The Bill That Took My Breath Away

Inhaler drugs are decades old, but treating asthma in the U.S. costs billions more than it should. Here’s why.

Eearly in the spring of last year, I suddenly found that the easy jaunt up the three stories to my condo had turned into a frightening ordeal. After getting up the stairs, I had to sit down for several minutes to catch my breath. I couldn’t even make it through my usual Sunday stroll around the local reservoir without taking a break.

My doctor’s diagnosis: My asthma, which had been in check for years, had intensified. The rescue inhaler I had been using to provide relief for occasional wheezing was no longer sufficient.

He prescribed a maintenance inhaler to reduce the likelihood of asthma flare-ups. The inhaler works only if it is faithfully used every day. And sure enough, after three weeks, the stairs no longer seemed as daunting as Mount Everest.

“There’s been a lot of that activity in the last 20 years. But the core three ingredients in the inhalers have not changed.”

But something else was now taking my breath away: the cost of that maintenance inhaler. I happened to glance at one of the “Statement of Benefit” notices my insurer sends after a claim, correspondence I typically consign to the junk mail pile. The notice listed the full cost of my asthma inhaler at $325 — about as much as a 40-inch LED television. Since a single inhaler lasts just one month, I calculated that a year’s supply would come to $4,000. Fortunately, as I’ll explain later, my copay was just a fraction of that amount.

That drug companies can command such high prices for potentially lifesaving medication is under new scrutiny following a spike in the cost of EpiPens, injection devices used to reverse severe allergic reactions to bee stings, peanuts, and other allergens.

I had first used maintenance inhalers in the early 1980s, when I got my diagnosis of asthma. I was surprised to find that three decades later, there was still no generic version. After all, the active ingredients — steroids — are hardly exotic. It’s what happens to them in the laboratory that keeps generics off the market.

“The original drug may go back decades,” said John Fahy, director of the Airway Clinical Research Center at the University of California at San Francisco. But if pharmaceutical companies “tweak the formulation, they can get a patent extension.”

“Delivery devices, formulation changes, modifying the drugs so they last longer — there’s been a lot of that activity in the last 20 years,” he continued. “But the core three ingredients in the inhalers have not changed.”

One of those changes came about within the last decade — at the behest of the federal government.

Remember the ozone layer scare back in 1980s? Huge gaps were opening in that critical atmospheric layer that protects us from skin cancer-causing ultraviolet radiation.

The culprit was chlorofluorocarbons (CFC), chemicals compound commonly found in air conditioners, refrigerators, and aerosol sprays. Under the Montreal Protocol, which entered into force in 1989, the world’s leading countries agreed to phase them out.

The compound also served as a propellant in asthma inhalers, but their use accounted for just one-tenth of one percent of CFCs emitted into the atmosphere. Still, the Food and Drug Administration announced in the late 1990s that it was considering banning CFC inhalers once the pharmaceutical industry came up with alternatives.

Erik R. Swenson, a pulmonary care specialist with the Veterans Administration and a professor at the University of Washington, sat on one of the FDA’s advisory panels on the inhaler question.

Swenson recalled that environmental experts said the ozone layer would repair itself in 50 years if CFCs were eliminated. When he asked them how much longer it would take if the CFCs in asthma inhalers were exempted, he recalled the answer as “roughly another week.”

Patient advocates focused their attention on a generic relief inhaler with the active ingredient albuterol that sold for $15 or less. They warned that if the inhalers were reformulated to replace CFCs, the generic version would be banned.

Their fears were realized after the pharmaceutical industry developed a substitute propellant, HFA (hydrofluoroalkane).

The FDA concluded that it wasn’t in a position to judge how perilous inhalers were to the ozone layer. It forced the generic inhalers off the market at the end of 2008.

In a document accompanying the ruling, the agency quoted a projection from an economic consultant who had been hired by the pharmaceutical giant GlaxoSmithKline: The reformulated rescue inhaler would increase the average cost per patient by just $16 a year.

That projection turned out to be optimistic. The average annual cost per individual using the albuterol inhalers rose to $208, a $71 increase, according to government estimates. That amount includes what was paid both out of pocket and by insurers.


Nationwide, total annual expenditures on albuterol increased to $1.6 billion, up from $984 million. That’s an increase of more than 60 percent, only a small part of which can be explained by the 10 percent rise in the number of people using inhalers.

These figures are based on a comparison between the average annual expenditures for the four years leading up to the ban (2004 to 2008) and those for the four years following the ban (2009 to 2013). To account for inflation, the numbers were adjusted to 2013 dollars. (They were compiled by the Agency for Healthcare Research and Quality, a division of the Department of Health and Human Services, using the household component of its annual Medical Expenditures Panel Survey.)

The International Pharmaceutical Aerosol Consortium vehemently denies that it sought to capitalize on the ozone scare.

The International Pharmaceutical Aerosol Consortium vehemently denies that it sought to capitalize on the ozone scare.

But the actual cost of the CFC ban may be billions of dollars more. Maintenance inhalers had also relied on CFCs. The switch to the HFA propellant “put a roadblock” in the way of a generic version of maintenance inhalers, Fahy said.

