According to a report in the January 28 issue of Archives of Internal Medicine, one of the JAMA/Archives journals, the decision-making trial by Medicare that results in the coverage for cardiovascular products or services generally includes patients who differ in age, sex and country of residence from Medicare beneficiaries.
Cardiovascular disease is the leading cause of death and disability among Medicare beneficiaries, according to background information in the article; expenses for this condition exceed those for any other. "Because Medicare expenditures continue to increase rapidly, it is necessary that coverage decisions be based on data most likely to maximize value and optimize outcomes for Medicare beneficiaries," the authors write. An independent panel of physicians and other professionals advises the Centers for Medicare and Medicaid Services (CMS) on medical technologies. Panelists review technology assessments prepared for each new medical product or service and then vote on the quality of evidence for health benefits.
Sanket S. Dhruva, B.A., and Rita F. Redberg, M.D., M.Sc., of the University of California at San Francisco School of Medicine performed a meta-analysis of all trials included in technology assessments considered by the CMS advisory panel between 1998 and 2006. For the panel's six meetings, 141 studies with a total of 40,009 participants were analyzed.
Compared with Medicare beneficiaries, clinical trial participants were an average of 60.1 years vs. 74.7, 75.4 percent vs. 41.8 percent male and 60 percent vs. zero lived in countries outside the United States. "The trials are conducted mostly in younger, healthier, male, non-U.S. populations," the authors write. "Medicare beneficiaries, on the other hand, are mostly older women with comorbid [co-occurring] conditions. The clinical trials primarily relied on to inform national coverage decisions simply do not reflect the Medicare patient population. Compounding this problem, data frequently are not reported by age, sex and race."
Elderly people and women are the most likely to be affected by these disparities and should be included in more clinical trials, the authors note. "The Food and Drug Administration already requests sex-specific data for new drug applications; it certainly would be consistent, and logical, for the CMS to require direct evidence of benefit in the coverage process. Alternatively, the CMS could issue a coverage decision with a requirement that continued coverage after a specified period depends on additional subgroup data, a variation of the newly introduced 'coverage with evidence development' initiative," they write. "Closer linkage of evidence to coverage would promote better value and improved outcomes for the rapidly growing and underrepresented population of Medicare beneficiaries."