Are some medicines so good they should be free? In diabetes, the answer may be Yes

Are some medicines so good they should be free? In diabetes, the answer
may be Yes



http://www.eurekalert.org/pub_releases/2005-07/uomh-asm071305.php

Public release date: 18-Jul-2005
Contact: Kara Gavin
kegavin@xxxxxxxxx
734-764-2220
University of Michigan Health System

Are some medicines so good they should be free? In diabetes, the answer
may be yes

Lives and money could be saved if co-pays for ACE inhibitors were
eliminated

ANN ARBOR, Mich. -- 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.

###

In addition to Rosen, Fendrick and Vijan, the authors of the new paper
include Harvard University researchers Mary Beth Hamel, M.D., Milton C.
Weinstein, Ph.D., and David M. Cutler, Ph.D. The research was funded in
part by the Primary Care Research Fund of the Brigham & Women's
Hospital. Reference: Annals of Internal Medicine, July 19, 2005, Vol.
143, No. 2.

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