ACE inhibitors should be available at no cost to the 8 million Americans over age 65 who have diabetes

Jul 18 2005

Nothing in life is free, the old saying goes. But maybe some things should be, according to a new University of Michigan Health System study.

Specifically, researchers find, a group of medicines called ACE inhibitors should be available at no cost to the 8 million Americans over age 65 who have diabetes. These drugs are so beneficial for these patients that even giving them away ultimately would save the Medicare system and society large amounts of money by preventing heart attacks, strokes and kidney failure, the study shows.

And of course, the drugs would save lives, and make life better for patients. The findings, based on a sophisticated computer analysis, appear in the July 19 Annals of Internal Medicine.

Right now, cost or lack of awareness keeps many older diabetes patients from taking ACE inhibitors, which reduce blood pressure and cut the risk of diabetes-related problems in the cardiovascular system and kidneys. In fact, fewer than half of patients who should take them actually do take them.

The new study is especially timely because for the first time ever, Medicare soon will begin covering part of the cost of prescription drugs for people over age 65. That should increase the use of ACE inhibitors by seniors with diabetes, as their out-of-pocket cost for the drug declines.

But under the new Medicare plan, seniors will still pay for part of their drug costs in the form of premiums, deductibles and co-pays -- and research has shown that even small out-of-pocket costs keep many people from taking drugs that can help them.

Says lead author Allison Rosen, M.D., M.P.H., Sc.D., "Patients' out-of-pocket costs such as co-pays are a blunt instrument designed to keep patients from over-using medications, but they create barriers to the use of essential and non-essential medications alike. Our analysis shows that removing all patient costs for diabetes patients taking ACE inhibitors could save Medicare both lives and money."

The same may be true for other drugs that have a major preventive benefit, she says; future studies will assess what would happen if patients could get them free or at a reduced cost.

That principle, called the "benefit-based co-pay," is gaining more attention in the insurance field as a more sophisticated way to structure prescription drug benefits. But Medicare's new drug plan currently doesn't provide for the approach.

The benefit-based co-pay was first proposed in 2001 by Mark Fendrick, M.D., a co-author on the new paper and professor of internal medicine at the U-M Medical School. Rosen, an assistant professor of internal medicine at U-M who performed the newly published research in part while at Harvard University, explores drug costs and benefits though computer models. She worked with Sandeep Vijan, M.D., M.S., of U-M and the VA Ann Arbor Healthcare Center, on the new paper.

The new finding is based on a model that takes into account the substantial known health benefits of ACE inhibitors, the rates and costs of diabetes-related complications among people over the age of 65, the current and projected costs and use of ACE inhibitors by older people with diabetes, and the impact of even modest cash payments on patients' prescription-filling behavior.

ACE inhibitors have been shown to slow the damage to the kidneys that is often experienced by people with diabetes, and prevent them from entering end-stage renal failure (ESRD) in which the kidneys essentially shut down and patients need dialysis. ACE inhibitors have also been shown to cut the extra-high risk of heart attacks and strokes faced by people with diabetes; around 60 percent of people with diabetes die of a cardiovascular problem.

"There are many drugs that are effective, but few that are this dramatically effective," says Vijan. "Our analyses suggest that co-payments for ACE inhibitors may actually cost Medicare and other insurers more money by providing barriers to use of these drugs. It is sound policy, both from a patient perspective and from a fiscal perspective, to analyze drug co-payments on a case-by-case basis."

"All in all, ACE inhibitors are widely recommended as important medications for almost anyone with diabetes to take," says Rosen. "But cost has been shown to get in the way. And so, the Medicare program -- and all American taxpayers -- are paying instead for the hospital bills of people who had heart attacks and strokes that might have been prevented if they'd been taking ACE inhibitors."

The researchers assumed that if Medicare made ACE inhibitors available for free to any enrollee with diabetes, the use of the drugs would increase from 40 percent of patients to 60 percent of patients. Based on research into the effect of co-pays on patient behavior, they projected that the new Medicare drug plan, which will cover about one-third of the cost of the drug, will increase usage from 40 percent to about 47 percent.

The researchers based their model on the drug called lisinopril, a generic ACE inhibitor sold as Zestril or Prinivil that costs around $200 to $300 per year, though bulk purchasers such as the Department of Defense health care system pay much less. The new Medicare drug plan will not negotiate prices on a national level because of a clause in the law that establishes it.

If Medicare paid for the cost of the drug for all adults over age 65 who have diabetes, added to the existing cost of all their healthcare until death, the total savings would be $1,606 over a lifetime for each Medicare recipient. The patients would also live longer and better; the researchers calculated that the approach could save one-quarter of a quality-adjusted life year (QALY) for each patient. QALY is a measure of both time lived and the quality of life during that time; for example, someone who was disabled by a stroke has a lower QALY than someone who has never had a stroke.

"In our society, we often pay for health strategies that provide health benefits at a reasonable but added cost," says Rosen. "But this strategy goes even further: it saves lives and saves money. Removing patient financial barriers for ACE inhibitors prevents expensive and life-threatening complications, and improves quality of life. In so doing, patients pay less, Medicare pays less, and everyone wins. It's a virtual no-brainer."

Even if the availability of free ACE inhibitors didn't cause a major upswing in the use of the drugs by these patients, the strategy would still pay for itself, Rosen says.

"If only 7 percent more people started taking ACE inhibitors when they were offered at no cost, Medicare would still save money. The more people that take advantage of the no-cost drugs, the bigger the savings for Medicare over the long term. And of course, each patient has a lower risk of heart attack, stroke, or kidney failure."

The researchers ran the computer model many times, making changes each time in 38 different variables. Ninety percent of the time, they found that no-cost ACE inhibitors saved money; the other 10 percent of the time they were cost-effective -- costing less than $20,000 per QALY gained.

The authors also looked at costs and savings on a societal, rather than Medicare, level -- including patients' productivity and the cost of caregiving for people with health-related disability. The savings were even greater than Medicare savings alone.

If Medicare were able to purchase ACE inhibitors for all its diabetes patients at the same low cost that the Department of Defense pays, the government's lifetime savings on each patient would be even higher. And it would only take a 1.1 percent increase in patient use of ACE inhibitors to make the program cost-saving.

Rosen notes that the analysis doesn't even take into account more recent evidence that ACE inhibitors can also help people with diabetes prevent nerve damage that can cost them their ability to walk, and eye damage that can leave them blind. Neither did it look at ACE inhibitors' role in preventing heart failure among elderly diabetes patients.

http://www.med.umich.edu