Out of Breath and Out of Pocket

In 2008 the FDA banned a class of asthma inhalers that contained ozone-depleting propellants. These banned inhalers were available in both generic and branded versions, and the ban left people with asthma-only branded inhalers only one option: inhalers utilizing a recently-developed propellant technology.

A new study has found that the out of pocket costs of the average asthma patient with private insurance in the country nearly doubled following the FDA ban.

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The research, led by Anupam Jena, assistant professor of health care policy and medicine at Harvard Medical School and an internist at Massachusetts General Hospital, measures the financial and health impact of the ban, which critics said would have a minimal environmental benefit. The findings were published online today in JAMA Internal Medicine.

“The goal of reducing the use of ozone-depleting chemicals is obviously an important one, but we wanted to see how patients with asthma were affected by this policy,” Jena said.

More than 25 million people in the U.S. rely on inhalers for short-acting relief of asthma symptoms.

Policy Change Effects

Jena and colleagues at the Leonard D. Schaeffer Center for Health Policy and Economics at the University of Southern California and the Division of Health Policy and Management, at the University of Minnesota School of Public Health in Minneapolis, wanted to know what the financial and health impacts of the policy change were.

The researchers found that branded inhalers cost patients from $5 to $75 more than generic inhalers, depending on insurance plan and type of inhaler used.

Across more than 140,000 asthma patients in 77 different health plans, the researchers found an average increase of $10 per inhaler prescription, or nearly double what patients with asthma paid out of pocket prior to the FDA ban.

While they saw a slight decline in overall inhaler use, they found no increase in hospitalizations and no decline in the use of maintenance drugs to control asthma.

An important limitation of the study is that it does not include patients without insurance, who might face more serious challenges with the new, more expensive inhalers, said study co-author Pinar Karaca-Mandic, associate professor in the Division of Health Policy and Management, at the University of Minnesota School of Public Health.

Ozone Depletion

The rule change was allowed under the U.S. Clean Air Act, which prohibits the use of nonessential technology that uses ozone-depleting chemicals.

Ozone depletion causes serious risks for humans, including an increased danger of skin cancer.

For years, the FDA allowed CFC-inhalers as medically necessary, but announced plans to phase them out in 2008 when new inhalers using a different propellant became available.

The ban has been controversial both because of concerns about increased costs for essential medication and because of skepticism about the relative value to the environment of banning CFC-propelled inhalers.

While damage to the ozone layer has significant, dangerous consequences, the share of emitted CFCs that come from inhalers was less than one-thousandth of total emissions, according to a 2011 Mother Jones article that cited estimates suggesting that the ban will likely have a “minimal” effect. The article also noted that the new inhalers use a propellant that is a known powerful greenhouse gas.

“Economics gives researchers and policymakers a set of tools that allow us to bring evidence to bear on complex policy decisions,” Jena said.

“In this case, patients with asthma have essentially subsidized environmental efforts to improve the ozone, by paying higher prices for their medications. To tackle tough problems like this we need to know the costs and benefits of all the policies being considered. Our study provides an important piece to that puzzle,” he said.

Anupam Jena, assistant professor of health care policy, is an economist/physician who studies a broad range of issues relating to healthcare, including medical malpractice and the economics of medial innovation. This video is part of a series in which researchers explain the importance of their work. Video: Rick Groleau

The study was funded by Health Early Independence Award 1DP50D017897-01 from the National Institutes of Health, by grants 5P01AG033559 and 5K01AG036740 from the National Institute on Aging, and by a University of Minnesota Academic Health Center Faculty Development Grant.