“This resulted in new formulations with new patents, but it did not result in major new treatment advances for patients,” he said. “Although seven new inhaled drugs have been approved for asthma over the last five years, none of these drugs target new disease pathways in the lungs.”

Medicare alone spent $4.1 billion to cover the cost of the major brands of maintenance inhalers in 2014, the latest year for which figures are available. For the same year, Medicare spent $680 million on albuterol-based relief inhalers. And the Medicare population, largely composed of people 65 and over, accounts for only 7 percent of the 25 million Americans who suffer from asthma, according to the Centers for Disease Control and Prevention.

Prominent brands of steroid inhalers include Pulmicort, Qvar, Flovent and Asmanex. They differ in delivery systems (spray or powder) and in their formulation. However, their active ingredients are steroids that have been on the market since at least the 1970s.

Following the CFC ban, the pharmaceutical industry came under fire for capitalizing on the ozone scare.

In an email, Maureen Donahue Hardwick, legal counsel for the International Pharmaceutical Aerosol Consortium, vehemently denied this charge. “IPAC’s member companies did not [her emphasis] proactively seek a phase out of CFCs,” she wrote, “and did not view this as some sort of commercial opportunity. Rather, the companies responded to the strong global concern … on the significant negative impacts to the ozone layer caused by CFCs and other ozone-depleting substances.”

While the ban on generic albuterol inhalers generated press attention at the time, and while the news media have occasionally called attention to the problem (notably in this front-page article by Elisabeth Rosenthal in The New York Times), there has been no widespread public outcry about the high cost of inhalers — even though asthma afflicts 1 in 11 children and 1 in 12 adults.

Who makes up the rest of the cost? Well, we all do, through higher premiums and taxes.

In large part, that’s because private or public insurance picks up most of the cost, and the size of copays does not necessarily correspond to the differences in the actual cost of prescriptions.

To find out what I’d pay without insurance, I checked the prices of two common inhalers on the drug-comparison website goodrx.com. The lowest price for a 120-dose Flovent HFA (220 mcg) inhaler, which is for maintenance use, was $337; for a 200-dose Ventolin HFA (90 mcg) inhaler, which is for immediate relief, the price was $58. (In Canada, the prices were $100 and $30, respectively.)

However, my out-of-pocket expense for each inhaler is the same: $16.67 (I buy them in bulk, at three for $50).

Who makes up the rest of the cost? Well, we all do, through higher premiums and taxes.

The soonest we may see a generic inhaler is next year, when several companies plan to come out with versions of the maintenance drug Advair. There’s no word on when albuterol, the rescue medicine, will be available again as a generic inhaler.

Producing generic versions of inhalers is much more complicated than making generic pills. Each inhaler is protected by multiple patents, which expire at different times and cover such components as the chemical formula and the delivery system. A patent lasts 20 years from the date it is filed.

Dr. Christopher Hardy Fanta, a Harvard professor who is director of Partners Asthma Center in Boston, reflected the frustration of asthma specialists interviewed for this story.

“The bee in my bonnet is that these inhaled steroids have been available since the mid to late 60s, and here we are 50 years later and there is no low-cost, generic steroid inhaler on the market,” he said. “And it seems like a crime.”

Steve Maas is a freelance journalist and former Boston Globe editor who lives in Brookline, Massachusetts.

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12 comments / Join the Discussion

    I am so sad that inhaler which i dont think is harmful to anything should be only accessed to via prescriptions from doctors and for those who dont have health insurance so we should just die. i spend $50 a month to buy inhaler on the black market to stay alive. this crazy.

    Reply

    Besides the expense of Flovent which is outrageous, I have had another problem that I would love an answer to. The mechanism frequently gives me less than a full dose. My pharmacist told me to run the holder under water. That would work a few times, and then I couldn’t get anything. Glaxo Smith Klein told me that was wrong and refused to replace the inhalers that I had trouble with which was every single one after what they said was a three inhaler replacement life time limit. I read the information sheet very carefully and am doing everything exactly as they say to. My next inhaler continues to have the problem. After two puffs it took five more to get anything. And that seems to be a pattern. I’m at my wits end and would appreciate any advice other than use a spacer since I already do that correctly. s-piper@comcast.net

