Research used by Centers for Medicaid and Medicare Services (CMS) to inform Medicare coverage decisions for cardiovascular products includes participants who differ by age, sex, and country of residence compared to Medicare beneficiaries.
The meta-analysis is published in the January 28 issue of Archives of Internal Medicine and was conducted by Sanket S. Dhruva and Dr. Rita F. Redberg of the University of California at San Francisco School of Medicine. The authors analyzed 141 studies with a total of 40,009 participants that comprised all clinical trials included in technology assessments considered by the CMS advisory panel from 1998 to 2006.
The study indicates that cardiovascular disease is the leading cause of death and disability among Medicare beneficiaries and it is also the most costly to treat. As Medicare expenditures rapidly rise, the authors argue, coverage decisions made by CMS should be “based on data most likely to maximize value and optimize outcomes for Medicare beneficiaries.” Currently, an independent panel of medical professionals reviews technology assessments for each new medical product or service and makes recommendations to CMS based on the perceived potential for health benefits.
Major results include:
- Clinical trial participants were younger by 14.6 years compared to the Medicare population.
- Clinical trial participants were more likely to be male.
- Trials were conducted in non-U.S. populations – 60% of clinical trial participants versus 0% of Medicare beneficiaries live in countries outside the United States.
The authors remark that, “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.”
The differences between the clinical trial populations and the actual Medicare population are most likely to affect elderly people and women. The authors suggest that these subgroups should be included in more clinical trials. “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.”
The researchers also propose that when a coverage decision is made, CMS could require additional subgroup data in order to continue coverage after a certain time period. This would be similar to the “coverage with evidence development” initiative that was recently introduced. The authors conclude that:
“Closer linkage of evidence to coverage would promote better value and improved outcomes for the rapidly growing and underrepresented population of Medicare beneficiaries.”
Included in the same issue of the journal is a commentary written by Dr. Noel S. Weiss and colleagues at the University of Washington, Seattle. These authors suggest that clinical trial results cannot always be generalized, and the results of randomized trials are “most directly generalizable to study-eligible patients who would have enrolled and who receive the same interventions provided in the trial setting.” They conclude by noting:
“Although the measured effect of a particular therapy on a health outcome in the study population included in a given trial will, in many instances, closely reflect the effect of that intervention on the corresponding outcome in other settings, this extrapolation should not be made reflexively.”
“Variations Between Clinical Trial Participants and Medicare Beneficiaries in Evidence Used for Medicare National Coverage Decisions”
Dhruva, Sanket S. and Redberg, Rita F.
Arch Intern Med. 2008;168(2):136-140. Vol. 168 No. 2, January 28, 2008.
Written by: Peter M Crosta, MA