which detailed the methods used, the report found.