    Reply

    Just a little background: I finished a Pediatric residency in 1970 after a rotating internship, some surgery, ER coverage, delivered 70+ babies. Then out of necessity ended up with more adult care than peds. Now retired Navy, where most docs, depending on their duty station, end up taking care of adults and children. Now working in Urgent Care seeing more adults than children.
    I practiced before we had Albuterol or ICS (Inhaled Corticosteroids). Those two revolutionized the treatment of asthma. Inhaled meds for asthma effective at a very low dose because of going straight to the tissues in need. Systemic steroids, for instance, are diluted by blood volume, then saturate other tissues and organs before entering the lungs. However, I am seeing asthmatics improperly diagnosed and treated. Some MD’s will improperly diagnose bronchitis multiple times before asthma is recognized. Patients with known asthma are not instructed about management and use of controllers (mainly the ICS). Asthmatics come in to Urgent Care Clinics with exacerbation and get treated with albuterol and systemic steroids (shot or pills). They should be instructed that if control poor or sx’s prolonged, the next step is the ICS, which may bring them under control, which will prevent their seeing a doctor or getting inappropriate systemic steroids. BTY, LABA/Steroid combinations being used inappropriately, even by pulmonologists (read the black box warnings) – that includes Advair, Dulara, Breo, Symbacort.
    The Steve Maas article is great, and the information essential, very important, and frankly shocking.
    The problem: The medical profession – all up and down the chain of responsibility: individual doctors, local and State Medical Societies, and the AMA (worthless bunch) – all enablers who do nothing to oppose or correct these corruptions by both government and pharmaceutical industry. Doctors for a half century have eschewed unions because they feel doctors and medical providers shouldn’t strike. But, that is really not what most unions do – they pay off legislators. Of course, the first strategy of a union ought to be presenting their case for reform to the voters who will then demand action from their legislators. However, it is more effective and less time consuming to just pay them off – through lobbyists or campaign contributions.
    Bottom line: we are all enablers.
    K street is where legislators go from being bribe takers to being bribe givers. To often legislators retire being filthy rich – follow the money! EARMARKS? That is when legislators buy each others votes using taxpayer money. The SWAMP is deeper and uglier than any of us can imagine.

    Reply

    The FDA and their fake medicine should be abolished. Asthma is a tremendous part of healthcare costs and if epi was still available OTC the costs would drop dramatically, but once again government sticks its grubby little mitts into it and makes a total mess and now all we have is deadly toxic albuterol.

    Reply

    I use to use primatene mist. It was cheap and lasted for over a year. I think it was 9 bucks or so. My asthma came back as an adult. When I checked on primatene mist it’s no longer available. Albuterol and steroid inhaler was outrageous. My insurance would cover some but 90 dollars out of pocket each month for medicines that were around 50 years? I didn’t buy it. I refuse to have my insurance pay big pharma. I plan to lose some weight and exercise again. Maybe that will help. I just found out my ex wife is taking humira. That drug is over 4000 a month! She doesn’t have that kind of money. Our healthcare is bankrupting america. It’s not that we are sicker it the drug companies robbing us. Look at the commercials. Then they go see doctors and try to have them recommend their products. Capitalism is ok so long as it’s ethical. Robbing patients and insurance companies maybe legal but it’s not ethical. I hope their is a special place in hell for the lawyers, big pharma, and other leeches that are Robbing the middle class

    Reply

    This was very interesting about asthma inhalers. I never have put that much thought into them before. But they are important! I currently don’t have asthma and I hope that I don’t have to encounter it too much in my life.

    Reply

    Great article. But there’s yet another problem — in my experience the reformulated inhalers are not as effective as the old ones. I noticed that first when I tried using an albuterol rescue inhaler and did not find the quick easing of airway constriction that I had felt with the old ones. Fortunately my problems were not acute, but it made me wary. It may be that the new inhalers are harder to use; the instructions seem far more complex. Or it may be that they somehow affect the distribution of the active agent.

    Don’t expect much from Advair. I tried Advair Discus several years ago, at my doctor’s suggestion, and found it completely ineffective. It gives no tactile sense of effectiveness.

    Reply

    Hello, good article. I agree this issue has criminal implications. My son has asthma, while I have bronchitis. Our medical inhalers are slightly different; however the expense is high on both accounts. We can’t afford to breathe. Even if we should be part of the economic elite, the cost is criminally high. Plus, the idea that others have the power to control our rights to life, is oppression.

    Reply

    You are so right about the new inhalers not working as well as the old ones. I’ve found the same sentiment on other sites. I no longer have insurance but get my inhalers through GoodRx. Walmart charges me $65. It doesn’t last as long and takes 2-3 puffs sometimes. I have to use it daily. I’ve seen many online pharmacies in Canada that have the old types I used to use for much less, $21-$35 depending how many you buy. I don’t have the guts to try buying through them but it won’t be long until I have to do something.

    Reply

    I have no insurance and have been sourcing my albuterol (Salbutamol) from outside the U.S. I have to use it 3-4 times a day. At 4 inhalations a day, that’s around 7 inhalers a year = $375. I’m curently using GSK Ventolin that I can get for less than $20 an inhaler. While they are not as fancy as the ProAir , no countdown meter on the back, they do their job. If you have yet to find a supplier I have been wanting to start an asthma buyers club. I have access to several generic brand inhalers, including Advair and Flovent for less than $50. You can email me at halbuterol@protonmail.com

    Reply

    Advair shouldn’t leave any tactile sense of effectiveness, as it’s a long term medicine, like Vanceril. It is meant for regular, long term use, and shouldn’t be used as a rescue inhaler. I’ve been taking medication steadily since the late 80’s. First it was a Proventil/Intal/Vanceril concoction, then Proventil and Intal were replaced with Serevent, and finally, the whole cocktail was swapped out for the Advair, which manages my symptoms quite well for the 12 hours its supposed to.

    Reply
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